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Dabrafenib Dosage

Applies to the following strength(s): 75 mg ; 50 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for Non-Small Cell Lung Cancer

150 mg orally twice a day, either used as monotherapy or in combination with trametinib.
Duration of Therapy: Until disease progression or unacceptable toxicity occurs.

Comments: Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to treatment initiation with FDA-approved tests: http://www.fda.gov/CompanionDiagnostics.

Uses: Treatment of:
-BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma as a single agent.
-BRAF V600E OR V600K Mutation-Positive Unresectable or Metastatic Melanoma in combination with trametinib.
-BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) in combination with trametinib.

Usual Adult Dose for Melanoma - Metastatic

150 mg orally twice a day, either used as monotherapy or in combination with trametinib.
Duration of Therapy: Until disease progression or unacceptable toxicity occurs.

Comments: Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to treatment initiation with FDA-approved tests: http://www.fda.gov/CompanionDiagnostics.

Uses: Treatment of:
-BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma as a single agent.
-BRAF V600E OR V600K Mutation-Positive Unresectable or Metastatic Melanoma in combination with trametinib.
-BRAF V600E Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) in combination with trametinib.

Renal Dose Adjustments

-Mild to Moderate Renal Impairment: No adjustment recommended.
-Severe Renal Impairment: Dose adjustment(s) may be required; however, an appropriate dose has not been established. Caution is recommended.

Liver Dose Adjustments

-Mild Hepatic Impairment: No adjustment recommended.
-Moderate to Severe Hepatic Impairment: Dose adjustment(s) may be required; however, an appropriate dose has not been established. Caution is recommended.

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.

-NEW PRIMARY CUTANEOUS MALIGNANCIES: No adjustment recommended.

-NEW PRIMARY NON-CUTANEOUS MALIGNANCIES: Permanently discontinue treatment in patients who develop RAS mutation-positive non-cutaneous malignancies.

DOSE REDUCTIONS FOR ADVERSE REACTIONS:
-First Dose Reduction: 100 mg twice a day
-Second Dose Reduction: 75 mg twice a day
-Third Dose Reduction: 50 mg twice a day
-Subsequent Modification: Permanently discontinue treatment if unable to tolerate 50 mg twice a day.

CARDIAC:
-Symptomatic Congestive Heart Failure; Absolute Decrease in Left Ventricular Ejection Fraction [LVEF] of Greater Than 20% from Baseline that is Below Lower Level of Normal [LLN]): Withhold treatment, then resume at same dose upon recovery of cardiac function.

PYREXIA:
-Fever of 101.3 to 104 Degrees Fahrenheit: Withhold treatment until fever resolves, then resume at same or lower dose level.
-Fever Higher Than 104 Degrees Fahrenheit; Fever Complicated by Rigors, Hypotension, Dehydration, or Renal Failure: Withhold treatment until fever resolves, then resume at lower dose level OR permanently discontinue treatment.

SKIN TOXICITY (Intolerable Grade 2, Grade 3, or Grade 4): Withhold treatment for up to 3 weeks
-If Improved: Resume at lower dose.
-If Not Improved: Permanently discontinue treatment.

UVEITIS (Severe OR Mild/Moderate that Does Not Respond to Ocular Therapy): Withhold treatment for up to 6 weeks.
-If Improved to Grade 0 to 1: Resume at same or lower dose level.
-If Not Improved: Permanently discontinue treatment.

OTHER ADVERSE REACTIONS:
INTOLERABLE GRADE 2; ANY GRADE 3: Withhold treatment.
-If Improved to Grade 0 to 1: Resume at lower dose level.
-If Not Improved: Permanently discontinue treatment.
FIRST OCCURRENCE OF ANY GRADE 4: Withhold treatment until improvement to Grade 0 to 1, then resume at lower dose level OR permanently discontinue treatment.
RECURRENT GRADE 4: Permanently discontinue treatment.

Comments:
-Dose adjustments are NOT recommended for this drug when it is administered in combination with trametinib for the following adverse reactions: retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED), interstitial lung disease (ILD)/pneumonitis, and uncomplicated venous thromboembolism.
-Consult the manufacturer product information for trametinib dosing recommendations.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:
-Direct patients to take this drug at least 1 hour before or 2 hours after a meal, and at similar times every day with an interval of approximately 12 hours between doses.
-Instruct patients to swallow drug capsules whole with water, and not to open, crush, chew, or break capsules.
-Warn patients not to mix capsule contents with food or liquids due to the chemical instability of this drug.
-Advise patients not to take a missed dose within 6 hours of the next scheduled dose.
-In the event of a vomited dose, counsel patients not to retake that dose and to resume dosing with the next scheduled dose.
-Consult the manufacturer product information for trametinib dosing recommendations prior to initiation of combination treatment with this drug.

Storage Requirements:
-Store at 25 degrees Celsius (77 degrees Fahrenheit); excursions are permitted from 15 to 30 degrees (59 to 86 Fahrenheit).

General:
-This drug is not indicated for treatment of wild-type BRAF melanoma or wild-type BRAF NSCLC.
-The safety and efficacy of using this drug in combination with trametinib has not been evaluated in patients with BRAF V600 mutation-positive melanoma with brain metastases.

Monitoring:
-CARDIOVASCULAR: LVEF by echocardiogram or multigated acquisition scan (before initiation of this drug with trametinib, 1 month after initiation of this drug, and then at 2- to 3-month intervals during treatment); blood pressure (baseline and during treatment); thrombosis signs and symptoms
-HEPATIC: Liver function (every 4 weeks for 6 months after treatment initiation of this drug with trametinib and thereafter as clinically indicated)
-OCULAR: Uveitis signs and symptoms (routinely during treatment)
-ONCOLOGIC: Cutaneous malignancies: Skin exam (prior to treatment initiation, monthly to every 2 months during treatment, and for up to 6 months following treatment discontinuation or until initiation of another antineoplastic therapy), head and neck exam with visual inspection of oral mucosa and lymph node palpation (prior to treatment initiation and every 3 months during treatment or as clinically appropriate), chest/abdomen CT scan (prior to treatment initiation and every 6 months during treatment or as clinically appropriate), secondary/recurrent malignancies (for up to 6 months following treatment discontinuation or until initiation of another antineoplastic therapy); Non-cutaneous malignancies: Anal exams and pelvic exams for women (before and at the end of treatment or when clinically indicated), CBC (as clinically indicated)
-RENAL: Serum creatinine, renal function (routinely during treatment, especially during and following severe pyrexia)

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