ADD THIS DRUG TO MY LIST

Select the drug indication to add to your list

MEKINIST
Melanoma and other skin cancers
Pancreatic, thyroid, and other endocrine cancers
Respiratory and thoracic cancers
Compare To Related Drugs
View/Edit/Compare Drugs In My List

Only 4 drugs may be compared at once

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. 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.

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 (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. 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 if absolute LVEF decreases by 10% from baseline and is less than the lower limit of normal (LLN); permanently discontinue if symptomatic cardiomyopathy or persistent asymptomatic LV dysfunction of >20% from baseline that is below LLN 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; avoid. 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, headache, arthralgia, myalgia, 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 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. 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 if absolute LVEF decreases by 10% from baseline and is less than the lower limit of normal (LLN); permanently discontinue if symptomatic cardiomyopathy or persistent asymptomatic LV dysfunction of >20% from baseline that is below LLN 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; avoid. 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, headache, arthralgia, myalgia, 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. 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. 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 if absolute LVEF decreases by 10% from baseline and is less than the lower limit of normal (LLN); permanently discontinue if symptomatic cardiomyopathy or persistent asymptomatic LV dysfunction of >20% from baseline that is below LLN 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; avoid. 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, headache, arthralgia, myalgia, dry skin, decreased appetite, hemorrhage, cough, dyspnea.

Generic Availability:

NO

How Supplied:

Tabs—30

Sign Up for Free e-Newsletters