Trametinib (tra-ME-ti-nib)

Treats melanoma (skin cancer), non-small cell lung cancer (NSCLC), anaplastic thyroid cancer (ATC), solid tumors, and low-grade glioma (LGG).

Brand Name(s):

Mekinist

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take the tablet at least 1 hour before or 2 hours after a meal.
• Oral liquid: A nurse or other trained health professional will give you this medicine. This medicine can be given using an oral dosing syringe or feeding tube.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If your next dose is less than 12 hours away, skip the missed dose and take the medicine at your regular dosing time. If your missed dose is more than 12 hours until the time you normally take a dose, take it as soon as you remember and go back to your regular dosing schedule.
• Store the tablets in the refrigerator and the oral liquid at room temperature. Keep the medicine in its original bottle. Do not freeze. Keep away from moisture and light.
• Throw away unused oral liquid after 35 days.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment with this medicine and for at least 4 months after your last dose.
• Do not breastfeed during treatment with this medicine and for at least 4 months after the last dose.
• Tell your doctor if you have kidney disease, liver disease, bleeding problems, blood clots, diabetes, eye problems, heart disease, low or high blood pressure, lung disease or breathing problems, or stomach or bowel problems.
• This medicine may cause the following problems:
  • Increased risk for other cancers (skin and non-skin cancer)
  • Bleeding problems or blood clots
  • Stomach and bowel perforation (tear or hole)
  • Heart problems (including heart failure)
  • Eye or vision problems
  • Interstitial lung disease or pneumonitis
  • Fever (which may be serious)
  • Serious infections
  • Serious skin reactions, including Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS)
  • High blood sugar
  • Hemophagocytic lymphohistiocytosis (HLH), which can be life-threatening
• This medicine could cause infertility in women. Talk with your doctor before using this medicine if you plan to have children.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bleeding gums, coughing up blood, unusual nosebleeds, red or dark brown urine, or red or black, tarry stools
• Blistering, peeling, or red skin rash, or swollen, painful, or tender lymph glands in neck, armpit, or groin
• Blurred vision, changes in vision
• Chest pain, trouble breathing, cough, cold sweat, or bluish-colored skin
• Fast, slow, or pounding heartbeat
• Fever, chills, change in how much or how often you urinate
• Increased hunger or thirst
• Numbness or weakness in your arm or leg, or on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Rapid weight gain, swelling in your hands, ankles, or feet
• Redness, swelling, peeling, or tenderness of the hands or feet
• Severe headache, lightheadedness, or dizziness
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Mild diarrhea, nausea, vomiting, stomach pain
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088