CellCept Mycophenolate Mofetil 250 mg Capsule, 100-count — NDC 0004-0259-01 (Billing 00004-0259-01)

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.

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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.

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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.]

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.

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.]

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.]

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.]