Adult Dosing
Unresectable metastatic melanoma
- Recommended dose: 960 mg PO bid
- First dose should be taken in the morning and the second dose in the evening approximetly 12 hours later
Notes:- Dose can be taken with or without a meal
- Do not cut/crush/chew the tablet; it should be swallowed whole with a full glass of water
- Patients are treated until disease progression or unacceptable toxicity occurs
- Missed dose can be taken up to 4 hours prior to the next dose to maintain the twice daily regimen; both doses should not be taken at the same time
- Refer to package insert for toxicity-related dose adjustments prior to prescribing vemurafenib
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Cutaneous squamous cell carcinoma (cuSCC), including both SCCs of the skin and keratoacanthomas, has been reported in patients treated with vemurafenib. Dermatologic examination should be considered prior to initiation of therapy and every two months while on therapy; any suspicious skin lesions should be sent for dermatopathologic evaluation and treated as per standard of care. Patients should be monitored for 6 months following discontinuation of vemurafenib
- Non-cutaneous squamous cell carcinomas (SCC) of the head and neck can occur in patients receiving the therapy, therefore closely monitor for signs or symptoms of new non-cutaneous SCC or other malignancies
- Serious hypersensitivity reactions, including anaphylaxis, generalized rash, erythema, or hypotension have occurred in association with vemurafenib and upon re-initiation of treatment. Permanently discontinue the treatment if severe hypersensitivity reactions occur
- Severe dermatologic reactions may occur during therapy; discontinue therapy permanently if severe dermatologic reactions occur
- Exposure-dependent QT prolongation was reported in previously treated patients with BRAF V600E mutation-positive metastatic melanoma. QT prolongation may result in an increased risk of ventricular arrhythmias, including Torsade de Pointes
- Therapy is not recommended in patients with uncorrectable electrolyte abnormalities, long QT syndrome, or who are taking medicinal products known to prolong the QT interval
- Discontinue the treatment permanently if QTc prolongation >500 ms and increased by >60 ms from pretreatment values
- Monitor ECG and electrolytes, including potassium, magnesium, and calcium before treatment with vemurafenib and after dose modification
- Monitoring of ECGs should occur 15 days after starting treatment and then monthly during the first 3 months of treatment, followed by every 3 months thereafter or more often as clinically indicated
- Liver laboratory abnormalities have been reported with vemurafenib. Monitor liver enzymes and bilirubin before therapy initiation and monthly during treatment, or as clinically indicated. Manage lab abnormalities with dose reduction, treatment interruption, or treatment discontinuation
- Mild to severe photosensitivity has been reported in patients treated with vemurafenib. Advise patients to avoid sun exposure while taking the drug and to wear protective clothing, use a broad spectrum UVA/UVB sunscreen and lip balm (SPF
30) when outdoors to help protect against sunburn - Uveitis has been reported in patients treated with vemurafenib. Treatment with steroid and mydriatic ophthalmic drops may be required to manage uveitis. Monitor signs and symptoms of uveitis regularly
- Skin lesions have been reported as new primary malignant melanoma in patients receiving vemurafenib
Cautions: Use cautiously in
- Severe renal impairment
- Severe hepatic impairment
- Electrolyte abnormalities
- Prolonged QT syndrome
- Concurrent QT prolonging agents
Supplemental Patient Information
- Inform patients that an assessment of BRAF V600E mutation with the FDA approved test is recommended for selection of patients appropriate for vemurafenib therapy
- Advise patients to avoid sun exposure while receiving therapy
Pregnancy Category:D
Breastfeeding: Safety unknown. Manufacturer recommends to discontinue breastfeeding when receiving vemurafenib.
