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Bexarotene 75 mg Capsule, Liquid Filled, 100-count — NDC 00378-6955-01 package photo
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Bexarotene 75 mg Capsule, Liquid Filled, 100-count — NDC 0378-6955-01 (Billing 00378-6955-01)

by Mylan Pharmaceuticals Inc. · 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

This is a package of 100 capsules of Bexarotene 75 mg Capsule, Liquid Filled from Mylan Pharmaceuticals Inc., marketed since Jul 2015 and currently FDA-listed. It is this product's only package size.

NDC 00378-6955-01
🏷️ FDA NDC (as labeled) 0378-6955-01 billing pads the labeler segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0378-6955-01
Product NDC 0378-6955
11-digit billing NDC 00378695501
NCPDP billing unit EA — each (per item)
Application # ANDA203174
SPL Set ID 2d1eb4bd-51f9-4c9b-9fb1-0be5e30a3dc5
Established class (EPC) Retinoid
Chemical class Retinoids
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-07-09
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance BEXAROTENE
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 044269
GCN 92373
HICL code 020832
Ingredient (HICL) Bexarotene
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1N
Therapeutic class — specific (HIC3) Anp - Selective Retinoid X Receptor Agonists (Rxr)
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name BEXAROTENE 75 MG CAPSULE
FDB brand name Bexarotene
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 044269
  • GCN: 92373
  • HICL (First Databank): 020832
  • AHFS class code: 10:00.00.00
Why two NDCs? The FDA registers this code as 0378-6955-01 — 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 → 00378-6955-01. 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 BEXAROTENE 75 MG CAPSULE Ingredient Bexarotene
📖 What it is MedlinePlus · NLM

Bexarotene is used to treat cutaneous T-cell lymphoma (CTCL, a type of lymphoma [cancer] that attacks the skin) in people whose disease could not be treated successfully with at least one other medication. Bexarotene is in a class of medications called retinoids. It works by stopping the growth of cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Bexarotene is used to treat cutaneous T-cell lymphoma — a type of cancer that mainly shows up in the skin. The capsule form (Targretin or generic bexarotene) is for people who've a...
  • Bexarotene capsules significantly raise blood fat levels — especially triglycerides — in most patients, and very high triglycerides can cause a serious condition called pancreatiti...
  • Why do I need so many blood tests while taking the capsules?
  • This is one of the most critical things about bexarotene — it causes serious birth defects and absolutely cannot be used during pregnancy. You'll need a negative pregnancy test bef...
📖 Read our full Bexarotene guide →
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 $23.47 —
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00378-6955-01 You're viewing this Main listing 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 2015-07-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Targretin 75 mg 00187-5526-75 Bausch 100 capsules — AB FDA listed —
Bexarotene 75 mgthis 00378-6955-01 Mylan 100 capsules — AB FDA listed —
bexarotene 75 mg 00591-2832-01 Actavis 100 capsules — AB FDA listed —
Bexarotene 75 mg 00832-0285-00 Upsher-Smith 100 capsules — AB FDA listed —
Bexarotene 75 mg 31722-0380-01 Camber 100 capsules — AB FDA listed —
Bexarotene 75 mg 42291-0072-01 AvKARE 100 capsules — AB FDA listed —
Bexarotene 75 mg 43975-0315-10 ANI 100 capsules — AB FDA listed —
Bexarotene 75 mg 69238-1250-01 Amneal 100 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2015
On the market since
Jul 2015
📍
2026
Currently FDA-listed
11 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 White
ShapeCapsule
ImprintB75
Size2 mm
ScoringNot scored
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 REK4960K2U
    Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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.

11 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

LabelerMylan Pharmaceuticals Inc.
Application holderBIONPHARMA INC
FDA applicationANDA203174 (ANDA)
Labeler code00378
First marketedJul 2015
Product typeHuman Prescription Drug
Portfolio473 products on file
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 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 96 words ▾

WARNING: BIRTH DEFECTS Bexarotene is a member of the retinoid class of drugs that is associated with birth defects in humans. Bexarotene also caused birth defects when administered orally to pregnant rats. Bexarotene must not be administered to a pregnant woman.

( 8.1 ) WARNING: BIRTH DEFECTS See full prescribing information for complete boxed warning. Bexarotene is a member of the retinoid class of drugs that is associated with birth defects in humans. Bexarotene also caused birth defects when administered orally to pregnant rats.

Bexarotene must not be administered to a pregnant woman. ( 8.1 )

🎯 Indications and Usage 60 words ▾

1 INDICATIONS AND USAGE Bexarotene capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. Bexarotene is a retinoid indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended initial dose of bexarotene capsules is 300 mg/m 2 /day (see Table 1). Bexarotene capsules should be taken as a single oral daily dose with a meal. For precautions to prevent pregnancy and birth defects in women of child-bearing potential [ see Use in Specific Populations (8.1) ].

Table 1: Bexarotene Capsules Initial Dose Calculation According to Body Surface Area Initial Dose Level (300 mg/m 2 /day) Number of 75 mg Bexarotene Capsules Body Surface Area (m 2 ) Total Daily Dose (mg/day) 0.88 to 1.12 300 4 1.13 to 1.37 375 5 1.38 to 1.62 450 6 1.63 to 1.87 525 7 1.88 to 2.12 600 8 2.13 to 2.37 675 9 2.38 to 2.62 750 10 Dose Modification Guidelines: The 300 mg/m 2 /day dose level of bexarotene capsules may be adjusted to 200 mg/m 2 /day then to 100 mg/m 2 /day, or temporarily suspended, if necessitated by toxicity.

When toxicity is controlled, doses may be carefully readjusted upward. If there is no tumor response after eight weeks of treatment and if the initial dose of 300 mg/m 2 /day is well tolerated, the dose may be escalated to 400 mg/m 2 /day with careful monitoring. Duration of Therapy: In clinical trials in CTCL, bexarotene was administered for up to 97 weeks.

Bexarotene capsules should be continued as long as the patient is deriving benefit. • Recommended initial dose is 300 mg/m 2 /day. ( 2 ) • Take bexarotene capsules as a single oral daily dose with a meal. ( 2 ) • Dose adjustment: may be adjusted to 200 mg/m 2 /day then to 100 mg/m 2 /day.

( 2 )

💊 Dosage Forms and Strengths 27 words ▾

3 DOSAGE FORMS AND STRENGTHS Capsules: 75 mg, white to off-white, oblong soft gelatin capsules printed with B75 in black ink. Capsules: 75 mg ( 3 )

⛔ Contraindications 121 words ▾

4 CONTRAINDICATIONS • Pregnancy ( Boxed Warning , 4.1 ) • Known hypersensitivity to bexarotene ( 4.2 )

4.1Pregnancy Bexarotene can cause fetal harm when administered to a pregnant female. Bexarotene is a member of the retinoid class of drugs that is associated with birth defects in humans and is contraindicated in females who are pregnant. Bexarotene was also teratogenic and caused developmental mortality when administered orally to pregnant rats.

If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential risk to a fetus.

4.2Hypersensitivity Bexarotene capsules are contraindicated in patients with a known serious hypersensitivity to bexarotene or other components of the product.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Hyperlipidemia: Bexarotene causes elevations in blood lipids. Obtain baseline values, monitor, and manage elevations during therapy by dose reduction, interruption, discontinuation and/or lipid lowering therapy. ( 5.1 , 5.11 ) • Pancreatitis: Interrupt bexarotene and evaluate if suspected.

( 5.2 ) • Hepatotoxicity, cholestasis, and hepatic failure: Interrupt or discontinue bexarotene and evaluate if liver chemistry tests exceed three times the upper limit of normal values. ( 5.3 ) • Hypothyroidism: Bexarotene therapy can cause hypothyroidism. Monitor and replace thyroid hormone if needed ( 5.5 ) • Neutropenia: Monitor for neutropenia.

Reduce bexarotene dose or interrupt as indicated. ( 5.6 ) • Photosensitivity: Minimize exposure to sunlight and artificial ultraviolet light during treatment. ( 5.10 )

5.1Hyperlipidemia Bexarotene induces substantial elevations in lipids in most patients. About 70% of patients with CTCL who received an initial dose of ≥300 mg/m 2 /day of bexarotene had fasting triglyceride levels greater than 2.5 times the upper limit of normal. About 55% had values over 800 mg/dL with a median of about 1,200 mg/dL in those patients.

Cholesterol elevations above 300 mg/dL occurred in approximately 60% and 75% of patients with CTCL who received an initial dose of 300 mg/m 2 /day or greater than 300 mg/m 2 /day, respectively. Decreases in high density lipoprotein (HDL) cholesterol to less than 25 mg/dL were seen in about 55% and 90% of patients receiving an initial dose of 300 mg/m 2 /day or greater than 300 mg/m 2 /day, respectively, of bexarotene. Monitor lipid changes and treat abnormalities during therapy.

The effects on triglycerides, HDL cholesterol, and total cholesterol were reversible with cessation of therapy, and could generally be mitigated by dose reduction and/or concomitant antilipemic therapy. Perform fasting blood lipid determinations before bexarotene therapy is initiated and weekly until the lipid response to bexarotene is established, which usually occurs within two to four weeks, and monitor at eight week intervals thereafter. Fasting triglycerides should be normal or normalized with appropriate intervention prior to initiating bexarotene therapy.

Maintain triglyceride levels below 400 mg/dL to reduce the risk of clinical sequelae [ see Warnings and Precautions (5.2) ]. If fasting triglycerides are elevated or become elevated during treatment, institute antilipemic therapy, and if necessary, reduce or interrupt the dose of bexarotene. In the 300 mg/m 2 /day initial dose group, 60% of patients were given lipid lowering drugs.

Atorvastatin was used in 48% (73/152) of patients with CTCL. Because of a potential drug-drug interaction, avoid gemfibrozil use with bexarotene [ see Drug Interactions (7) ].

5.2Pancreatitis Acute pancreatitis, including a fatal case, has been reported in four patients with CTCL and in six patients with non-CTCL cancers treated with bexarotene; the cases were associated with marked elevations of fasting serum triglycerides, the lowest being 770 mg/dL in one patient. One patient with advanced non‑CTCL cancer died of pancreatitis. Interrupt bexarotene and evaluate if pancreatitis is suspected.

Patients with CTCL who have risk factors for pancreatitis (e.g., prior pancreatitis, uncontrolled hyperlipidemia, excessive alcohol consumption, uncontrolled diabetes mellitus, biliary tract disease, and medications known to increase triglyceride levels or to be associated with pancreatic toxicity) may be at greater risk for pancreatitis associated with bexarotene [ see Warnings and Precautions (5.1) ].

5.3Hepatotoxicity, cholestasis, and hepatic failure Bexarotene caused elevations in liver chemistry tests (LFTs) in 5% (AST), 2% (ALT), and 0% (bilirubin) in patients with CTCL receiving an initial dose of 300 mg/m 2 /day. In contrast, with an initial dose greater than 300 mg/m 2 /day of bexarotene, the incidence of LFT elevations was higher at 7% (SGOT/A… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information: • Hyperlipidemia [ see Warnings and Precautions (5.1) ] • Pancreatitis [ see Warnings and Precautions (5.2) ] • Hepatotoxicity, cholestasis, and hepatic failure [ see Warnings and Precautions (5.3) ] • Hypothyroidism [ see Warnings and Precautions (5.4) ] • Neutropenia [ see Warnings and Precautions (5.5) ] • Cataracts [ see Warnings and Precautions (5.6) ] • Vitamin A Supplementation Hazard [ see Warnings and Precautions (5.7) ] • Hypoglycemia Risk in Patients with Diabetes Mellitus [ see Warnings and Precautions (5.8) ] • Photosensitivity [ see Warnings and Precautions (5.9) ] • Laboratory Tests [ see Warnings and Precautions (5.10) ] • Drug/Laboratory Test Interactions [ see Warnings and Precautions (5.11) ] The most common adverse reactions (greater than 10%) include: hyperlipidemia, hypercholesteremia, headache, hypothyroidism, asthenia, leukopenia, rash, nausea, infection, peripheral edema, abdominal pain, and dry skin.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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. The safety of bexarotene has been evaluated in two clinical trials of 152 patients with CTCL who received bexarotene for up to 97 weeks and in 352 patients in other trials. The mean duration of therapy for the 152 patients with CTCL was 166 days.

The most common adverse events reported with an incidence of at least 10% in patients with CTCL treated at an initial dose of 300 mg/m 2 /day of bexarotene are shown in Table 2. The events at least possibly related to treatment are lipid abnormalities (elevated triglycerides, elevated total and LDL cholesterol and decreased HDL cholesterol), hypothyroidism, headache, asthenia, rash, leukopenia, anemia, nausea, infection, peripheral edema, abdominal pain, and dry skin. Most adverse events occurred at a greater incidence in patients treated at starting doses of greater than 300 mg/m 2 /day (see Table 2).

Adverse reactions leading to bexarotene dose reduction or discontinuation in at least two patients were hyperlipemia, neutropenia/leukopenia, diarrhea, fatigue/lethargy, hypothyroidism, headache, liver function test abnormalities, rash, pancreatitis, nausea, anemia, allergic reaction, muscle spasm, pneumonia, and confusion. The NCI Grade 3 and NCI Grade 4 adverse reactions reported in two or more patients with CTCL treated at an initial dose of 300 mg/m 2 /day of bexarotene (see Table 3) were hypertriglyceridemia, pruritus, headache, peripheral edema, leukopenia, rash, and hypercholesteremia.

Most of these moderately severe or severe adverse events occurred at a higher rate in patients treated at starting doses of greater than 300 mg/m 2 /day than in patients treated at a starting dose of 300 mg/m 2 /day. In patients with CTCL receiving an initial dose of 300 mg/m 2 /day, the incidence of NCI Grade 3 or 4 elevations in triglycerides and total cholesterol was 28% and 25%, respectively (Table 4). In contrast, in patients with CTCL receiving greater than 300 mg/m 2 /day, the incidence of NCI Grade 3 or 4 elevated triglycerides and total cholesterol was 45% and 45%, respectively.

Other Grade 3 and 4 laboratory abnormalities are shown in Table 3. In addition to the 152 patients enrolled in the two CTCL trials, 352 patients received bexarotene as monotherapy for various advanced malignancies at doses from 5 mg/m 2 /day to 1,000 mg/m 2 /day. The common adverse reactions (incidence greater than 10%) were similar to those seen in patients with CTCL.

In the 504 pa… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Effect of Other Drugs on Bexarotene Gemfibrozil: Concomitant administration of bexarotene and gemfibrozil resulted in increases in plasma concentrations of bexarotene. Concomitant administration of gemfibrozil with bexarotene is not recommended. Effect of Bexarotene on Other Drugs Bexarotene may be an inducer for the CYP3A4 enzymes, and may reduce plasma concentrations of other substrates metabolized by CYP3A4.

Drug products which may be affected include oral or other systemic hormonal contraceptives. Thus, if treatment with bexarotene is intended for a female with reproductive potential, it is strongly recommended that a non-hormonal contraception be considered. [ see Use in Specific Populations (8.3) , Clinical Pharmacology (12.3) ]. Laboratory Test Interference CA125 assay values in patients with ovarian cancer may be increased by bexarotene therapy.

Drug Interactions Effect of Other Drugs on Bexarotene CYP3A4 Inhibitors/Inducers: In a clinical study, concomitant administration of multiple doses of ketoconazole with bexarotene did not alter bexarotene plasma concentrations. This suggests that bexarotene elimination is not dependent on CYP3A4 metabolism. Paclitaxel plus Carboplatin: The co-administration of paclitaxel (200 mg/m 2 IV dose over 3 hours) plus carboplatin (at a dose expected to achieve an AUC of 6 mg●min/mL) with bexarotene (400 mg/m 2 orally once daily) increased the exposure to bexarotene (AUC 0-24 and C max ) by 2-fold compared to bexarotene alone .

Atorvastatin: Bexarotene concentrations were not affected by concomitant atorvastatin administration. Effect of Bexarotene on Other Drugs Bexarotene did not significantly inhibit the following enzymes in human liver microsomes: CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4. In vitro data suggested a potential for bexarotene to inhibit CYP2C8 and induce CYP3A4.

Atorvastatin: The exposure (AUC) to atorvastatin (a substrate for CYP3A4) decreased by half when atorvastatin was co-administered with bexarotene (400 mg/m 2 orally once daily). Tamoxifen: Based on interim data, concomitant administration of bexarotene and tamoxifen resulted in approximately a 35% decrease in plasma concentrations of tamoxifen, possibly through induction of CYP3A4 by bexarotene. Paclitaxel: The exposure (AUC) to paclitaxel (a substrate for CYP3A4 and CYP2C8) decreased by 19% when paclitaxel (200 mg/m 2 IV dose over 3 hours) was co-administered with bexarotene (400 mg/m 2 orally once daily).

Carboplatin: The co-administration of bexarotene (400 mg/m 2 orally once daily) had no effect on the exposure to free or total carboplatin.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Bexarotene, a retinoid, can cause fetal harm based on findings from animal studies when administered to a pregnant female and is contraindicated during pregnancy. Bexarotene was teratogenic and caused developmental mortality in rats following oral administration during organogenesis [see Data ] . Bexarotene must not be given to a pregnant female or a female who intends to become pregnant.

If pregnancy does occur during treatment with bexarotene, immediately discontinue the drug and advise the pregnant female of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.

Data Animal Data Bexarotene caused malformations when administered orally to pregnant rats during days 7 to 17 of gestation. Developmental abnormalities included incomplete ossification at 4 mg/kg/day and cleft palate, depressed eye bulge/microphthalmia, and small ears at 16 mg/kg/day. The plasma AUC of bexarotene in rats at 4 mg/kg/day is approximately one third the AUC in humans at the recommended daily dose.

At doses greater than 10 mg/kg/day, bexarotene caused developmental mortality. The no effect dose for fetal effects in rats was 1 mg/kg/day (producing an AUC approximately one sixth of the AUC at the recommended human daily dose).

8.2Lactation Risk Summary There is no information regarding the presence of bexarotene in human milk, the effects on the breast fed infant, or the effects on milk production. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from bexarotene, discontinue breastfeeding during treatment with bexarotene.

8.3Females and Males of Reproductive Potential Pregnancy Testing Obtain a negative serum pregnancy test (e.g., serum beta-human chorionic gonadotropin [beta-HCG]) with a sensitivity of at least 50 mlU/L within one week prior to bexarotene therapy. Obtain another pregnancy test at monthly intervals while the patient remains on bexarotene. Contraception Females Bexarotene can cause fetal harm when administered to a pregnant female [ see Use in Specific Populations (8.1) ].

Females of reproductive potential should be advised to avoid becoming pregnant when bexarotene is used. Effective contraception must be used for one month prior to the initiation of therapy, during therapy and for at least one month following discontinuation of therapy; it is recommended that two reliable forms of contraception be used simultaneously unless abstinence is the chosen method. Bexarotene can potentially induce metabolic enzymes and thereby theoretically reduce the plasma concentrations of oral or other systemic hormonal contraceptives [ see Drug Interactions (7) ].

Thus, if treatment with bexarotene is intended in a female with reproductive potential, it is strongly recommended that one of the two reliable forms of contraception should be non-hormonal. Bexarotene therapy should be initiated on the second or third day of a normal menstrual period. No more than a one month supply of bexarotene should be given to the patient so that the results of pregnancy testing can be assessed and counseling regarding avoidance of pregnancy and birth defects can be reinforced.

Males Male patients with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must use condoms during sexual intercourse while taking bexarotene and for at least one month after the last dose of drug.

8.4Pediatric Use Safety and effectiveness of bexarotene in pediatric patients have not been established.

8.5Geriatric Use Of the total patients with CTCL in clinical trials of bexarotene, 64% were 60 years or older, while 33% were 70 years or older. No overall differences in safety were observed between p… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Bexarotene, a retinoid, can cause fetal harm based on findings from animal studies when administered to a pregnant female and is contraindicated during pregnancy. Bexarotene was teratogenic and caused developmental mortality in rats following oral administration during organogenesis [see Data ] . Bexarotene must not be given to a pregnant female or a female who intends to become pregnant.

If pregnancy does occur during treatment with bexarotene, immediately discontinue the drug and advise the pregnant female of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.

Data Animal Data Bexarotene caused malformations when administered orally to pregnant rats during days 7 to 17 of gestation. Developmental abnormalities included incomplete ossification at 4 mg/kg/day and cleft palate, depressed eye bulge/microphthalmia, and small ears at 16 mg/kg/day. The plasma AUC of bexarotene in rats at 4 mg/kg/day is approximately one third the AUC in humans at the recommended daily dose.

At doses greater than 10 mg/kg/day, bexarotene caused developmental mortality. The no effect dose for fetal effects in rats was 1 mg/kg/day (producing an AUC approximately one sixth of the AUC at the recommended human daily dose).

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Safety and effectiveness of bexarotene in pediatric patients have not been established.

🧓 Geriatric Use 74 words ▾

8.5Geriatric Use Of the total patients with CTCL in clinical trials of bexarotene, 64% were 60 years or older, while 33% were 70 years or older. No overall differences in safety were observed between patients 70 years or older and younger patients, but greater sensitivity of some older individuals to bexarotene cannot be ruled out. Responses to bexarotene were observed across all age group decades, without preference for any individual age group decade.

🆘 Overdosage 62 words ▾

10 OVERDOSAGE Doses up to 1,000 mg/m 2 /day of bexarotene have been administered in short-term trials in patients with advanced cancer without acute toxic effects. Single doses of 1,500 mg/kg and 720 mg/kg were tolerated without significant toxicity in rats and dogs, respectively. These doses are approximately 30 and 50 times, respectively, the recommended human dose on a mg/m 2 basis.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Bexarotene selectively binds and activates retinoid X receptor subtypes (RXRα, RXRβ, RXRγ). RXRs can form heterodimers with various receptor partners such as retinoic acid receptors (RARs), vitamin D receptor, thyroid receptor, and peroxisome proliferator activator receptors (PPARs). Once activated, these receptors function as transcription factors that regulate the expression of genes that control cellular differentiation and proliferation.

Bexarotene inhibits the growth in vitro of some tumor cell lines of hematopoietic and squamous cell origin. It also induces tumor regression in vivo in some animal models. The exact mechanism of action of bexarotene in the treatment of cutaneous T-cell lymphoma (CTCL) is unknown.

12.3Pharmacokinetics Terminal half-life of bexarotene is approximately seven hours. Studies in patients with advanced malignancies show approximate single dose linearity within the therapeutic range. Absorption After oral administration of bexarotene, bexarotene is absorbed with a T max of about two hours.

Plasma bexarotene AUC and C max values resulting from a 75 to 300 mg dose were 35% and 48% higher, respectively, after a fat-containing meal than after a glucose solution. Distribution Bexarotene is highly bound (>99%) to plasma proteins. The plasma proteins to which bexarotene binds have not been elucidated, and the ability of bexarotene to displace drugs bound to plasma proteins and the ability of drugs to displace bexarotene binding have not been studied.

Elimination Metabolism Four bexarotene metabolites have been identified in plasma: 6- and 7-hydroxy-bexarotene and 6- and 7‑ oxo-bexarotene. In vitro studies suggest that cytochrome P450 3A4 is the major cytochrome P450 responsible for formation of the oxidative metabolites and that the oxidative metabolites may be glucuronidated. The oxidative metabolites are active in in vitro assays of retinoid receptor activation, but the relative contribution of the parent and any metabolites to the efficacy and safety of bexarotene is unknown.

Excretion The renal elimination of bexarotene and its metabolites was examined in patients with Type 2 diabetes mellitus. Urinary elimination of bexarotene and its known metabolites is a minor excretory pathway (<1% of administered dose). Pharmacokinetics in Specific Populations Age: Based on the population pharmacokinetic analysis of data for 232 patients aged ≥65 years and 343 patients aged <65 years, age has no statistically significant effect on bexarotene pharmacokinetics.

Body Weight and Gender: Based on the population pharmacokinetics analysis of data for 614 patients with a weight range of 26 to 145 kg, the bexarotene apparent clearance increases with increasing body weight. Gender has no statistically significant effect on bexarotene pharmacokinetics. Race: Based on the population pharmacokinetic analysis of data for 540 Caucasian and 44 Black patients, bexarotene pharmacokinetics are similar in Blacks and Caucasians.

There are insufficient data to evaluate potential differences in the pharmacokinetics of bexarotene for other races. Renal Impairment: No formal studies have been conducted with bexarotene in patients with renal impairment. Urinary elimination of bexarotene and its known metabolites is a minor excretory pathway (<1% of administered dose), but because renal impairment can result in significant protein binding changes, pharmacokinetics may be altered in patients with renal impairment.

Hepatic Impairment: No specific studies have been conducted with bexarotene in patients with hepatic impairment. Because less than 1% of the dose is excreted in the urine unchanged and there is in vitro evidence of extensive hepatic contribution to bexarotene elimination, hepatic impairment would be expected to lead to greatly decreased clearance. Drug Interactions Effect of Other Drugs on Bexarotene CYP3A4 Inhibitors/Inducers: In a clinical study, concomitant administration of… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 106 words ▾

12.1Mechanism of Action Bexarotene selectively binds and activates retinoid X receptor subtypes (RXRα, RXRβ, RXRγ). RXRs can form heterodimers with various receptor partners such as retinoic acid receptors (RARs), vitamin D receptor, thyroid receptor, and peroxisome proliferator activator receptors (PPARs). Once activated, these receptors function as transcription factors that regulate the expression of genes that control cellular differentiation and proliferation.

Bexarotene inhibits the growth in vitro of some tumor cell lines of hematopoietic and squamous cell origin. It also induces tumor regression in vivo in some animal models. The exact mechanism of action of bexarotene in the treatment of cutaneous T-cell lymphoma (CTCL) is unknown.

📦 How Supplied / Storage and Handling 62 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Bexarotene capsules are supplied as 75 mg white to off-white, oblong soft gelatin capsules printed with B75 in black ink, in high density polyethylene bottles with child-resistant closures. Bottles of 100 capsules: NDC 0378-6955-01 Store at 2° to 25°C (36° to 77°F). Avoid exposing to high temperatures and humidity after the bottle is opened. Protect from light.

📋 Description 154 words ▾

11 DESCRIPTION Bexarotene capsules contain bexarotene, a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs). The chemical name of bexarotene is 4-[1-(5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl) ethenyl] benzoic acid, and the structural formula is as follow: Bexarotene is an off-white to white powder with a molecular weight of 348.48 and a molecular formula of C 24 H 28 O 2 .

It is insoluble in water and slightly soluble in vegetable oils and ethanol, USP. Each bexarotene capsule contains 75 mg of bexarotene for oral administration. It also contains the following inactive ingredients: polyethylene glycol 400, NF, polysorbate 20, NF, povidone, USP, and butylated hydroxyanisole, NF.

The capsule shell contains gelatin, NF, water, sorbitol sorbitan solution, NF, glycerin, USP and titanium dioxide, USP. The imprinting ink contains hypromellose, USP, iron oxide black, and polyethylene glycol, USP. Bexarotene Structural Formula

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Inform the patient or caregiver about the following: Birth Defects Advise patients that bexarotene capsules are contraindicated in pregnancy [see Contraindications (4.1) ]. Bexarotene capsules are member of the retinoid class of drugs that is associated with birth defects in humans [see Use In Specific Populations (8.1) ]. • Advise females of reproductive potential that they must avoid pregnancy while taking bexarotene capsules and for at least one month following discontinuation of therapy. • Advise females of reproductive potential of the importance of monthly pregnancy testing while taking bexarotene capsules. • Advise females of reproductive potential to use effective contraception for one month prior to the initiation of therapy, during therapy, and for at least one month following discontinuation of therapy and that two reliable forms of contraception should be used simultaneously, one of which should be non-hormonal. • Advise females of reproductive potential that bexarotene capsules therapy should be initiated on the second or third day of a normal menstrual period. • Instruct patient to immediately stop taking bexarotene capsules if she becomes pregnant while taking this drug. • Advise male patients with sexual partners who are pregnant, possibly pregnant, or who could become pregnant that they must use condoms during sexual intercourse while taking bexarotene capsules and for at least one month after the last dose of the drug.

Pancreatitis Advise patients of the risk of developing pancreatitis, which may be accompanied by nausea, vomiting, and abdominal or back pain and to immediately contact their healthcare provider if these symptoms occur [see Warnings and Precautions (5.2) ] . Hepatotoxicity Inform patients of the possibility of developing liver function abnormalities and serious hepatic toxicity. Advise patients to immediately contact their healthcare provider if signs of liver failure occur, including jaundice, anorexia, bleeding, or bruising [see Warnings and Precautions (5.3) ] .

Neutropenia Advise patients of the possibility of developing neutropenia and to immediately contact their healthcare provider should they develop a fever, particularly in association with any suggestion of infection [see Warnings and Precautions (5.5) ] . Cataracts Advise patients of the possibility of developing new or worsening cataracts and to inform their healthcare provider about any changes in their vision during treatment with bexarotene capsules [see Warnings and Precautions (5.6) ] . Vitamin A Supplementation Hazard Advise patients to limit vitamin A intake to ≤15,000 IU/day to avoid potential additive toxic effects.

Hypoglycemia and Diabetes Mellitus Advise patients of the possibility of developing hypoglycemia when using insulin, agents enhancing insulin secretion, or insulin-sensitizers while on bexarotene capsules therapy. Instruct patients on these medications to check their blood sugar frequently and to notify their physicians of any changes in blood sugar level [see Warnings and Precautions (5.8) ] . Photosensitivity Advise patients of potential increased skin sensitivity to sunlight while taking bexarotene capsules and to minimize exposure to sunlight and artificial ultraviolet light [see Warnings and Precautions (5.9) ] .

Laboratory Tests Advise patients of laboratory testing which will occur during therapy to monitor lipids, liver function, thyroid function, and white blood cell counts [see Warnings and Precautions (5.10) ]. If applicable, advise patients of monthly pregnancy testing [see Use In Specific Populations (8.3) ] . Administration Instructions Advise patients to take bexarotene capsules with a meal [see DOSAGE AND ADMINISTRATION ].

All trademarks or registered trademarks are the trademarks or registered trademarks of their respective owners. Manufactured for: Mylan Pharmaceuticals Inc. M… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Terminal half-life of bexarotene is approximately seven hours. Studies in patients with advanced malignancies show approximate single dose linearity within the therapeutic range. Absorption After oral administration of bexarotene, bexarotene is absorbed with a T max of about two hours.

Plasma bexarotene AUC and C max values resulting from a 75 to 300 mg dose were 35% and 48% higher, respectively, after a fat-containing meal than after a glucose solution. Distribution Bexarotene is highly bound (>99%) to plasma proteins. The plasma proteins to which bexarotene binds have not been elucidated, and the ability of bexarotene to displace drugs bound to plasma proteins and the ability of drugs to displace bexarotene binding have not been studied.

Elimination Metabolism Four bexarotene metabolites have been identified in plasma: 6- and 7-hydroxy-bexarotene and 6- and 7‑ oxo-bexarotene. In vitro studies suggest that cytochrome P450 3A4 is the major cytochrome P450 responsible for formation of the oxidative metabolites and that the oxidative metabolites may be glucuronidated. The oxidative metabolites are active in in vitro assays of retinoid receptor activation, but the relative contribution of the parent and any metabolites to the efficacy and safety of bexarotene is unknown.

Excretion The renal elimination of bexarotene and its metabolites was examined in patients with Type 2 diabetes mellitus. Urinary elimination of bexarotene and its known metabolites is a minor excretory pathway (<1% of administered dose). Pharmacokinetics in Specific Populations Age: Based on the population pharmacokinetic analysis of data for 232 patients aged ≥65 years and 343 patients aged <65 years, age has no statistically significant effect on bexarotene pharmacokinetics.

Body Weight and Gender: Based on the population pharmacokinetics analysis of data for 614 patients with a weight range of 26 to 145 kg, the bexarotene apparent clearance increases with increasing body weight. Gender has no statistically significant effect on bexarotene pharmacokinetics. Race: Based on the population pharmacokinetic analysis of data for 540 Caucasian and 44 Black patients, bexarotene pharmacokinetics are similar in Blacks and Caucasians.

There are insufficient data to evaluate potential differences in the pharmacokinetics of bexarotene for other races. Renal Impairment: No formal studies have been conducted with bexarotene in patients with renal impairment. Urinary elimination of bexarotene and its known metabolites is a minor excretory pathway (<1% of administered dose), but because renal impairment can result in significant protein binding changes, pharmacokinetics may be altered in patients with renal impairment.

Hepatic Impairment: No specific studies have been conducted with bexarotene in patients with hepatic impairment. Because less than 1% of the dose is excreted in the urine unchanged and there is in vitro evidence of extensive hepatic contribution to bexarotene elimination, hepatic impairment would be expected to lead to greatly decreased clearance. Drug Interactions Effect of Other Drugs on Bexarotene CYP3A4 Inhibitors/Inducers: In a clinical study, concomitant administration of multiple doses of ketoconazole with bexarotene did not alter bexarotene plasma concentrations.

This suggests that bexarotene elimination is not dependent on CYP3A4 metabolism. Paclitaxel plus Carboplatin: The co-administration of paclitaxel (200 mg/m 2 IV dose over 3 hours) plus carboplatin (at a dose expected to achieve an AUC of 6 mg●min/mL) with bexarotene (400 mg/m 2 orally once daily) increased the exposure to bexarotene (AUC 0-24 and C max ) by 2-fold compared to bexarotene alone . Atorvastatin: Bexarotene concentrations were not affected by concomitant atorvastatin administration.

Effect of Bexarotene on Other Drugs Bexarotene did not significantly inhibit the following enzymes in human liver microsomes: CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Bexarotene was evaluated in two clinical trials in 152 patients with advanced and early stage cutaneous T-cell lymphoma (CTCL) in two multicenter, open-label, historically-controlled clinical trials conducted in the U.S., Canada, Europe, and Australia. The advanced disease patients had disease refractory to at least one prior systemic therapy (median of two, range one to six prior systemic therapies) and had been treated with a median of five (range 1 to 11) prior systemic, irradiation, and/or topical therapies.

Early disease patients were intolerant to, had disease that was refractory to, or had reached a response plateau of six months on, at least two prior therapies. The patients entered had been treated with a median of 3.5 (range 2 to 12) therapies (systemic, irradiation, and/or topical). The two clinical trials enrolled a total of 152 patients, 102 of whom had disease refractory to at least one prior systemic therapy, 90 with advanced disease and 12 with early disease.

This is the patient population for whom bexarotene is indicated. Patients were initially treated with a starting dose of 650 mg/m 2 /day with a subsequent reduction of starting dose to 500 mg/m 2 /day. Neither of these starting doses was tolerated, and the starting dose was then reduced to 300 mg/m 2 /day.

If, however, a patient on 300 mg/m 2 /day of bexarotene showed no response after eight or more weeks of therapy, the dose could be increased to 400 mg/m 2 /day. Tumor response was assessed in both trials by observation of up to five baseline-defined index lesions using a Composite Assessment of Index Lesion Disease Severity (CA). This endpoint was based on a summation of the grades, for all index lesions, of erythema, scaling, plaque elevation, hypopigmentation or hyperpigmentation, and area of involvement.

Also considered in response assessment was the presence or absence of cutaneous tumors and extracutaneous disease manifestations. All tumor responses required confirmation over at least two assessments separated by at least four weeks. A partial response was defined as an improvement of at least 50% in the index lesions without worsening, or development of new cutaneous tumors or non-cutaneous manifestations.

A complete clinical response required complete disappearance of all manifestations of disease, but did not require confirmation by biopsy. At the initial dose of 300 mg/m 2 /day, 1/62 (1.6%) of patients had a complete clinical tumor response and 19/62 (30%) of patients had a partial tumor response. The rate of relapse (25% increase in CA or worsening of other aspects of disease) in the 20 patients who had a tumor response was 6/20 (30%) over a median duration of observation of 21 weeks, and the median duration of tumor response had not been reached.

Responses were seen as early as 4 weeks and new responses continued to be seen at later visits. In one post-approval clinical trial with a total of 59 subjects (29 in 300 mg/m 2 /day dose group and 30 in the 150 mg/m 2 /day dose), the objective response rate was higher in the bexarotene 300 mg/m 2 /day group than in the bexarotene 150 mg/m 2 /day group with respect to the CA (34.5% vs 23.3%), Physicians Global Assessment (PGA) (37.9% vs 20.0%), and percent BSA involvement (34.5% vs 23.3%). The median duration of response in the bexarotene 300 mg/m 2 /day group based on the CA, PGA, and percent BSA involvement was 86.5 days, 72.0 days and 60.0 days respectively.

While in the bexarotene 150 mg/m 2 /day group the median duration of response based on the CA, PGA, and percent BSA involvement was 55 days, 119.0 days and 118.0 days respectively. The median time to cutaneous tumor response (the time to cutaneous tumor response for a given subject is defined as the time interval from the first day of bexarotene treatment to the time of the first observation when the subject with subsequent confirmation of response meets criteria for CR, CCR or PR) in the bexarotene 300 mg/m 2 /day group bas… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 88 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to assess the carcinogenic potential of bexarotene have not been conducted. Bexarotene is not mutagenic to bacteria (Ames assay) or mammalian cells (mouse lymphoma assay). Bexarotene was not clastogenic in vivo (micronucleus test in mice).

No formal fertility studies were conducted with bexarotene. Bexarotene caused testicular degeneration when oral doses of 1.5 mg/kg/day were given to dogs for 91 days (producing an AUC of approximately one fifth the AUC at the recommended human daily dose).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 85 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to assess the carcinogenic potential of bexarotene have not been conducted. Bexarotene is not mutagenic to bacteria (Ames assay) or mammalian cells (mouse lymphoma assay). Bexarotene was not clastogenic in vivo (micronucleus test in mice).

No formal fertility studies were conducted with bexarotene. Bexarotene caused testicular degeneration when oral doses of 1.5 mg/kg/day were given to dogs for 91 days (producing an AUC of approximately one fifth the AUC at the recommended human daily dose).

📄 Patient Package Insert ~3 min read ▾

Patient Information BEXAROTENE (beks-AIR-oh-teen) capsules What is the most important information I should know about bexarotene capsules? Bexarotene capsules can cause serious side effects, including major birth defects to an unborn baby, if taken during pregnancy. For females who can become pregnant: • You should avoid becoming pregnant during treatment with bexarotene capsules. • Do not take bexarotene capsules if you are pregnant or plan to become pregnant. • Your healthcare provider will do a pregnancy test, within one week before you start bexarotene capsules, and each month during treatment with bexarotene capsules to make sure that you are not pregnant. • You must use two effective forms of birth control together starting one month before you begin treatment with bexarotene capsules, during treatment, and for one month after stopping bexarotene capsules .

Birth control pills (oral contraceptives) and other hormonal forms of birth control may not be effective if used with bexarotene capsules. At least one of the forms of birth control that you choose should not contain hormones. Talk to your healthcare provider about what forms of birth control may be right for you during treatment with bexarotene capsules. • You should start taking bexarotene capsules on the second or third day of a normal menstrual period .

Follow your healthcare provider’s instructions about when to start bexarotene capsules. • Call your healthcare provider right away, if you become pregnant or think that you are pregnant during treatment with bexarotene capsules, and for one month after you stop taking bexarotene capsules. For males : • You must use a condom with female partners who are pregnant, might be pregnant, or who are able to become pregnant, during treatment with bexarotene capsules and for at least one month after your last dose. What are bexarotene capsules?

Bexarotene capsules are prescription medicine used to treat the skin problems that happen with a type of cancer called cutaneous T-cell lymphoma (CTCL) after treatment with at least one other type of medicine by mouth or injection, did not work or has stopped working. It is not known if bexarotene capsules is safe and effective in children. Who should not take bexarotene capsules?

Do not take bexarotene capsules: • if you are pregnant or plan to become pregnant. See “ What is the most important information I should know about bexarotene capsules?” • if you are allergic to bexarotene or any of the ingredients in bexarotene capsules. See the end of this leaflet for a complete list of ingredients in bexarotene capsules.

Before taking bexarotene capsules, tell your healthcare provider about all of your medical conditions, including if you: • have or have had problems with your pancreas, including pancreatitis • have or have had gallbladder problems • have or have had liver problems • have thyroid problems • have diabetes • have high levels of fats (lipids) called cholesterol or triglycerides in your blood • have cataracts or a history of cataracts • drink alcohol • are pregnant, plan to become pregnant, or think you may be pregnant.

See “What is the most important information I should know about bexarotene capsules?” • are breastfeeding or plan to breastfeed. It is not known if bexarotene passes into your breast milk. You should not breastfeed during treatment with bexarotene capsules.

Talk to your healthcare provider about the best way to feed your baby during treatment with bexarotene capsules. Tell your healthcare provider about all of the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. Using bexarotene capsules with certain other medicines can affect each other.

How should I take bexarotene capsules? • Take bexarotene capsules exactly as your healthcare provider tells you. • Your healthcare provider will tell you how many bexarotene capsules to take each day. Your healthcare provider may change your daily dose of bexarotene… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 147 words ▾

PRINCIPAL DISPLAY PANEL – 75 mg NDC 0378-6955-01 Bexarotene Capsules 75 mg PHARMACIST: Dispense the accompanying Patient Information Leaflet to each patient. Rx only 100 Capsules Each capsule contains: Bexarotene 75 mg Inactive ingredients: Each capsule contains polyethylene glycol 400, NF, polysorbate 20, NF, povidone, USP, and butylated hydroxyanisol, NF. The capsule shell contains gelatin, NF, water, sorbitol sorbitan solution, NF, glycerin, USP, and titanium dioxide, USP.

The imprinting ink contains hypromellose, USP, iron oxide black, and polyethylene glycol, USP. Usual Dosage: See package insert. Store at 2° to 25°C (36° to 77°F).

AVOID EXPOSING TO HIGH TEMPERATURES AND HUMIDITY AFTER THE BOTTLE IS OPENED. PROTECT FROM LIGHT. KEEP OUT OF REACH OF CHILDREN.

PATIENT: READ ACCOMPANYING PATIENT INFORMATION CAREFULLY. Manufactured by: Patheon Softgels, Inc. High Point, NC 27265 Manufactured for: Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A. Mylan.com RBNR6955A1 70036788 Bexarotene Capsules 75 mg Bottle Label

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 Bexarotene — the program that covers self-administered drugs. 6 manufacturers.
⚠️ 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 Bexarotene. 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
$12.07M
Claims incl. refills
2.2K
Beneficiaries
937
Spend / beneficiary
$12,883.82
Spend / claim
$5,382.14
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.

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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 Mylan Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Mylan Pharmaceuticals 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.
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.
← 00378-6921-91 · Mylan 00378-6960-93 · Mylan →
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.