Uses

Trametinib is used to treat various cancers (such as skin, thyroid, lung, solid tumors, brain). It belongs to a class of drugs known as kinase inhibitors. Trametinib works by slowing or stopping the growth of cancer cells.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start taking trametinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily at least 1 hour before or 2 hours after a meal. If you vomit, do not take another dose to catch up. Take your next dose at the regular time.

If you are using the tablets, swallow the tablets whole. Do not crush or break the tablets.

If your child is using the liquid form of this medication, read the Instructions for Use before you start giving trametinib and each time you get a refill. Gently swirl the bottle for 30 seconds to mix the solution prior to each dose. Learn how to carefully measure the dose using the bottle adapter and oral syringe provided. Do not use a household spoon because you may not get the correct dose. If you have any questions, consult your doctor or pharmacist.

The liquid form may also be given through a tube into the stomach (nasogastric or gastric tube). If you are giving this medication through a nasogastric or gastric tube, ask your health care professional for detailed instructions on how to give it.

The dosage is based on your medical condition and response to treatment. Children's dose is also based on weight.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

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.

Side Effects

Dizziness, diarrhea, nausea/vomiting, stomach pain, dry/itchy skin, acne, and dry mouth may occur. 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
• fever/chills

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
• 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:

• rash
• swollen lymph nodes
• 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.

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, breast-feeding is not recommended while using this drug and for 4 months after the last dose. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as BRAF testing, heart imaging, blood pressure, blood sugar, skin checks) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is within 12 hours of your next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store the tablets in the original container in the refrigerator away from light and moisture. Keep the desiccant (drying agent) in the bottle. Keep all medications away from children and pets.

Store the liquid form of this medication in the original container at room temperature away from light. Do not freeze. Keep the container upright and tightly closed when not in use. Discard any unused liquid medication 35 days after it has been mixed by your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.