Usual Adult Dose for Cutaneous T-cell Lymphoma

300 mg/m2/day orally once a day with a meal

Duration of Therapy: This drug should be continued as long as the patient is deriving benefit. In clinical trials with CTCL patients, this drug was administered for up to 118 weeks.

Comments: If there is no tumor response after 8 weeks of treatment and the initial dose was well-tolerated, the dose may be escalated to 400 mg/m2/day with careful monitoring.

Use: Treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients refractory to at least one prior systemic therapy.

Renal Dose Adjustments

No adjustment recommended; however, caution is advised due to renal impairment potentially causing significant drug protein binding changes.

Liver Dose Adjustments

No adjustment recommended; however, caution is advised due to the potential of greatly decreased drug clearance.

Dose Adjustments

If Toxicity Occurs:

• Reduce dose to 200 mg/m2/day then to 100 mg/m2/day, or temporarily suspend treatment.
• Carefully readjust dose upward when toxicity is controlled.

• Institute antilipemic therapy.
• If necessary, reduce dose to 200 mg/m2/day then to 100 mg/m2/day, or discontinue treatment.

Precautions

US BOXED WARNING: This drug should not be administered to pregnant women because it is a retinoid, a class of drugs associated with birth defects in humans. It has also caused birth defects in pregnant rats.

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

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:

• For female patients of reproductive potential, this drug should be initiated on the second or third day of a normal menstrual period.
• The drug capsule should be swallowed whole and not chewed.

• This drug should be stored between 2 to 25 degrees Celsius (36 to 77 Fahrenheit), and should be kept away from light, heat, and humidity.

• No more than a 1-month supply of this drug should be given so that the results of pregnancy testing can be assessed.

• Endocrine: Thyroid function tests (baseline and at least monthly during treatment), blood sugar levels
• Hepatic: LFTs (baseline; after 1, 2, and 4 weeks of treatment initiation; and if stable, at least every 8 weeks thereafter)
• Hematologic: CBC with differential and hemoglobin (baseline, weekly during first month, and monthly thereafter)
• Metabolic: Fasting blood lipids (before treatment initiation, weekly until the lipid response to this drug is established, and at 8-week intervals thereafter)

• Avoid eating grapefruit and drinking grapefruit juice during therapy.
• This drug may cause side effects such as dizziness and vision problems that can affect your ability to perform certain activities; avoid driving and potentially dangerous activities such as operating machinery until you know how this drug affects you.