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Tafinlar + Mekinist for:

Patients and Caregivers

Important Safety Information for TAFINLAR and MEKINIST when used in combination
may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuSCC).
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Indication: TAFINLAR and MEKINIST are prescription medicines that can be used together, 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 gene

 

TAFINLAR in combination with MEKINIST cannot be used to treat people with a type of skin cancer called wild-type BRAF melanoma. This type of skin cancer does not have an abnormal BRAF gene. 

Your healthcare provider will perform a test to make sure that TAFINLAR + MEKINIST in combination is right for you.

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

Patients and Caregivers

About TAFINLAR + MEKINIST in Combination

TAFINLAR® (dabrafenib) and MEKINIST® (trametinib) are prescription medicines that can be used together, 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 gene

 

TAFINLAR in combination with MEKINIST cannot be used to treat people with a type of skin cancer called wild-type BRAF melanoma. This type of skin cancer does not have an abnormal BRAF gene.

Your healthcare provider will perform a test to make sure that TAFINLAR + MEKINIST in combination is right for you.

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

Patient Support

Co-Pay Assistance Program

At Novartis, we are committed to supporting you with your treatment.

That is why we developed a co-pay assistance program—so you can access the medicine you need.

Eligible commercially insured and cash-paying patients who are 18 years of age or older may:

  • Pay a $10 co-pay for a 30-day supply of TAFINLAR or MEKINIST
    • Minimum 14-day supply
    • Maximum 90-day supply
  • Save up to a maximum of $25,000 per calendar year
  • Save an unlimited number of times through March 31, 2016

Pay a $10 co-pay on your TAFINLAR prescription (if eligible)

Pay a $10 co-pay on your MEKINIST prescription (if eligible)

Patient Assistance Now Oncology 

Novartis Oncology is committed to helping patients living with cancer receive the medicines they need. PANO offers quick and easy access to information about our wide range of resources.

You can get information about our Patient Assistance Now Oncology support program by calling 1-800-282-7630 to speak with a member of our knowledgeable staff dedicated to making access to therapy as simple and convenient as possible.

Resources

Want to learn more?

Download this patient education brochure to find out more about your treatment with TAFINLAR + MEKINIST in combination.

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TAFINLAR Medication Guide

View PDF

MEKINIST Patient Information Leaflet

View PDF

INDICATION

TAFINLAR and MEKINIST are prescription medicines that can be used together, 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 gene

TAFINLAR in combination with MEKINIST cannot be used to treat people with a type of skin cancer called wild-type BRAF melanoma. This type of skin cancer does not have an abnormal BRAF gene.

Your healthcare provider will perform a test to make sure that TAFINLAR + MEKINIST in combination is right for you.

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

Important Safety Information for TAFINLAR and MEKINIST when used in combination

TAFINLAR may cause serious side effects, including risks 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 in people who take TAFINLAR. TAFINLAR and MEKINIST in combination may cause new cancers, including basal cell carcinoma. Talk with 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 you start taking TAFINLAR, and every 2 months while taking TAFINLAR, to look for any new skin cancers. Your healthcare provider may continue to check your skin for 6 months after you stop taking TAFINLAR.

Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare 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 healthcare provider and get medical help right away if you have any unusual 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 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 or pale arm or leg

Heart problems, including heart failure

Your healthcare provider should check your heart function before you start taking TAFINLAR and MEKINIST in combination and during treatment. 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

TAFINLAR and MEKINIST in combination can cause severe eye problems that can 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
  • seeing color dots
  • halo (seeing blurred outline around objects)
  • eye pain, swelling, or redness

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

TAFINLAR and MEKINIST in combination can cause fever, which may 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 healthcare 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 healthcare 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 healthcare provider should check your blood sugar levels closely during treatment with TAFINLAR and MEKINIST. 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

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 healthcare provider if you have any of the following signs or symptoms of anemia or breakdown of red blood cells:

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

TAFINLAR and MEKINIST in combination may 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 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 during treatment with TAFINLAR and MEKINIST in combination.

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

  • tiredness
  • nausea or vomiting
  • stomach-area (abdominal) pain
  • diarrhea
  • cough
  • swelling of the face, arms, or legs
  • headache
  • night sweats
  • decreased appetite
  • constipation
  • muscle or joint aches

Other side effects

Fertility problems

TAFINLAR and MEKINIST in combination 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.

Low sperm counts

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

Nursing mothers

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

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, or dizziness.

These are not all of the possible side effects of TAFINLAR and MEKINIST, alone and in combination. For more information about side effects, ask your healthcare provider or pharmacist.

Before you take TAFINLAR and MEKINIST in combination, tell your healthcare 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 healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TAFINLAR and certain other medicines can affect each other, causing side effects. TAFINLAR may affect the way other medicines work, and other medicines may affect how TAFINLAR works. You can ask your pharmacist for a list of medicines that may interact with TAFINLAR.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Please read the Medication Guide for TAFINLAR and the Patient Information Leaflet for MEKINIST, and discuss any questions you have with your healthcare 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 GlaxoSmithKline at 1-888-825-5249.

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

 

References: 1. TAFINLAR [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2014. 2. MEKINIST [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2014.