Dabrafenib Dosage

Medically reviewed by Drugs.com. Last updated on Aug 12, 2024.

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:

For unresectable or metastatic melanoma: Until disease progression or unacceptable toxicity
In the adjuvant melanoma setting: Until disease recurrence or unacceptable toxicity for up to 1 year

Comments:

The presence of BRAF (B-Raf proto-oncogene, serine/threonine kinase) V600E mutation in tumor specimens should be confirmed before starting treatment with this drug as a single agent.
The presence of BRAF V600E or V600K mutation in tumor specimens should be confirmed before starting treatment with this drug and trametinib.
For information on US FDA-approved tests for the detection of BRAF V600 mutations in melanoma: www.fda.gov/companiondiagnostics
Limitations of Use: This drug is not indicated for treatment of patients with wild-type BRAF solid tumors.

Uses:

As a single agent, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation (as detected by a US 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 a US FDA-approved test)
In combination with trametinib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations (as detected by a US FDA-approved test) and involvement of lymph node(s), after complete resection

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:

The presence of BRAF V600E mutation in tumor specimens should be confirmed before starting treatment with this drug and trametinib.
For information on US FDA-approved tests for the detection of BRAF V600E mutations in non-small cell lung cancer (NSCLC): www.fda.gov/companiondiagnostics
Limitations of Use: This drug is not indicated for treatment of patients with wild-type BRAF solid tumors.

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:

The presence of BRAF V600E mutation in tumor specimens should be confirmed before starting treatment with this drug and trametinib.
A US FDA-approved test for the detection of BRAF V600E mutation in anaplastic thyroid cancer (ATC) is not currently available.

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:

This indication is approved under accelerated approval based on overall response rate and duration of response; continued approval may depend on verification and description of clinical benefit in confirmatory trial(s).
The presence of BRAF V600E mutation in tumor specimens should be confirmed before starting treatment with this drug and trametinib.
A US FDA-approved test for the detection of BRAF V600E mutation in solid tumors other than melanoma and NSCLC is not currently available.
Limitations of Use: This drug is not indicated for treatment of patients with wild-type BRAF solid tumors.

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:

Weight 26 to 37 kg: 75 mg orally twice a day
Weight 38 to 50 kg: 100 mg orally twice a day
Weight at least 51 kg: 150 mg orally twice a day

Tablets for Oral Suspension:

Weight 8 to 9 kg: 20 mg orally twice a day
Weight 10 to 13 kg: 30 mg orally twice a day
Weight 14 to 17 kg: 40 mg orally twice a day
Weight 18 to 21 kg: 50 mg orally twice a day
Weight 22 to 25 kg: 60 mg orally twice a day
Weight 26 to 29 kg: 70 mg orally twice a day
Weight 30 to 33 kg: 80 mg orally twice a day
Weight 34 to 37 kg: 90 mg orally twice a day
Weight 38 to 41 kg: 100 mg orally twice a day
Weight 42 to 45 kg: 110 mg orally twice a day
Weight 46 to 50 kg: 130 mg orally twice a day
Weight at least 51 kg: 150 mg orally twice a day

Duration of Therapy: Until disease progression or unacceptable toxicity

Comments:

This indication is approved under accelerated approval based on overall response rate and duration of response; continued approval may depend on verification and description of clinical benefit in confirmatory trial(s).
The presence of BRAF V600E mutation in tumor specimens should be confirmed before starting treatment with this drug and trametinib.
A US FDA-approved test for the detection of BRAF V600E mutation in solid tumors other than melanoma and NSCLC is not currently available.
Limitations of Use: This drug is not indicated for treatment of patients with wild-type BRAF solid tumors.

Usual Pediatric Dose for Malignant Glioma

1 year and older:
Capsules:

Weight 26 to 37 kg: 75 mg orally twice a day
Weight 38 to 50 kg: 100 mg orally twice a day
Weight at least 51 kg: 150 mg orally twice a day

Tablets for Oral Suspension:

Weight 8 to 9 kg: 20 mg orally twice a day
Weight 10 to 13 kg: 30 mg orally twice a day
Weight 14 to 17 kg: 40 mg orally twice a day
Weight 18 to 21 kg: 50 mg orally twice a day
Weight 22 to 25 kg: 60 mg orally twice a day
Weight 26 to 29 kg: 70 mg orally twice a day
Weight 30 to 33 kg: 80 mg orally twice a day
Weight 34 to 37 kg: 90 mg orally twice a day
Weight 38 to 41 kg: 100 mg orally twice a day
Weight 42 to 45 kg: 110 mg orally twice a day
Weight 46 to 50 kg: 130 mg orally twice a day
Weight at least 51 kg: 150 mg orally twice a day

Duration of Therapy: Until disease progression or unacceptable toxicity

Comments:

The presence of BRAF V600E mutation in tumor specimens should be confirmed before starting treatment with this drug and trametinib.
A US FDA-approved test for the detection of BRAF V600E mutation in low-grade glioma (LGG) is not currently available.

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:

Renal dysfunction (estimated GFR 15 to 89 mL/min/1.73 m2) has no clinically relevant effect on the pharmacokinetics of this drug.

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:

Mild liver dysfunction has no effect on systemic exposure to this drug and its metabolites.
Since hepatic metabolism and biliary secretion are the primary routes of elimination of this drug and its metabolites, patients with moderate or severe liver dysfunction may have increased exposure; an appropriate dosage has not been established for these patients.

Dose Adjustments

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

First dose reduction: 50 mg orally twice a day
Subsequent modification: This drug should be permanently discontinued if unable to tolerate 50 mg orally twice a day.

If recommended dosage is 100 mg orally twice a day:

First dose reduction: 75 mg orally twice a day
Second dose reduction: 50 mg orally twice a day
Subsequent modification: This drug should be permanently discontinued if unable to tolerate 50 mg orally twice a day.

If recommended dosage is 150 mg orally twice a day:

First dose reduction: 100 mg orally twice a day
Second dose reduction: 75 mg orally twice a day
Third dose reduction: 50 mg orally twice a day
Subsequent modification: This drug should be permanently discontinued if unable to tolerate 50 mg orally twice a day.

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

First dose reduction: 10 mg orally twice a day
Second and third dose reduction: Not applicable

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

First dose reduction: 20 mg orally twice a day
Second dose reduction: 10 mg orally twice a day
Third dose reduction: Not applicable

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

First dose reduction: 30 mg orally twice a day
Second dose reduction: 20 mg orally twice a day
Third dose reduction: 10 mg orally twice a day

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

First dose reduction: 30 mg orally twice a day
Second dose reduction: 20 mg orally twice a day
Third dose reduction: 10 mg orally twice a day

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

First dose reduction: 40 mg orally twice a day
Second dose reduction: 30 mg orally twice a day
Third dose reduction: 20 mg orally twice a day

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

First dose reduction: 50 mg orally twice a day
Second dose reduction: 40 mg orally twice a day
Third dose reduction: 20 mg orally twice a day

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

First dose reduction: 50 mg orally twice a day
Second dose reduction: 40 mg orally twice a day
Third dose reduction: 30 mg orally twice a day

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

First dose reduction: 60 mg orally twice a day
Second dose reduction: 50 mg orally twice a day
Third dose reduction: 30 mg orally twice a day

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

First dose reduction: 70 mg orally twice a day
Second dose reduction: 50 mg orally twice a day
Third dose reduction: 30 mg orally twice a day

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

First dose reduction: 70 mg orally twice a day
Second dose reduction: 60 mg orally twice a day
Third dose reduction: 40 mg orally twice a day

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

First dose reduction: 90 mg orally twice a day
Second dose reduction: 70 mg orally twice a day
Third dose reduction: 40 mg orally twice a day

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

First dose reduction: 100 mg orally twice a day
Second dose reduction: 80 mg orally twice a day
Third dose reduction: 50 mg orally twice a day

DOSAGE MODIFICATIONS FOR ADVERSE REACTIONS:
New Primary Malignancies:

Noncutaneous RAS (rat sarcoma viral oncogene homolog) mutation-positive malignancies: This drug should be permanently discontinued.

Cardiomyopathy:

Symptomatic congestive heart failure or absolute decrease in left ventricular ejection fraction (LVEF) of greater than 20% from baseline that is below lower limit of normal (LLN): This drug should be withheld until LVEF improves to at least the institutional LLN and absolute decrease to 10% or less compared to baseline, then should resume at same dose.

Uveitis:

Uveitis, including iritis and iridocyclitis: For mild or moderate uveitis that does not respond to ocular therapy, or for severe uveitis: This drug should be withheld for up to 6 weeks.
If improved to grade 0 to 1: This drug should resume at same or lower dose.
If not improved: This drug should be permanently discontinued.

Febrile Reactions:

Fever of 38C to 40C (100.4F to 104F), or first symptoms in case of recurrence: This drug should be withheld until fever resolves, then should resume at same or lower dose.
Fever higher than 40C (104F) or fever complicated by rigors, hypotension, dehydration, or renal failure: This drug should be withheld until febrile reactions resolve for at least 24 hours, then should resume at lower dose, OR this drug should be permanently discontinued.

Skin Toxicities:

Grade 3 or 4 or intolerable grade 2: This drug should be withheld for up to 3 weeks.
If improved: This drug should resume at lower dose.
If not improved: This drug should be permanently discontinued.
Severe cutaneous adverse reactions: This drug should be permanently discontinued.

Other Adverse Reactions, including Hemorrhage:

Any grade 3 or intolerable grade 2: This drug should be withheld.
If improved to grade 0 to 1: This drug should resume at lower dose.
If not improved: This drug should be permanently discontinued.
First occurrence of any grade 4: This drug should be withheld until improves to grade 0 to 1, then should resume at lower dose, OR this drug should be permanently discontinued.
Recurrent grade 4: This drug should be permanently discontinued.

Comments:

Other Adverse Reactions: Dose modifications are not recommended for this drug when administered with trametinib for the following adverse reactions of trametinib: retinal vein occlusion, retinal pigment epithelial detachment, interstitial lung disease/pneumonitis, and uncomplicated venous thromboembolism; dose modification of this drug is not needed for new primary cutaneous malignancies.
The manufacturer product information for trametinib should be consulted for dose modifications for adverse reactions associated with trametinib.

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:

Due to high plasma protein binding, hemodialysis is unlikely to effectively remove this drug.

Other Comments

Administration advice:

Administer at the same time each day, about 12 hours apart.
Administer at least 1 hour before or 2 hours after a meal.
Do not open, crush, or break the capsules.
Before use of the oral suspension, instruct patients/caregivers on proper dosing and administration of the tablets for oral suspension; do not swallow whole, chew, or crush the tablets for oral suspension.
Administer the oral suspension immediately after preparation from cup, oral dosing syringe, or feeding tube; if not administered within 30 minutes after preparation, discard the oral suspension.

Storage requirements:

Store at 20C to 25C (68F to 77F); excursions permitted between 15C and 30C (59F and 86F).
Store and dispense in original bottle with the desiccant.

Reconstitution/preparation techniques (tablets for oral suspension):

The oral suspension should be prepared with about 5 mL of water for 1 to 4 tablets, and about 10 mL of water for 5 to 15 tablets in the provided cup.
The water and prescribed number of tablets should be gently stirred with the handle of a teaspoon until the tablets are fully dissolved.
It may take at least 3 minutes to fully dissolve the tablets.
Once the tablets for oral suspension are dissolved, the suspension will be cloudy white.
The manufacturer product information should be consulted.

General:

Limitations of Use:
This drug is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.
This drug is not indicated for treatment of patients with wild-type BRAF solid tumors.
The manufacturer product information for trametinib should be consulted for dosing information, including dose modifications for adverse reactions associated with trametinib.

Monitoring:

Cardiovascular: LVEF by echocardiogram or multigated acquisition (MUGA) scan (before starting combination therapy, after 1 month of therapy, and then every 2 to 3 months during therapy)
Dermatologic: For new/worsening serious skin reactions
Hematologic: For signs of hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency (G6PD)
Infections/Infestations: For signs/symptoms of infection (during and after severe pyrexia)
Metabolic: Serum glucose levels in patients with preexisting diabetes or hyperglycemia (at start of therapy and as clinically appropriate)
Ocular: For visual signs/symptoms of uveitis, e.g., change in vision, photophobia, eye pain
Oncologic: For cutaneous malignancies (before starting this drug, every 2 months during therapy, and for up to 6 months after discontinuation); for signs/symptoms of noncutaneous malignancies
Renal: Serum creatinine and other signs of renal function (during and after severe pyrexia)

Patient advice:

Read the US FDA-approved patient labeling (Medication Guide and Instructions for Use).
Contact health care provider immediately for any new lesions, changes to existing skin lesions, or signs/symptoms of other malignancies.
Contact health care provider to seek immediate medical attention for signs/symptoms of unusual bleeding or hemorrhage.
Immediately report to health care provider any signs/symptoms of heart failure.
Contact health care provider if any changes in vision occur.
Contact health care provider if a fever develops while taking this drug.
Contact health care provider for progressive or intolerable rash; contact health care provider immediately if signs/symptoms of a severe skin reactions develop.
Contact health care provider to report symptoms of severe hyperglycemia.
Patients with known G6PD deficiency: Contact health care provider to report signs/symptoms of anemia or hemolysis.
Patients of childbearing potential: Inform health care provider of a known/suspected pregnancy; use effective nonhormonal contraception during therapy and for 2 weeks after the last dose.
Male patients with female partners of childbearing potential: Use condoms during therapy and for 2 weeks after the last dose.
Do not breastfeed during therapy and for 2 weeks after the last dose.
If a dose is missed, do not take it if it is less than 6 hours until the next dose.
If vomiting occurs after administration of this drug, do not take an additional dose; take the next dose at its scheduled time.