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MedsAcross

Molecule

Bexarotene

Retinoid
Available on requestOrphanOncology
Presentations
4
Brands
1
Manufacturers
1
Available from stock
0

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. MedsAcross supplies Bexarotene for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Retinoid
ATC classification
L01XF03 Bexarotene · Cancer medicines (antineoplastics), subgroup L01X, subgroup L01XFL01XX25 Bexarotene · Cancer medicines (antineoplastics), subgroup L01X, subgroup L01XX
US FDA first approval
29 December 1999
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral, Topical
Dosage forms
Capsule, Gel
Identifiers
UNII A61RXM4375RxCUI 233272CAS 153559-49-0DrugBank DB00307Q418192

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

TARGRETIN ® (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. TARGRETIN (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.

Source: US FDA prescribing information

How it works

Bexarotene selectively binds and activates retinoid X receptor subtypes (RXRα, RXRß, 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.

Source: US FDA prescribing information

Dosing overview

The recommended initial dose of TARGRETIN is 300 mg/m 2 /day. TARGRETIN 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. Table 1: TARGRETIN Initial Dose Calculation According to Body Surface Area Initial Dose Level (300 mg/m 2 /day) Number of 75 mg TARGRETIN Capsules Body Surface Area (m 2 ) Total Daily Dose (mg/day) 0.88 – 1.12 300 4 1.13 – 1.37 375 5 1.38 – 1.62 450 6 1.63 – 1.87 525 7 1.88 – 2.12 600 8 2.13 – 2.37 675 9 2.38 – 2.62 750 10 Dose Modification Guidelines: The 300 mg/m 2 /day dose level of TARGRETIN 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.

Source: US FDA prescribing information

Contraindications

• Pregnancy (Boxed Warning, 4.1 ) • Known hypersensitivity to bexarotene Pregnancy TARGRETIN can cause fetal harm when administered to a pregnant female. TARGRETIN 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.

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (birth defects targretin): 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. TARGRETIN must not be administered to a pregnant woman. WARNING: BIRTH DEFECTS TARGRETIN is a member of the retinoid class of drugs that is associated with birth defects in humans. • Hyperlipidemia: TARGRETIN causes elevations in blood lipids. Obtain baseline values, monitor, and manage elevations during therapy by dose reduction, interruption, discontinuation and/or lipid lowering therapy. • Pancreatitis: Interrupt TARGRETIN and evaluate if suspected. • Hepatotoxicity, Cholestasis, and Hepatic Failure: Interrupt or discontinue TARGRETIN and evaluate if liver chemistry tests exceed three times the upper limit of normal values.

Source: US FDA prescribing information

Side effects

The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information: • Hyperlipidemia • Pancreatitis • Hepatotoxicity, Cholestasis, and Hepatic Failure • Hypothyroidism • Neutropenia • Cataracts • Vitamin A Supplementation Hazard • Hypoglycemia Risk in Patients with Diabetes Mellitus • Photosensitivity • Laboratory Tests • Drug/Laboratory Test Interactions 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.

Source: US FDA prescribing information

Interactions

Effect of Other Drugs on TARGRETIN Gemfibrozil: Concomitant administration of TARGRETIN and gemfibrozil resulted in increases in plasma concentrations of bexarotene. Concomitant administration of gemfibrozil with TARGRETIN is not recommended. Effect of TARGRETIN on Other Drugs TARGRETIN 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 TARGRETIN is intended for a female with reproductive potential, it is strongly recommended that a non-hormonal contraception be considered. Laboratory Test Interference CA125 assay values in patients with ovarian cancer may be increased by TARGRETIN therapy.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

4 presentations of Bexarotene, sorted by availability.

MedicineManufacturerRegisterAvailability
Bexarotene 75 mg capsuleOralGeneric name—US FDAAvailable on request
Bexarotene 1% gelTopicalGeneric name—US FDAAvailable on request
Targretin 1% gelTopicalBausch HealthUS FDAAvailable on request
Targretin 75 mg capsuleOralBausch HealthUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 29 December 1999Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Bexarotene in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Bexarotene available for export from India?

Yes, on request. MedsAcross lists 4 presentations of Bexarotene and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Bexarotene have?

The catalogue lists 1 brand names for Bexarotene, including Targretin.

Is Bexarotene approved by the US FDA?

Yes. The US FDA first approved Bexarotene on 29 December 1999, according to Drugs@FDA.

Is Bexarotene authorised in the European Union?

Yes. Bexarotene has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Bexarotene need cold chain shipping?

No listed presentation of Bexarotene is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Bexarotene in?

Bexarotene is classified under ATC code L01XF03 (Bexarotene).

References

  1. Targretin prescribing information (Bausch Health). U.S. National Library of Medicine, DailyMed. Retrieved 30 April 2020
  2. Targretin: European public assessment report (EPAR). European Medicines Agency. Retrieved 12 August 2025

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