Tafinlar

TAFINLAR- dabrafenib mesylate capsule
Novartis Pharmaceuticals Corporation

1 INDICATIONS AND USAGE

1.1 BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma

TAFINLAR® is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

1.2 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma

TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1)].

1.3 Adjuvant Treatment of BRAF V600E or V600K Mutation-Positive Melanoma

TAFINLAR is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection [see Dosage and Administration (2.1)].

1.4 BRAF V600E Mutation-Positive Metastatic NSCLC

TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test [see Dosage and Administration (2.1)].

1.5 BRAF V600E Mutation-Positive Locally Advanced or Metastatic Anaplastic Thyroid Cancer

TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options [see Dosage and Administration (2.1)].

1.6 Limitations of Use

TAFINLAR is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF NSCLC, or wild-type BRAF ATC [see Warnings and Precautions (5.2)].

2 DOSAGE AND ADMINISTRATION

2.1 Patient Selection

Melanoma

  • Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR as a single agent [see Warnings and Precautions (5.2), Clinical Studies (14.1)].
  • Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib [see Warnings and Precautions (5.2), Clinical Studies (14.2, 14.3)].
  • 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 [see Clinical Studies (14.4)].
  • 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 [see Clinical Studies (14.5)]. An FDA-approved test for the detection of BRAF V600E mutation in ATC is not currently available.

2.2 Recommended Dosage for Unresectable or Metastatic Melanoma

The recommended dosage of TAFINLAR is 150 mg orally taken twice daily, as a single agent or in combination with trametinib, until disease progression or unacceptable toxicity. Refer to the trametinib prescribing information for recommended trametinib dosing information.

2.3 Recommended Dosage for the Adjuvant Treatment of Melanoma

The recommended dosage of TAFINLAR is 150 mg orally taken twice daily in combination with trametinib until disease recurrence or unacceptable toxicity for up to 1 year. Refer to the trametinib prescribing information for recommended trametinib dosing information.

2.4 Recommended Dosage for NSCLC

The recommended dosage of TAFINLAR is 150 mg orally taken twice daily, in combination with trametinib until disease recurrence or unacceptable toxicity. Refer to the trametinib prescribing information for recommended trametinib dosing information.

2.5 Recommended Dosage for ATC

The recommended dosage of TAFINLAR is 150 mg orally taken twice daily, in combination with trametinib until disease recurrence or unacceptable toxicity. Refer to the trametinib prescribing information for recommended trametinib dosing information.

2.6 Administration

  • Take TAFINLAR at doses approximately 12 hours apart.
  • Take TAFINLAR at least 1 hour before or 2 hours after a meal [see Clinical Pharmacology (12.3)].
  • Do not take a missed dose of TAFINLAR within 6 hours of the next dose of TAFINLAR.
  • Do not open, crush, or break TAFINLAR capsules.

2.7 Dosage Modifications for Adverse Reactions

Dose reductions for adverse reactions associated with TAFINLAR are presented in Table 1.

Table 1. Recommended Dose Reductions for TAFINLAR for Adverse Reactions
Action Recommended Dose
First Dose Reduction 100 mg orally twice daily
Second Dose Reduction 75 mg orally twice daily
Third Dose Reduction 50 mg orally twice daily
Subsequent Modification Permanently discontinue if unable to tolerate TAFINLAR 50 mg orally twice daily

Dosage modifications for adverse reactions associated with TAFINLAR are presented in Table 2.

Table 2. Recommended Dosage Modifications for TAFINLAR for Adverse Reactions
a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.b See Table 1 for recommended dose reductions of TAFINLAR.c Dose modifications are not recommended for TAFINLAR when administered with trametinib for the following adverse reactions of trametinib: retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED), interstitial lung disease/pneumonitis, and uncomplicated venous thromboembolism. Dose modification of TAFINLAR is not required for new primary cutaneous malignancies.d Dose modification is required for TAFINLAR when administered with trametinib for Grade 3 and Grade 4 hemorrhage [see Warnings and Precautions (5.3)]
Severity of Adverse Reactiona Dosage Modification for TAFINLAR b
New Primary Malignancies [see Warnings and Precautions (5.1)]
Non-Cutaneous RAS Mutation-positive Malignancies Permanently discontinue TAFINLAR.
Cardiomyopathy [see Warnings and Precautions (5.4)]
  • Symptomatic congestive heart failure
  • Absolute decrease in left ventricular ejection fraction (LVEF) of greater than 20% from baseline that is below lower limit of normal (LLN)
Withhold TAFINLAR until LVEF improves to at least the institutional LLN and absolute decrease to less than or equal to 10% compared to baseline, then resume at same dose.
Uveitis [see Warnings and Precautions (5.5)]
  • Uveitis, including iritis and iridocyclitis
For mild or moderate uveitis does not respond to ocular therapy, or for severe uveitis, withhold TAFINLAR for up to 6 weeks.
  • If improved to Grade 0-1, then resume TAFINLAR at same or lower dose.
  • If not improved, permanently discontinue TAFINLAR.
Febrile Reactions [see Warnings and Precautions (5.6)]
  • Fever of 101.3°F to 104°F
Withhold TAFINLAR until fever resolves, then resume at same or lower dose.
  • Fever higher than 104°F
  • Fever complicated by rigors, hypotension, dehydration, or renal failure
  • Withhold TAFINLAR until fever resolves, then resume at lower dose.
Or
  • Permanently discontinue TAFINLAR.
Skin Toxicities [see Warnings and Precautions (5.7)]
  • Intolerable Grade 2
  • Grade 3 or 4
Withhold TAFINLAR for up to 3 weeks.
  • If improved, resume TAFINLAR at lower dose.
  • If not improved, permanently discontinue TAFINLAR.
  • Severe cutaneous adverse reactions (SCARs)
Permanently discontinue TAFINLAR.
Other Adverse Reactionsc,d
  • Intolerable Grade 2
  • Any Grade 3
Withhold TAFINLAR.
  • If improved to Grade 0-1, resume TAFINLAR at lower dose.
  • If not improved, permanently discontinue TAFINLAR.
  • First occurrence of any Grade 4
  • Withhold TAFINLAR until improves to Grade 0-1, then resume at a lower dose.
Or
  • Permanently discontinue TAFINLAR.
  • Recurrent Grade 4
Permanently discontinue TAFINLAR.

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

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