Usual Adult Dose for Basal Cell Carcinoma

200 mg orally once a day until disease progression or unacceptable toxicity

Comments:

• Prior to therapy initiation, serum creatinine kinase (CK) levels and renal function tests should be obtained.
• Verify pregnancy status in all patients of reproductive potential.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

No adjustment recommended.

Dose Adjustments

For the following conditions, interrupt therapy until resolution of symptoms then resume at 200 mg/day:

• Severe or intolerable musculoskeletal adverse reactions
• First occurrence of serum CK elevation between 2.5 and 10 x ULN
• Recurrent serum CK elevation between 2.5 and 5 x ULN

• Serum CK elevation greater than 2.5 x ULN with worsening renal function
• Serum CK elevation greater than 10 x ULN
• Recurrent serum CK elevation greater than 5 x ULN
• Recurrent severe or intolerable musculoskeletal adverse reactions

Precautions

US BOXED WARNINGS:

• This drug can cause embryofetal death or severe birth defects when administered to a pregnant woman and is embryotoxic, fetotoxic, and teratogenic in animals.
• Verify the pregnancy status of females of reproductive potential prior to initiating therapy.
• Advise females of reproductive potential to use effective contraception during therapy and for at least 20 months after.
• Advise males of the potential risk of exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during therapy for at least 8 months after.

• None

Dialysis

Data not available

Other Comments

Administration Advice:

• This drug should be taken on an empty stomach at least 1 hour before or 2 hours after a meal.
• This drug should be taken at the same time each day.
• A missed dose should be skipped; treatment should be resumed with the next scheduled dose.
• Swallow capsules whole; do not chew or crush.
• If a dose is missed, take it within 6 hours after the missed dose. If more than 6 hours have passed, do not to take the missed dose.

• Embryofetal Toxicity: Pregnancy test (before treatment initiation)
• Musculoskeletal: Baseline serum CK and creatinine levels (before treatment initiation, periodically during treatment, and as clinically indicated; at least weekly during treatment in patients with musculoskeletal adverse reactions with concurrent serum CK elevations greater than 2.5 x ULN)
• Renal: Renal function tests (before treatment initiation)

• This drug can interact with a variety of medications. Tell your doctor about all the medications you take, including prescription and over-the-counter drugs, vitamins, dietary and herbal supplements.

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