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.

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.

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.

• 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.

• 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.

• 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

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.

• 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.

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

• 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.