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Trametinib

Generic Name: trametinib (tra-ME-ti-nib)
Brand Name: Mekinist

Trametinib is used for:

Treating certain types of skin cancer (melanoma). It is used alone or in combination with dabrafenib. It may also be used for other conditions as determined by your doctor.

Trametinib is a kinase inhibitor. It works by preventing the growth of cancer cells.

Do NOT use trametinib if:

  • you are allergic to any ingredient in trametinib

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using trametinib:

Some medical conditions may interact with trametinib. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of bleeding problems or blood clots
  • if you have heart problems (eg, heart failure; fast, slow, or irregular heartbeat), high blood pressure, liver or kidney problems, lung or breathing problems, or eye or vision problems
  • if you have skin problems or you have long-term sun exposure
  • if you have taken another medicine like this one (eg, dabrafenib)

Some MEDICINES MAY INTERACT with trametinib. However, no specific interactions with trametinib are known at this time.

Ask your health care provider if trametinib may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use trametinib:

Use trametinib as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with trametinib. Talk to your pharmacist if you have questions about this information.
  • Trametinib may be used along with dabrafenib, which also comes with an extra patient information sheet called a Medication Guide. Read it carefully.
  • Take trametinib by mouth on an empty stomach at least 1 hour before or 2 hours after a meal.
  • If you are taking trametinib with dabrafenib, take it at the same time as one of your doses of dabrafenib.
  • Continue to take trametinib even if you feel well. Do not miss any doses.
  • If you miss a dose of trametinib, take it as soon as possible. If it is within 12 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use trametinib.

Important safety information:

  • Do NOT take more than the recommended dose, change your dose, or stop taking trametinib without checking with your doctor.
  • Tell your doctor or dentist that you take trametinib before you receive any medical or dental care, emergency care, or surgery.
  • Trametinib may increase the risk of developing other types of cancer, including another type of skin cancer, when used with dabrafenib. Contact your doctor right away if you experience any unusual symptoms, a new wart, a change in the size or color of a mole, or any other skin changes (eg, skin sore or reddish bump that bleeds or does not heal). Your doctor will check your skin for changes every 2 months while you are taking trametinib with dabrafenib and for up to 6 months after the last dose. Discuss with your doctor the benefits and risks of taking trametinib.
  • Severe and sometimes fatal bleeding has been reported in patients taking trametinib with dabrafenib. Contact your doctor right away if you have any unusual signs of bleeding, including coughing up blood or blood clots; dark, tarry, or bloody stools; unusual headache, dizziness, or weakness; or vomiting blood or vomit that looks like coffee grounds.
  • Serious and sometimes fatal blood clots in the arms, legs, or lungs have occurred in patients taking trametinib with dabrafenib. Contact your doctor right away if you develop chest pain; cool or pale arm or leg; pain or swelling in the arms or legs; sudden shortness of breath; or trouble breathing.
  • Serious and sometimes fatal heart problems, including heart failure, have been reported in patients using trametinib. Your doctor will check your heart function before treatment and while you take trametinib. Contact your doctor right away if you have fast heartbeat; shortness of breath; swelling in the hands, ankles, legs, or feet; or unusual light-headedness.
  • Trametinib can cause severe vision problems that can lead to loss of vision. Tell your doctor right away if you have any vision changes (eg, blurred vision; loss of vision; seeing color dots; seeing halos or blurred outline around objects; eye pain, swelling, or redness).
  • Trametinib may cause a fever, which may be serious, when used with dabrafenib. In some cases, dehydration, low blood pressure, dizziness, or kidney problems may happen with the fever. Tell your doctor right away if you have fever or chills, symptoms of dehydration (eg, dry mouth or eyes, sluggishness, unusual weakness), light-headedness, severe or persistent dizziness, fainting, or decreased urination.
  • Trametinib may raise your blood sugar when used with dabrafenib. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Diabetes patients - Check blood sugar levels closely if you are taking trametinib with dabrafenib. Ask your doctor before you change the dose of your diabetes medicine.
  • If you may become pregnant, you must use an effective form of birth control while you are taking trametinib and for at least 4 months after stopping it. If you have questions about effective birth control, talk with your doctor.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using trametinib with dabrafenib. To prevent pregnancy, use an effective nonhormonal form of birth control (eg, condoms).
  • Trametinib may cause fertility problems in women. This may affect your ability to become pregnant. Discuss any questions or concerns with your doctor.
  • Trametinib may lower sperm counts if taken with dabrafenib. This may affect your ability to father a child. Contact your doctor to talk about family planning or if you have any questions or concerns.
  • Lab tests, including blood pressure, heart function, eye exams, and skin exams, may be performed while you use trametinib. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Trametinib should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Trametinib may cause harm to the fetus. Do not become pregnant while you are taking it and for at least 4 months after you stop taking it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking trametinib while you are pregnant. It is not known if trametinib is found in breast milk. Do not breast-feed while taking trametinib.

Possible side effects of trametinib:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; cough; decreased appetite; diarrhea; dry skin; headache; mild stomach pain; muscle or joint aches; nausea; night sweats; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue); acne-like rash; bleeding from the gums, nose, eyes, vagina, or rectum; blood in the urine; blurred vision; mouth sores or blisters; muscle pain, weakness, or cramping; new or worsening lung or breathing problems (eg, cough, shortness of breath); pain, redness, swelling, or tenderness of the hands, of the feet, or around the fingernails or toenails; red, swollen, blistered, or peeling skin; severe or persistent diarrhea; severe or persistent headache, light-headedness, or dizziness; sudden, unexplained weight gain; swelling of the hands, feet, or ankles.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of trametinib:

Store trametinib in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C) in the original container with the lid tightly closed. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Do not throw away the desiccant packet in the bottle. Keep trametinib out of the reach of children and away from pets.

General information:

  • If you have any questions about trametinib, please talk with your doctor, pharmacist, or other health care provider.
  • Trametinib is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take trametinib or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about trametinib. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to trametinib. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using trametinib.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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