What is Mekinist nad how is it used?

Mekinist is a prescription medicine used:

• alone or in combination with a medicine called dabrafenib to treat 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.
• 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.

Mekinist should not be used to treat people who already have received a BRAF inhibitor for treatment of their melanoma, and it did not work or is no longer working.

• 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, and
  • 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)
  • that has spread to other parts of the body and you have no satisfactory treatment options, and
  • that has a certain type of abnormal “BRAF” gene

What are the possible side effects of Mekinist?

Mekinist may cause serious side effects, including:

• See “What is the most important information I should know about Mekinist?”
• bleeding problems. Mekinist 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:
  • 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. Mekinist 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. see “bleeding problems” above
  • diarrhea (loose stools) or more bowel movements than usual
  • stomach-area (abdomen) pain or tenderness
  • fever
  • nausea
• blood clots. Mekinist 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
• heart problems, including heart failure. Your healthcare provider should check your heart function before and during treatment with Mekinist. Call your healthcare provider right away if you have any of the following signs and symptoms of a heart problem:
  • feeling like your heart is pounding or racing
  • shortness of breath
  • swelling of your ankles and feet
  • feeling lightheaded

• eye problems. Mekinist can cause severe eye problems that might lead to blindness. Call 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)
  • eye pain, swelling, or redness
• lung or breathing problems. Mekinist can cause 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
• fever. Fever is common during treatment with Mekinist and dabrafenib, but it may also be serious. When taking Mekinist with dabrafenib, fever may happen more often or may be more severe. In some cases, chills or shaking chills, too much fluid loss (dehydration), low blood pressure, dizziness, or kidney problems may happen with the fever. Call your healthcare provider right away if you get a fever during treatment with Mekinist.
• serious skin reactions. Skin rash is a common side effect of Mekinist. Mekinist can also cause other skin reactions. In some cases these rashes and other skin reactions can be severe or serious, and may need to be treated in a hospital or lead to death.

Tell your healthcare provider if you get a skin rash or acne that bothers you or worsens.

Tell your healthcare provider right away if you develop any of the following signs or symptoms of a severe skin reaction, including:

• • blisters or peeling of your skin
  • blisters on your lips, or around your mouth or eyes
  • mouth sores
  • high fever or flu-like symptoms
  • enlarged lymph nodes
• increased blood sugar (hyperglycemia). Some people may develop high blood sugar or worsening diabetes during treatment with Mekinist and dabrafenib. If you are diabetic, your healthcare provider should check your blood sugar levels closely during treatment with Mekinist and 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

The most common side effects of Mekinist when taken alone include:

• rash
• diarrhea. Call your healthcare provider if you get severe diarrhea.
• swelling of the face, arms, or legs

The most common side effects of Mekinist when taken with dabrafenib in people with melanoma that hasspread to other parts of the body or cannot be removed by surgery include:

• fever
• diarrhea
• rash
• vomiting
• nausea
• high blood pressure (hypertension)
• chills
• swelling of the face, arms, or legs

The most common side effects of Mekinist when taken with dabrafenib to help prevent melanoma from coming back after the cancer has been removed by surgery include:

• fever
• chills
• fatigue
• diarrhea
• nausea
• vomiting
• headache
• joint aches
• rash
• muscle aches

The most common side effects of Mekinist when taken with dabrafenib in people with NSCLC include:

• fever

• fatigue
• nausea
• vomiting
• diarrhea
• dry skin
• decreased appetite
• rash
• swelling of face, arms, and legs
• chills
• bleeding
• cough
• shortness of breath

Mekinist can cause new or worsening high blood pressure (hypertension).

Your healthcare provider should check your blood pressure during treatment with Mekinist. Call your healthcare provider right away if you develop high blood pressure, your blood pressure worsens, or you have severe headache, lightheadedness, blurry vision, or dizziness.

Mekinist may cause fertility problems in females. This could affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of Mekinist.

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 Novartis Pharmaceuticals Corporation at 1-888-669-6682.

DOSAGE AND ADMINISTRATION

Patient Selection

Melanoma

• Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with MEKINIST as a single agent or in combination with dabrafenib [see Clinical Studies].
• Information on FDA-approved tests for the detection of BRAF V600 mutations in melanoma is available at: http://www.fda.gov/CompanionDiagnostics.

NSCLC

• Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with MEKINIST and dabrafenib [see Clinical Studies].
• Information on FDA-approved tests for the detection of BRAF V600E mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.

ATC

• Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with MEKINIST and dabrafenib [see Clinical Studies]. An FDA-approved test for the detection of BRAF V600E mutation in ATC is not currently available.

Recommended Dosage For Unresectable Or Metastatic Melanoma

The recommended dosage of MEKINIST is 2 mg orally taken once daily, as a single agent or in combination with dabrafenib, until disease progression or unacceptable toxicity. Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information.

Recommended Dosage For The Adjuvant Treatment Of Melanoma

The recommended dosage of MEKINIST is 2 mg orally taken once daily in combination with dabrafenib until disease recurrence or unacceptable toxicity for up to 1 year. Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information.

Recommended Dosage For NSCLC

The recommended dosage of MEKINIST is 2 mg orally taken once daily in combination with dabrafenib until disease recurrence or unacceptable toxicity. Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information.

Recommended Dosage For ATC

The recommended dosage of MEKINIST is 2 mg orally taken once daily in combination with dabrafenib until disease recurrence or unacceptable toxicity. Refer to the dabrafenib prescribing information for recommended dabrafenib dosing information.