Tafinlar

What is Tafinlar?

Tafinlar is a prescription medicine used:

• alone or in combination with a medicine called trametinib 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 trametinib, to help prevent melanoma that has a certain type of abnormal “BRAF” gene from coming back after the cancer has been removed by surgery.
• in combination with trametinib 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 trametinib 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 trametinib to treat solid tumors in adults and children 6 years and older
  • that cannot be removed with 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.

Tafinlar is not for use in treating people with colorectal cancer or wild-type BRAF solid tumors.

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

It is not known if Tafinlar used alone is safe and effective in children.

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

Tafinlar may cause serious side effects, including:

• Risk of new cancers. Tafinlar, when used alone or with trametinib, may cause skin cancers, called cutaneous squamous cell carcinoma (cuSCC), keratoacanthoma, basal cell carcinoma, or melanoma.
  
  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 treatment with Tafinlar, every 2 months during treatment with Tafinlar, and for up to 6 months after you stop taking Tafinlar 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 Tafinlar.

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

What should I tell my healthcare provider before taking Tafinlar?

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

• have had bleeding problems
• have heart problems
• have eye problems
• have liver or kidney problems
• have diabetes
• plan to have surgery, dental, or other medical procedures
• have a deficiency of the glucose-6-phosphate dehydrogenase (G6PD) enzyme
• are pregnant or plan to become pregnant. Tafinlar 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 Tafinlar.
    • You should use effective birth control (contraception) during treatment with Tafinlar and for 2 weeks after your last dose of Tafinlar.
    • Birth control methods that contain hormones (such as birth control pills, injections, or transdermal systems) may not work as well during treatment with Tafinlar and you could become pregnant. You should use another effective method of birth control during treatment with Tafinlar.
    • 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 Tafinlar.
  • 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 Tafinlar and for at least 2 weeks after your last dose of Tafinlar.
• are breastfeeding or plan to breastfeed. It is not known if Tafinlar passes into your breast milk. Do not breastfeed during treatment and for 2 weeks after your last dose of Tafinlar. 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 Tafinlar?

• Take Tafinlar exactly as your healthcare provider tells you. Do not change your dose or stop Tafinlar unless your healthcare provider tells you.
• Your healthcare provider may change your dose of Tafinlar, temporarily stop, or completely stop your treatment with Tafinlar if you develop certain side effects.
• Take Tafinlar 2 times a day, about 12 hours apart.
• Take Tafinlar at least 1 hour before or 2 hours after a meal.
• Do not open, crush, or break Tafinlar capsules.
• If you miss a dose of Tafinlar, take it as soon as you remember. If it is within 6 hours of your next scheduled dose, just take your next dose at your regular time. Do not make up for the missed dose.

What are the possible side effects of Tafinlar?

Tafinlar may cause serious side effects, including:

• See “What is the most important information I should know about Tafinlar?”
• bleeding problems. Tafinlar, when taken with trametinib, 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 stool that looks like tar
• heart problems, including heart failure. Your healthcare provider should check your heart function before and during treatment with Tafinlar. 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 or feet
  • feeling lightheaded
• eye problems. Tafinlar 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
  • see color dots
  • halo (see blurred outline around objects)
  • eye pain, swelling, or redness
• fever. Fever is common during treatment with Tafinlar, but may also be serious. When taking Tafinlar with trametinib, 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 Tafinlar.
  Your healthcare provider may temporarily or permanently stop your treatment, or change your dose of Tafinlar with trametinib 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 Tafinlar. Tafinlar 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 Tafinlar. If you are diabetic, your healthcare provider should check your blood sugar levels closely during treatment with Tafinlar. 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 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:
  • yellow skin (jaundice)
  • weakness or dizziness
  • shortness of breath

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

• thickening of the outer layers of the skin
• warts
• headache
• hair loss
• fever
• redness, swelling, peeling, or tenderness of hands or feet
• joint aches

The most common side effects of Tafinlar when taken with trametinib in people with melanoma that has spread to other parts of the body or cannot be removed by surgery include:

• fever
• chills
• rash
• joint aches
• headache
• cough

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

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

The most common side effects of Tafinlar when taken with trametinib in people with NSCLC include:

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

The most common side effects of Tafinlar when taken with trametinib 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
• headache
• muscle and joint aches
• swelling of your arms and legs

The most common side effects of Tafinlar when taken with trametinib 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
• skin infection around fingernails or toenails

Tafinlar 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.

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.

These are not all of the possible side effects of Tafinlar.
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 Tafinlar

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Tafinlar for a condition for which it was not prescribed. Do not give Tafinlar 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 Tafinlar that is written for health professionals.

How should I store Tafinlar?

• Store Tafinlar at room temperature between 68°F to 77°F (20°C to 25°C).

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

What are the ingredients in Tafinlar?

Active ingredient: dabrafenib
Inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose
Capsule shells: hypromellose, red iron oxide (E172), titanium dioxide (E171).

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