Dabrafenib, a BRAF inhibitor, is approved for the treatment of various cancers, including melanoma and lung cancer. Dosage varies significantly depending on the indication.
Dabrafenib Capsules Recommended Dosage
1. Adult Patients
The recommended dose of dabrafenib capsules for adult patients is 150 mg orally twice daily.
2. Pediatric Patients
The recommended dose of dabrafenib capsules for pediatric patients weighing at least 26 kg is based on weight. The recommended dose of dabrafenib capsules has not yet been determined. Patients weighing less than 26 kg:
26 to 37 kg: 75 mg dabrafenib orally twice daily.
38 to 50 kg: 100 mg orally twice daily.
Over 51 kg: 150 mg orally twice daily.
Recommended Dosage of Dabrafenib Oral Suspension:
Adult and Pediatric Patients
8-9 kg: 20 mg dabrafenib suspension twice daily.
10-13 kg: 30 mg dabrafenib suspension twice daily.
14-17 kg: 40 mg dabrafenib suspension twice daily.
18-21 kg: 50 mg dabrafenib suspension twice daily.
22-25 kg: 60 mg dabrafenib suspension twice daily.
26-29 kg: 70 mg dabrafenib suspension twice daily.
30-33 kg: 80 mg dabrafenib suspension twice daily.
34-37 kg: 90 mg dabrafenib suspension twice daily.
38-41 kg: 100 mg dabrafenib suspension orally twice daily.
42-45 kg: 110 mg dabrafenib suspension orally twice daily.
46-50 kg: 30 mg dabrafenib suspension orally twice daily.
≥51 kg: 150 mg dabrafenib suspension orally twice daily.
Dabrafenib Treatment Duration
1. For patients with unresectable or metastatic melanoma or solid tumors, metastatic non-small cell lung cancer, or locally advanced or metastatic anaplastic thyroid cancer, the recommended duration of treatment is until disease progression or unacceptable toxicity.
2. In adjuvant melanoma settings, the recommended duration of treatment is until disease recurrence or unacceptable toxicity, up to a maximum of 1 year.
3. For pediatric patients with low-grade gliomas, the recommended duration of treatment is until disease progression or unacceptable toxicity.
4. When used in combination with trametinib, please refer to the trametinib prescribing information for recommended trametinib dosage information.
Dabrafenib Dosage Adjustment
1. Recommended Dose Reduction for Adverse Reactions to Dabrafenib Capsules
(1) Starting Dose: 150 mg (twice daily orally)
First Reduction: 100 mg, twice daily orally.
Second Reduction: 75 mg, twice daily orally.
Third Reduction: 50 mg, twice daily orally.
(2) Starting Dose: 100 mg (twice daily orally)
First Reduction: 75 mg, twice daily orally.
Second Reduction: 50 mg, twice daily orally.
Third Reduction: Not Applicable
(3) Starting Dose: 75 mg (twice daily orally)
First Reduction: 50 mg, twice daily orally.
Subsequent Reductions: Not Applicable
If the patient cannot tolerate the lowest dose of 50 mg twice daily orally, dabrafenib capsules must be permanently discontinued.
2. Recommended Dose Reduction of Dabrafenib Suspension
(1) Weight 8-9 kg (Recommended dose: 20 mg twice daily)
Initial dose reduction: 10 mg dabrafenib suspension orally twice daily.
Subsequent dose reduction: Not applicable.
(2) Weight 10-13 kg (Recommended dose: 30 mg twice daily)
Initial dose reduction: 20 mg dabrafenib suspension orally twice daily.
Second dose reduction: 10 mg dabrafenib suspension orally twice daily.
Third dose reduction: Not applicable.
(3) Weight 14-17 kg (Recommended dose: 40 mg twice daily)
Initial dose reduction: 30 mg dabrafenib suspension orally twice daily.
Second dose reduction: 20 mg dabrafenib suspension orally twice daily.
Third dose reduction: 10 mg dabrafenib suspension orally twice daily.
(4) Weight 18-21kg (Recommended dose: 50mg twice daily)
Initial dose reduction: 30mg dabrafenib suspension orally twice daily.
Second dose reduction: 20mg dabrafenib suspension orally twice daily.
Third dose reduction: 10mg dabrafenib suspension orally twice daily.
(5) Weight 22-25kg (Recommended dose: 60mg twice daily)
Initial dose reduction: 40mg dabrafenib suspension orally twice daily.
Second dose reduction: 30mg dabrafenib suspension orally twice daily.
Third dose reduction: 20mg dabrafenib suspension orally twice daily.
(6) Weight 26-29kg (Recommended dose: 70mg twice daily)
Initial dose reduction: 50mg dabrafenib suspension orally twice daily.
Second dose reduction: 40 mg dabrafenib suspension orally twice daily.
Third dose reduction: 20 mg dabrafenib suspension orally twice daily.
(7) Weight 30-33 kg (Recommended dose: 80 mg twice daily)
First dose reduction: 50 mg dabrafenib suspension orally twice daily.
Second dose reduction: 40 mg dabrafenib suspension orally twice daily.
Third dose reduction: 30 mg dabrafenib suspension orally twice daily.
(8) Weight 34-37 kg (Recommended dose: 90 mg twice daily)
First dose reduction: 60 mg dabrafenib suspension orally twice daily.
Second dose reduction: 50 mg dabrafenib suspension orally twice daily.
Third dose reduction: 30 mg dabrafenib suspension orally twice daily.
(9) Weight 38-41kg (Recommended dose: 100mg twice daily)
First dose reduction: 70mg dabrafenib suspension orally twice daily.
Second dose reduction: 50mg dabrafenib suspension orally twice daily.
Third dose reduction: 30mg dabrafenib suspension orally twice daily.
(10) Weight 42-45kg (Recommended dose: 110mg twice daily)
First dose reduction: 70mg dabrafenib suspension orally twice daily.
Second dose reduction: 60mg dabrafenib suspension orally twice daily.
Third dose reduction: 40mg dabrafenib suspension orally twice daily.
(11) Weight 46-50kg (Recommended dose: 130mg twice daily)
First dose reduction: 90mg dabrafenib suspension orally twice daily.
Second dose reduction: 70 mg dabrafenib suspension orally twice daily.
Third dose reduction: 40 mg dabrafenib suspension orally twice daily.
(12) Weight ≥ 51 kg (Recommended dose: 150 mg twice daily)
First dose reduction: 100 mg dabrafenib suspension orally twice daily.
Second dose reduction: 80 mg dabrafenib suspension orally twice daily.
Third dose reduction: 50 mg dabrafenib suspension orally twice daily.
Recommended dose adjustment for adverse reactions of dabrafenib
1. New primary malignant tumors
Non-cutaneous RAS mutation-positive malignant tumors: Permanently discontinue dabrafenib.
2. Cardiomyopathy
(1) Symptomatic cardiomyopathy: Discontinue dabrafenib until left ventricular ejection fraction (LVEF) recovers to ≥ lower limit of normal (LLN) and an absolute decrease from baseline of ≤10%.
(2) Resume dabrafenib at the original dose after the target is achieved.
(3) LVEF decreases by more than 20% from baseline and is lower than the institutional LLN: Treatment is the same as above (suspend until the recovery standard is met).
3. Uveitis (including iritis and iridocyclitis)
(1) Mild/moderate uveitis (unresponsive to ophthalmic treatment) or severe uveitis: Suspend dabrafenib for up to 6 weeks.
(2) If improvement to grade 0-1: Resume dabrafenib at the original dose or a lower dose.
(3) If no improvement: Permanently discontinue dabrafenib.
4. Febrile Reaction
(1) Fever 38℃–40℃ (or recurrence of initial symptoms): Suspend dabrafenib until the fever subsides, then resume at the original dose or a lower dose.
(2) Fever >40℃: Suspend dabrafenib until the febrile reaction subsides for ≥24 hours, then resume at a lower dose.
(3) Fever with chills, hypotension, dehydration, or renal failure: Resume dabrafenib at a lower dose or permanently discontinue it.
5. Skin Toxicity
(1) Grade 2 intolerable: Discontinue dabrafenib for up to 3 weeks.
(2) Grade 3 or 4: Resume at a lower dose if improvement is seen. If no improvement is seen, permanently discontinue dabrafenib.
(3) Severe Skin Adverse Reactions (SCAR): Permanently discontinue dabrafenib.
6. Other Adverse Reactions (including bleeding events)
(1) Grade 2 intolerable adverse reaction: Discontinue dabrafenib.
(2) Any Grade 3 adverse reaction: Resume dabrafenib at a lower dose if improvement to Grade 0-1. If no improvement is seen, permanently discontinue dabrafenib.
(3) First occurrence of Grade 4 adverse reaction: Discontinue dabrafenib until improvement to Grade 0-1, then resume at a lower dose or permanently discontinue dabrafenib.
(4) Recurrent Grade 4 Adverse Reactions: Permanent discontinuation of dabrafenib.
Dabrafenib Administration
1. Dosage Management
Take dabrafenib at the same time each day, approximately 12 hours apart. Do not take missed doses of dabrafenib within 6 hours of your next dose. If vomiting occurs after dabrafenib administration, do not take an extra dose. Take your next dose at the scheduled time.
2. Dabrafenib Capsules
Take dabrafenib capsules on an empty stomach (at least 1 hour before or 2 hours after a meal). Do not open, squeeze, or break dabrafenib capsules.
3. Dabrafenib Suspension Tablets
Before administering oral suspension tablets, instruct caregivers (and the appropriate patient) on the correct dosage and administration of dabrafenib for oral suspension. Take oral suspension on an empty stomach (at least 1 hour before or 2 hours after a meal). If pediatric patients cannot tolerate fasting, breastfeeding and/or infant formula may be given on demand. Do not swallow whole, chew or crush dabrafenib tablets as an oral suspension.
