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Tafinlar is the brand name for dabrafenib and is available as an oral capsule and a tablet for oral suspension.

Tafinlar is available as a 50 mg and 75 mg oral capsule and a 10 mg tablet for suspension.

Tafinlar is a kinase inhibitor that is used to treat:

• Melanoma with certain BRAF mutations
• Advanced melanoma, given after surgery and used with
• Mekinist (trametinib)
• Melanoma that has spread (metastatic) or can’t be removed by surgery, used alone or with Mekinist (trametinib)
• Metastatic non-small cell lung cancer (NSCLC) with a certain BRAF mutation, used with Mekinist (trametinib)
• Metastatic anaplastic thyroid cancer (ATC) with a certain BRAF mutation, used with Mekinist (trametinib)
• Solid tumors with a certain BRAF mutation that have spread (metastatic) or can’t be removed by surgery, used with Mekinist (trametinib)
• Low-grade glioma (LGG) with a certain BRAF mutation, used with Mekinist (trametinib)

Tafinlar s a kinase inhibitor known as a BRAF inhibitor. The BRAF protein is part of a whole chain of proteins that help cells grow. When the BRAF protein is mutated, the cancer grows uncontrollably and can spread more quickly. By blocking BRAF, it helps stop tumor growth.

Tafinlar is dosed as follows:

• Adults: The typical dose is 150 mg by mouth twice a day (about 12 hours apart)
• Children: The dose is based on your child’s body weight. The typical dose ranges from 20 mg to 150 mg by mouth twice a day (about 12 hours apart)

Tafinlar is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Tafinlar:

• High blood sugar
• Higher liver enzymes in the blood
• Fever
• Tiredness
• Changes in other blood test results
• Rash
• Nausea
• Headache
• Chills
• Diarrhea
• Vomiting
• Cough
• Muscle or joint pain
• Constipation

Serious side effects are rare with Tafinlar. Contact your healthcare provider immediately if you experience any of the following.

• Bleeding: nosebleed, blood in stool, sudden and severe headache
• Serious eye problems: sudden and severe eye pain, sudden vision loss
• Serious skin reactions: painful blisters, skin wounds, peeling skin, fever, muscle aches
• Serious blood problems: fever, severe tiredness, weakness, trouble breathing

The following medications may interact with Tafinlar:

• Avoid concurrent administration of strong inhibitors of CYP3A4 or CYP2C8
• Concomitant use with agents that are sensitive substrates of CYP3A4
• CYP2C8, CYP2C9, CYP2C19, or CYP2B6 may result in loss of efficacy of these agents

Novartis Pharmaceuticals

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

• Dabrafenib