trametinib
What is the most important information I should know about trametinib?
Using trametinib with dabrafenib may increase your risk of developing new skin cancer. Ask your doctor about the risk. Tell your doctor if you notice new skin symptoms such as redness, warts, sores that will not heal, or a mole that has changed in size or color.
What is trametinib?
Trametinib is used alone or in combination with another medicine called dabrafenib (Tafinlar) to treat certain types of cancer in people who have a "BRAF" gene mutation. These medicines are for use in treating:
- melanoma (skin cancer) that cannot be treated with surgery or has spread to other parts of the body (metastatic), or to prevent melanoma from coming back after surgery;
- metastatic non-small cell lung cancer; or
- advanced or metastatic anaplastic thyroid cancer for which there are no other treatment options.
Trametinib may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking trametinib?
Tell your doctor if you have ever had:
- heart disease, high blood pressure;
- diabetes;
- lung disease;
- liver or kidney disease;
- a stomach or intestinal disorder;
- eye problems (especially a problem with your retina); or
- bleeding problems, or a blood clot.
Using trametinib with dabrafenib may increase your risk of developing new skin cancer. Ask your doctor about the risk. Tell your doctor if you notice new skin symptoms such as redness, warts, sores that will not heal, or a mole that has changed in size or color.
Trametinib can harm an unborn baby if the mother or the father is using this medicine.
- If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 4 months after your last dose.
- It may be harder for you get pregnant while using this medicine. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.
- If you are a man, use condoms if your sex partner is pregnant or is able to get pregnant, even if you've had a vasectomy. Keep using condoms for at least 4 months after your last dose.
- Tell your doctor right away if a pregnancy occurs.
Do not breastfeed while using this medicine, and for at least 4 months after your last dose.
How should I take trametinib?
Your doctor will make sure you have the correct tumor type to be treated with trametinib.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Take trametinib on an empty stomach, at least 1 hour before or 2 hours after a meal.
Your doctor will need to check your skin every 2 months while you are using trametinib, and for up to 6 months after your last dose.
Your blood pressure and heart function will need to be checked often. You may also need regular vision examinations.
You may be given steroid medication if you have a fever and severe chills for 3 days or longer. Use the steroid for as long as your doctor has prescribed.
Store in the refrigerator and protect from light. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative. Do not store trametinib tablets in a pill box.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking trametinib?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of trametinib?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects are more likely to occur if you take trametinib and dabrafenib together. Call your doctor at once if you have:
- cough, feeling short of breath;
- fever, chills, feeling light-headed;
- little or no urination;
- severe headache, blurred vision, and dizziness;
- nausea, stomach pain, severe diarrhea;
- increased thirst or urination;
- eye pain or swelling, vision changes, seeing halos around lights, seeing color "dots" in your vision;
- severe skin rash, skin pain or swelling, redness and peeling skin on your hands or feet;
- signs of bleeding --weakness, dizziness, headache, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- signs of a blood clot --chest pain, sudden cough or trouble breathing, pain or swelling in an arm or leg, pale skin, cold feeling in an arm or leg; or
- signs of a heart problem --shortness of breath (even with mild exertion), pounding heartbeats, swelling in your feet or ankles.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- nausea, vomiting, diarrhea, loss of appetite;
- fever, chills, tiredness;
- headache;
- bleeding;
- increased blood pressure;
- muscle or joint pain;
- cough, shortness of breath;
- swelling in your arms, face, and legs; or
- rash, dry skin.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect trametinib?
Other drugs may affect trametinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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