Bexarotene Topical Dosage

Medically reviewed by Drugs.com. Last updated on Dec 9, 2024.

Usual Adult Dose for Cutaneous T-cell Lymphoma

Initial dose: Apply a generous coating to the lesion once every other day for 1 week

• Increase at weekly intervals to once day, then twice daily, then 3 times a day, up to 4 times a day according to individual lesion tolerance

Maintenance dose: 2 to 4 applications daily
Maximum dose: 4 applications per day
Duration of therapy: As long as benefit is derived

Comments:

• Most responses were seen at twice daily dosing or higher.
• Consider reducing frequency for application site toxicity.
• Temporarily discontinue for severe irritation, for a few days until symptoms subside.
• Response may occur as soon as 4 weeks, but most take longer; longest onset for first response was 392 days.
• Do not use occlusive dressings with this product.

Renal Dose Adjustments

Data not available

• There are no controlled data in renal impairment.
• Urinary excretion of the drug and its active metabolites is less than 1% of the oral dose.
• Pharmacokinetics may be altered in renal insufficiency due to significant changes in protein binding.

Liver Dose Adjustments

Data not available

• No studies have been conducted in hepatic insufficiency.
• Greatly decreased clearance is expected in hepatic impairment.
• There is evidence of extensive hepatic involvement in elimination; less than 1% of the urinary excretion of an oral dose is excreted unchanged.

Precautions

US BOXED WARNING(S): PREGNANCY

• Not for use in pregnant patients or those who plan to become pregnant.
• Patients should contact their healthcare provider immediately if they become pregnant while using this drug or within one month of stopping the drug.
• Patients that are capable of becoming pregnant must have a negative pregnancy test within one week of starting this drug and monthly during treatment.
• Effective contraception must be used continuously beginning one month before treatment and continuing for one month after stopping treatment.
• Concomitant use of 2 forms of reliable contraception (e.g. condoms, diaphragms, cervical caps, IUDs, spermicides) is strongly recommended.
• Males with a partner that is pregnant or capable of becoming pregnant should discuss precautions with their healthcare provider.

CONTRAINDICATIONS:

• Hypersensitivity to any of the ingredients
• Pregnancy or intention to become pregnant; stop use immediately if pregnancy occurs
• Animal oral administration studies during days 7 to 17 of pregnancy showed fetal malformations, developmental abnormalities, developmental mortality, and dysmorphogenesis.
• Advise patients of childbearing potential to avoid pregnancy; consider the possibility of pregnancy at therapy initiation: obtain a negative pregnancy test one week prior to therapy initiation, repeat at least monthly during therapy and for at least 1 month after end of therapy.
• Dispense only 1 month supplies pending pregnancy test results and reinforcement of counseling to avoid pregnancy.
• Two simultaneous reliable contraceptive methods (or abstinence) are recommended during therapy and for at least 1 month after end of therapy.
• Males with sexual partners who are pregnant or may become pregnant should use condoms during intercourse during therapy and for at least 1 month after end of therapy.
• Initiate therapy on the second or third day of normal menses.

Safety and efficacy have not been established in patients younger than 18 years.

Dialysis

Data not available

Other Comments

Administration advice:

• Apply sufficient gel for a generous coating of the lesion.
• Allow gel to dry before covering with clothing.
• Avoid applying to skin around lesions; irritation may occur.
• Do not apply near mucosal surfaces.
• Do not use occlusive dressings with this product.
• Not intended for systemic use.
• Use in combination with other cutaneous T-cell lymphoma (CTCL) therapies has not been studied.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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