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Important Safety Information:

TAFINLAR® (dabrafenib) and MEKINIST® (trametinib) may cause serious side effects, including the risk of new cancers: TAFINLAR, when used in combination with MEKINIST, may cause a type of skin cancer c

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Approved Use:

TAFINLAR and MEKINIST are prescription medicines that can be used in combination to treat people with a type of skin cancer called melanoma, that has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable), and that has a certain type of abnormal

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TAFINLAR + MEKINIST

TAFINLAR and MEKINIST are prescription medicines that can be used in combination to treat people with a type of skin cancer called melanoma that has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable), and that has a certain type of abnormal “BRAF” (V600E or V600K mutation-positive) gene.

TAFINLAR, in combination with MEKINIST, is not used to treat people with a type of skin cancer called wild-type BRAF melanoma. MEKINIST should not be used to treat people who already have received a BRAF inhibitor for treatment of their melanoma.

Your health care provider will perform a test to make sure that TAFINLAR and MEKINIST, in combination, are right for you.

It is not known if TAFINLAR and MEKINIST, in combination, are safe and effective in children.

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BRAF+ Advanced Melanoma

Melanoma is a type of skin cancer that begins in the cells which give skin its color (melanocytes). Advanced melanoma occurs when melanoma cells spread to other parts of the body.

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Indication

TAFINLAR and MEKINIST are prescription medicines that can be used in combination to treat people with a type of skin cancer called melanoma:

  • That has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable), and
  • That has a certain type of abnormal “BRAF” (V600E or V600K mutation-positive) gene.

TAFINLAR, in combination with MEKINIST, is not used to treat people with a type of skin cancer called wild-type BRAF melanoma. MEKINIST should not be used to treat people who already have received a BRAF inhibitor for treatment of their melanoma.

Your health care provider will perform a test to make sure that TAFINLAR and MEKINIST, in combination, are right for you.

It is not known if TAFINLAR and MEKINIST, in combination, are safe and effective in children.

Important Safety Information

TAFINLAR and MEKINIST may cause serious side effects, including the risk of new cancers: TAFINLAR, when used in combination with MEKINIST, may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuSCC). New melanoma lesions have also occurred. TAFINLAR and MEKINIST in combination may cause new cancers, including basal cell carcinoma. Talk with your health care provider about your risk for these cancers.

Check your skin and tell your health care provider right away about any skin changes, including a new wart, skin sore, or reddish bump that bleeds or does not heal, or a change in size or color of a mole.

Your health care provider should check your skin before you start treatment, and every 2 months while on treatment, to look for any new skin cancers. Your health care provider should continue to check your skin for 6 months after you stop taking TAFINLAR and MEKINIST.

Your health care provider should also check for cancers that may not occur on the skin. Tell your health care provider about any new symptoms that have developed while taking TAFINLAR and MEKINIST in combination.

TAFINLAR and MEKINIST in combination may cause serious side effects, including:

Bleeding problems. TAFINLAR and MEKINIST in combination can cause serious bleeding problems, especially in your brain or stomach, and can lead to death. Call your health care provider and get medical help right away if you have any signs of bleeding, including:

  • 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

Blood clots. TAFINLAR and MEKINIST in combination can cause blood clots in your arms or legs, which can travel to your lungs and 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 health care provider should check your heart function before you start taking TAFINLAR and MEKINIST in combination, and during treatment. Call your health care 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. TAFINLAR and MEKINIST, in combination, can cause severe eye problems that can lead to blindness. Call your health care provider right away if you get these symptoms of eye problems:

  • blurred vision, loss of vision, or other vision changes
  • seeing color dots
  • halo (seeing blurred outline around objects)
  • eye pain, swelling, or redness

Lung or breathing problems. TAFINLAR and MEKINIST, in combination, can cause lung or breathing problems. Tell your health care 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 TAFINLAR and MEKINIST, but it may also be serious. When taking TAFINLAR and MEKINIST, in combination, fever may happen often or may be 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 health care provider right away if you get a fever while taking TAFINLAR or MEKINIST.

Skin reactions. Rash and other skin reactions are a common side effect of TAFINLAR and MEKINIST in combination. In some cases these rashes and other skin reactions can be severe, and may need to be treated in a hospital. Call your health care provider if you get any of the following symptoms:

  • skin rash that bothers you or does not go away
  • acne
  • redness, swelling, peeling, or tenderness of hands or feet
  • skin redness

Increased blood sugar (hyperglycemia). Some people may develop high blood sugar or worsening diabetes during treatment with TAFINLAR and MEKINIST in combination. If you are diabetic, your health care provider should check your blood sugar levels closely during treatment with TAFINLAR and MEKINIST. Your diabetes medicine may need to be changed. Tell your health care 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

TAFINLAR may cause healthy red blood cells to break down too early in people with glucose-6-phosphate dehydrogenase (G6PD) deficiency. This may lead to a type of anemia called hemolytic anemia, where the body does not have enough healthy red blood cells. Tell your health care provider if you have any of the following signs or symptoms:

  • yellow skin (jaundice)
  • weakness or dizziness
  • shortness of breath

TAFINLAR and MEKINIST, in combination, can harm your unborn baby. Females who are able to become pregnant should use birth control (contraception) during treatment with TAFINLAR and MEKINIST in combination, and for 4 months after stopping treatment with TAFINLAR and MEKINIST.

Birth control using hormones (such as birth control pills, injections, or patches) may not work as well while you are taking TAFINLAR and MEKINIST in combination. You should use another effective method of birth control while taking TAFINLAR and MEKINIST in combination.

Talk to your health care provider about birth control methods that may be right for you during this time.

Tell your health care provider right away if you become pregnant, or think you might be pregnant, during treatment with TAFINLAR and MEKINIST in combination.

Common side effects of TAFINLAR and MEKINIST when used in combination include:

  • nausea
  • chills
  • diarrhea
  • vomiting
  • high blood pressure (hypertension)
  • swelling of the face, arms, or legs
  • headache
  • joint aches
  • cough

New or worsening high blood pressure (hypertension). Your health care provider should check your blood pressure during treatment with MEKINIST. Call your health care provider right away if you develop high blood pressure, your blood pressure worsens or you have severe headache, lightheadedness, or dizziness.

Fertility problems. TAFINLAR and MEKINIST, in combination, may cause fertility problems in females. This could affect your ability to become pregnant. Talk to your health care provider if this is a concern for you.

Low sperm counts. TAFINLAR may cause lower sperm counts in males. This could affect the ability to father a child. Talk to your health care provider if this is a concern for you.

Nursing mothers. It is not known if TAFINLAR and/or MEKINIST pass into your breast milk. Do not breastfeed during treatment, and for 4 months after your last dose of TAFINLAR and MEKINIST. Talk to your health care provider about the best way to feed your baby during this time.

These are not all of the possible side effects of TAFINLAR and MEKINIST. For more information about side effects, ask your health care provider or pharmacist.

Before you take TAFINLAR and MEKINIST in combination, tell your health care provider if you:

  • have had bleeding problems or blood clots
  • have heart problems
  • have eye problems
  • have lung or breathing problems
  • have high blood pressure (hypertension)
  • have liver or kidney problems
  • have diabetes
  • plan to have surgery, dental, or other medical procedures
  • have a deficiency of the G6PD enzyme
  • have any other medical conditions
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TAFINLAR and MEKINIST with certain other medicines can affect each other, causing side effects. TAFINLAR and MEKINIST may affect the way other medicines work, and other medicines can affect how TAFINLAR and MEKINIST work. You can ask your pharmacist for a list of medicines that may interact with TAFINLAR and MEKINIST. Know the medicines you take. Keep a list of them to show your health care provider and pharmacist when you get a new medicine.

Please read the Medication Guide for TAFINLAR and the Patient Information for MEKINIST, and discuss any questions you have with your health care provider.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Novartis at 1-888-669-6682.

Please see full Prescribing Information for TAFINLAR, including Medication Guide, and full Prescribing Information for MEKINIST, including Patient Information.