Trametinib

Trametinib is used, either alone or with dabrafenib, to treat certain types of cancer of the skin, lung, or thyroid.

Trametinib is also used together with dabrafenib to treat solid tumors or a type of brain tumor in adults and children who are at least 1 year old.

Trametinib is often given when the cancer has spread to other parts of the body and surgery is not an option.

Your doctor will confirm that you have the right type of tumor to be treated with trametinib.

Trametinib tablets are used only in adults and children who weigh at least 57 pounds (26 kg).

Trametinib may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take trametinib tablet once per day on an empty stomach, at least 1 hour before or 2 hours after a meal.

Trametinib oral solution may be taken once per day on an empty stomach, at least 1 hour before or 2 hours after a meal, or with a low-fat meal when taken alone. Trametinib oral solution in combination with dabrafenib should be taken on an empty stomach, at least 1 hour before or 2 hours after a meal. If needed, breastfeeding or baby formula may be given.

Take the medicine at the same time each day.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

Swallow the tablet whole and do not crush, chew, or break it.

Read and carefully follow any Instructions for Use provided for the oral solution before preparing your first dose. Measure a dose with the supplied measuring device (not a kitchen spoon). The oral solution can also be given through a feeding tube. Ask your doctor or pharmacist if you do not understand these instructions.

If you vomit shortly after taking trametinib, do not take another dose. Take your next dose as scheduled.

Your blood pressure will need to be checked often, and you will need frequent medical tests including your heart function. Your dose or medication schedule may be changed based on the results. Make sure to not miss any follow-up appointments.

Your doctor should check your skin before starting, during treatment, and up to 6 months after treatment with trametinib. Tell your doctor if you notice any new skin changes such as redness, sores that will not heal, a new wart, or mole that has changed in size or color.

Do not change your dose or dosing schedule without your doctor's advice.

Store at room temperature in the original container away from moisture and light. Use within the number of days specified in the Instructions for Use provided with your medicine. Do not freeze. Your pharmacist can provide more information about how to store this medicine.

Using trametinib with dabrafenib may raise your chances of developing other kinds of cancer. Inform your doctor if you see any new skin symptoms.

Tell your doctor if you have or have ever had:

• heart problems, high blood pressure;
• diabetes;
• lung or breathing problems;
• a stomach or intestinal disorder;
• eye problems (especially with your retina);
• trouble swallowing;
• bleeding problems, blood clot; or
• liver or kidney disease.

Using trametinib together with dabrafenib may increase your risk of developing other types of cancer. Ask your doctor about this risk.

Trametinib can harm an unborn baby if the mother or the father is using trametinib.

• 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. Tell your doctor if you become pregnant.
• If you are a man, use condoms if your sex partner is able to get pregnant. Keep using birth control, even if you had a vasectomy 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.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Trametinib may cause serious side effects. Call your doctor at once if you have:

• unusual bruising or bleeding, new signs of infection (fever, weakness, cough, diarrhea, problems urinating);
• worsening acne or skin rash, flu-like symptoms, mouth sores;
• cough, feeling short of breath;
• severe headache, blurred vision, pounding in your neck or ears;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
• signs of eye problems--eye pain or swelling, vision changes, seeing halos around lights, seeing color "dots" in your vision;
• signs of bleeding inside the body--weakness, dizziness, headache, red or pink urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• signs of a blood clot or heart problems--feeling lightheaded, chest pain, sudden cough or trouble breathing, pounding or irregular heartbeats, pain or swelling, pale skin, cold feeling in an arm or leg; or
• a hole (perforation) in your digestive tract--fever, severe stomach pain, change in bowel habits.

Your cancer treatments may be changed, delayed, or permanently discontinued if you have certain side effects.

Common side effects of trametinib may include:

• nausea, vomiting, diarrhea, loss of appetite, constipation;
• fever, chills, tiredness, stomach pain;
• headache;
• bleeding;
• increased blood pressure;
• muscle, bone, or joint pain;
• cough, shortness of breath;
• swelling in your arms, face, and legs; or
• rash, acne, dry skin, skin infection around nails.

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.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may affect trametinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are taking.