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CellCept Mycophenolate Mofetil hydrochloride 500 mg/20mL Injection, Powder, Lyophilized, For Solution — NDC 00004-0298-09 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CellCept Mycophenolate Mofetil hydrochloride 500 mg/20mL Injection, Powder, Lyophilized, For Solution — NDC 0004-0298-09 (Billing 00004-0298-09)

by Genentech, Inc. · 4 VIAL in 1 CARTON / 20 mL in 1 VIAL

This is a package of CellCept Mycophenolate Mofetil hydrochloride 500 mg/20mL Injection, Powder, Lyophilized, For Solution from Genentech, Inc., marketed since Aug 1998 and currently FDA-listed. It is this product's only package size.

NDC 00004-0298-09
🏷️ FDA NDC (as labeled) 0004-0298-09 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0004-0298-09 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0004 labeler · 0298 product · 09 package
Package marketed since
Aug 12, 1998
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0004029809 3
FDA record last changed
Sep 17, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0004-0298-09
Product NDC 0004-0298
11-digit billing NDC 00004029809
NCPDP billing unit EA — each (per item)
RxCUI 199058, 200060, 213394, 311880, 311881, 616435, 616444, 616447
UNII 9242ECW6R0, UXH81S8ZVB
Application # NDA050758
SPL Set ID 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40
Established class (EPC) Antimetabolite Immunosuppressant
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1998-08-12
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance MYCOPHENOLATE MOFETIL HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 040376
GCN 47569
HICL code 018603
Ingredient (HICL) Mycophenolate Mofetil Hcl
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2E
Therapeutic class — specific (HIC3) Immunosuppressives
AHFS code 90:28.08.92
AHFS class Antimetabolites, Immunosupp Therapy Misc
FDB label name CELLCEPT 500 MG VIAL
FDB brand name Cellcept
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 040376
  • GCN: 47569
  • HICL (First Databank): 018603
  • AHFS class code: 90:28.08.92
  • RxCUI (RxNorm): 199058
Why two NDCs? The FDA registers this code as 0004-0298-09 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00004-0298-09. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name CELLCEPT 500 MG VIAL Ingredient Mycophenolate Mofetil Hcl
📗 Our plain-language guide HelloPharmacist
  • It helps prevent your body from rejecting a transplanted kidney, heart or liver. It is always used with other immunosuppressant medicines. Adults and children 3 months and older ca...
  • It is usually taken twice a day by mouth, or given by IV in the hospital if you can't swallow medicine at first. Follow your transplant team's directions exactly. Do not switch to...
  • Diarrhea, nausea, vomiting, low white blood cells, anemia and infections are common. High blood pressure and headaches also occur. Call your doctor if side effects are severe or yo...
  • Antacids with magnesium or aluminum, and sevelamer, should be taken at least 2 hours after mycophenolate. Acid reducers like pantoprazole or lansoprazole may lower its effect. Chec...
📖 Read our full Mycophenolate guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $8.49 $678.98 / 80 ml
Medicare Part B allowsASP · J7519 $0.399 / J7519 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)0004-0298-09
11-digit billing NDC00004-0298-09
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ7519
DescriptorInjection, mycophenolate mofetil, 10 mg
Billing units / pkg200 units
How the units are derivedThis package is 1; the HCPCS unit is 10 MG, so one package = 200 billing units.
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00004-0298-09 You're viewing this Main listing 4 VIAL in 1 CARTON / 20 mL in 1 VIAL 1998-08-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
CellCept 500 mg/20mLthis 00004-0298-09 Genentech, 4 vials — AP FDA listed —
Mycophenolate Mofetil 500 mg/20mL 42023-0172-04 Par 4 vials — AP FDA listed —
Mycophenolate Mofetil 500 mg/20mL 54288-0141-04 BPI 4 vials — AP FDA listed —
Mycophenolate Mofetil 500 mg/20mL 67457-0386-81 Mylan 4 vials — AP FDA listed —
Mycophenolate Mofetil 500 mg/20mL 71288-0803-21 Meitheal 4 vials — AP FDA listed —
mycophenolate mofetil 500 mg/20mL 72485-0415-04 ARMAS 4 vials — AP FDA listed —
mycophenolate mofetil 500 mg/20mL 83270-0000-04 ONESOURCE 4 vials — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1998
On the market since
Aug 1998
📍
2026
Currently FDA-listed
28 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color purple / blue / brown
ShapeCapsule
ImprintCellCept;250;Roche
Size19 mm
ScoringNot scored
FlavorFruit
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerGenentech, Inc.
Application holderROCHE PALO ALTO LLC
FDA applicationNDA050758 (NDA)
Labeler code00004
First marketedAug 1998
Product typeHuman Prescription Drug
Portfolio93 products on file

More NDCs from Genentech, Inc. labeler code 00004

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 207 words ▾

WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1) , Use in Special Populations (8.1 , 8.3) ] .

Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2) ] . Increased susceptibility to bacterial, viral, fungal and protozoal infections, including opportunistic infections and viral reactivation of hepatitis B and C, which may lead to hospitalizations and fatal outcomes [see Warnings and Precautions (5.3) ] . WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS See full prescribing information for complete boxed warning Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations.

Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1) ]. Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2) ] .

Increased susceptibility to infections, including opportunistic infections and severe infections with fatal outcomes [see Warnings and Precautions (5.3) ].

🎯 Indications and Usage 93 words ▾

1 INDICATIONS AND USAGE CELLCEPT [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1) ], heart [see Clinical Studies (14.2) ] or liver transplants [see Clinical Studies (14.3) ] , in combination with other immunosuppressants. CELLCEPT is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION ADULTS DOSAGE Kidney Transplant 1 g twice daily, orally or intravenously (IV) over no less than 2 h ( 2.2 ) Heart Transplant 1.5 g twice daily orally or IV, over no less than 2 h ( 2.3 ) Liver Transplant 1.5 g twice daily orally or 1g twice daily IV over no less than 2 h ( 2.4 ) PEDIATRICS Kidney Transplant 600 mg/m 2 orally twice daily, up to maximum of 2 g daily ( 2.2 ) Heart Transplant 600 mg/m 2 orally twice daily (starting dose) up to a maximum of 900 mg/m 2 twice daily (3 g or 15 mL of oral suspension) ( 2.3 ) Liver Transplant 600 mg/m 2 orally twice daily (starting dose) up to a maximum of 900 mg/m 2 twice daily (3 g or 15 mL of oral suspension) ( 2.4 ) CELLCEPT Intravenous is an alternative when patients cannot tolerate oral medication.

Administer within 24 hours following transplantation, until patients can tolerate oral medication, up to 14 days. ( 2.1 ) Reduce or interrupt dosing in the event of neutropenia. ( 2.5 ) See full prescribing information (FPI) for: adjustments for renal impairment and neutropenia ( 2.5 ), preparation of oral suspension and IV solution.

( 2.6 )

2.1Important Administration Instructions CELLCEPT should not be used without the supervision of a physician with experience in immunosuppressive therapy. CELLCEPT Capsules, Tablets and Oral Suspension CELLCEPT oral dosage forms (capsules, tablets or oral suspension) should not be used interchangeably with mycophenolic acid delayed-release tablets without supervision of a physician with experience in immunosuppressive therapy because the rates of absorption following the administration of CELLCEPT oral dosage forms and mycophenolic acid delayed-release tablets are not equivalent.

CELLCEPT tablets should not be crushed and CELLCEPT capsules should not be opened or crushed. Patients should avoid inhalation or contact of the skin or mucous membranes with the powder contained in CELLCEPT capsules and oral suspension. If such contact occurs, they must wash the area of contact thoroughly with soap and water.

In case of ocular contact, rinse eyes with plain water. The initial oral dose of CELLCEPT should be given as soon as possible following kidney, heart or liver transplant. It is recommended that CELLCEPT be administered on an empty stomach.

In stable transplant patients, however, CELLCEPT may be administered with food if necessary [see Clinical Pharmacology (12.3) ]. Once reconstituted, CELLCEPT Oral Suspension must not be mixed with any liquids prior to dose administration. If needed, CELLCEPT Oral Suspension can be administered via a nasogastric tube with a minimum size of 8 French (minimum 1.7 mm interior diameter).

Patients should be instructed to take a missed dose as soon as they remember, except if it is closer than 2 hours to the next scheduled dose; in this case, they should continue to take CELLCEPT at the usual times. CELLCEPT Intravenous CELLCEPT Intravenous is recommended for patients unable to take oral CELLCEPT. CELLCEPT Intravenous should be administered within 24 hours following transplant.

CELLCEPT Intravenous can be administered for up to 14 days; however, patients should be switched to oral CELLCEPT as soon as they can tolerate oral medication. CELLCEPT Intravenous must be reconstituted before use [see Dosage and Administration (2.6) ] . CELLCEPT Intravenous is incompatible with other intravenous infusion solutions and should not be mixed or administered concurrently via the same infusion catheter with other intravenous drugs or infusion admixtures.

CELLCEPT Intravenous must not be administered as a bolus. Following reconstitution, CELLCEPT Intravenous must be administered by slow intravenous infusion over a period of no less than 2 hours by either peripheral or central vein, as rapid infusion increases the risk of local adverse reactions such as phlebitis and thrombosis [see Adverse Reactions (6.1) ] .

2.2Dosage Recommendations for Kidney Transplant Patients Adults The recommended dosage for adult kidne… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 127 words ▾

3 DOSAGE FORMS AND STRENGTHS CELLCEPT is available in the following dosage forms and strengths: Capsules 250 mg mycophenolate mofetil, two-piece hard gelatin capsules, blue-brown, "CELLCEPT 250" printed in black on the blue cap and "Roche" on the brown body Tablets 500 mg mycophenolate mofetil, lavender-colored, caplet-shaped, film-coated tablets engraved with "CELLCEPT 500" on one side and "Roche" on the other For oral suspension 35 g mycophenolate mofetil white to off-white powder for reconstitution (200 mg/mL upon reconstitution) For injection 500 mg mycophenolate mofetil white to off-white lyophilized powder, in a single-dose vial for reconstitution Capsules: 250 mg Tablets: 500 mg For Oral Suspension: 35 g mycophenolate mofetil, powder for reconstitution (200 mg/mL upon reconstitution) For Injection: 500 mg mycophenolate mofetil in a single-dose vial for reconstitution.

⛔ Contraindications 80 words ▾

4 CONTRAINDICATIONS CELLCEPT is contraindicated in patients with a history of hypersensitivity, including anaphylaxis, to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product [see Warnings and Precautions (5.8) ] . CELLCEPT Intravenous is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN). History of hypersensitivity, including anaphylaxis, to mycophenolate mofetil, mycophenolic acid or any component of the drug product ( 4 ) Patients allergic to Polysorbate 80 (present in CELLCEPT IV) ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Blood Dyscrasias (Neutropenia, Red Blood Cell Aplasia): Monitor with blood tests; consider treatment interruption or dose reduction. ( 5.4 ) Gastrointestinal Complications: Monitor for complications such as bleeding, ulceration and perforations, particularly in patients with underlying gastrointestinal disorders. ( 5.5 ) Hypoxanthine-Guanine Phosphoribosyl-Transferase Deficiency: Avoid use of CELLCEPT.

( 5.6 ) Acute Inflammatory Syndrome Associated with Mycophenolate Products: Monitor for this paradoxical inflammatory reaction. ( 5.7 ) Hypersensitivity Reactions: Discontinue CELLCEPT; treat and monitor until signs and symptoms resolve. ( 5.8 ) Immunizations: Avoid live attenuated vaccines.

( 5.9 ) Local Reactions with Rapid Intravenous Administration: CELLCEPT Intravenous must not be administered by rapid or bolus intravenous injection. ( 5.10 ) Phenylketonurics: Oral suspension contains aspartame. ( 5.11 ) Blood Donation: Avoid during therapy and for 6 weeks thereafter.

( 5.12 ) Semen Donation: Avoid during therapy and for 90 days thereafter. ( 5.13 ) Potential Impairment on Driving and Use of Machinery: CELLCEPT may affect ability to drive or operate machinery. ( 5.15 )

5.1Embryofetal Toxicity Use of MMF during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney and nervous system. Females of reproductive potential must be made aware of these risks and must be counseled regarding pregnancy prevention and planning. Avoid use of MMF during pregnancy if safer treatment options are available [see Use in Specific Populations (8.1 , 8.3) ].

5.2Lymphoma and Other Malignancies Patients receiving immunosuppressants, including CELLCEPT, are at increased risk of developing lymphomas and other malignancies, particularly of the skin [see Adverse Reactions (6.1) ]. The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent. For patients with increased risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen with a high protection factor.

Post-transplant lymphoproliferative disorder (PTLD) developed in 0.4% to 1% of patients receiving CELLCEPT (2 g or 3 g) with other immunosuppressive agents in controlled clinical trials of kidney, heart and liver transplant patients [see Adverse Reactions (6.1) ]. The majority of PTLD cases appear to be related to Epstein Barr Virus (EBV) infection. The risk of PTLD appears greatest in those individuals who are EBV seronegative, a population which includes many young children.

In pediatric patients, no other malignancies besides PTLD were observed in clinical trials [see Adverse Reactions (6.1) ].

5.3Serious Infections Patients receiving immunosuppressants, including CELLCEPT, are at increased risk of developing bacterial, fungal, protozoal and new or reactivated viral infections, including opportunistic infections. The risk increases with the total immunosuppressive load. These infections may lead to serious outcomes, including hospitalizations and death [see Adverse Reactions (6.1 , 6.2) ].

Serious viral infections reported include: Polyomavirus-associated nephropathy (PVAN), especially due to BK virus infection JC virus-associated progressive multifocal leukoencephalopathy (PML), and Cytomegalovirus (CMV) infections: CMV seronegative transplant patients who receive an organ from a CMV seropositive donor are at highest risk of CMV viremia and CMV disease. Viral reactivation in patients infected with Hepatitis B and C COVID-19 Consider dose reduction or discontinuation of CELLCEPT in patients who develop new infections or reactivate viral infections, weighing the risk that reduced immunosuppression rep… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Embryofetal Toxicity [see Warnings and Precautions (5.1) ] Lymphomas and Other Malignancies [see Warnings and Precautions 5.2) ] Serious Infections [see Warnings and Precautions (5.3) ] Blood Dyscrasias: Neutropenia, Pure Red Cell Aplasia [see Warnings and Precautions (5.4) ] Gastrointestinal Complications [see Warnings and Precautions (5.5) ] Acute Inflammatory Syndrome Associated with Mycophenolate Products [see Warnings and Precautions (5.7) ] Hypersensitivity Reactions [see Warnings and Precautions (5.8) ] The most common adverse reactions in clinical trials (20 % or greater) include diarrhea, leukopenia, infection, vomiting, and there is evidence of a higher frequency of certain types of infections e.g., opportunistic infection.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. An estimated total of 1557 adult patients received CELLCEPT during pivotal clinical trials in the prevention of acute organ rejection. Of these, 991 were included in the three renal studies, 277 were included in one hepatic study, and 289 were included in one cardiac study.

Patients in all study arms also received cyclosporine and corticosteroids. The data described below primarily derive from five randomized, active-controlled double-blind 12-month trials of CELLCEPT in de novo kidney (3) heart (1) and liver (1) transplant patients [see Clinical Studies (14.1 , 14.2 , and 14.3) ] . CELLCEPT Oral The incidence of adverse reactions for CELLCEPT was determined in five randomized, comparative, double-blind trials in the prevention of rejection in kidney, heart and liver transplant patients (two active- and one placebo-controlled trials, one active-controlled trial, and one active-controlled trial, respectively) [see Clinical Studies (14.1 , 14.2 and 14.3) ] .

The three de novo kidney studies with 12-month duration compared two dose levels of oral CELLCEPT (1 g twice daily and 1.5 g twice daily) with azathioprine (2 studies) or placebo (1 study) when administered in combination with cyclosporine (Sandimmune®) and corticosteroids to prevent acute rejection episodes. One study also included anti-thymocyte globulin (ATGAM®) induction therapy. In the de novo heart transplantation study with 12-month duration, patients received CELLCEPT 1.5 g twice daily (n=289) or azathioprine 1.5 to 3 mg/kg/day (n=289), in combination with cyclosporine (Sandimmune® or Neoral®) and corticosteroids as maintenance immunosuppressive therapy.

In the de novo liver transplantation study with 12-month duration, patients received CELLCEPT 1 g twice daily intravenously for up to 14 days followed by CELLCEPT 1.5 g twice daily orally or azathioprine 1 to 2 mg/kg/day intravenously followed by azathioprine 1 to 2 mg/kg/day orally, in combination with cyclosporine (Neoral®) and corticosteroids as maintenance immunosuppressive therapy. The total number of patients enrolled was 565. Approximately 53% of the kidney transplant patients, 65% of the heart transplant patients, and 48% of the liver transplant patients were treated for more than 1 year.

Adverse reactions reported in ≥ 20% of patients in the CELLCEPT treatment groups are presented below. The safety data of three kidney transplantation studies are pooled together. Table 5 Adverse Reactions in Controlled Studies of De Novo Kidney, Heart or Liver Transplantation Reported in ≥20% of Patients in the CELLCEPT Group Adverse drug reaction Kidney Studies Heart Study Liver Study CellCept 2g/day (n=501) or 3g/day (n=490) AZA 1 to 2 mg/kg/day or 100 to 1… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS See FPI for drugs that may interfere with systemic exposure and reduce CELLCEPT efficacy: antacids with magnesium or aluminum hydroxide, proton pump inhibitors, drugs that interfere with enterohepatic recirculation, telmisartan, calcium-free phosphate binders. ( 7.1 ) CELLCEPT may reduce effectiveness of oral contraceptives. Use of additional barrier contraceptive methods is recommended.

( 7.2 ) See FPI for other important drug interactions. ( 7 )

7.1Effect of Other Drugs on CELLCEPT Table 7 Drug Interactions with CELLCEPT that Affect Mycophenolic Acid (MPA) Exposure Antacids with Magnesium or Aluminum Hydroxide Clinical Impact Concomitant use with an antacid containing magnesium or aluminum hydroxide decreases MPA systemic exposure [see Clinical Pharmacology (12.3) ] , which may reduce CELLCEPT efficacy. Prevention or Management Administer magnesium or aluminum hydroxide containing antacids at least 2h after CELLCEPT administration. Proton Pump Inhibitors (PPIs) Clinical Impact Concomitant use with PPIs decreases MPA systemic exposure [see Clinical Pharmacology (12.3) ] , which may reduce CELLCEPT efficacy.

Prevention or Management Monitor patients for alterations in efficacy when PPIs are co-administered with CELLCEPT. Examples Lansoprazole, pantoprazole Drugs that Interfere with Enterohepatic Recirculation Clinical Impact Concomitant use with drugs that directly interfere with enterohepatic recirculation, or indirectly interfere with enterohepatic recirculation by altering the gastrointestinal flora, can decrease MPA systemic exposure [see Clinical Pharmacology (12.3) ] , which may reduce CELLCEPT efficacy. Prevention or Management Monitor patients for alterations in efficacy or CELLCEPT related adverse reactions when these drugs are co-administered with CELLCEPT.

Examples Cyclosporine A, trimethoprim/sulfamethoxazole, bile acid sequestrants (cholestyramine), rifampin as well as aminoglycoside, cephalosporin, fluoroquinolone and penicillin classes of antimicrobials Drugs Modulating Glucuronidation Clinical Impact Concomitant use with drugs inducing glucuronidation decreases MPA systemic exposure, potentially reducing CELLCEPT efficacy, while use with drugs inhibiting glucuronidation increases MPA systemic exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of CELLCEPT related adverse reactions.

Prevention or Management Monitor patients for alterations in efficacy or CELLCEPT related adverse reactions when these drugs are co-administered with CELLCEPT. Examples Telmisartan (induces glucuronidation); isavuconazole (inhibits glucuronidation). Calcium Free Phosphate Binders Clinical Impact Concomitant use with calcium free phosphate binders decrease MPA systemic exposure [see Clinical Pharmacology (12.3) ] , which may reduce CELLCEPT efficacy.

Prevention or Management Administer calcium free phosphate binders at least 2 hours after CELLCEPT. Examples Sevelamer

7.2Effect of CELLCEPT on Other Drugs Table 8 Drug Interactions with CELLCEPT that Affect Other Drugs Drugs that Undergo Renal Tubular Secretion Clinical Impact When concomitantly used with CELLCEPT, its metabolite MPAG, may compete with drugs eliminated by renal tubular secretion which may increase plasma concentrations and/or adverse reactions associated with these drugs. Prevention or Management Monitor for drug-related adverse reactions in patients with renal impairment. Examples Acyclovir, ganciclovir, probenecid, valacyclovir, valganciclovir Combination Oral Contraceptives Clinical Impact Concomitant use with CELLCEPT decreased the systemic exposure to levonorgestrel, but did not affect the systemic exposure to ethinylestradiol [see Clinical Pharmacology (12.3) ] , which may result in reduced combination oral contraceptive effectiveness.

Prevention or Management Use additional barrier contraceptive methods.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Male Patients: Sexually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for at least 90 days after cessation of treatment ( 8.3 )

8.1Pregnancy Risk Summary Use of mycophenolate mofetil (MMF) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems [see Human Data ] . Oral administration of mycophenolate to rats and rabbits during the period of organogenesis produced congenital malformations and pregnancy loss at doses less than the recommended clinical dose (0.01 to 0.05 times the recommended clinical doses in kidney and heart transplant patients) [see Animal Data ].

Consider alternative immunosuppressants with less potential for embryofetal toxicity. Risks and benefits of CELLCEPT should be discussed with the pregnant woman. The estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear .

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data A spectrum of congenital malformations (including multiple malformations in individual newborns) has been reported in 23 to 27% of live births in MMF exposed pregnancies, based on published data from pregnancy registries. Malformations that have been documented include external ear, eye, and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system.

Based on published data from pregnancy registries, the risk of first trimester pregnancy loss has been reported at 45 to 49% following MMF exposure. Animal Data In animal reproductive toxicology studies, there were increased rates of fetal resorptions and malformations in the absence of maternal toxicity. Oral administration of MMF to pregnant rats from Gestational Day 7 to Day 16 produced increased embryofetal lethality and fetal malformations including anophthalmia, agnathia, and hydrocephaly at doses equivalent to 0.015 and 0.01 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for BSA.

Oral administration of MMF to pregnant rabbits from Gestational Day 7 to Day 19 produced increased embryofetal lethality and fetal malformations included ectopia cordis, ectopic kidneys, diaphragmatic hernia, and umbilical hernia at dose equivalents as low as 0.05 and 0.03 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for BSA.

8.2Lactation Risk Summary There are no data on the presence of mycophenolate in human milk, or the effects on milk production. There are limited data in the National Transplantation Pregnancy Registry on the effects of mycophenolate on a breastfed child [see Data ] . Studies in rats treated with MMF have shown mycophenolic acid (MPA) to be present in milk.

Because available data are limited, it is not possible to exclude potential risks to a breastfeeding infant. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for CELLCEPT and any potential adverse effects on the breastfed infant from CELLCEPT or from the underlying maternal condition. Data Limited information is available from the National Transplantation Pregnancy Registry.

Of seven infants reported by the National Transplantation Pregnancy Registry to have been breastfed while the mother was taking mycophenolate, all were born at 34-40 weeks gestation, and breastfed for up to 14 months. No adverse events were reported.

8.3Females and Males of Reproductive Potential Females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malforma… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Use of mycophenolate mofetil (MMF) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems [see Human Data ] . Oral administration of mycophenolate to rats and rabbits during the period of organogenesis produced congenital malformations and pregnancy loss at doses less than the recommended clinical dose (0.01 to 0.05 times the recommended clinical doses in kidney and heart transplant patients) [see Animal Data ].

Consider alternative immunosuppressants with less potential for embryofetal toxicity. Risks and benefits of CELLCEPT should be discussed with the pregnant woman. The estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear .

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data A spectrum of congenital malformations (including multiple malformations in individual newborns) has been reported in 23 to 27% of live births in MMF exposed pregnancies, based on published data from pregnancy registries. Malformations that have been documented include external ear, eye, and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system.

Based on published data from pregnancy registries, the risk of first trimester pregnancy loss has been reported at 45 to 49% following MMF exposure. Animal Data In animal reproductive toxicology studies, there were increased rates of fetal resorptions and malformations in the absence of maternal toxicity. Oral administration of MMF to pregnant rats from Gestational Day 7 to Day 16 produced increased embryofetal lethality and fetal malformations including anophthalmia, agnathia, and hydrocephaly at doses equivalent to 0.015 and 0.01 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for BSA.

Oral administration of MMF to pregnant rabbits from Gestational Day 7 to Day 19 produced increased embryofetal lethality and fetal malformations included ectopia cordis, ectopic kidneys, diaphragmatic hernia, and umbilical hernia at dose equivalents as low as 0.05 and 0.03 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for BSA.

🧒 Pediatric Use 203 words ▾

8.4Pediatric Use Safety and effectiveness have been established in pediatric patients 3 months and older for the prophylaxis of organ rejection of allogenic kidney, heart or liver transplants. Kidney Transplant Use of CELLCEPT in this population is supported by evidence from adequate and well-controlled studies of CELLCEPT in adults with additional data from one open-label, pharmacokinetic and safety study of CELLCEPT in pediatric patients after receiving allogeneic kidney transplant (100 patients, 3 months to 18 years of age) [see Dosage and Administration (2.2) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , Clinical Studies (14.1) ] .

Heart Transplant and Liver Transplant Use of CELLCEPT in pediatric heart transplant and liver transplant patients is supported by adequate and well-controlled studies and pharmacokinetic data in adult heart transplant and liver transplant patients. Additional supportive data include pharmacokinetic data in pediatric kidney transplant and pediatric liver transplant patients (8 liver transplant patients, 9 months to 5 years of age, in an open-label, pharmacokinetic and safety study) and published evidence of clinical efficacy and safety in pediatric heart transplant and pediatric liver transplant patients [see Dosage and Administration (2.3 , 2.4) , Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , Clinical Studies (14.1) ] .

🧓 Geriatric Use 77 words ▾

8.5Geriatric Use Clinical studies of CELLCEPT did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between geriatric and younger patients. In general, dose selection for a geriatric patient should take into consideration the presence of decreased hepatic, renal or cardiac function and of concomitant drug therapies [see Adverse Reactions (6.1) , Drug Interactions (7) ].

🆘 Overdosage 189 words ▾

10 OVERDOSAGE Possible signs and symptoms of acute overdose include hematological abnormalities such as leukopenia and neutropenia, and gastrointestinal symptoms such as abdominal pain, diarrhea, nausea, vomiting, and dyspepsia. The experience with overdose of CELLCEPT in humans is limited. The reported effects associated with overdose fall within the known safety profile of the drug.

The highest dose administered to kidney transplant patients in clinical trials has been 4 g/day. In limited experience with heart and liver transplant patients in clinical trials, the highest doses used were 4 g/day or 5 g/day. At doses of 4 g/day or 5 g/day, there appears to be a higher rate, compared to the use of 3 g/day or less, of gastrointestinal intolerance (nausea, vomiting, and/or diarrhea), and occasional hematologic abnormalities, particularly neutropenia [see Warnings and Precautions (5.4) ] .

Treatment and Management MPA and the phenolic glucuronide metabolite of MPA (MPAG) are usually not removed by hemodialysis. However, at high MPAG plasma concentrations (>100 µg/mL), small amounts of MPAG are removed. By increasing excretion of the drug, MPA can be removed by bile acid sequestrants, such as cholestyramine [see Clinical Pharmacology (12.3) ].

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Mycophenolate mofetil (MMF) is absorbed following oral administration and hydrolyzed to mycophenolic acid (MPA), the active metabolite. MPA is a selective uncompetitive inhibitor of the two isoforms (type I and type II) of inosine monophosphate dehydrogenase (IMPDH) leading to inhibition of the de novo pathway of guanosine nucleotide synthesis and blocks DNA synthesis. The mechanism of action of MPA is multifaceted and includes effects on cellular checkpoints responsible for metabolic programming of lymphocytes.

MPA shifts transcriptional activities in lymphocytes from a proliferative state to catabolic processes. In vitro studies suggest that MPA modulates transcriptional activities in human CD4 + T-lymphocytes by suppressing the Akt/mTOR and STAT5 pathways that are relevant to metabolism and survival, leading to an anergic state of T-cells whereby the cells become less responsive to antigenic stimulation. Additionally, MPA enhanced the expression of negative co-stimulators such as CD70, PD-1, CTLA-4, and transcription factor FoxP3 as well as decreased the expression of positive co-stimulators CD27 and CD28.

MPA decreases proliferative responses of T- and B-lymphocytes to both mitogenic and allo-antigenic stimulation, antibody responses, as well as the production of cytokines from lymphocytes and monocytes such as GM-CSF, IFN-ɣ, IL-17, and TNF-α. Additionally, MPA prevents the glycosylation of lymphocyte and monocyte glycoproteins that are involved in intercellular adhesion to endothelial cells and may inhibit recruitment of leukocytes into sites of inflammation and graft rejection. Overall, the effect of MPA is cytostatic and reversible.

12.2Pharmacodynamics There is a lack of information regarding the pharmacodynamic effects of MMF.

12.3Pharmacokinetics Absorption Following oral and intravenous administration, MMF undergoes complete conversion to MPA, the active metabolite. In 12 healthy volunteers, the mean absolute bioavailability of oral MMF relative to intravenous MMF was 94%. Two 500 mg CELLCEPT tablets have been shown to be bioequivalent to four 250 mg CELLCEPT capsules.

Five mL of the 200 mg/mL constituted CELLCEPT oral suspension have been shown to be bioequivalent to four 250 mg capsules. The mean (±SD) pharmacokinetic parameters estimates for MPA following the administration of MMF given as single doses to healthy volunteers, and multiple doses to kidney, heart, and liver transplant patients, are shown in Table 10 . The area under the plasma-concentration time curve (AUC) for MPA appears to increase in a dose-proportional fashion in kidney transplant patients receiving multiple oral doses of MMF up to a daily dose of 3 g (1.5g twice daily) (see Table 10 ).

Table 10 Pharmacokinetic Parameters for MPA [mean (±SD)] Following Administration of MMF to Healthy Volunteers (Single Dose), and Kidney, Heart, and Liver Transplant Patients (Multiple Doses) Healthy Volunteers Dose/Route T max (h) C max (mcg/mL) Total AUC (mcg∙h/mL) Single dose 1 g/oral 0.80 (±0.36) (n=129) 24.5 (±9.5) (n=129) 63.9 (±16.2) (n=117) Kidney Transplant Patients (twice daily dosing) Time After Transplantation Dose/Route T max (h) C max (mcg/mL) Interdosing Interval AUC(0-12h) (mcg∙h/mL) 5 days 1 g/iv 1.58 (±0.46) (n=31) 12.0 (±3.82) (n=31) 40.8 (±11.4) (n=31) 6 days 1 g/oral 1.33 (±1.05) (n=31) 10.7 (±4.83) (n=31) 32.9 (±15.0) (n=31) Early (Less than 40 days) 1 g/oral 1.31 (±0.76) (n=25) 8.16 (±4.50) (n=25) 27.3 (±10.9) (n=25) Early (Less than 40 days) 1.5 g/oral 1.21 (±0.81) (n=27) 13.5 (±8.18) (n=27) 38.4 (±15.4) (n=27) Late (Greater than 3 months) 1.5 g/oral 0.90 (±0.24) (n=23) 24.1 (±12.1) (n=23) 65.3 (±35.4) (n=23) Heart transplant Patients (twice daily dosing) Time After Transplantation Dose/Route T max (h) C max (mcg/mL) Interdosing Interval AUC(0-12h) (mcg∙h/mL) Early (Day before discharge) 1.5 g/oral 1.8 (±1.3) (n=11) 11.5 (±6.8) (n=11) 43.3 (±20.8) (n=9) Late (Greater than 6 months) 1.5 g… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action ~1 min read ▾

12.1Mechanism of Action Mycophenolate mofetil (MMF) is absorbed following oral administration and hydrolyzed to mycophenolic acid (MPA), the active metabolite. MPA is a selective uncompetitive inhibitor of the two isoforms (type I and type II) of inosine monophosphate dehydrogenase (IMPDH) leading to inhibition of the de novo pathway of guanosine nucleotide synthesis and blocks DNA synthesis. The mechanism of action of MPA is multifaceted and includes effects on cellular checkpoints responsible for metabolic programming of lymphocytes.

MPA shifts transcriptional activities in lymphocytes from a proliferative state to catabolic processes. In vitro studies suggest that MPA modulates transcriptional activities in human CD4 + T-lymphocytes by suppressing the Akt/mTOR and STAT5 pathways that are relevant to metabolism and survival, leading to an anergic state of T-cells whereby the cells become less responsive to antigenic stimulation. Additionally, MPA enhanced the expression of negative co-stimulators such as CD70, PD-1, CTLA-4, and transcription factor FoxP3 as well as decreased the expression of positive co-stimulators CD27 and CD28.

MPA decreases proliferative responses of T- and B-lymphocytes to both mitogenic and allo-antigenic stimulation, antibody responses, as well as the production of cytokines from lymphocytes and monocytes such as GM-CSF, IFN-ɣ, IL-17, and TNF-α. Additionally, MPA prevents the glycosylation of lymphocyte and monocyte glycoproteins that are involved in intercellular adhesion to endothelial cells and may inhibit recruitment of leukocytes into sites of inflammation and graft rejection. Overall, the effect of MPA is cytostatic and reversible.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1Handling and Disposal Mycophenolate mofetil (MMF) has demonstrated teratogenic effects in humans [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . CELLCEPT tablets should not be crushed and CELLCEPT capsules should not be opened or crushed. Wearing disposable gloves is recommended during reconstitution and when wiping the outer surface of the bottle/cap and the table after reconstitution.

Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in CELLCEPT capsules, CELLCEPT Oral Suspension (before or after constitution), or CELLCEPT Intravenous (during or after preparation) [see Dosage and Administration (2.6) ]. Follow applicable special handling and disposal procedures 1 .

16.2CELLCEPT (mycophenolate mofetil capsules) 250 mg Capsules Blue-brown, two-piece hard gelatin capsules, printed in black with "CELLCEPT 250" on the blue cap and "Roche" on the brown body. Sizes Bottle of 100 NDC 0004-0259-01 Bottle of 500 NDC 0004-0259-43 Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)

16.3CELLCEPT (mycophenolate mofetil tablets) 500 mg Tablets Lavender-colored, caplet-shaped, film-coated tablets engraved with "CELLCEPT 500" on one side and "Roche" on the other Sizes Bottle of 100 NDC 0004-0260-01 Bottle of 500 NDC 0004-0260-43 Storage and Dispensing Information: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Dispense in light-resistant containers, such as the manufacturer's original containers.

16.4CELLCEPT Oral Suspension (mycophenolate mofetil), for oral suspension For oral suspension: 35 g mycophenolate mofetil, white to off-white powder blend for constitution to a white to off-white mixed-fruit flavor suspension 225 mL bottle with bottle adapter and 2 oral dispensers NDC 0004-0261-29 Storage Store dry powder at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store constituted suspension at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) for up to 60 days. Storage in a refrigerator at 2°C to 8°C (36°F to 46°F) is acceptable.

Do not freeze.

16.5CELLCEPT Intravenous (mycophenolate mofetil for injection) For injection: 500 mg mycophenolate mofetil in a 20 mL sterile single-dose vial cartons of 4 vials Cartons of 4 single-dose vials NDC 0004-0298-09 Storage Store powder and reconstituted infusion solution at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

📦 Storage and Handling ~1 min read ▾

16.2CELLCEPT (mycophenolate mofetil capsules) 250 mg Capsules Blue-brown, two-piece hard gelatin capsules, printed in black with "CELLCEPT 250" on the blue cap and "Roche" on the brown body. Sizes Bottle of 100 NDC 0004-0259-01 Bottle of 500 NDC 0004-0259-43 Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)

16.3CELLCEPT (mycophenolate mofetil tablets) 500 mg Tablets Lavender-colored, caplet-shaped, film-coated tablets engraved with "CELLCEPT 500" on one side and "Roche" on the other Sizes Bottle of 100 NDC 0004-0260-01 Bottle of 500 NDC 0004-0260-43 Storage and Dispensing Information: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Dispense in light-resistant containers, such as the manufacturer's original containers.

16.4CELLCEPT Oral Suspension (mycophenolate mofetil), for oral suspension For oral suspension: 35 g mycophenolate mofetil, white to off-white powder blend for constitution to a white to off-white mixed-fruit flavor suspension 225 mL bottle with bottle adapter and 2 oral dispensers NDC 0004-0261-29 Storage Store dry powder at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store constituted suspension at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) for up to 60 days. Storage in a refrigerator at 2°C to 8°C (36°F to 46°F) is acceptable.

Do not freeze.

16.5CELLCEPT Intravenous (mycophenolate mofetil for injection) For injection: 500 mg mycophenolate mofetil in a 20 mL sterile single-dose vial cartons of 4 vials Cartons of 4 single-dose vials NDC 0004-0298-09 Storage Store powder and reconstituted infusion solution at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

📋 Description ~2 min read ▾

11 DESCRIPTION CELLCEPT (mycophenolate mofetil) is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate.

It has an empirical formula of C 23 H 31 NO 7 , a molecular weight of 433.50, and the following structural formula: MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol.

The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W).

The pH of the reconstituted solution is 2.4 to 4.1. CELLCEPT is available for oral administration as capsules containing 250 mg of MMF, tablets containing 500 mg of MMF, and as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF. Inactive ingredients in CELLCEPT 250 mg capsules include croscarmellose sodium, magnesium stearate, povidone (K-90) and pregelatinized starch.

The capsule shells contain black iron oxide, FD&C blue #2, gelatin, red iron oxide, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and yellow iron oxide. Inactive ingredients in CELLCEPT 500 mg tablets include croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone (K-90), and Opadry ® lavender Y-5R-10272-A (hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, polyethylene glycol 400, FD&C Blue No. 2 aluminum lake [indigo carmine aluminum lake], and red iron oxide).

Inactive ingredients in CELLCEPT Oral Suspension include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, mixed fruit flavor, sodium citrate dihydrate, sorbitol, soybean lecithin, and xanthan gum. CELLCEPT Intravenous is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride.

It has an empirical formula of C 23 H 31 NO 7 HCl and a molecular weight of 469.96. CELLCEPT Intravenous is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial contains 500 mg of mycophenolate mofetil equivalent to 542 mg of mycophenolate mofetil hydrochloride.

The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of CELLCEPT Intravenous to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a slightly yellow solution of MMF, 6 mg/mL [see Dosage and Administration (2.6) ].

Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ).

17.1Embryofetal Toxicity Pregnancy loss and malformations Inform females of reproductive potential and pregnant women that use of CELLCEPT during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations. Advise that they must use an acceptable form of contraception [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1 , 8.3) ]. Contraception Discuss pregnancy testing, pregnancy prevention and planning with females of reproductive potential [see Use in Specific Populations (8.3) ].

Females of reproductive potential must use an acceptable form of birth control during the entire CELLCEPT therapy and for 6 weeks after stopping CELLCEPT, unless the patient chooses abstinence . CELLCEPT may reduce effectiveness of oral contraceptives. Use of additional barrier contraceptive methods is recommended [see Use in Specific Populations (8.3) ].

For patients who are considering pregnancy, discuss appropriate alternative immunosuppressants with less potential for embryofetal toxicity. Risks and benefits of CELLCEPT should be discussed with the patient. Advise sexually active male patients and/or their partners to use effective contraception during the treatment of the male patient and for at least 90 days after cessation of treatment.

This recommendation is based on findings of animal studies [see Use in Specific Populations (8.3) , Nonclinical Toxicology (13.1) ].

17.2Development of Lymphoma and Other Malignancies Inform patients that they are at increased risk of developing lymphomas and other malignancies, particularly of the skin, due to immunosuppression [see Warnings and Precautions (5.2) ] . Advise patients to limit exposure to sunlight and ultraviolet (UV) light by wearing protective clothing and use of broad-spectrum sunscreen with high protection factor.

17.3Increased Risk of Serious Infections Inform patients that they are at increased risk of developing a variety of infections due to immunosuppression. Instruct them to contact their physician if they develop any of the signs and symptoms of infection explained in the Medication Guide [see Warnings and Precautions (5.3) ] .

17.4Blood Dyscrasias Inform patients that they are at increased risk for developing blood adverse effects such as anemia or low white blood cells. Advise patients to immediately contact their healthcare provider if they experience any evidence of infection, unexpected bruising, or bleeding, or any other manifestation of bone marrow suppression [see Warnings and Precautions (5.4) ] .

17.5Gastrointestinal Tract Complications Inform patients that CELLCEPT can cause gastrointestinal tract complications including bleeding, intestinal perforations, and gastric or duodenal ulcers. Advise the patient to contact their healthcare provider if they have symptoms of gastrointestinal bleeding, or sudden onset or persistent abdominal pain [see Warnings and Precautions (5.5) ] .

17.6Acute Inflammatory Syndrome Inform patients that acute inflammatory reactions have been reported in some patients who received CELLCEPT. Some reactions were severe, requiring hospitalization. Advise patients to contact their physician if they develop fever, joint stiffness, joint pain or muscle pains [see Warnings and Precautions (5.7) ] .

17.7Hypersensitivity Reactions Inform patients of the potential risk of hypersensitivity reactions. Advise patients to stop taking CELLCEPT and seek immediate medical attention if signs or symptoms of hypersensitivity reaction occur (such as swelling of face, lips, tongue, or throat; difficulty breathing or swallowing) [see Warnings and Precautions (5.8) ] .

17.8Immunizations Inform patients that CELLCEPT can interfere with the usual response to immunizations. Before seeking vaccines on their own, advise patients to discuss fi… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 7 2026 MEDICATION GUIDE CELLCEPT ® [SEL-sept] (mycophenolate mofetil capsules) (mycophenolate mofetil tablets) CELLCEPT ® [SEL-sept] (mycophenolate mofetil for oral suspension) CELLCEPT ® [SEL-sept] (mycophenolate mofetil for injection) Read the Medication Guide that comes with CELLCEPT before you start taking it and each time you refill your prescription.

There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. What is the most important information I should know about CELLCEPT?

CELLCEPT can cause serious side effects, including: Increased risk of loss of a pregnancy (miscarriage) and higher risk of birth defects. Females who take CELLCEPT during pregnancy have a higher risk of miscarriage during the first 3 months (first trimester), and a higher risk that their baby will be born with birth defects. If you are a female who can become pregnant , your doctor must talk with you about acceptable birth control methods (contraceptive counseling) to use while taking CELLCEPT.

You should have 1 pregnancy test immediately before starting CELLCEPT and another pregnancy test 8 to 10 days later. Pregnancy tests should be repeated during routine follow-up visits with your doctor. Talk to your doctor about the results of all of your pregnancy tests.

You must use acceptable birth control during your entire CELLCEPT treatment and for 6 weeks after stopping CELLCEPT, unless at any time you choose to avoid sexual intercourse (abstinence) with a man completely. CELLCEPT decreases blood levels of the hormones in birth control pills that you take by mouth. Birth control pills may not work as well while you take CELLCEPT, and you could become pregnant.

If you take birth control pills while using CELLCEPT you must also use another form of birth control. Talk to your doctor about other birth control methods that you can use while taking CELLCEPT. If you are a sexually active male whose female partner can become pregnant while you are taking CELLCEPT , use effective contraception during treatment and for at least 90 days after stopping CELLCEPT.

If you plan to become pregnant , talk with your doctor. Your doctor will decide if other medicines to prevent rejection may be right for you. If you become pregnant while taking CELLCEPT , do not stop taking CELLCEPT.

Call your doctor right away. You and your doctor may decide that other medicines to prevent rejection may be right for you. Increased risk of getting certain cancers.

People who take CELLCEPT have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Tell your doctor if you have: unexplained fever, prolonged tiredness, weight loss or lymph node swelling a brown or black skin lesion with uneven borders, or one part of the lesion does not look like the other a change in the size and color of a mole a new skin lesion or bump any other changes to your health Increased risk of getting serious infections. CELLCEPT weakens the body's immune system and affects your ability to fight infections.

Serious infections can happen with CELLCEPT and can lead to hospitalizations and death. These serious infections can include: Viral infections. Certain viruses can live in your body and cause active infections when your immune system is weak.

Viral infections that can happen with CELLCEPT include: Shingles, other herpes infections, and cytomegalovirus (CMV). CMV can cause serious tissue and blood infections. BK virus.

BK virus can affect how your kidney works and cause your transplanted kidney to fail. Hepatitis B and C viruses. Hepatitis viruses can affect how your liver works.

Talk to your doctor about how hepatitis viruses may affect you. COVID-19 A brain infection called Progressive Multifocal Leukoencephalopathy (PML). In some patients, CELLCEPT may cause an infection of the brain that may cause death.

You a… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption Following oral and intravenous administration, MMF undergoes complete conversion to MPA, the active metabolite. In 12 healthy volunteers, the mean absolute bioavailability of oral MMF relative to intravenous MMF was 94%. Two 500 mg CELLCEPT tablets have been shown to be bioequivalent to four 250 mg CELLCEPT capsules.

Five mL of the 200 mg/mL constituted CELLCEPT oral suspension have been shown to be bioequivalent to four 250 mg capsules. The mean (±SD) pharmacokinetic parameters estimates for MPA following the administration of MMF given as single doses to healthy volunteers, and multiple doses to kidney, heart, and liver transplant patients, are shown in Table 10 . The area under the plasma-concentration time curve (AUC) for MPA appears to increase in a dose-proportional fashion in kidney transplant patients receiving multiple oral doses of MMF up to a daily dose of 3 g (1.5g twice daily) (see Table 10 ).

Table 10 Pharmacokinetic Parameters for MPA [mean (±SD)] Following Administration of MMF to Healthy Volunteers (Single Dose), and Kidney, Heart, and Liver Transplant Patients (Multiple Doses) Healthy Volunteers Dose/Route T max (h) C max (mcg/mL) Total AUC (mcg∙h/mL) Single dose 1 g/oral 0.80 (±0.36) (n=129) 24.5 (±9.5) (n=129) 63.9 (±16.2) (n=117) Kidney Transplant Patients (twice daily dosing) Time After Transplantation Dose/Route T max (h) C max (mcg/mL) Interdosing Interval AUC(0-12h) (mcg∙h/mL) 5 days 1 g/iv 1.58 (±0.46) (n=31) 12.0 (±3.82) (n=31) 40.8 (±11.4) (n=31) 6 days 1 g/oral 1.33 (±1.05) (n=31) 10.7 (±4.83) (n=31) 32.9 (±15.0) (n=31) Early (Less than 40 days) 1 g/oral 1.31 (±0.76) (n=25) 8.16 (±4.50) (n=25) 27.3 (±10.9) (n=25) Early (Less than 40 days) 1.5 g/oral 1.21 (±0.81) (n=27) 13.5 (±8.18) (n=27) 38.4 (±15.4) (n=27) Late (Greater than 3 months) 1.5 g/oral 0.90 (±0.24) (n=23) 24.1 (±12.1) (n=23) 65.3 (±35.4) (n=23) Heart transplant Patients (twice daily dosing) Time After Transplantation Dose/Route T max (h) C max (mcg/mL) Interdosing Interval AUC(0-12h) (mcg∙h/mL) Early (Day before discharge) 1.5 g/oral 1.8 (±1.3) (n=11) 11.5 (±6.8) (n=11) 43.3 (±20.8) (n=9) Late (Greater than 6 months) 1.5 g/oral 1.1 (±0.7) (n=52) 20.0 (±9.4) (n=52)

54.1AUC(0-12h) values quoted are extrapolated from data from samples collected over 4 hours. (±20.4) (n=49) Liver transplant Patients (twice daily dosing) Time After Transplantation Dose/Route T max (h) C max (mcg/mL) Interdosing Interval AUC(0-12h) (mcg∙h/mL) 4 to 9 days 1 g/iv 1.50 (±0.517) (n=22) 17.0 (±12.7) (n=22) 34.0 (±17.4) (n=22) Early (5 to 8 days) 1.5 g/oral 1.15 (±0.432) (n=20) 13.1 (±6.76) (n=20) 29.2 (±11.9) (n=20) Late (Greater than 6 months) 1.5 g/oral 1.54 (±0.51) (n=6) 19.3 (±11.7) (n=6) 49.3 (±14.8) (n=6) In the early post-transplant period (less than 40 days post-transplant), kidney, heart, and liver transplant patients had mean MPA AUCs approximately 20% to 41% lower and mean C max approximately 32% to 44% lower compared to the late transplant period (i.e., 3 to 6 months post-transplant) (non-stationarity in MPA pharmacokinetics).

Mean MPA AUC values following administration of 1 g twice daily intravenous CELLCEPT over 2 hours to kidney transplant patients for 5 days were about 24% higher than those observed after oral administration of a similar dose in the immediate post-transplant phase. In liver transplant patients, administration of 1 g twice daily intravenous CELLCEPT followed by 1.5 g twice daily oral CELLCEPT resulted in mean MPA AUC estimates similar to those found in kidney transplant patients administered 1 g CELLCEPT twice daily. Effect of Food Food (27 g fat, 650 calories) had no effect on the extent of absorption (MPA AUC) of MMF when administered at doses of 1.5 g twice daily to kidney transplant patients.

However, MPA C max was decreased by 40% in the presence of food [see Dosage and Administration (2.1) ]. Distribution The mean (±SD) apparent volume of distribution of MPA in 12 healthy volunteers was appro… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 14 words ▾

12.2Pharmacodynamics There is a lack of information regarding the pharmacodynamic effects of MMF.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Kidney Transplantation Adults The three de novo kidney transplantation studies compared two dose levels of oral CELLCEPT (1 g twice daily and 1.5 g twice daily) with azathioprine (2 studies) or placebo (1 study) to prevent acute rejection episodes. One of the two studies with azathioprine (AZA) control arm also included anti-thymocyte globulin (ATGAM ® ) induction therapy. The geographic location of the investigational sites of these studies are included in Table 13 .

In all three de novo kidney transplantation studies, the primary efficacy endpoint was the proportion of patients in each treatment group who experienced treatment failure within the first 6 months after transplantation. Treatment failure was defined as biopsy-proven acute rejection on treatment or the occurrence of death, graft loss or early termination from the study for any reason without prior biopsy-proven rejection. CELLCEPT, in combination with corticosteroids and cyclosporine, reduced (statistically significant at 0.05 level) the incidence of treatment failure within the first 6 months following transplantation ( Table 13 ).

Patients who prematurely discontinued treatment were followed for the occurrence of death or graft loss, and the cumulative incidence of graft loss and patient death combined are summarized in Table 14 . Patients who prematurely discontinued treatment were not followed for the occurrence of acute rejection after termination. Table 13 Treatment Failure in De Novo Kidney Transplantation Studies *Does not include death and graft loss as reason for early termination.

USA Study CELLCEPT 2 g/day CELLCEPT 3 g/day AZA 1 to 2 mg/kg/day (N=499 patients) (n=167 patients) (n=166 patients) (n=166 patients) All 3 groups received anti-thymocyte globulin induction, cyclosporine and corticosteroids All treatment failures 31.1% 31.3% 47.6% Early termination without prior acute rejection 9.6% 12.7% 6.0% Biopsy-proven rejection episode on treatment 19.8% 17.5% 38.0% Europe/Canada/Australia Study (N=503 patients) CELLCEPT 2 g/day (n=173 patients) CELLCEPT 3 g/day (n=164 patients) AZA 100 to 150 mg/day (n=166 patients) No induction treatment administered; all 3 groups received cyclosporine and corticosteroids.

All treatment failures 38.2% 34.8% 50.0% Early termination without prior acute rejection 13.9% 15.2% 10.2% Biopsy-proven rejection episode on treatment 19.7% 15.9% 35.5% Europe Study CELLCEPT 2 g/day CELLCEPT 3 g/day Placebo (N=491 patients) (n=165 patients) (n=160 patients) (n=166 patients) No induction treatment administered; all 3 groups received cyclosporine and corticosteroids. All treatment failures 30.3% 38.8% 56.0% Early termination without prior acute rejection 11.5% 22.5% 7.2% Biopsy-proven rejection episode on treatment 17.0% 13.8% 46.4% No advantage of CELLCEPT at 12 months with respect to graft loss or patient death (combined) was established ( Table 14 ).

Numerically, patients receiving CELLCEPT 2 g/day and 3 g/day experienced a better outcome than controls in all three studies; patients receiving CELLCEPT 2 g/day experienced a better outcome than CELLCEPT 3 g/day in two of the three studies. Patients in all treatment groups who terminated treatment early were found to have a poor outcome with respect to graft loss or patient death at 1 year. Table 14 De Novo Kidney Transplantation Studies Cumulative Incidence of Combined Graft Loss or Patient Death at 12 Months Study CELLCEPT 2 g/day CELLCEPT 3 g/day Control (AZA or Placebo) USA 8.5% 11.5% 12.2% Europe/Canada/Australia 11.7% 11.0% 13.6% Europe 8.5% 10.0% 11.5% Pediatrics- De Novo Kidney transplantation PK Study with Long Term Follow-Up One open-label, safety and pharmacokinetic study of CELLCEPT oral suspension 600 mg/m 2 twice daily (up to 1 g twice daily) in combination with cyclosporine and corticosteroids was performed at centers in the United States (9), Europe (5) and Australia (1) in 100 pediatric patients (3 months to 18 years of age) for the prevention… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 104-week oral carcinogenicity study in mice, MMF in daily doses up to 180 mg/kg was not tumorigenic. The highest dose tested was 0.2 times the recommended clinical dose (2 g/day) in renal transplant patients and 0.15 times the recommended clinical dose (3 g/day) in cardiac transplant patients when corrected for differences in body surface area (BSA). In a 104-week oral carcinogenicity study in rats, MMF in daily doses up to 15 mg/kg was not tumorigenic.

The highest dose was 0.035 times the recommended clinical dose in kidney transplant patients and 0.025 times the recommended clinical dose in heart transplant patients when corrected for BSA. While these animal doses were lower than those given to patients, they were maximal in those species and were considered adequate to evaluate the potential for human risk [see Warnings and Precautions (5.2) ]. The genotoxic potential of MMF was determined in five assays.

MMF was genotoxic in the mouse lymphoma/thymidine kinase assay and the in vivo mouse micronucleus assay. MMF was not genotoxic in the bacterial mutation assay, the yeast mitotic gene conversion assay or the Chinese hamster ovary cell chromosomal aberration assay. MMF had no effect on fertility of male rats at oral doses up to 20 mg/kg/day.

This dose represents 0.05 times the recommended clinical dose in renal transplant patients and 0.03 times the recommended clinical dose in cardiac transplant patients when corrected for BSA. In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (principally of the head and eyes) in the first generation offspring in the absence of maternal toxicity. This dose was 0.01 times the recommended clinical dose in renal transplant patients and 0.005 times the recommended clinical dose in cardiac transplant patients when corrected for BSA.

No effects on fertility or reproductive parameters were evident in the dams or in the subsequent generation.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 104-week oral carcinogenicity study in mice, MMF in daily doses up to 180 mg/kg was not tumorigenic. The highest dose tested was 0.2 times the recommended clinical dose (2 g/day) in renal transplant patients and 0.15 times the recommended clinical dose (3 g/day) in cardiac transplant patients when corrected for differences in body surface area (BSA). In a 104-week oral carcinogenicity study in rats, MMF in daily doses up to 15 mg/kg was not tumorigenic.

The highest dose was 0.035 times the recommended clinical dose in kidney transplant patients and 0.025 times the recommended clinical dose in heart transplant patients when corrected for BSA. While these animal doses were lower than those given to patients, they were maximal in those species and were considered adequate to evaluate the potential for human risk [see Warnings and Precautions (5.2) ]. The genotoxic potential of MMF was determined in five assays.

MMF was genotoxic in the mouse lymphoma/thymidine kinase assay and the in vivo mouse micronucleus assay. MMF was not genotoxic in the bacterial mutation assay, the yeast mitotic gene conversion assay or the Chinese hamster ovary cell chromosomal aberration assay. MMF had no effect on fertility of male rats at oral doses up to 20 mg/kg/day.

This dose represents 0.05 times the recommended clinical dose in renal transplant patients and 0.03 times the recommended clinical dose in cardiac transplant patients when corrected for BSA. In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (principally of the head and eyes) in the first generation offspring in the absence of maternal toxicity. This dose was 0.01 times the recommended clinical dose in renal transplant patients and 0.005 times the recommended clinical dose in cardiac transplant patients when corrected for BSA.

No effects on fertility or reproductive parameters were evident in the dams or in the subsequent generation.

📚 References 8 words ▾

15 REFERENCES 1. "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

📖 Instructions for Use ~3 min read ▾

Instructions for Use CELLCEPT ® [SEL-sept] (mycophenolate mofetil) oral suspension Read this Instructions for Use before you take or give CELLCEPT for the first time and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Important: Always use the oral dispenser provided with CELLCEPT Oral Suspension to make sure you measure the right amount of medicine. If your CELLCEPT Oral Suspension does not come with the oral dispenser, contact your pharmacist. Call your pharmacist if your oral dispenser is lost or damaged.

Your pharmacist will write the expiration date on your CELLCEPT Oral Suspension bottle label. Do not use CELLCEPT after the expiration date. Ask your doctor or pharmacist if you have any questions or are unsure about how to take or give the right amount of medicine.

The CELLCEPT Oral Suspension should not be mixed with any type of liquids before taking or giving the dose. Do not let the CELLCEPT Oral Suspension come in contact with the skin. If this happens, wash the skin well with soap and water.

If the CELLCEPT Oral Suspension gets in the eyes, rinse the eyes with plain water. If you spill any CELLCEPT Oral Suspension, wipe it up using paper towels wet with water. Put the child-resistant bottle cap back on the bottle and wipe the outside of the bottle with wet paper towels.

Supplies needed to take or give a dose of CELLCEPT Oral Suspension : To take or give a dose of CELLCEPT Oral Suspension, you will need the bottle of medicine and the oral dispenser provided with the medicine ( See Figure 1 ). Your pharmacist will insert the bottle adapter in the CELLCEPT Oral Suspension bottle. Do not remove the bottle adapter from the bottle.

Figure 1 Taking or giving a dose of CELLCEPT Oral Suspension: Step 1 : With the child-resistant cap on the bottle, shake the bottle well for about 5 seconds before each use. Step 2 : Open the bottle by firmly pressing down on the child-resistant bottle cap and turning it to the left (counter-clockwise). Do not throw away the child-resistant bottle cap.

Step 3 : Place the bottle on a flat surface. Before inserting the tip of the oral dispenser into the bottle adapter, push the plunger completely down toward the tip of the oral dispenser. Use 1 hand to hold the bottle upright.

Insert the oral dispenser tip firmly into the opening of the bottle adapter. Step 4 : Carefully turn the bottle upside down with the oral dispenser tip in place. Slowly pull the plunger down to withdraw your prescribed dose.

Do not pull the plunger out of the oral dispenser (See Figure 2 ). Step 5 : Leave the oral dispenser tip in the bottle and turn the bottle to an upright position. Slowly remove the oral dispenser tip from the bottle.

If there are air bubbles in the oral dispenser or if you have withdrawn the wrong dose, insert the oral dispenser tip back into the bottle adapter while the bottle is in an upright position. Push the plunger gently all the way up so the CELLCEPT Oral Suspension flows back into the bottle. Repeat Step 4 .

Step 6 : Place the tip of the oral dispenser in the mouth directed towards the cheek and slowly push the plunger down until the oral dispenser is empty. Step 7 : Put the child-resistant bottle cap back on the bottle and turn the cap to the right (clockwise) to close the bottle. Keep the bottle tightly closed after each use.

Step 8 : Rinse the oral dispenser under running tap water after each use: Remove the plunger from the oral dispenser. Rinse the oral dispenser and plunger with water only and let them air dry on a paper towel. When the oral dispenser and plunger are dry, put the plunger back in the oral dispenser for the next use.

Do not throw away the oral dispenser. Store the oral dispenser in a clean, dry place. Do not boil the oral dispenser.

Do not use solvent-containing wipes to clean the oral dispenser. Do not use cloths or wipes to dry the oral dispe… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Bottle Carton NDC 0004-0260-43 CellCept ® (mycophenolate mofetil tablets) 500 mg Each tablet contains 500 mg mycophenolate mofetil. Rx only Attention Pharmacist: Dispense the accompanying Medication Guide to each patient. For additional Medication Guides call 1-800-617-8191 or visit www.gene.com/gene/ products/information/cellcept. 500 tablets Genentech 10235320 PRINCIPAL DISPLAY PANEL - 500 mg Tablet Bottle Carton

PRINCIPAL DISPLAY PANEL - 250 mg Capsule Bottle Carton NDC 0004-0259-43 CellCept ® (mycophenolate mofetil capsules) 250 mg Each capsule contains 250 mg mycophenolate mofetil. Rx only Attention Pharmacist: Dispense the accompanying Medication Guide to each patient. For additional Medication Guides call 1-800-617-8191 or visit www.gene.com/gene/ products/information/cellcept.

500 capsules Genentech 10235316 PRINCIPAL DISPLAY PANEL - 250 mg Capsule Bottle Carton

PRINCIPAL DISPLAY PANEL - 500 mg Vial Carton NDC 0004-0298-09 CellCept ® Intravenous (mycophenolate mofetil for injection) 500 mg FOR INTRAVENOUS INFUSION ONLY. Each single-dose vial contains the equivalent of 500 mg mycophenolate mofetil (equivalent to 542 mg of mycophenolate mofetil hydrochloride), 25 mg polysorbate 80 and 5 mg citric acid. Sodium hydroxide or hydrochloric acid may have been used to adjust pH.

Attention Pharmacist: Dispense the accompanying Medication Guide to each patient. For additional Medication Guides, call 1-800-617-8191 or visit www.gene.com/gene/products/information/cellcept. Rx only 4 Single-Dose Vials Genentech 10215811 PRINCIPAL DISPLAY PANEL - 500 mg Vial Carton

PRINCIPAL DISPLAY PANEL - 200 mg/mL Bottle Carton NDC 0004-0261-29 CellCept ® Oral Suspension (mycophenolate mofetil for oral suspension) 200 mg/mL Each mL contains 200 mg mycophenolate mofetil after constitution. Attention Pharmacist: Dispense the accompanying Medication Guide to each patient. For additional Medication Guides, call 1-800-617-8191 or visit www.gene.com/gene/products/information/cellcept.

Rx only Genentech 10225425 PRINCIPAL DISPLAY PANEL - 200 mg/mL Bottle Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Cellcept — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Cellcept. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$894.4K
Claims incl. refills
392
Beneficiaries
216
Spend / beneficiary
$4,140.65
Spend / claim
$2,281.58
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for CellCept (this brand).

Top reported reactions

Diarrhoea6,998
Pyrexia5,718
Pneumonia5,347
Cytomegalovirus Infection4,935
Fatigue4,620
Nausea4,580
Condition Aggravated4,526

Reporter sex

0 reports

Serious outcomes

Death24,303
Life-threatening12,461
Disabling4,397
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 11,589 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Genentech, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Genentech, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J7519 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00004-0261-29 · Genentech, 00004-0800-07 · Genentech, →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.