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MEKINIST
Melanoma and other skin cancers
Respiratory and thoracic cancers
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Drug Name:

MEKINIST Rx

Generic Name and Formulations:
Trametinib 0.5mg, 2mg; tabs.

Company:
Novartis Pharmaceuticals Corp

Therapeutic Use:

Indications for MEKINIST:

As monotherapy or in combination with dabrafenib for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.

Limitations Of use:

Not indicated for treatment of patients who have progressed on prior BRAF-inhibitor therapy.

Adult:

Confirm presence of BRAF V600E or V600K mutation prior to initiation. Take at same time each day, at least 1hr before or 2hrs after a meal. Monotherapy or in combination with dabrafenib: 2mg once daily; continue until disease progression or unacceptable toxicity. Dose modifications: see full labeling.

Children:

Not established.

Warnings/Precautions:

See full labeling for dabrafenib 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, pulmonary embolism (permanently discontinue if life-threatening), colitis, GI perforations, skin toxicities and secondary infections. Permanently discontinue for all Grade 4 hemorrhagic events or any Grade 3 events that do not improve. Risk of cardiomyopathy; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold if absolute LVEF decreases by 10% from baseline and is less than the lower limit of normal; permanently discontinue if symptomatic cardiomyopathy or persistent asymptomatic LV dysfunction is unresolved within 4wks. Perform eye exam periodically and at any time for visual disturbances; permanently discontinue if retinal vein occlusion develops or retinal pigment epithelial detachment persists. Permanently discontinue if interstitial lung disease or pneumonitis occurs. Withhold if fever >104°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. Severe renal or moderate-to-severe hepatic impairment. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during and for 4 months after treatment. Pregnancy. Nursing mothers: not recommended (during and for 4 months after last dose).

Pharmacological Class:

Kinase inhibitor.

Adverse Reactions:

Rash, diarrhea, lymphedema. In combination with dabrafenib: also pyrexia, chills, fatigue, nausea, vomiting, hypertension, peripheral edema, dry skin, decreased appetite, hemorrhage, cough, dyspnea.

Generic Availability:

NO

How Supplied:

Tabs—30

Indications for MEKINIST:

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

Adult:

Confirm presence of BRAF V600E mutation prior to initiation. Take at same time each day, at least 1hr before or 2hrs after a meal. Monotherapy or in combination with dabrafenib: 2mg once daily; continue until disease progression or unacceptable toxicity. Dose modifications: see full labeling.

Children:

Not established.

Warnings/Precautions:

See full labeling for dabrafenib 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, pulmonary embolism (permanently discontinue if life-threatening), colitis, GI perforations, skin toxicities and secondary infections. Permanently discontinue for all Grade 4 hemorrhagic events or any Grade 3 events that do not improve. Risk of cardiomyopathy; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold if absolute LVEF decreases by 10% from baseline and is less than the lower limit of normal; permanently discontinue if symptomatic cardiomyopathy or persistent asymptomatic LV dysfunction is unresolved within 4wks. Perform eye exam periodically and at any time for visual disturbances; permanently discontinue if retinal vein occlusion develops or retinal pigment epithelial detachment persists. Permanently discontinue if interstitial lung disease or pneumonitis occurs. Withhold if fever >104°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. Severe renal or moderate-to-severe hepatic impairment. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during and for 4 months after treatment. Pregnancy. Nursing mothers: not recommended (during and for 4 months after last dose).

Pharmacological Class:

Kinase inhibitor.

Adverse Reactions:

Rash, diarrhea, lymphedema. In combination with dabrafenib: also pyrexia, chills, fatigue, nausea, vomiting, hypertension, peripheral edema, dry skin, decreased appetite, hemorrhage, cough, dyspnea.

Generic Availability:

NO

How Supplied:

Tabs—30

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