Tafinlar (Dabrafenib Mesylate)

What is TAFINLAR and how is it used?

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

What are the possible side effects of 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 also 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.

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

Some signs include:

  • 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.

They 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.

They include:

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

The most common side effects of TAFINLAR when taken with trametinib in people with NSCLC.

They include:

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

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.

DESCRIPTION

Dabrafenib mesylate is a kinase inhibitor. The chemical name for dabrafenib mesylate is N-{3-[5-(2-amino-4pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzene sulfonamide, methanesulfonate salt. It has the molecular formula C23H20F3N5O2S2•CH4O3S and a molecular weight of 615.68, Dabrafenib mesylate has the following chemical structure:

TAFINLAR® (dabrafenib) - Structural Formula - Illustration

Dabrafenib mesylate is a white to slightly colored solid with three pKas: 6.6, 2.2, and -1.5. It is very slightly soluble at pH 1 and practically insoluble above pH 4 in aqueous media.

TAFINLAR (dabrafenib) capsules for oral use are supplied as 50 mg and 75 mg capsules for oral administration. Additionally, each 50 mg capsule contains 59.25 mg dabrafenib mesylate equivalent to 50 mg of dabrafenib free base, each 75 mg capsule contains 88.88 mg dabrafenib mesylate equivalent to 75 mg of dabrafenib free base. The inactive ingredients of TAFINLAR are colloidal silicon dioxide, magnesium stearate, and microcrystalline cellulose. Capsule shells contain hypromellose, red iron oxide (E172), and titanium dioxide (E171).PROFESSIONAL

Indications

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What is TAFINLAR and how is it used?

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

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.

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

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.

DESCRIPTION

Dabrafenib mesylate is a kinase inhibitor. The chemical name for dabrafenib mesylate is N-{3-[5-(2-amino-4pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzene sulfonamide, methanesulfonate salt. It has the molecular formula C23H20F3N5O2S2•CH4O3S and a molecular weight of 615.68. Dabrafenib mesylate has the following chemical structure:

TAFINLAR® (dabrafenib) - Structural Formula - Illustration

Dabrafenib mesylate is a white to slightly colored solid with three pKas: 6.6, 2.2, and -1.5. It is very slightly soluble at pH 1 and practically insoluble above pH 4 in aqueous media.

TAFINLAR (dabrafenib) capsules for oral use are supplied as 50 mg and 75 mg capsules for oral administration. Each 50 mg capsule contains 59.25 mg dabrafenib mesylate equivalent to 50 mg of dabrafenib free base. Each 75 mg capsule contains 88.88 mg dabrafenib mesylate equivalent to 75 mg of dabrafenib free base. The inactive ingredients of TAFINLAR are colloidal silicon dioxide, magnesium stearate, and microcrystalline cellulose. Capsule shells contain hypromellose, red iron oxide (E172), and titanium dioxide (E171).

Limitations Of Use

TAFINLAR is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF NSCLC, or wild-type BRAF ATC [see WARNINGS AND PRECAUTIONS].