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TAFINLAR
Melanoma and other skin cancers
Pancreatic, thyroid, and other endocrine cancers
Respiratory and thoracic cancers
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Drug Name:

TAFINLAR Rx

Generic Name and Formulations:
Dabrafenib 50mg, 75mg; caps.

Company:
Novartis Pharmaceuticals Corp

Therapeutic Use:

Indications for TAFINLAR:

Treatment of unresectable or metastatic melanoma as monotherapy in patients with BRAF V600E mutation, or in combination with trametinib in patients with BRAF V600E or V600K mutations, as detected by an FDA-approved test. In combination with trametinib for the adjuvant treatment of melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and lymph node involvement, following complete resection.

Limitations Of use:

Not indicated for the treatment of wild-type BRAF melanoma.

Adult:

Confirm presence of BRAF V600E or V600K mutation prior to initiation. Swallow whole. Take at least 1hr before or 2hrs after a meal. Monotherapy or in combination with trametinib: 150mg twice daily (approx. 12hrs apart); continue until disease progression or unacceptable toxicity. Adjuvant treatment with trametinib: 150mg twice daily (approx. 12hrs apart); continue until disease recurrence or unacceptable toxicity for up to 1 year. Dose modifications: see full labeling.

Children:

Not established.

Warnings/Precautions:

See full labeling for trametinib prior to starting combination therapy. Increased incidence of new primary cutaneous malignancies; perform skin evaluation prior to initiation, every 2 months during therapy, and up to 6 months after discontinuation. Monitor for non-cutaneous malignancies; permanently discontinue if RAS mutation-positive malignancy occurs. Permanently discontinue for all Grade 4 hemorrhagic events or any persistent Grade 3 events. Risk of cardiomyopathy with trametinib; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold for symptomatic cardiomyopathy or asymptomatic LV dysfunction of >20% from baseline that is below institutional lower limit of normal. Withhold if fever ≥101.3°F or any serious febrile reaction occurs and evaluate for infection; prophylaxis with antipyretics may be needed when resuming. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Monitor for visual signs/symptoms of uveitis; permanently discontinue for persistent Grade ≥2 lasting >6wks. G6PD deficiency: monitor for hemolytic anemia. Severe renal or moderate-to-severe hepatic impairment. Embryo-fetal toxicity. Females of reproductive potential should use highly effective non-hormonal contraception during and for 2wks after last dose. Pregnancy; avoid. Nursing mothers: not recommended (during and for 2wks after last dose).

Pharmacological Class:

Kinase inhibitor.

Interactions:

Avoid concomitant strong CYP3A4 or CYP2C8 inhibitors (eg, ketoconazole, gemfibrozil); if unavoidable, monitor closely. May antagonize effects of CYP3A4, CYP2C8, CYP2C9, CYP2C19, CYP2B6 substrates (eg, midazolam, warfarin, dexamethasone, hormonal contraceptives); consider alternatives or monitor.

Adverse Reactions:

Hyperkeratosis, headache, pyrexia, arthralgia, papilloma, alopecia, palmar-plantar erythrodysesthesia syndrome; skin toxicity (may be serious). In combination with trametinib: also chills, fatigue, rash, nausea, vomiting, diarrhea, myalgia, dry skin, decreased appetite, edema, hemorrhage, cough, dyspnea.

Generic Availability:

NO

How Supplied:

Caps—120


Data provided by MPR.

Indications for TAFINLAR:

In combination with trametinib for the treatment of locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.

Limitations Of use:

Not indicated for the treatment of wild-type BRAF ATC.

Adult:

Confirm presence of BRAF V600E mutation prior to initiation. Swallow whole. Take at least 1hr before or 2hrs after a meal. In combination with trametinib: 150mg twice daily (approx. 12hrs apart); continue until disease recurrence or unacceptable toxicity. Dose modifications: see full labeling.

Children:

Not established.

Warnings/Precautions:

See full labeling for trametinib prior to starting combination therapy. Increased incidence of new primary cutaneous malignancies; perform skin evaluation prior to initiation, every 2 months during therapy, and up to 6 months after discontinuation. Monitor for non-cutaneous malignancies; permanently discontinue if RAS mutation-positive malignancy occurs. Permanently discontinue for all Grade 4 hemorrhagic events or any persistent Grade 3 events. Risk of cardiomyopathy with trametinib; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold for symptomatic cardiomyopathy or asymptomatic LV dysfunction of >20% from baseline that is below institutional lower limit of normal. Withhold if fever ≥101.3°F or any serious febrile reaction occurs and evaluate for infection; prophylaxis with antipyretics may be needed when resuming. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Monitor for visual signs/symptoms of uveitis; permanently discontinue for persistent Grade ≥2 lasting >6wks. G6PD deficiency: monitor for hemolytic anemia. Severe renal or moderate-to-severe hepatic impairment. Embryo-fetal toxicity. Females of reproductive potential should use highly effective non-hormonal contraception during and for 2wks after last dose. Pregnancy; avoid. Nursing mothers: not recommended (during and for 2wks after last dose).

Pharmacological Class:

Kinase inhibitor.

Interactions:

Avoid concomitant strong CYP3A4 or CYP2C8 inhibitors (eg, ketoconazole, gemfibrozil); if unavoidable, monitor closely. May antagonize effects of CYP3A4, CYP2C8, CYP2C9, CYP2C19, CYP2B6 substrates (eg, midazolam, warfarin, dexamethasone, hormonal contraceptives); consider alternatives or monitor.

Adverse Reactions:

Hyperkeratosis, headache, pyrexia, arthralgia, papilloma, alopecia, palmar-plantar erythrodysesthesia syndrome; skin toxicity (may be serious). In combination with trametinib: also chills, fatigue, rash, nausea, vomiting, diarrhea, myalgia, dry skin, decreased appetite, edema, hemorrhage, cough, dyspnea.

Generic Availability:

NO

How Supplied:

Caps—120


Data provided by MPR.

Indications for TAFINLAR:

In combination with trametinib for the treatment of metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation, as detected by an FDA-approved test.

Limitations Of use:

Not indicated for the treatment of wild-type BRAF NSCLC.

Adult:

Confirm presence of BRAF V600E mutation prior to initiation. Swallow whole. Take at least 1hr before or 2hrs after a meal. In combination with trametinib: 150mg twice daily (approx. 12hrs apart); continue until disease recurrence or unacceptable toxicity. Dose modifications: see full labeling.

Children:

Not established.

Warnings/Precautions:

See full labeling for trametinib prior to starting combination therapy. Increased incidence of new primary cutaneous malignancies; perform skin evaluation prior to initiation, every 2 months during therapy, and up to 6 months after discontinuation. Monitor for non-cutaneous malignancies; permanently discontinue if RAS mutation-positive malignancy occurs. Permanently discontinue for all Grade 4 hemorrhagic events or any persistent Grade 3 events. Risk of cardiomyopathy with trametinib; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold for symptomatic cardiomyopathy or asymptomatic LV dysfunction of >20% from baseline that is below institutional lower limit of normal. Withhold if fever ≥101.3°F or any serious febrile reaction occurs and evaluate for infection; prophylaxis with antipyretics may be needed when resuming. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Monitor for visual signs/symptoms of uveitis; permanently discontinue for persistent Grade ≥2 lasting >6wks. G6PD deficiency: monitor for hemolytic anemia. Severe renal or moderate-to-severe hepatic impairment. Embryo-fetal toxicity. Females of reproductive potential should use highly effective non-hormonal contraception during and for 2wks after last dose. Pregnancy; avoid. Nursing mothers: not recommended (during and for 2wks after last dose).

Pharmacological Class:

Kinase inhibitor.

Interactions:

Avoid concomitant strong CYP3A4 or CYP2C8 inhibitors (eg, ketoconazole, gemfibrozil); if unavoidable, monitor closely. May antagonize effects of CYP3A4, CYP2C8, CYP2C9, CYP2C19, CYP2B6 substrates (eg, midazolam, warfarin, dexamethasone, hormonal contraceptives); consider alternatives or monitor.

Adverse Reactions:

Hyperkeratosis, headache, pyrexia, arthralgia, papilloma, alopecia, palmar-plantar erythrodysesthesia syndrome; skin toxicity (may be serious). In combination with trametinib: also chills, fatigue, rash, nausea, vomiting, diarrhea, myalgia, dry skin, decreased appetite, edema, hemorrhage, cough, dyspnea.

Generic Availability:

NO

How Supplied:

Caps—120


Data provided by MPR.

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