Tafinlar

— THERAPEUTIC DISORDERS TREATED —
  • Melanoma and other skin cancers
  • Pancreatic, thyroid, and other endocrine cancers
  • Respiratory and thoracic cancers
  • Solid tumors

Tafinlar Generic Name & Formulations

General Description

Dabrafenib 50mg, 75mg; caps.

Pharmacological Class

Kinase inhibitor.

How Supplied

Caps—120

Generic Availability

NO

Tafinlar Indications

Indications

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 for treatment of colorectal cancer because of known intrinsic resistance to BRAF inhibition. Not for treatment of wild-type BRAF solid tumors.

Tafinlar Dosage and Administration

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 for adverse reactions: see full labeling.

Children

Not established.

Tafinlar Contraindications

Not Applicable

Tafinlar Boxed Warnings

Not Applicable

Tafinlar Warnings/Precautions

Warnings/Precautions

See full labeling for trametinib prior to starting combination therapy. Increased incidence of new 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 or any persistent Grade 3 hemorrhagic 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 LLN. Withhold if fever ≥100.4°F, evaluate infection and assess renal function; prophylaxis with antipyretics when resuming or give steroids for subsequent pyrexia. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Monitor for uveitis; if occurs, withhold and treat as clinically indicated; 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. Advise to use effective non-hormonal contraception (females of reproductive potential) or use of condoms (males w. female partners) during and for ≥2wks after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2wks after last dose).

Tafinlar Pharmacokinetics

See Literature

Tafinlar Interactions

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.

Tafinlar Adverse Reactions

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, constipation, dermatitis acneiform, abdominal pain, paronychia.

Tafinlar Clinical Trials

See Literature

Tafinlar Note

Not Applicable

Tafinlar Patient Counseling

See Literature

Tafinlar Generic Name & Formulations

General Description

Dabrafenib 50mg, 75mg; caps.

Pharmacological Class

Kinase inhibitor.

How Supplied

Caps—120

Generic Availability

NO

Tafinlar Indications

Indications

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 for treatment of colorectal cancer because of known intrinsic resistance to BRAF inhibition. Not for treatment of wild-type BRAF solid tumors.

Tafinlar Dosage and Administration

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 for adverse reactions: see full labeling.

Children

Not established.

Tafinlar Contraindications

Not Applicable

Tafinlar Boxed Warnings

Not Applicable

Tafinlar Warnings/Precautions

Warnings/Precautions

See full labeling for trametinib prior to starting combination therapy. Increased incidence of new 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 or any persistent Grade 3 hemorrhagic 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 LLN. Withhold if fever ≥100.4°F, evaluate infection and assess renal function; prophylaxis with antipyretics when resuming or give steroids for subsequent pyrexia. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Monitor for uveitis; if occurs, withhold and treat as clinically indicated; 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. Advise to use effective non-hormonal contraception (females of reproductive potential) or use of condoms (males w. female partners) during and for ≥2wks after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2wks after last dose).

Tafinlar Pharmacokinetics

See Literature

Tafinlar Interactions

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.

Tafinlar Adverse Reactions

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, constipation, dermatitis acneiform, abdominal pain, paronychia.

Tafinlar Clinical Trials

See Literature

Tafinlar Note

Not Applicable

Tafinlar Patient Counseling

See Literature

Tafinlar Generic Name & Formulations

General Description

Dabrafenib 50mg, 75mg; caps.

Pharmacological Class

Kinase inhibitor.

How Supplied

Caps—120

Generic Availability

NO

Tafinlar Indications

Indications

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 for treatment of colorectal cancer because of known intrinsic resistance to BRAF inhibition. Not for treatment of wild-type BRAF solid tumors.

Tafinlar Dosage and Administration

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 for adverse reactions: see full labeling.

Children

Not established.

Tafinlar Contraindications

Not Applicable

Tafinlar Boxed Warnings

Not Applicable

Tafinlar Warnings/Precautions

Warnings/Precautions

See full labeling for trametinib prior to starting combination therapy. Increased incidence of new 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 or any persistent Grade 3 hemorrhagic 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 LLN. Withhold if fever ≥100.4°F, evaluate infection and assess renal function; prophylaxis with antipyretics when resuming or give steroids for subsequent pyrexia. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Monitor for uveitis; if occurs, withhold and treat as clinically indicated; 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. Advise to use effective non-hormonal contraception (females of reproductive potential) or use of condoms (males w. female partners) during and for ≥2wks after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2wks after last dose).

Tafinlar Pharmacokinetics

See Literature

Tafinlar Interactions

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.

Tafinlar Adverse Reactions

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, constipation, dermatitis acneiform, abdominal pain, paronychia.

Tafinlar Clinical Trials

See Literature

Tafinlar Note

Not Applicable

Tafinlar Patient Counseling

See Literature

Tafinlar Generic Name & Formulations

General Description

Dabrafenib 50mg, 75mg; caps.

Pharmacological Class

Kinase inhibitor.

How Supplied

Caps—120

Generic Availability

NO

Tafinlar Indications

Indications

In combination with trametinib, for the treatment of unresectable or metastatic solid tumors in adult and pediatric patients with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.

Limitations of Use

Not for treatment of colorectal cancer because of known intrinsic resistance to BRAF inhibition. Not for treatment of wild-type BRAF solid tumors.

Tafinlar Dosage and Administration

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: ≥18yrs: 150mg twice daily (approx. 12hrs apart); continue until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.

Children

<6yrs or <26kg: not established. 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: 6–17yrs (26–37kg): 75mg twice daily (approx. 12hrs apart); (38–50kg): 100mg twice daily; (≥51kg): 150mg twice daily; continue until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.

Tafinlar Contraindications

Not Applicable

Tafinlar Boxed Warnings

Not Applicable

Tafinlar Warnings/Precautions

Warnings/Precautions

See full labeling for trametinib prior to starting combination therapy. Increased incidence of new 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 or any persistent Grade 3 hemorrhagic 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 LLN. Withhold if fever ≥100.4°F, evaluate infection and assess renal function; prophylaxis with antipyretics when resuming or give steroids for subsequent pyrexia. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Monitor for uveitis; if occurs, withhold and treat as clinically indicated; 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. Advise to use effective non-hormonal contraception (females of reproductive potential) or use of condoms (males w. female partners) during and for ≥2wks after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2wks after last dose).

Tafinlar Pharmacokinetics

See Literature

Tafinlar Interactions

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.

Tafinlar Adverse Reactions

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, constipation, dermatitis acneiform, abdominal pain, paronychia.

Tafinlar Clinical Trials

See Literature

Tafinlar Note

Not Applicable

Tafinlar Patient Counseling

See Literature

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