Tafinlar

Tafinlar is a prescription medication used to treat a certain type of melanoma (a type of skin cancer). Tafinlar belongs to a group of drugs called kinase inhibitors. These work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

Tafinlar comes as a capsule to take by mouth. It is usually taken twice a day on an empty stomach, 1 hour before or 2 hours after a meal. Take Tafinlar about 12 hours apart at around the same times every day.

Common side effects include thickening of the outer layers of the skin, headache, and joint aches.

Tafinlar is a prescription medication used to treat a certain type of melanoma (a type of skin cancer) that cannot be treated with surgery or that has spread to other parts of the body.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Glaxo SmithKline Pharmaceuticals

Common side effects include the following:

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

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Tafinlar. For more information about side effects, ask your healthcare provider or pharmacist.

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 GSK at 1-888-825-5249.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antacids, such as aluminum hydroxide/magnesium hydroxide (Maalox), calcium carbonate (Tums) or calcium carbonate and magnesium (Rolaids)
• certain medications for seizures such as carbamazepine (Carbatrol, Epitol, Tegretol), phenobarbital (Luminal), and phenytoin (Dilantin, Phenytek)
• clarithromycin (Biaxin, in PrevPac)
• dexamethasone (Decadron)
• gemfibrozil (Lopid)
• ketoconazole (Nizoral)
• medications to reduce stomach acid, such as cimetidine (Tagamet), esomeprazole (Nexium), famotidine (Pepcid), omeprazole (Prilosec, Prilosec OTC, Zegerid), pantoprazole (Protonix), and ranitidine (Zantac)
• midazolam (Versed)
• nefazodone
• rifampin (Rifadin, in Rifamate, in Rifater, Rimactane)
• warfarin (Coumadin, Jantoven)

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Tafinlar including the following:

Do not take Tafinlar if you are allergic to Tafinlar or to any of its ingredients.

• bleeding problems. Tafinlar , in combination with trametinib, 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
  • cough up blood or blood clots
  • vomit blood or your vomit looks like “coffee grounds”
  • red or black stools that look like tar

• blood clots. Tafinlar , in combination with trametinib, can cause blood clots in your arms or legs, which can travel to your lungs and can lead to death. Get medical help right awayif 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 in combination with Tafinlar 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 alone, or in combination with 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 (seeing blurred outline around objects)
  • eye pain, swelling, or redness

• fever. Tafinlar alone or in combination with trametinib can cause fever which may be serious. When taking Tafinlar, in combination 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 while taking Tafinlar.

• skin reactions. Rash is a common side effect of Tafinlar alone, or when used in combination with trametinib. Tafinlar  alone, or in combination with trametinib, can also cause other skin reactions. 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, alone or in combination with trametinib. If you are diabetic, your healthcare provider should check your blood sugar levels closely during treatment with Tafinlar alone or in combination with trametinib. 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 of anemia or breakdown of red blood cells:

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

Do not take Tafinlar if you are allergic to Tafinlar or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Tafinlar, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Tafinlar, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• 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
• have any other medical conditions
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. Tafinlar can harm your unborn baby. Females who are able to become pregnant should use birth control during treatment and for 4 weeks after stopping Tafinlar.

Birth control using hormones (such as birth control pills, injections, or patches) may not work as well while you are taking Tafinlar. You should use another effective method of birth control while taking Tafinlar. Talk to your healthcare provider about birth control methods that may be right for you.

Tell your healthcare provider right away if you become pregnant during treatment with Tafinlar.

Tell your healthcare provider right away if you become pregnant during treatment with Tafinlar.

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

• Take Tafinlar exactly as your healthcare provider tells you. Do not change your dose or stop Tafinlar unless your healthcare provider tells you.
• 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, 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. If you take too much Tafinlar, call your healthcare provider or go to the nearest hospital emergency room right away.
• Tafinlar may be taken as a single agent or Tafinlar may be taken in combination with trametinib.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of Tafinlar is 150 mg orally twice daily taken at least 1 hour before or at least 2 hours after a meal.

OR

Tafinlar 150 mg can be taken orally twice daily, approximately 12 hours apart, in combination with trametinib 2 mg orally once daily.

If you take too much Tafinlar, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to Tafinlar. Your doctor will check your skin for any changes before, every 2 months during your treatment, and for up to 6 months after treatment.
• Keep this and all other medications out of the reach of children.