This dosage information may not include all the information needed to use Vemurafenib safely and effectively. See additional information for Vemurafenib.
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Melanoma - Metastatic
960 mg orally twice a day.
Renal Dose Adjustments
No adjustment to the starting dose is needed for patients with preexisting mild and moderate renal impairment. Vemurafenib should be used with caution in patients with preexisting severe renal impairment.
Liver Dose Adjustments
No adjustment to the starting dose is needed for patients with preexisting mild and moderate hepatic impairment. Vemurafenib should be used with caution in patients with preexisting severe hepatic impairment.
No dosage adjustment is recommended based on gender, weight, or geriatric status.
Management of symptomatic adverse drug reactions or prolongation of QTc may require dose modification, treatment interruption, or treatment discontinuation of vemurafenib.
Recommended dose modification for adverse events graded by the Common Terminology Criteria for Adverse Events v4.0 (CTC-AE) is as follows:
For CTC-AE Grade 1 or Grade 2 (tolerable): Maintain vemurafenib at a dose of 960 mg orally twice daily.
For CTC-AE Grade 2 (intolerable) or Grade 3: For a first appearance, interrupt treatment until grade 0-1 and resume dosing at 720 mg orally twice daily. For a second appearance, interrupt treatment until grade 0-1 and resume dosing at 480 mg orally twice daily. For a third appearance, discontinue vemurafenib permanently.
For CTC-AE Grade 4: For a first appearance, discontinue vemurafenib permanently or interrupt vemurafenib until grade 0-1 and resume dosing at 480 mg orally twice daily. For a second appearance, discontinue vemurafenib permanently.
Confirmation of BRAF V600E mutation-positive melanoma as detected by an FDA approved test is required for selection of patients for vemurafenib therapy. The efficacy and safety of vemurafenib have not been established in patients with wild-type BRAF melanoma.
Cutaneous squamous cell carcinomas (cuSCC) and new primary malignant melanomas have been reported in patients treated with vemurafenib. It is recommended to perform dermatologic evaluations prior to initiation of therapy, every 2 months while on therapy and should be considered for 6 months following discontinuation of vemurafenib. Cases of cuSCC and new primary malignant melanomas may be managed with excision, and treatment may be continued without dose modification.
Permanent discontinuation of vemurafenib is recommended in patients who experience severe hypersensitivity or severe dermatologic reactions.
QT prolongation has been reported in association with vemurafenib use. Electrocardiogram (ECG) and electrolytes should be monitored before treatment with vemurafenib and after any dose modifications. ECG monitoring should be repeated 15 days after treatment start, monthly during the first 3 months of treatment, and then every 3 months, or more frequently if clinically indicated. Initiation of vemurafenib is not recommended for patients with baseline QTc above 500 ms, and treatment should be temporarily interrupted for posttreatment QTc values greater than 500 ms. If after any electrolyte abnormalities are corrected, and cardiac risk factors for QT prolongation are controlled, the QTc returns to below 500 ms, vemurafenib therapy may be reinitiated at a lower dose. If QTc remains above 500 ms and has increased by 60 ms or more from baseline, permanent discontinuation of vemurafenib is recommended.
Liver laboratory abnormalities have occurred with vemurafenib. Liver enzymes (transaminases and alkaline phosphatase) and bilirubin should be monitored before treatment and monthly during treatment, or as clinically indicated. Laboratory abnormalities may be managed with dose reduction, treatment interruption, or treatment discontinuation.
Mild to severe photosensitivity has been reported in patients treated with vemurafenib. All patients should be advised to avoid sun exposure while on vemurafenib. Patients should be advised to wear protective clothing and use a broad spectrum UVA/UVB sunscreen and lip balm (SPF greater than or equal to 30) when outdoors. Dose modifications are recommended for intolerable grade 2 (tender erythema covering 10 to 30% body surface area) or greater photosensitivity.
Serious ophthalmologic reactions, including uveitis, iritis and retinal vein occlusion, have been reported. Patients should be monitored routinely for ophthalmologic reactions. Treatment with steroid and mydriatic ophthalmic drops may be required to manage uveitis.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Data not available.
Vemurafenib can be taken with or without a meal.
Vemurafenib tablets should be swallowed whole with a glass of water. Vemurafenib tablets should not be chewed or crushed.
It is recommended that patients are treated with vemurafenib until disease progression or unacceptable toxicity occurs.