Trametinib

Trametinib is a prescription medication used to treat a certain type of melanoma (a type of skin cancer) that cannot be treated with surgery or that has spread to other parts of the body.

This medication is also approved to treat those with a certain type of lung cancer when given with another medication called dabrafenib. 

Trametinib belongs to a group of drugs called kinase inhibitors. These work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

Trametinib comes as a tablet to take by mouth. It is usually taken once a day on an empty stomach, at least 1 hour before or 2 hours after a meal. Take trametinib at around the same time every day.

Common side effects include rash, diarrhea, and swelling of the face, arms, or legs.

Trametinib is a prescription medication used alone or in combination with dabrafenib to treat a certain type of melanoma (a type of skin cancer) that cannot be treated with surgery or that has spread to other parts of the body and that has a certain type of abnormal “BRAF” gene. 

This medication is not to be given to those who already have received a BRAF inhibitor for the treatment of their skin cancer, and it did not work or is no longer working.

Trametinib is also approved in combination with dabrafenib to treat a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic NSCLC), and that has a certain type of abnormal “BRAF V600E” gene. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Trametinib may be found in some form under the following brand names:

• Mekinist

Common side effects of trametinib include:

• rash
• diarrhea
• swelling of the face, arms, or legs

When trametinib is given with dabrafenib, the following are common side effects:

• fever
• diarrhea
• rash
• nausea/vomiting
• chills
• swelling of face, arms, and legs

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been studied. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Trametinib may cause serious side effects, including:

• heart problems, including heart failure. Your healthcare provider should check your heart function before you start taking trametinib and during treatment. Signs and symptoms of heart problems may include:
  • feeling like your heart is pounding or racing
  • shortness of breath
  • swelling of your ankles and feet
  • feeling lightheaded
• eye problems. Trametinib can cause eye problems including blindness. Tell your healthcare provider right away if you get these symptoms of eye problems:
  • blurred vision, loss of vision, or other vision changes
  • see color dots
  • halo (seeing blurred outline around objects)
• lung or breathing problems. Tell your healthcare provider if you have any new or worsening symptoms of lung or breathing problems, including:
  • shortness of breath
  • cough
• serious skin reactions. Rash is a common side effect of trametinib and in some cases can be severe and can result in admission to the hospital if severe. Tell your healthcare provider if you get any of the following symptoms:
  • skin rash
  • acne
  • redness, swelling, peeling, or tenderness of hands or feet
  • skin redness
• increased blood sugar. Some people may develop high blood sugar or worsening diabetes during treatment with trametinib, alone or in combination with dabrafenib. If you have diabetes, your healthcare provider should check your blood sugar levels closely during treatment with trametinib alone or in combination with dabrafenib. Your diabetes medicine may need to be changed. Tell your healthcare provider if you have any of the following symptoms of severe high blood sugar:
  • increased thirst
  • urinating more often than normal, or urinating an increased amount of urine
• bleeding problems. This medication can cause serious bleeding problems, especially in your brain or stomach, and can lead to death. Call your healthcare provider and get medical help right away if you have any signs of bleeding, including:
  • headaches, dizziness, or feeling weak
  • cough up blood or blood clots
  • vomit blood or your vomit looks like “coffee grounds”
  • red or black stools that look like tar
• inflammation of the intestines, or tears (perforation) of the stomach or intestines. This medication can cause inflammation of your intestines, or tears in the stomach or intestines that can lead to death. Tell your healthcare provider immediately if you have any of the following symptoms:
  • bleeding
  • diarrhea (loose stools) or more bowel movements than usual
  • stomach-area pain or tenderness
  • fever
  • nausea
• blood clots. Trametinib can cause blood clots in your arms or legs, which can travel to your lungs and can lead to death. Get medical help right away if you have the following symptoms:
  • chest pain
  • sudden shortness of breath or trouble breathing
  • pain in your legs with or without swelling
  • swelling in your arms or legs
  • a cool pale arm or leg

When trametinib is given with dabrafenib, there is a chance for developing a type of skin cancer, called cutaneous squamous cell carcinoma (cuSCC) and new cancers including basal cell carcinoma. 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

Do not take trametinib if you are allergic to it or to any of its inactive ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication, there are no specific foods that you must exclude from your diet.

Before you take trametinib, tell your healthcare provider if you:

• are allergic to this medication or to any of its ingredients 
• have heart problems
• have lung or breathing problems
• have eye problems
• have high blood pressure (hypertension)
• have liver or kidney problems
• have any other medical conditions
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. Trametinib can harm your unborn baby. Women who may become pregnant should use effective birth control (contraception) during treatment with trametinib and for 4 months after stopping treatment. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant during treatment with trametinib.

It is not known if trametinib passes into your breast milk. You and your healthcare provider should decide if you will take trametinib or breastfeed. You should not do both.

Do not breastfeed during treatment and for 4 months after your last dose of trametinib. Talk to your healthcare provider about the best way to feed your baby during this time.

• Take trametinib exactly as your healthcare provider tells you to take it. Do not change your dose or stop trametinib unless your healthcare provider tells you.
• Take trametinib one time a day.
• Take trametinib 1 hour before or 2 hours after meals.
• If you miss a dose, take it as soon as you remember. If it is within 12 hours of your next scheduled dose, skip the missed dose. Just take the next dose at your regular time.
• Trametinib can be given alone or with dabrafenib. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose is 2 mg by mouth once daily. Take at least 1 hour before or 2 hours after a meal. Do not take a missed dose within 12 hours of the next dose.

Trametinib can be given alone or with dabrafenib. 

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store trametinib in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze.
• Keep trametinib dry and away from moisture.
• The bottle of trametinib contains a desiccant packet to help keep your medicine dry. Do not throw away the desiccant packet.
• Keep trametinib in its original bottle. Do not place tablets in a pill box.
• Safely throw away trametinib that is out of date or no longer needed.
• Keep trametinib and all medicine out of the reach of children.