Trametinib oral tablets

What is this medicine?

TRAMETINIB (tra me ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat melanoma, non-small cell lung cancer, and thyroid cancer.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach, at least 1 hour before or 2 hours after food. Do not take with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• blurred vision

• cough

• diarrhea

• eye pain

• feeling faint or lightheaded

• rash, fever, and swollen lymph nodes

• redness, blistering, peeling, or loosening of the skin, including inside the mouth

• severe headaches

• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose

• signs and symptoms of a blood clot such as breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm or leg

• signs and symptoms of heart failure like breathing problems; fast, irregular heartbeat; sudden weight gain; swelling of the ankles, feet, hands; unusually weak or tired

• signs and symptoms of high blood sugar such as dizziness; dry mouth; dry skin; fruity breath; nausea; stomach pain; increased hunger or thirst; increased urination

• stomach pain

• unusually weak or tired

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

• decreased appetite

• joint pain

• muscle pain

• nausea, vomiting

What may interact with this medicine?

Drug interactions have not been identified.

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 if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 12 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

Where should I keep my medicine?

Store between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Keep this medicine in the original container. Throw away any unused medicine after the expiration date.

Keep out of the reach of children.

What should I tell my health care provider before I take this medicine?

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

• diabetes

• eye disease, vision problems

• heart disease

• high blood pressure

• history of bleeding problems

• history of blood clots

• inflammatory bowel disease

• kidney disease

• liver disease

• lung or breathing disease, like asthma

• stomach or intestine problems

• an unusual or allergic reaction to trametinib, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress.

Your vision may be tested before and during use of this medicine. Tell your doctor or health care professional right away if you have any change in your eyesight.

Do not become pregnant while taking this medicine or for 4 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Do not breast-feed an infant while taking this medicine or for 4 months after stopping it.

Males who get this medicine must use a condom during sex with females who can get pregnant. If you get a women pregnant, the baby could have birth defects. The baby could die before they are born. You will need to continue wearing a condom for at least 4 months after stopping the medicine. Tell your healthcare provider right away if your partner becomes pregnant while you are taking this medicine.

This medicine may make it more difficult to get pregnant. Talk to your healthcare professional if you are concerned about your fertility.