Bexarotene 10 mg/g Gel
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Retinoid class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Topical bexarotene is used to treat cutaneous T-cell lymphoma (CTCL, a type of lymphoma [cancer] that attacks the skin that could not be treated with other medications. Bexarotene is in a class of medications called retinoids. It works by stopping the growth of cancer cells.
Read the full MedlinePlus article ↗- Bexarotene is used to treat the skin symptoms of a cancer called cutaneous T-cell lymphoma, or CTCL. It's not a traditional chemotherapy — it's a retinoid, meaning it's related to...
- What exactly is bexarotene used for — is it a chemotherapy?
- Bexarotene can affect several important things in your body — your blood fat levels (triglycerides and cholesterol), your liver, your thyroid, and your white blood cell count. Thes...
- Why do I need so many blood tests while I'm on this medication?
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💊 What it looks like
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🧪 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.
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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.
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UNII 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
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UNII 9XZ8H6N6OH
A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
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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.
4 inactive ingredients listed in the exact product block matched to this NDC.
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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
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💲 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 system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $338.56 | $20,313.72 / 60 g |
| Medicare drug plans payPart D · Q2 2026 | $328.76 | $19,725.38 / 60 g |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Targretin 1 g/100g 00187-5525-60 | Bausch | 1 tube | — | AB | FDA listed | — |
| Bexarotene 10 mg/gthis 69238-2088-06 | Amneal | 1 tube | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69238-2088-06 You're viewing this | 1 TUBE in 1 CARTON (69238-2088-6) / 60 g in 1 TUBE | 2022-05-04 | Active |
🧭 About this NDC listing & data coverage
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) | ✓ Available |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Bexarotene gel, 1% is indicated for the topical treatment of cutaneous lesions in patients with CTCL (Stage IA and IB) who have refractory or persistent disease after other therapies or who have not tolerated other therapies.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Bexarotene gel, 1% should be initially applied once every other day for the first week. The application frequency should be increased at weekly intervals to once daily, then twice daily, then three times daily and finally four times daily according to individual lesion tolerance. Generally, patients were able to maintain a dosing frequency of two to four times per day.
Most responses were seen at dosing frequencies of two times per day and higher. If application site toxicity occurs, the application frequency can be reduced. Should severe irritation occur, application of drug can be temporarily discontinued for a few days until the symptoms subside.
See CONTRAINDICATIONS: Pregnancy . Sufficient gel should be applied to cover the lesion with a generous coating. The gel should be allowed to dry before covering with clothing.
Because unaffected skin may become irritated, application of the gel to normal skin surrounding the lesions should be avoided. In addition, do not apply the gel near mucosal surfaces of the body. A response may be seen as soon as four weeks after initiation of therapy but most patients require longer application.
With continued application, further benefit may be attained. The longest onset time for the first response among the responders was 392 days based on the Composite Assessment of Index Lesion Severity in the multicenter study. In clinical trials, bexarotene gel, 1% was applied for up to 172 weeks.
Bexarotene gel, 1% should be continued as long as the patient is deriving benefit. Occlusive dressings should not be used with bexarotene gel, 1%. BEXAROTENE GEL, 1% IS A TOPICAL THERAPY AND IS NOT INTENDED FOR SYSTEMIC USE.
BEXAROTENE GEL, 1% HAS NOT BEEN STUDIED IN COMBINATION WITH OTHER CTCL THERAPIES.
⛔ Contraindications ▾
CONTRAINDICATIONS Bexarotene gel, 1% is contraindicated in patients with a known hypersensitivity to bexarotene or other components of the product. PREGNANCY Bexarotene gel, 1% may cause fetal harm when administered to a pregnant woman. Bexarotene gel must not be given to a pregnant woman or a woman who intends to become pregnant.
If a woman becomes pregnant while taking bexarotene gel, bexarotene gel must be stopped immediately and the woman given appropriate counseling. 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.
At doses greater than 10 mg/kg/day, bexarotene caused developmental mortality. The no-effect oral dose in rats was 1 mg/kg/day. Plasma bexarotene concentrations in patients with CTCL applying bexarotene gel, 1% were generally less than one hundredth the C max associated with dysmorphogenesis in rats, although some patients had C max levels that were approximately one eighth the concentration associated with dysmorphogenesis in rats.
Women of child-bearing potential should be advised to avoid becoming pregnant when bexarotene gel is used. The possibility that a woman of child-bearing potential is pregnant at the time therapy is instituted should be considered. A negative pregnancy test (e.g., serum beta-human chorionic gonadotropin, beta-HCG) with a sensitivity of at least 50 mIU/L should be obtained within one week prior to bexarotene gel therapy, and the pregnancy test must be repeated at monthly intervals while the patient remains on bexarotene gel.
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. Male patients with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must use condoms during sexual intercourse while applying bexarotene gel and for at least one month after the last dose of drug. Bexarotene gel therapy should be initiated on the second or third day of a normal menstrual period.
No more than a one month supply of bexarotene gel 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.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The safety of bexarotene gel has been assessed in clinical studies of 117 patients with CTCL who received bexarotene gel for up to 172 weeks. In the multicenter open-label study, 50 patients with CTCL received bexarotene gel for up to 98 weeks. The mean duration of therapy for these 50 patients was 199 days.
The most common adverse events reported with an incidence at the application site of at least 10% in patients with CTCL were rash, pruritus, skin disorder, and pain. Adverse events leading to dose reduction or study drug discontinuation in at least two patients were rash, contact dermatitis, and pruritus. Of the 49 patients (98%) who experienced any adverse event, most experienced events categorized as mild (9 patients, 18%) or moderate (27 patients, 54%).
There were 12 patients (24%) who experienced at least one moderately severe adverse event. The most common moderately severe events were rash (7 patients, 14%) and pruritus (3 patients, 6%). Only one patient (2%) experienced a severe adverse event (rash).
In the patients with CTCL receiving bexarotene gel, adverse events reported regardless of relationship to study drug at an incidence of ≥5% are presented in Table 1. A similar safety profile for bexarotene gel was demonstrated in the Phase I-II program. For the 67 patients enrolled in the Phase I-II program, the mean duration of treatment was 436 days (range 12 to 1,203 days).
As in the multicenter study, the most common adverse events regardless of relationship to study drug in the Phase I-II program were rash (78%), pain (40%), and pruritus (40%). Table 1. Incidence of All Adverse Events* and Application Site Adverse Events with Incidence ≥5% for All Application Frequencies of Bexarotene Gel in the Multicenter CTCL Study All Adverse Events Application Site Adverse Events COSTART 5 Body System/Preferred Term N = 50 n (%) N = 50 n (%) Skin and Appendages Contact Dermatitis 1 7 (14) 4 (8) Exfoliative Dermatitis 3 (6) 0 Pruritus 2 18 (36) 9 (18) Rash 3 36 (72) 28 (56) Maculopapular Rash 3 (6) 0 Skin Disorder (NOS) 4 13 (26) 9 (18) Sweating 3 (6) 0 Body as a Whole Asthenia 3 (6) 0 Headache 7 (14) 0 Infection 9 (18) 0 Pain 15 (30) 9 (18) Cardiovascular Edema 5 (10) 0 Peripheral Edema 3 (6) 0 Hemic and Lymphatic Leukopenia 3 (6) 0 Lymphadenopathy 3 (6) 0 WBC Abnormal 3 (6) 0 Metabolic and Nutritional Hyperlipemia 5 (10) 0 Nervous Paresthesia 3 (6) 3 (6) Respiratory Cough Increased 3 (6) 0 Pharyngitis 3 (6) 0 * Regardless of association with treatment Includes Investigator terms such as: 1 Contact dermatitis, irritant contact dermatitis, irritant dermatitis 2 Pruritus, itching, itching of lesion 3 Erythema, scaling, irritation, redness, rash, dermatitis 4 Skin inflammation, excoriation, sticky or tacky sensation of skin; NOS = Not Otherwise Specified To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com
🔄 Drug Interactions ▾
DRUG-DRUG INTERACTIONS Patients who are applying bexarotene gel should not concurrently use products that contain DEET ( N,N -diethyl- m -toluamide), a common component of insect repellent products. An animal toxicology study showed increased DEET toxicity when DEET was included as part of the formulation. No formal studies to evaluate drug interactions with bexarotene have been conducted.
Bexarotene oxidative metabolites appear to be formed through cytochrome P450 3A4. On the basis of the metabolism of bexarotene by cytochrome P450 3A4, concomitant ketoconazole, itraconazole, erythromycin and grapefruit juice could increase bexarotene plasma concentrations. Similarly, based on data that gemfibrozil increases bexarotene concentrations following oral bexarotene administration, concomitant gemfibrozil could increase bexarotene plasma concentrations.
However, due to the low systemic exposure to bexarotene after low to moderately intense gel regimens (see CLINICAL PHARMACOLOGY ), increases that occur are unlikely to be of sufficient magnitude to result in adverse effects. No drug interaction data are available on concomitant administration of bexarotene gel and other CTCL therapies.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use Of the total patients with CTCL in clinical studies of bexarotene gel, 62% were under 65 years and 38% were 65 years or older. No overall differences in safety were observed between patients 65 years of age or older and younger patients, but greater sensitivity of some older individuals to bexarotene gel cannot be ruled out. Responses to bexarotene gel were observed across all age group decades, without preference for any individual age group decade.
🆘 Overdosage ▾
OVERDOSAGE Systemic toxicity following acute overdosage with topical application of bexarotene gel is unlikely because of low systemic plasma levels observed with normal therapeutic doses. There is no specific antidote for overdosage. There has been no experience with acute overdose of bexarotene gel in humans. Any overdose with bexarotene gel should be treated with supportive care for the signs and symptoms exhibited by the patient.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism 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.
Pharmacokinetics General Plasma concentrations of bexarotene were determined during clinical studies in patients with CTCL or following repeated single or multiple-daily dose applications of bexarotene gel, 1% for up to 132 weeks. Plasma bexarotene concentrations were generally less than 5 ng/mL and did not exceed 55 ng/mL. However, only two patients with very intense dosing regimens (> 40% BSA lesions and QID dosing) were sampled.
Plasma bexarotene concentrations and the frequency of detecting quantifiable plasma bexarotene concentrations increased with increasing percent body surface area treated and increasing quantity of bexarotene gel applied. The sporadically observed and generally low plasma bexarotene concentrations indicated that, in patients receiving doses of low to moderate intensity, there is a low potential for significant plasma concentrations following repeated application of bexarotene gel. 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 (see PRECAUTIONS: Protein Binding ). The uptake of bexarotene by organs or tissues has not been evaluated. Metabolism Four bexarotene metabolites have been identified in plasma following oral administration of bexarotene: 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 gel is unknown. Elimination The renal elimination of bexarotene and its metabolites was examined in patients with Type 2 diabetes mellitus following oral administration of bexarotene.
Neither bexarotene nor its metabolites were excreted in urine in appreciable amounts. SPECIAL POPULATIONS Elderly, Gender, Race: Because of a large number of immeasurable plasma concentrations (< 1ng/mL), any potential pharmacokinetic differences between Special Populations could not be assessed. Pediatric: Studies to evaluate bexarotene pharmacokinetics in the pediatric population have not been conducted (see PRECAUTIONS: Pediatric Use ).
Renal Insufficiency: No formal studies have been conducted with bexarotene gel in patients with renal insufficiency. Urinary elimination of bexarotene and its known metabolites is a minor excretory pathway (<1% of an orally administered dose), but because renal insufficiency can result in significant protein binding changes, pharmacokinetics may be altered in patients with renal insufficiency (see PRECAUTIONS: Renal Insufficiency ). Hepatic Insufficiency: No specific studies have been conducted with bexarotene gel in patients with hepatic insufficiency.
Because less than 1% of the dose of oral bexarotene is excreted in the urine unchanged and there is in vitro evidence of extensive hepatic contribution to bexarotene elimination, h…
🧬 Mechanism of Action ▾
Mechanism 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 ▾
HOW SUPPLIED Bexarotene gel, 1% is supplied as a clear, colorless gelled solution free from lumps and foreign matter with homogeneous consistency packaged in white aluminum tubes with a white pointed cap fitted on it containing 60 g (600 mg active bexarotene). 60 g tube ..............................................................................................NDC 69238-2088-6 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid exposing to high temperatures and humidity after the tube is opened.
Protect from light. Distributed by: Amneal Pharmaceuticals, LLC Bridgewater, NJ 08807 Rev. 11-2021-00
📋 Description ▾
DESCRIPTION Bexarotene gel, 1% contains bexarotene and is intended for topical application only. Bexarotene is 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 is 4-[1-(3,5,5,8,8-pentamethyl-5,6,7,8-tetrahydronaphthalen-2-yl)ethenyl] benzoic acid, and the structural formula is as follows: Bexarotene is a white to off-white powder with a molecular weight of 348.478 and a molecular formula of C 24 H 28 O 2 . It is practically insoluble in water, slightly soluble in methanol, sparingly soluble in acetone, soluble in dimethyl sulfoxide, slightly soluble in ethanol and very slightly soluble in vegetable oil. Bexarotene gel, 1% is a clear gelled solution containing 1.0% (w/w) bexarotene in a base of dehydrated alcohol, polyethylene glycol 400, hydroxypropyl cellulose, and butylated hydroxytoluene.
Structural Formula