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Trametinib

Precautions

Before taking trametinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, heart disease (heart failure), lung problems, bleeding/blood problems, diabetes, eye problems, stomach/intestinal problems (such as diverticulitis).

This drug may make you dizzy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially swelling of the arms/legs and loss of appetite.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using trametinib. Trametinib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 4 months after the last dose. Men (including those who have had a vasectomy) using this medication should ask about reliable forms of birth control during treatment and for 4 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 4 months after the last dose. Consult your doctor before breastfeeding.

Side Effects

Dizziness, diarrhea, nausea/vomiting, stomach pain, dry/itchy skin, acne, and dry mouth may occur. Weight gain may also occur in children. If any of these effects last or get worse, tell your doctor or pharmacist promptly. To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

Pain or sores in the mouth and throat may occur. Brush your teeth carefully/gently, avoid using mouthwash that contains alcohol, and rinse your mouth often with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: signs of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), signs of lung disease (such as cough, shortness of breath, rapid breathing), signs of skin infection (such as red/peeling/warm skin), signs of muscle damage (such as muscle pain/tenderness/weakness, unusual tiredness), signs of kidney problems (such as change in the amount of urine), easy bleeding/bruising.

Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as blurred vision, loss of vision, blind spots/shadows in the center of your vision, sensitivity to light), signs of bleeding in the brain (such as severe headache, weakness on one side of the body, vision problems, trouble speaking, seizures, or confusion), signs of serious stomach/intestinal problems (such as severe stomach/abdominal pain, black/bloody stools, vomit that contains blood or looks like coffee grounds, diarrhea with blood/mucus), sudden pain/swelling/redness (usually in the leg), chest pain, fast/irregular heartbeat, trouble breathing.

Trametinib may make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Although this medication is used to treat certain skin cancers, it may rarely cause new skin cancer or other cancers. Tell your doctor right away if you notice unusual skin changes (such as skin sores/lumps, warts, change in the size/color of a mole, skin bump that bleeds or does not heal). Your doctor should check your skin before starting treatment, every 2 months during treatment, and for up to 6 months after stopping this medication.

Trametinib can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.