Dabrafenib Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Melanoma - Metastatic

Single agent therapy: 150 mg orally twice a day, approximately 12 hours apart.
Combination therapy: 150 mg orally twice a day, approximately 12 hours apart, in combination with trametinib 2 mg orally once a day.

Duration of therapy:
-Continue until disease progression or unacceptable toxicity occurs.

Comments:
-Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation as a single agent.
-Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with dabrafenib in combination with trametinib.
-Take either at least 1 hour before or at least 2 hours after a meal.

FDA approved indications:
-Unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
-In combination with trametinib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.

Renal Dose Adjustments

Mild to moderate renal dysfunction: No adjustment recommended
Severe renal impairment: An appropriate dose has not been established.

Liver Dose Adjustments

Mild Liver Dysfunction: No adjustment recommended
Moderate to Severe Liver Dysfunction: Dose adjustment may be required; however, an appropriate dose has not been established.

Dose Adjustments

First dose reduction: 100 mg orally twice daily
Second dose reduction: 75 mg orally twice daily
Third dose reduction: 50 mg orally twice daily
If unable to tolerate 50 mg twice daily: Discontinue dabrafenib

For New Primary Cutaneous Malignancies that develop: No dose modifications are recommended.
For New Primary Non-Cutaneous Malignancies: Permanently discontinue in patients who develop RAS mutation-positive non-cutaneous malignancies.

Fever 101.3F to 104F:
-Withhold dabrafenib until adverse reaction resolves, then resume at same dose or at a reduced level.

Fever higher than 104F or fever with complications (rigors, hypotension, dehydration or renal failure):
-Either permanently discontinue dabrafenib, or
-Withhold dabrafenib until adverse reaction resolves, then resume at a reduced dose level.

Intolerable Grade 2 skin toxicity or Grade 3 or 4 skin toxicity:
-Withhold dabrafenib for up to 3 weeks.
-If improved, resume at a lower dose level.
-If not improved, permanently discontinue

Symptomatic congestive heart failure or absolute decrease in LVEF of greater than 20% from baseline that is below LLN:
-Withhold dabrafenib.
-If improved, resume at the same dose.

Life threatening Pulmonary Embolism:
-Permanently discontinue dabrafenib.

Uveitis and Iritis:
-Withhold dabrafenib for up to 6 weeks.
-If improved to Grade 1 or less, then resume at the same dose.
-If not improved, permanently discontinue.

Other:
Intolerable Grade 2 adverse reactions or any Grade 3 adverse reactions:
-Withhold dabrafenib until adverse reaction resolves to Grade 1 or less, then resume at a reduced dose level.
-If not improved, permanently discontinue.

First occurrence of any Grade 4 adverse reaction:
-Either permanently discontinue dabrafenib, or
-Withhold dabrafenib until adverse reaction resolves to Grade 1 or less, then resume at a reduced dose level.

Recurrent Grade 4 adverse reaction:
-Permanently discontinue dabrafenib.

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

Other Comments

Patient advice:
-Dabrafenib should be taken either at least 1 hour before or at least 2 hours after a meal
-Do not open, crush, or break the dabrafenib capsule.
-Do not take a missed dose within 6 hours of the next dose.
-When administered in combination with trametinib, take the once-daily dose of trametinib at the same time each day with either the morning dose or the evening dose of dabrafenib.

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