MedeliX
Start asking

Bexarotene

Targretin · ATC code L01XF03

Also known as: Bexaroten, Beksaroten · Brand names: Targretin, Bexagia, Bexaroten Cipla, Beksar, Bexgratin

Key facts
Active substance
Bexarotene
ATC code
L01XF03
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Targretin 75 mg soft capsules
Marketing authorisation holder
H.A.C. Pharma
Information as of
2026-10-29

Key facts

Bexarotene is a retinoid that selectively activates retinoid X receptors. It is used to treat skin manifestations of advanced-stage cutaneous T-cell lymphoma in adults.

What it is used for

  • Skin manifestations of advanced-stage cutaneous T-cell lymphoma (CTCL) in adults refractory to at least one systemic treatment.

Dosing

  • Targretin (75 mg soft capsules): recommended initial dose 300 mg/m2/day, calculated from body surface area; take with a meal and swallow capsules intact without chewing.
  • For adverse reactions (e.g. raised triglycerides) the dose may be reduced to 200 mg/m2/day and if necessary to 100 mg/m2/day, or treatment discontinued – details in the full text.
  • Hepatic insufficiency: contraindicated. Not recommended in children below 18 years.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients.
  • Pregnancy and lactation; women of child-bearing potential without effective birth control.
  • History of pancreatitis; uncontrolled hypercholesterolaemia or hypertriglyceridaemia; hypervitaminosis A.
  • Uncontrolled thyroid disease; hepatic insufficiency; ongoing systemic infection.

Important warnings

  • Hyperlipidaemia: check fasting lipids before starting and weekly until the lipid response is established; do not combine with gemfibrozil.
  • Acute pancreatitis associated with raised triglycerides; patients with risk factors should generally not be treated.
  • Liver tests: at baseline, weekly in the first month, then monthly; consider suspension or discontinuation above three times the upper limit of normal.
  • Thyroid: reductions in T4 and TSH; check thyroid function at baseline and at least monthly. Leucopenia: monitor white cell counts.
  • Possible photosensitivity – minimise sun exposure and avoid sun lamps. Patients should not donate blood.

Side effects

  • Most common at the recommended initial dose: hyperlipaemia (mainly raised triglycerides, 74%), hypothyroidism (29%), hypercholesterolaemia (28%), headache (27%), leucopenia (20%), pruritus (20%), asthenia (19%), rash (16%), exfoliative dermatitis (15%) and pain (12%).
  • Serious: acute pancreatitis, liver test elevations.

Interactions

  • Gemfibrozil substantially increases bexarotene levels; combination not recommended.
  • CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin) may increase levels; CYP3A4 inducers (e.g. rifampicin, phenytoin) may decrease them.
  • Bexarotene may reduce the efficacy of oral contraceptives and may enhance the effect of insulin, sulfonylureas or thiazolidinediones (hypoglycaemia).

Pregnancy and breastfeeding

  • Contraindicated in pregnancy and lactation. Negative pregnancy test within one week before starting; effective contraception (two reliable forms recommended, one non-hormonal) during and for at least one month after treatment.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • BexagiaPelpharma Handels Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Bexaroten CiplaCipla Europe Nv · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • BeksarNOBEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • BexgratinKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 9 more European countries
Denmark
Bexarotene
Finland
Bexarotene Amdipharm
France
Bexarotene Cipla
Iceland
Targretin
Italy
Bexarotene Cipla
Liechtenstein
Targretin
Norway
Bexarotene Amdipharm, Targretin
Spain
Bexaroteno Cipla
Sweden
Bexarotene Amdipharm

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Targretin – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/targretin-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.