Trametinib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat a certain type of skin cancer. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause serious heart, skin, lung, or eye problems. This medicine may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); kinase inhibitor

Generic and brand names: trametinib, oral; Mekinist

What is this medicine used for?

This medicine is taken by mouth alone or along with dabrafenib to treat a certain kind of spreading melanoma that is linked to an abnormal BRAF gene.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Bleeding problems or blood clots
• Diabetes
• Heart disease
• Liver or kidney problems
• Eye problems
• High blood pressure
• Lung or breathing problems

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Use effective birth control during treatment with this medicine and for at least 4 months after you stop treatment. If you are taking this medicine along with dabrafenib, dabrafenib may cause hormonal birth control to be less effective. Talk with your healthcare provider if you need birth control. Do not breast-feed while you are taking this medicine.

This medicine may affect your ability to become pregnant.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval. Do not take more of it or for longer than prescribed. Taking too much increases the risk of serious side effects.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine is taken once a day, at the same time each day. Take the medicine at least 1 hour before or at least 2 hours after a meal. Swallow the tablets whole with water. Do not crush or chew them.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is within 12 hours of the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: blurred vision; partial or complete loss of vision.

What should I watch out for?

This medicine may cause heart problems, including heart failure. Tell your healthcare provider right away if you have any unusual bruising or bleeding, chest pain, trouble breathing, fast or irregular heartbeat, lightheadedness, or swelling in your arms, legs, ankles, or feet.

Your healthcare provider may check your heart before your start treatment and regularly during treatment to see how this medicine affects you. You may also have blood tests regularly while you are receiving this medicine. Keep all appointments.

This medicine may cause serious eye problems. Contact your healthcare provider if you have eye pain, swelling, or redness, or any vision changes. You may need vision tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may cause serious lung or skin problems. Tell your healthcare provider if you have trouble breathing or an unexplained cough. Tell your healthcare provider if you have any redness, peeling, swelling, or pain on your hands or feet, acne, or any skin rash.

When taken along with dabrafenib, this medicine may cause different types of skin cancer. Your healthcare provider will check your skin regularly while you are taking this medicine, and for up to 6 months after you stop taking this medicine.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

If you have diabetes: Taking this medicine along with dabrafenib may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Fever; chest pain; slow, fast, or irregular heartbeat; severe dizziness or fainting; shortness of breath; trouble breathing; severe cough; unexplained tiredness or weakness; swelling in your arms, legs, ankles or feet, or any unexplained swelling; pain or redness in your legs; skin rash or redness; acne; pain, redness, swelling, peeling, or blisters on the face, palms of your hands, or soles of your feet; mole or skin changes; warts; sores that don’t heal; mouth sores or blisters; eye pain; blurred vision, loss of vision, or vision changes (seeing colored dots or halo); severe headache; unusual bruising or bleeding; coughing up blood; black or tarry bowel movements; vomiting blood or vomit looks like coffee grounds; severe or ongoing diarrhea; frequent urination and constant thirst; decreased urination.

Other: Dry skin; dry mouth; mild diarrhea; mild nausea, vomiting, or stomach pain; tiredness; constipation; night sweats; decreased appetite; joint and muscle pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Aripiprazole (Abilify)
• Axitinib (Inlyta)
• Saxagliptin (Onglyza)

Do not start or stop any medicines, including nonprescription medicines and natural remedies, without your healthcare provider’s approval.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in its original container in the refrigerator. The original container has a small packet to help keep your medicine dry. Do not throw away the packet. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.