Select therapeutic use:

Melanoma and other skin cancers:

Indications for MEKINIST:

As monotherapy in BRAF-inhibitor treatment-naïve patients 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. In combination with dabrafenib 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.

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 (approx. 24hrs apart); continue until disease progression or unacceptable toxicity. Adjuvant treatment with dabrafenib: 2mg once daily (approx. 24hrs 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 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. Withhold if uncomplicated deep vein thrombosis or pulmonary embolism occurs for up to 3wks. Permanently discontinue for all Grade 4 hemorrhagic events or any persistent Grade 3 events. Risk of cardiomyopathy; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold for up to 4wks if absolute LVEF decreases by ≥10% from baseline and is less than the lower limit of normal (LLN); permanently discontinue if symptomatic cardiomyopathy or absolute LVEF decrease of >20% from baseline that is below LLN. Perform eye exam periodically and at any time for visual disturbances; withhold for up to 3wks, if retinal pigment epithelial detachment is diagnosed. Permanently discontinue if documented retinal vein occlusion, interstitial lung disease or pneumonitis occurs. Withhold if fever >104°F or any serious febrile reaction occurs and evaluate for infection; monitor renal function if severe; prophylaxis with antipyretics may be needed when resuming. Withhold if intolerable or severe skin toxicity occurs; permanently discontinue if unresolved after 3wks. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Severe renal or moderate-to-severe hepatic impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after last dose).

Pharmacologic Class:

Kinase inhibitor.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Tabs—30

Pricing for MEKINIST

2mg tablet (Qty: 30)
Appx. price $11206
GoodRx

Pancreatic, thyroid, and other endocrine cancers:

Indications for MEKINIST:

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

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. In combination with dabrafenib: 2mg once daily (approx. 24hrs apart); continue until disease recurrence 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. Withhold if uncomplicated deep vein thrombosis or pulmonary embolism occurs for up to 3wks. Permanently discontinue for all Grade 4 hemorrhagic events or any persistent Grade 3 events. Risk of cardiomyopathy; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold for up to 4wks if absolute LVEF decreases by ≥10% from baseline and is less than the lower limit of normal (LLN); permanently discontinue if symptomatic cardiomyopathy or absolute LVEF decrease of >20% from baseline that is below LLN. Perform eye exam periodically and at any time for visual disturbances; withhold for up to 3wks, if retinal pigment epithelial detachment is diagnosed. Permanently discontinue if documented retinal vein occlusion, interstitial lung disease or pneumonitis occurs. Withhold if fever >104°F or any serious febrile reaction occurs and evaluate for infection; monitor renal function if severe; prophylaxis with antipyretics may be needed when resuming. Withhold if intolerable or severe skin toxicity occurs; permanently discontinue if unresolved after 3wks. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Severe renal or moderate-to-severe hepatic impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after last dose).

Pharmacologic Class:

Kinase inhibitor.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Tabs—30

Pricing for MEKINIST

2mg tablet (Qty: 30)
Appx. price $11206
GoodRx

Respiratory and thoracic cancers:

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. In combination with dabrafenib: 2mg once daily (approx. 24hrs apart); continue until disease recurrence 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. Withhold if uncomplicated deep vein thrombosis or pulmonary embolism occurs for up to 3wks. Permanently discontinue for all Grade 4 hemorrhagic events or any persistent Grade 3 events. Risk of cardiomyopathy; assess LVEF prior to initiation, after one month, and then at every 2–3 month intervals during treatment; withhold for up to 4wks if absolute LVEF decreases by ≥10% from baseline and is less than the lower limit of normal (LLN); permanently discontinue if symptomatic cardiomyopathy or absolute LVEF decrease of >20% from baseline that is below LLN. Perform eye exam periodically and at any time for visual disturbances; withhold for up to 3wks, if retinal pigment epithelial detachment is diagnosed. Permanently discontinue if documented retinal vein occlusion, interstitial lung disease or pneumonitis occurs. Withhold if fever >104°F or any serious febrile reaction occurs and evaluate for infection; monitor renal function if severe; prophylaxis with antipyretics may be needed when resuming. Withhold if intolerable or severe skin toxicity occurs; permanently discontinue if unresolved after 3wks. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Severe renal or moderate-to-severe hepatic impairment. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after last dose).

Pharmacologic Class:

Kinase inhibitor.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Tabs—30

Pricing for MEKINIST

2mg tablet (Qty: 30)
Appx. price $11206
GoodRx