Tafinlar Dosage

Patient Selection

Melanoma

• Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR as a single agent.
• Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib.
• Information on FDA-approved tests for the detection of BRAF V600 mutations in melanoma is available at: http://www.fda.gov/CompanionDiagnostics.

NSCLC

• Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib.
• Information on FDA-approved tests for the detection of BRAF V600E mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.

ATC

• ​Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib.
• ​Information on FDA-approved tests for the detection of BRAF V600E mutations in ATC is available at: http://www.fda.gov/CompanionDiagnostics.

Solid Tumors

• Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib. An FDA-approved test for the detection of BRAF V600E mutation in solid tumors other than melanoma and NSCLC is not currently available.

Low-Grade Glioma

• Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib. An FDA-approved test for the detection of BRAF V600E mutation in LGG is not currently available.

Recommended Dosage

TAFINLAR Capsules

Adult Patients

The recommended dosage for TAFINLAR capsules in adult patients is 150 mg taken orally twice daily.

Pediatric Patients

The recommended dosage for TAFINLAR capsules in pediatric patients who weigh at least 26 kg is based on body weight (Table 1). A recommended dosage of TAFINLAR capsules has not been established in patients who weigh less than 26 kg.

TAFINLAR Tablets for Oral Suspension

Adult and Pediatric Patients

The recommended dosage for TAFINLAR tablets for oral suspension for adult and pediatric patients is based on body weight (Table 2).

Duration of Treatment

• The recommended duration of treatment for patients with unresectable or metastatic melanoma or solid tumors, metastatic NSCLC, or locally advanced or metastatic anaplastic thyroid cancer is until disease progression or unacceptable toxicity.
• The recommended duration of treatment in the adjuvant melanoma setting is until disease recurrence or unacceptable toxicity for up to 1 year.
• The recommended duration of treatment for pediatric patients with LGG is until disease progression or until unacceptable toxicity.

Combination Therapy with Trametinib

Refer to the trametinib prescribing information for recommended trametinib dosing information.

Administration

• ​Take TAFINLAR at the same time each day, approximately 12 hours apart.
• ​Do not take a missed dose of TAFINLAR within 6 hours of the next dose of TAFINLAR.
• ​If vomiting occurs after TAFINLAR administration, do not take an additional dose. Take the next dose at its scheduled time.

TAFINLAR Capsules

• ​Take TAFINLAR capsules on an empty stomach (at least 1 hour before or 2 hours after a meal).
• ​Do not open, crush, or break TAFINLAR capsules.

TAFINLAR Tablets for Oral Suspension

• ​Prior to use of the oral suspension, instruct caregivers (and if appropriate, patients) on proper dosing and administration of TAFINLAR tablets for oral suspension.
• ​Take the oral suspension on an empty stomach (at least 1 hour before or 2 hours after a meal). Breastfeeding and/or baby formula may be given on demand if a pediatric patient is unable to tolerate the fasting conditions.
• Do not swallow whole, chew or crush TAFINLAR tablets for oral suspension.

Preparation and Administration

• Prepare the oral suspension with approximately 5 mL of water for 1 to 4 tablets, and approximately 10 mL of water for 5 to 15 tablets in the provided dosing cup.
• Gently stir the water and prescribed number of tablets 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 are dissolved, the oral suspension will be cloudy white.
• Administer the oral suspension immediately after preparation from a dosing cup, oral syringe or feeding tube (10 French gauge or larger for 1 to 3 tablets; 12 French gauge or larger for 4 to 15 tablets).
• Discard the oral suspension if not administered within 30 minutes after preparation.

Dosage Modifications for Adverse Reactions

Dose reductions for adverse reactions associated with TAFINLAR are presented in Tables 3 and 4.

Dosage modifications for adverse reactions associated with TAFINLAR are presented in Table 5.

Refer to the trametinib prescribing information for dose modifications for adverse reactions associated with trametinib.