Applies to the following strength(s): 25 mg/mL
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Usual Adult Dose for:
Additional dosage information:
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
-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.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-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.
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- Other brands: Torisel