【Drug Name】

Name: Trametinib Tablets

Product Name: TRAMEDX

【Specification】

2mg

【Indications】

TRAMEDX is a prescription medicine used:

• alone or in combination with a medicine called dabrafenib to treat a type of skin cancer called melanoma:

o that has spread to other parts of the body or cannot be removed by surgery, and

o that has a certain type of abnormal “BRAF” gene.

• in combination with dabrafenib, to help prevent melanoma that has a certain type of abnormal “BRAF” gene from coming back after the cancer has been removed by surgery.

• in combination with dabrafenib to treat a type of lung cancer called non-small cell lung cancer (NSCLC)

o that has spread to other parts of the body, and

o that has a certain type of abnormal “BRAF” gene.

• in combination with dabrafenib to treat a type of thyroid cancer called anaplastic thyroid cancer (ATC)

o that has spread to other parts of the body and you have no satisfactory treatment options, and

o that has a certain type of abnormal “BRAF” gene.

• in combination with dabrafenib to treat solid tumors in adults and children 6 years and older

o that cannot be removed by surgery or have spread to other parts of the body, and that have gotten worse (progressed) and you have no satisfactory treatment options, and

o that have a certain type of abnormal “BRAF” gene.

【Recommended Dosage】

• Take TRAMEDX exactly as your healthcare provider tells you to take it. Do not change your dose or stop TRAMEDX 

unless your healthcare provider tells you.

• Your healthcare provider may change your dose of TRAMEDX, temporarily stop, or completely stop your treatment 

with TRAMEDX if you develop certain side effects. 

• Take TRAMEDX 1 time a day, about every 24 hours.

• Take TRAMEDX at least 1 hour before or 2 hours after a meal.

If you miss a dose, take it as soon as you remember. If it is less than 12 hours before your next scheduled dose, skip the missed dose. Just take the next dose at your regular time.

【Side Effects】

• Risk of new skin cancers. TRAMEDX, when used with dabrafenib, may cause skin cancers, called cutaneous squamous cell carcinoma, keratoacanthoma, basal cell carcinoma, or melanoma.

Talk to your healthcare provider about your risk for these cancers.

Check your skin and tell your healthcare provider right away about any skin changes, including a:

• new wart

• skin sore or reddish bump that bleeds or does not heal

• change in size or color of a mole

• bleeding problems. TRAMEDX can cause serious bleeding problems, especially in your brain or stomach, that can 

lead to death. Call your healthcare provider and get medical help right away if you have any signs of bleeding, 

including:

o headaches, dizziness, or feeling weak

o cough up blood or blood clots

o vomit blood or your vomit looks like “coffee grounds”

o red or black stools that look like tar

• inflammation of the intestines, or tears (perforation) of the stomach or intestines. TRAMEDX can cause 

inflammation of your intestines, or tears in the stomach or intestines that can lead to death. Tell your healthcare 

provider right away if you have any of the following symptoms:

o bleeding. See “bleeding problems” above.

o diarrhea (loose stools) or more bowel movements than usual

o stomach-area (abdomen) pain or tenderness

o fever

o nausea

【Storage】

• Store TRAMEDX in the refrigerator between 36°F to 46°F (2°C to 8°C).

• Keep TRAMEDX dry and away from moisture and light.

• Keep TRAMEDX in its original bottle. Do not place tablets in a pill box.

• Safely throw away TRAMEDX that is out of date or no longer needed.

Keep TRAMEDX and all medicine out of the reach of children.