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

Trametinib is also used to treat solid tumors in adults and children at least 6 years old.

Trametinib is also used to treat a type of brain tumor called low grade glioma in adults and children at least 1 years old.

Trametinib is often given when the cancer has spread to other parts of the body, when surgery is not an option, or to keep the cancer from coming back after surgery.

Your doctor will make sure you have the correct tumor type to be treated with trametinib.

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

Using trametinib may increase your risk of developing other cancers. Ask your doctor about this risk.

Trametinib comes as a tablet and a solution (liquid) to take by mouth. It is usually taken once a day on an empty stomach, at least 1 hour before or 2 hours after a meal. Take trametinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take trametinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Do not stop taking trametinib without talking to your doctor.

Swallow the tablets whole; do not break or crush them. Tell your doctor if you cannot swallow the tablets whole.

If you vomit after you take trametinib, do not take another dose. Continue your regular dosing schedule.

Your doctor may adjust your dose of trametinib depending on your response to treatment and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

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

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

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

Follow all instructions for the oral suspension before preparing your first dose. Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon). The oral suspension can also be given through a feeding tube. Ask your doctor or pharmacist if you do not understand these instructions.

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

You will need frequent medical tests to help determine if it is safe for you to keep receiving trametinib. Your dose or medication schedule may be changed based on the results. Make sure to not miss any follow-up appointment.

Check your skin regularly during treatment and up to 6 months after taking trametinib. Tell your doctor if you notice any new skin change such as redness, sores that will not heal, a new wart, or a mole that has changed in size or color.

Store the tablet in the refrigerator, do not freeze. Keep the medicine in the original container, along with the packet or canister of moisture-absorbing preservative. Do not store tablets in a pill box.

Store the mixed oral suspension at room temperature away from moisture and heat. Throw the oral suspension away after 35 days.

Tell your doctor if you have ever had:

• heart problems, high blood pressure;

• diabetes;

• lung or breathing problems;

• a stomach or intestinal disorder;

• eye problems (especially with your retina);

• bleeding problems, blood clot; or

• liver or kidney disease.

Using trametinib may increase your risk of developing other cancers. 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 during treatment if your sex partner is able to get pregnant. Keep using birth control 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.

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.

Keep this medication in the container it came in, tightly closed, away from moisture and light, and out of the reach of children. Do not place the tablets in other containers, such as daily or weekly pill boxes. Store it in a refrigerator, but do not freeze it. Do not remove the desiccant (small packet included with medication to absorb moisture) from your bottle.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

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

Get emergency medical help if you have signs of an allergic reaction (hives, difficult 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.

Some people taking trametinib have developed a perforation (a hole or tear) or swelling in the stomach or intestines. Call your doctor if you have severe stomach pain, bleeding, diarrhea, fever, or nausea.

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);

• a skin rash;

• 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--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 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.

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.

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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to see if it is safe for you to receive trametinib and to check your body's response to trametinib. Your doctor will also check your skin for any changes before you begin treatment, every 2 months during your treatment, and for up to 6 months after treatment. Your doctor will also check your blood pressure from time to time as needed.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.