Usual Adult Dose for Renal Cell Carcinoma

1.34 mg orally once a day for 21 days followed by 7 days off (28-day cycle) until disease progression or unacceptable toxicity

Use: For adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following 2 or more prior systemic therapies

Renal Dose Adjustments

Mild/moderate/severe renal impairment (CrCl 15 to 89 mL/min): No adjustment recommended.
End-stage renal disease: Data not available

Liver Dose Adjustments

Mild (total bilirubin less than or equal to upper limit of normal [ULN] with AST greater than ULN or total bilirubin greater than 1 to 1.5 x ULN with any AST) hepatic impairment: No adjustment recommended.
Moderate (total bilirubin greater than 1.5 to 3 x ULN with any AST) hepatic impairment: Reduce dose to 0.89 mg orally once a day for 21 days followed by 7 days off (28-day cycle)
Severe (total bilirubin greater than 3 to 10 x ULN with any AST) hepatic impairment: Data not available

Dose Adjustments

Initiate medical management for diarrhea, nausea, or vomiting prior to dose interruption or reduction.

Recommended dose modifications:

• Reduce the dose to 0.89 mg orally once a day for 21 days followed by 7 days off for a 28-day cycle.

• Grade 3: Withhold therapy for Grade 3 that persists despite antihypertensive therapy; resume at reduced dose when hypertension is controlled at less than or equal to Grade 2.
• Grade 4: Permanently discontinue therapy.

• Grade 3: Withhold until improvement to Grade 0, 1, or baseline; resume at reduced dose or discontinue therapy based on severity and persistence of adverse reaction.
• Grade 4: Permanently discontinue therapy.

• Any Grade: Permanently discontinue therapy.

• Grade 3 or 4: Permanently discontinue therapy.

• Two grams or greater proteinuria in 24 hours: Withhold therapy until less than or equal to 2 grams of proteinuria in 24 hours; resume at a reduced dose; permanently discontinue for nephrotic syndrome.

• Any Grade: Permanently discontinue therapy.

• Persistent or intolerable Grade 2 or 3 adverse reaction:
• Grade 4 laboratory abnormality: Withhold therapy until improvement to Grade 0, 1, or baseline; resume at reduced dose.
• Grade 4 adverse reaction: Permanently discontinue therapy.

Precautions

CONTRAINDICATIONS:

• None

Dialysis

Data not available

Other Comments

Administration advice:

• This drug can be taken with or without food.
• Swallow the capsule whole with a glass of water.
• Swallow capsule whole; do not open, crush, or chew the capsule.
• If a dose is missed, the next dose should be taken at the next scheduled time; do not take two doses at the same time.
• In the case of vomiting a replacement dose should not be taken; the next dose should be taken at the next scheduled time.

• Store at 20C to 25C (68F to 77F); excursions permitted between 15C to 30C (59F to 86F).