"The U.S. Food and Drug Administration today granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs."...
If your healthcare provider prescribes MEKINIST for you in combination with dabrafenib, also read the Medication Guide that comes with dabrafenib.
What is MEKINIST?
MEKINIST is a prescription medicine used by itself or in combination with dabrafenib 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 alone to treat people who already 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 had bleeding problems or blood clots
- have heart problems
- have eye problems
- have lung or breathing 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.
- Females who are able to become pregnant should use effective birth control (contraception) during treatment with MEKINIST and for 4 months after stopping treatment.
- Birth control using hormones (such as birth control pills, injections, or patches) may not work as well while you are taking MEKINIST in combination with dabrafenib. You should use another effective method of birth control while taking MEKINIST in combination with dabrafenib.
- Talk to your healthcare provider about birth control methods that may be right for you during this time.
- 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. If you are taking MEKINIST in combination with dabrafenib, you can take it at the same time as one of your doses of dabrafenib.
- Take MEKINIST at least 1 hour before or 2 hours after a meal.
- 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
- bleeding problems. MEKINIST, when taken in
combination with dabrafenib, can cause serious bleeding problems,especially in
your brain or stomach, and can lead to death. Call your healthcare provider and
get medical help right away if you have any unusual signs of bleeding, including:
- headaches, dizziness, or feeling weak
- cough up blood or blood clots
- vomit blood or your vomit looks like “coffee grounds”
- red or black stools that look like tar
- blood clots. MEKINIST, when taken in combination
with dabrafenib, can cause blood clots in your arms or legs, which can travel
to your lungs and can lead to death. Get medical help right away if you have
the following symptoms:
- chest pain
- sudden shortness of breath or trouble breathing
- pain in your legs with or without swelling
- swelling in your arms or legs
- a cool or pale arm or leg
- heart problems, including heart failure. Your
healthcare provider should check your heart function before you start taking
MEKINIST by itself or in combination with dabrafenib, and during treatment.
Call your healthcare provider right away if you have any of the following signs
and symptoms of a heart problem:
- feeling like your heart is pounding or racing
- shortness of breath
- swelling of your ankles and feet
- feeling lightheaded
- eye problems. MEKINIST can cause severe eye
problems that might lead to blindness. Call 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)
- eye pain, swelling, or redness
- lung or breathing problems. Tell your healthcare
provider if you have any new or worsening symptoms of lung or breathing
- shortness of breath
- skin reactions. Rash is a common side effect of
MEKINIST. MEKINIST can also cause other skin reactions. In some cases these
rashes and other skin reactions can be severe, and may need to be treated in a
hospital. Call your healthcare provider if you get any of the following
- skin rash that bothers you or does not go away
- redness, swelling, peeling, or tenderness of hands or feet
- skin redness
- fever. MEKINIST in combination with dabrafenib can cause fever, which may be serious. In some cases, chills or shaking chills, too much fluid loss (dehydration), low blood pressure, dizziness, or kidney problems may happen with the fever. Call your healthcare provider right away if you get a fever while taking MEKINIST.
- increased blood sugar (hyperglycemia). Some people
may develop high blood sugar or worsening diabetes during treatment with
MEKINIST in combination with dabrafenib. If you are diabetic, your healthcare
provider should check your blood sugar levels closely during treatment with
MEKINIST in combination with dabrafenib. Your diabetes medicine may need to be
changed. Tell your healthcare provider if you have any of the following
symptoms of severe high blood sugar:
- increased thirst
- urinating more often than normal or urinating an increased amount of urine
The most common side effects of MEKINIST when used alone include:
- diarrhea. Call your healthcare provider if you get severe diarrhea.
- swelling of the face, arms, or legs
Other common side effects of MEKINIST when used in combination with dabrafenib include:
- nausea or vomiting
- stomach-area (abdominal) pain
- swelling of the face, arms, or legs
- night sweats
- decreased appetite
- muscle or joint aches
MEKINIST can cause new or worsening high blood pressure (hypertension). Your healthcare provider should check your blood pressure during treatment with MEKINIST. Call your healthcare provider right away if you develop high blood pressure, your blood pressure worsens, or you have severe headache, lightheadedness, or dizziness.
MEKINIST may cause fertility problems in females. This could affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you.
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 and light.
- 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: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate (vegetable source), mannitol, microcrystalline cellulose, sodium lauryl sulfate.
Tablet Coating: hypromellose, iron oxide red (2-mg tablets), iron oxide yellow (0.5-mg tablets), polyethylene glycol, polysorbate 80 (2-mg tablets), titanium dioxide.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 1/22/2014
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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