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Dabrafenib Dosage

Medically reviewed by Drugs.com. Last updated on Mar 7, 2023.

Applies to the following strengths: 75 mg; 50 mg; 10 mg

Usual Adult Dose for Melanoma - Metastatic

150 mg orally twice a day

Duration of Therapy:


Comments:

Uses:

Usual Adult Dose for Non-Small Cell Lung Cancer

150 mg orally twice a day
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:


Use: In combination with trametinib, for the treatment of patients with metastatic NSCLC with BRAF V600E mutation as detected by a US FDA-approved test

Usual Adult Dose for Thyroid Cancer

150 mg orally twice a day
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:


Use: In combination with trametinib, for the treatment of patients with locally advanced or metastatic ATC with BRAF V600E mutation and with no satisfactory locoregional treatment options

Usual Adult Dose for Solid Tumors

150 mg orally twice a day
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:


Use: In combination with trametinib, for the treatment of patients with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed after prior treatment and have no satisfactory alternative treatment options

Usual Pediatric Dose for Solid Tumors

1 year and older:
Capsules:


Tablets for Oral Suspension:

Duration of Therapy: Until disease progression or unacceptable toxicity

Comments:

Use: In combination with trametinib, for the treatment of patients with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed after prior treatment and have no satisfactory alternative treatment options

Usual Pediatric Dose for Malignant Glioma

1 year and older:
Capsules:


Tablets for Oral Suspension:

Duration of Therapy: Until disease progression or unacceptable toxicity

Comments:

Use: In combination with trametinib, for the treatment of patients with LGG with a BRAF V600E mutation who require systemic therapy

Renal Dose Adjustments

Data not available

Comments:

Liver Dose Adjustments

Mild liver dysfunction (bilirubin up to the upper limit of normal [ULN] and AST greater than ULN or bilirubin greater than 1 to 1.5 times ULN [1 to 1.5 x ULN] and any AST): No adjustment recommended
Moderate (bilirubin greater than 1.5 to 3 x ULN and any AST) or severe (bilirubin greater than 3 to 10 x ULN and any AST) liver dysfunction: Data not available

Comments:

Dose Adjustments

DOSAGE REDUCTIONS FOR ADVERSE REACTIONS:
CAPSULES:
If recommended dosage is 75 mg orally twice a day:


If recommended dosage is 100 mg orally twice a day:

If recommended dosage is 150 mg orally twice a day:

TABLETS FOR ORAL SUSPENSION:
Weight 8 to 9 kg (recommended dosage: 20 mg orally twice a day):

Weight 10 to 13 kg (recommended dosage: 30 mg orally twice a day):

Weight 14 to 17 kg (recommended dosage: 40 mg orally twice a day):

Weight 18 to 21 kg (recommended dosage: 50 mg orally twice a day):

Weight 22 to 25 kg (recommended dosage: 60 mg orally twice a day):

Weight 26 to 29 kg (recommended dosage: 70 mg orally twice a day):

Weight 30 to 33 kg (recommended dosage: 80 mg orally twice a day):

Weight 34 to 37 kg (recommended dosage: 90 mg orally twice a day):

Weight 38 to 41 kg (recommended dosage: 100 mg orally twice a day):

Weight 42 to 45 kg (recommended dosage: 110 mg orally twice a day):

Weight 46 to 50 kg (recommended dosage: 130 mg orally twice a day):

Weight at least 51 kg (recommended dosage: 150 mg orally twice a day):

DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS:
New Primary Malignancies:

Cardiomyopathy:

Uveitis:

Febrile Reactions:

Skin Toxicities:

Other Adverse Reactions, including Hemorrhage:

Comments:

Precautions

CONTRAINDICATIONS: None

Safety and efficacy of this drug in combination with trametinib have not been established in patients younger than 1 year with unresectable/metastatic solid tumors with BRAF V600 E mutation or LGG with BRAF V600E mutation. Safety and efficacy of this drug as a single agent have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments:

Other Comments

Administration advice:


Storage requirements:

Reconstitution/preparation techniques (tablets for oral suspension):

General:

Monitoring:

Patient advice:

Further information

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