Usual Adult Dose for Renal Cell Carcinoma

25 mg IV infusion over a 30 to 60 minute period once a week
Duration of therapy: Treat until disease progression or unacceptable toxicity

Comments: IV diphenhydramine 25 to 50 mg (or similar antihistamine) should be given approximately 30 minutes before the start of each dose

Use: Advanced renal cell carcinoma

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild hepatic impairment (bilirubin greater than 1 and up to 1.5 times upper limit of normal [ULN] or AST greater than ULN but bilirubin less than or equal to ULN): Reduce dose to 15 mg/week

Dose Adjustments

• Absolute neutrophil count less than 1,000/mm3, platelet count less than 75,000/mm3, or NCI CTACAE grade 3 or greater adverse reactions: Hold drug. Once toxicities have resolved to grade 2 or less, drug may be restarted with the dose reduced by 5 mg/week to a dose no lower than 15 mg/week.
• Concomitant use of strong CYP450 3A4/5 inducers: Avoid or consider a dose increase to 50 mg/week. If the strong inducer is discontinued, the drug dose should be returned to the dose used prior.
• Concomitant use of strong CYP450 3A4 inhibitors: Avoid or consider dose reduction to 12.5 mg/week. If the strong inhibitor is discontinued, a washout period of approximately 1 week should be allowed before the drug dose is adjusted back to the dose used prior.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients

Dialysis

Data not available

Other Comments

Administration advice:

• Administration of the final diluted solution should be completed within 6 hours from the time that the drug is reconstituted.
• The use of an infusion pump is the preferred method of administration.
• The undiluted drug injection should not be added directly to aqueous infusion solutions.
• Do not use if particulates are present or if discolored; use a new vial.
• Preparation, handling, and disposal of this drug should be performed in a manner consistent with safe procedures for cytotoxic agents.
• The manufacturer product information should be consulted for further administration and preparation information.

• Refrigerate and protect from light.

• The drug is degraded by both acids and bases; combinations with agents capable of modifying solution pH should be avoided.

• Test serum glucose before and during treatment.
• Assess AST and bilirubin levels before treatment initiation and periodically thereafter.
• Monitor patients throughout the IV infusion for hypersensitivity reactions and have appropriate supportive care available.
• Monitor for the occurrence of infections, including opportunistic infections.
• Test serum cholesterol and triglycerides before and during treatment.
• Monitor renal function at baseline and during treatment.
• Perform baseline radiographic assessment by lung computed tomography scan or chest radiograph prior to therapy initiation and periodically thereafter.
• Monitor for occurrence of clinical respiratory symptoms.

• Vaccinations may be less effective if given while being treated with this drug.
• Avoid close contact with live vaccines and those who have received live vaccines during treatment.
• Fetal harm may occur with this drug; avoid pregnancy during treatment. Women who are able to become pregnant and men who take this drug should use birth control during treatment and for at least 3 months after stopping treatment. If pregnancy occurs, contact your doctor immediately.
• Tell your doctor about all the medications you take, including prescription and over-the-counter drugs, vitamins, dietary and herbal supplements, so possible interactions can be evaluated.
• Do not drink grapefruit juice or eat grapefruit while taking this drug as it may increase the drug amount in your blood to a harmful level.
• Do not use St. John's Wort while taking this drug as it may decrease the drug amount in your blood.