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

• 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.

• 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.

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.