Mektovi

Mektovi is a prescription medication used to treat melanoma which has spread to other parts of the body or cannot be removed by surgery.

Mektovi belongs to a group of drugs called monoclonal antibodies and works by blocking signaling pathways in cancer cells.

This medication comes in tablet form and is usually taken twice daily, with or without food.

Common side effects include fatigue, nausea, diarrhea and vomiting. 

Mektovi is a prescription medicine used in combination with a medicine called encorafenib to treat people with a type of skin cancer called melanoma:

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

• that has a certain type of abnormal “BRAF” gene

Your healthcare provider will perform a test to make sure that Mektovi is right for you. It is not known if Mektovi is safe and effective in children.

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

Serious side effects have been reported with Mektovi. See the “Mektovi Precautions” section.

The most common side effects of Mektovi when taken with encorafenib, include:

• fatigue
• nausea
• diarrhea
• vomiting
• abdominal pain

These are not all the possible side effects of Mektovi. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Array BioPharma Inc. at 1-844-792-7729.

No drug interactions have been observed by the manufacturer. 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.

Serious side effects have been reported with Mektovi including the following:

• Heart problems, including heart failure. Tell your healthcare provider right away if you have some or all of the following symptoms of heart problems.
  • feeling like your heart is pounding or racing
  • shortness of breath
  • swelling of your ankles and feet
  • feeling lightheaded
• Blood clots. Tell your healthcare provider right away if you have some or all of the following symptoms of blood clots.
  • chest pain
  • sudden shortness of breath or trouble breathing
  • pain in your legs with or without swelling
  • swelling in your arms and legs
  • a cool pale arm or leg
• Eye problems. Tell your healthcare provider right away if you have some or all of the following symptoms of eye problems.
  • blurred vision, loss of vision, or other vision changes
  • seeing colored dots
  • seeing halos (blurred outline around objects)
  • eye pain, swelling, or redness
• Lung or breathing problems. Tell your healthcare provider right away if you have some or all of the following symptoms of lung or breathing problems.
  • shortness of breath
  • cough
• Liver problems. Tell your healthcare provider right away if you have some or all of the following symptoms of liver problems.
  • yellowing of your skin or the white part of your eyes (jaundice)
  • dark or brown urine
  • nausea or vomiting
  • loss of appetite
• Muscle problems. Tell your healthcare provider right away if you have some or all of the following symptoms of muscle problems.
  • weakness
  • muscle aches or pain
  • dark, reddish urine
• Bleeding problems. Tell your healthcare provider right away if you have some or all of the following symptoms of bleeding problems.
  • headaches, dizziness, or feeling weak
  • coughing up blood or blood clots
  • vomiting blood or your vomit looks like "coffee grounds"
  • red or black stools that look like tar

Mektovi can cause dizziness and visual changes. Do not drive or operate heavy machinery until you know how Mektovi affects you.

Do not take Mektovi if you:

• are allergic to Mektovi or to any of its 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 Mektovi, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Mektovi, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have heart problems
• have had blood clots
• have eye problems
• have lung or breathing problems
• have liver or kidney problems
• have any muscle problems
• have bleeding problems
• have high blood pressure (hypertension)
• 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.

In animal studies, pregnant animals were given Mektovi and had some babies born with problems or had loss of pregnancy. Because of this and the effect Mektovi has in the body, Mektovi should not be used by pregnant women.

Women who are able to become pregnant should use birth control while being treated with Mektovi and for at least 30 days after treatment.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Mektovi crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, women should not breastfeed during treatment with Mektovi and for 3 days after the final dose.

• Take Mektovi exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking Mektovi unless your healthcare provider tells you to.
• Your healthcare provider may change your dose of Mektovi, temporarily stop, or completely stop your treatment with Mektovi if you develop certain side effects.
• Take Mektovi in combination with encorafenib by mouth 2 times a day, about 12 hours apart.
• Mektovi may be taken with or without food.
• If you miss a dose of Mektovi, take it as soon as you remember. If it is within 6 hours of your next scheduled dose, take your next dose at your regular time. Do not make up for the missed dose.
• Do not take an extra dose if you vomit after taking your scheduled dose. Take your next dose at your regular time.
• If you stop treatment with encorafenib, talk to your healthcare provider about whether your Mektovi treatment may need to be stopped.

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:

• other medical conditions you have
• how you respond to this medication

The recommended dose of Mektovi is 45 mg orally taken twice daily, about 12 hours apart.

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

• Store Mektovi at room temperature.
• Keep this and all medicines out of the reach of children.