"The U.S. Food and Drug Administration today approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin "...
What is MEKINIST?
MEKINIST is a prescription medicine used to treat people with a type of skin cancer called melanoma:
- that has spread to other parts of the body or cannot be removed by surgery, and
- that has a certain type of abnormal “BRAF” gene
MEKINIST should not be used to treat people who have received a BRAF inhibitor for treatment of their melanoma.
Your healthcare provider will perform a test to make sure that MEKINIST is right for you.
It is not known if MEKINIST is safe and effective in children.
What should I tell my healthcare provider before taking MEKINIST?
Before you take MEKINIST, tell your healthcare provider if you:
- have heart problems
- have lung or breathing problems
- have eye problems
- have high blood pressure (hypertension)
- have liver or kidney problems
- have any other medical conditions
- are pregnant or plan to become pregnant. MEKINIST can
harm your unborn baby.
- Women who may become pregnant should use effective birth control (contraception) during treatment with MEKINIST and for 4 months after stopping treatment. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant during treatment with MEKINIST.
- are breastfeeding or plan to breastfeed. It is not known if MEKINIST passes into your breast milk. You and your healthcare provider should decide if you will take MEKINIST or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take MEKINIST?
- Take MEKINIST exactly as your healthcare provider tells you to take it. Do not change your dose or stop MEKINIST unless your healthcare provider tells you.
- Take MEKINIST one time a day.
- Take MEKINIST 1 hour before or 2 hours after meals.
- If you miss a dose, take it as soon as you remember. If it is within 12 hours of your next scheduled dose, skip the missed dose. Just take the next dose at your regular time.
- If you take too much MEKINIST, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of MEKINIST?
MEKINIST may cause serious side effects, including:
- heart problems, including heart failure. Your
healthcare provider should check your heart function before you start taking
MEKINIST and during treatment. Signs and symptoms of heart problems may include:
- feeling like your heart is pounding or racing
- shortness of breath
- swelling of your ankles and feet
- feeling lightheaded
- eye problems. MEKINIST can cause eye problems
including blindness. Tell your healthcare provider right away if you get these
symptoms of eye problems:
- blurred vision, loss of vision, or other vision changes
- see color dots
- halo (seeing blurred outline around objects)
- lung or breathing problems. Tell your healthcare
provider if you have any new or worsening symptoms of lung or breathing
- shortness of breath
- skin rash. Rash is the most common side effect of
MEKINIST and in some cases can be severe and can result in admission to the
hospital if severe. Tell your healthcare provider if you get any of the
- skin rash
- redness, swelling, peeling, or tenderness of hands or feet
- skin redness
The most common side effects of MEKINIST include:
- swelling of the face, arms, or legs
MEKINIST can cause new or worsening high blood pressure (hypertension). Your healthcare provider should check your blood pressure during treatment with MEKINIST. Tell your healthcare provider if you develop high blood pressure, your blood pressure worsens, or you have severe headache, lightheadedness, or dizziness.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of MEKINIST. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store MEKINIST?
- Store MEKINIST in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze.
- Keep MEKINIST dry and away from moisture.
- The bottle of MEKINIST contains a desiccant packet to help keep your medicine dry. Do not throw away the desiccant packet.
- Keep MEKINIST in its original bottle. Do not place tablets in a pill box.
- Safely throw away MEKINIST that is out of date or no longer needed.
Keep MEKINIST and all medicine out of the reach of children.
General information about MEKINIST
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use MEKINIST for a condition for which it was not prescribed. Do not give MEKINIST to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your healthcare provider or pharmacist for information about MEKINIST that is written for health professionals.
For more information, go to www.MEKINIST.com or call 1-888-825-5249.
What are the ingredients in MEKINIST?
Active ingredient: trametinib
Tablet Core: mannitol, microcrystalline cellulose, hypromellose, croscarmellose sodium, magnesium stearate (vegetable source), sodium lauryl sulfate, colloidal silicon dioxide. Tablet Coating: hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80 (2-mg tablets), iron oxide yellow (0.5-mg tablets), iron oxide red (2-mg tablets).
This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 6/6/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Mekinist Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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