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Vemurafenib Dosage

Medically reviewed by Drugs.com. Last updated on Nov 13, 2017.

Applies to the following strengths: 240 mg

Usual Adult Dose for Melanoma - Metastatic

960 mg orally every 12 hours until disease progression or unacceptable toxicity

Comments:
-Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of therapy.

Use: BRAF V600 mutation-positive unresectable or metastatic melanoma

Usual Adult Dose for Histiocytosis

960 mg orally every 12 hours until disease progression or unacceptable toxicity

Comments:
-Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of therapy.

Use: For Erdheim-Chester Disease (ECD) with BRAF V600 mutation

Renal Dose Adjustments

-Mild to moderate renal dysfunction: No adjustment recommended.
-Severe renal dysfunction: Data not available

Liver Dose Adjustments

-Mild to moderate hepatic dysfunction: No adjustment recommended.
-Severe hepatic dysfunction: Monitor closely.

Dose Adjustments

NEW PRIMARY CUTANEOUS MALIGNANCIES:
-No adjustment recommended.

PERMANENTLY DISCONTINUE THERAPY FOR:
-Grade 4 adverse reaction, first appearance (if appropriate) or second appearance.
-QTc prolongation greater than 500 ms and increased by greater than 60 ms from pre-treatment values.

WITHHOLD THERAPY FOR:
-Intolerable Grade 2 or greater adverse reactions.
-Upon recovery to Grade 1 or less, restart therapy at a reduced dose of 720 mg orally 2 times a day for first appearance of intolerable Grade 2 or Grade 3 adverse reactions OR 480 mg orally 2 times a day for second appearance of Grade 2 (if intolerable) or Grade 3 adverse reactions or for first appearance of Grade 4 adverse reaction (if appropriate).
-Do not dose reduce to below 480 mg orally 2 times a day.

DOSE MODIFICATION FOR STRONG CYP450 3A4 INDUCERS:
-Avoid concomitant use of strong CYP450 3A4 inducers during therapy.
-If concomitant use is unavoidable, increase the dose of this drug by 240 mg as tolerated.
-After discontinuation of a strong CYP450 3A4 inducer for 2 weeks, resume the dose of this drug that was taken prior to initiating the strong CYP450 3A4 inducer.

Precautions

CONTRAINDICATIONS:
-None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of this drug.
-This drug can be taken with or without a meal; however, consistent intake of both daily doses on an empty stomach should be avoided.
-Do not crush or chew tablets.
-A missed dose can be taken up to 4 hours prior to the next dose.
-Do not take an additional dose if vomiting occurs after administration but continue with the next scheduled dose.

Storage requirements:
-Store at room temperature 20C to 25C (68F to 77F); excursions permitted between 15C and 30C (59F and 86F).
-Store in the original container with the lid tightly closed.

General:
-This drug is not indicated for treatment of patients with wild-type BRAF melanoma.

Patient advice:
-This drug can cause mild to severe photosensitivity. Avoid sun exposure, wear protective clothing, and use a broad-spectrum UVA/UVB sunscreen and lip balm (SPF 30 or higher) when outdoors to help protect against sunburn.
-This drug can cause other serious side effects. Notify your healthcare provider immediately if you develop a rash, have trouble breathing or swallowing, feet faint, have swelling of the face, lips, or tongue, have a fast heartbeat, experience blistering or peeling of skin, or develop a fever.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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