Mekinist

What is Mekinist?

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.
• in combination with dabrafenib to treat solid tumors in adults and children 6 years and older
  • 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
  • that have a certain type of abnormal “BRAF” gene.

Mekinist is not for use in treating people with colorectal cancer.

Your healthcare provider will perform a test to make sure that Mekinist is right for you.

It is not known if Mekinist used in combination with dabrafenib is safe and effective in children younger than 6 years of age. It is not known if Mekinist used alone is safe and effective in children.

What is the most important information I should know about Mekinist?

Mekinist may cause serious side effects, including:

• Risk of new skin cancers. Mekinist, 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
    
    Your healthcare provider should check your skin before treatment with Mekinist and dabrafenib, every 2 months during treatment with Mekinist and dabrafenib and for up to 6 months after you stop taking Mekinist and dabrafenib to look for any new skin cancers.
    
    Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that develop during treatment with Mekinist with dabrafenib.

See "What are the possible side effects of Mekinist?" for more information about side effects.

What should I tell my healthcare provider before taking Mekinist?

Before you take Mekinist, tell your healthcare provider about all of your medical conditions, including if you:

• have had bleeding problems or blood clots
• have stomach problems
• have inflammation of the colon
• have heart problems
• have eye problems
• have lung or breathing problems
• have high blood pressure (hypertension)
• have liver or kidney problems
• have diabetes
• are pregnant or plan to become pregnant. Mekinist can harm your unborn baby.
  • Females who are able to become pregnant:
    • Your healthcare provider will do a test to see if you are pregnant before starting treatment with Mekinist.
    • You should use effective birth control (contraception) during treatment with Mekinist and for 4 months after your last dose of Mekinist.
    • Talk to your healthcare provider about birth control methods that may be right for you during this time.
    • Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with Mekinist.
  • Males (including those who have had a vasectomy) with a female partner who is able to become pregnant:
    • Use condoms during sexual intercourse during treatment with Mekinist and for at least 4 months after your last dose of Mekinist.
• are breastfeeding or plan to breastfeed. It is not known if Mekinist passes into your breast milk. o Do not breastfeed during treatment and for 4 months after your last dose of Mekinist. Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Mekinist?

• Take Mekinist exactly as your healthcare provider tells you to take it. Do not change your dose or stop Mekinist unless your healthcare provider tells you.
• Your healthcare provider may change your dose of Mekinist, temporarily stop, or completely stop your treatment with Mekinist if you develop certain side effects.
• Take Mekinist one time a day, about every 24 hours.
• Take Mekinist 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.

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.
  Your healthcare provider may temporarily or permanently stop your treatment, or change your dose of Mekinist with dabrafenib if you have fevers. Your healthcare provider will treat you as needed for your fever and any signs and symptoms of infection, and should check your kidney function during and after you have had severe fever.
• 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
  • mouth sores
  • blisters on your lips, or around your mouth or eyes
  • 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 has spread to other parts of the body or cannot be removed by surgery include:

• fever
• diarrhea. Call your healthcare provider if you get severe 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. Call your healthcare provider if you get severe 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
• rash
• fatigue
• swelling of face, arms, and legs
• nausea
• chills
• vomiting
• bleeding
• diarrhea. Call your healthcare provider if you get severe diarrhea.
• cough
• dry skin
• shortness of breath
• decreased appetite

The most common side effects of Mekinist when taken with dabrafenib in adults with solid tumors that cannot be removed by surgery or have spread to other parts of the body include:

• fever
• bleeding
• tiredness
• cough
• nausea
• vomiting
• rash
• constipation
• chills
• diarrhea. Call your healthcare provider if you get severe diarrhea.
• headache
• muscle and joint aches
• swelling of your arms, and legs

The most common side effects of Mekinist when taken with dabrafenib in children with solid tumors that cannot be removed by surgery or have spread to other parts of the body include:

• fever
• acne
• rash
• headache
• vomiting
• stomach-area (abdomen) pain
• tiredness
• nausea
• dry skin
• bleeding
• cough
• constipation
• diarrhea. Call your healthcare provider if your child gets severe diarrhea.
• skin infection around fingernails or toenails

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.

General information about the safe and effective use of Mekinist

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Mekinist for a condition for which it was not prescribed. Do not give Mekinist to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Mekinist that is written for health professionals.

How should I store Mekinist?

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

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

What are the ingredients in Mekinist?

Active ingredient: trametinib
Inactive ingredients:
Tablet Core: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate (vegetable source), mannitol, microcrystalline cellulose, sodium lauryl sulfate.
Tablet Coating: hypromellose, iron oxide red (2 mg tablets), iron oxide yellow (0.5 mg tablets), polyethylene glycol, polysorbate 80 (2 mg tablets), titanium dioxide.

For more information, go to www.MEKINIST.com or call 1-888-669-6682.