Trametinib Tablets

What is this medication?

TRAMETINIB (tra ME ti nib) treats some types of cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Mekinist

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorder
• Blood clots
• Diabetes
• Eye disease
• Heart disease
• High blood pressure
• Inflammatory bowel disease, such as colitis
• Kidney disease
• Liver disease
• Lung or breathing disease
• Stomach or intestine problems
• An unusual or allergic reaction to trametinib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. Take it on an empty stomach, at least 1 hour before or 2 hours after food. Your care team may change your dose or tell you to stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

Talk to your care team about the use of this medication in children. While it may be given to children as young as 1 year for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is more than 12 hours late. If it is more than 12 hours late, skip the missed dose. Take the next dose at the normal time.

What may interact with this medication?

Interactions have not been studied.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress.

Talk to your care team about your risk of cancer. You may be more at risk of certain types of cancer if you take this medication.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bruising or bleeding.

Your vision may be tested before and during use of this medication. Tell your care team right away if you have any change in your eyesight.

This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 4 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 4 months after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 4 months after the last dose.

Do not breastfeed while taking this medication and for 4 months after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Blurry vision, vision loss, seeing wavy or bent objects or blind spots with dark, light, or flashing spots
• Fever, rash, swollen lymph nodes, confusion, trouble walking, loss of balance or coordination, seizures
• Dry cough, shortness of breath or trouble breathing
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• High fever
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Sudden or severe stomach pain, bloody diarrhea, fever, nausea, vomiting

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Diarrhea
• Dry skin
• Fatigue
• Headache
• Nausea
• Skin rash
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Protect from light and moisture. Keep the container tightly closed. Do not throw out the packet in the container. It keeps the medication dry. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.