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TAFINLAR + MEKINIST is known as a targeted therapy (or treatment). This means that it is designed to specifically control the abnormal BRAF V600E mutation and slow the growth of cancerous cells. TAFINLAR + MEKINIST is a combination therapy of 2 medications that work together to target and treat the tumor.

 

Research shows that more children have a reduction in tumor size with TAFINLAR + MEKINIST than with chemotherapy (vincristine and carboplatin).

What are the benefits of TAFINLAR + MEKINIST?
In a clinical trial:
TAFINLAR + MEKINIST 47% overall response rate vs chemotherapy 11% overall response rate
  • Tumors disappeared completely in 3% (2 out of 73) of patients treated with TAFINLAR + MEKINIST and 3% (1 out of 37) of patients treated with chemotherapy

  • Tumors shrank in 44% (32 out of 73) of patients treated with TAFINLAR + MEKINIST and 8% (3 out of 37) of patients treated with chemotherapy

TAFINLAR + MEKINIST half of the children were alive at 20.1 months without disease progression vs chemotherapy 7.4 months

TAFINLAR + MEKINIST is an FDA-approved treatment that was researched in 110 children with BRAF V600E+ low-grade glioma (LGG) whose cancer returned after surgery or was not able to be removed by surgery.

  • 110 children → 73 treated with TAFINLAR + MEKINIST, 37 treated with chemotherapy (vincristine and carboplatin)

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Does TAFINLAR + MEKINIST have side effects?

Serious side effects
For a complete list of potential side effects, please see “Important Safety Information" below. Serious side effects associated with TAFINLAR + MEKINIST include risk of new skin cancers, bleeding problems, inflammation of the intestines or tears (perforation) of the stomach or intestines, blood clots, heart problems, eye problems, lung or breathing problems, fever, serious skin reactions, increased blood sugar, a type of anemia called hemolytic anemia, and hemophagocytic lymphohistiocytosis.

TAFINLAR + MEKINIST has side effects that you should be aware of. The most common side effects seen when using TAFINLAR + MEKINIST in children with LGG are:

  • Fever

  • Rash

  • Headache

  • Vomiting

  • Muscle and bone pain

  • Tiredness

  • Dry skin

  • Diarrhea

  • Nausea

  • Bleeding

  • Stomach-area (abdomen) pain

  • Acne

Talk to your child’s health care provider right away if they experience any side effects. Your child’s health care provider may choose to modify, interrupt, or discontinue treatment.

Here are some helpful tips on how to manage the most commonly seen side effects:

Side Effects

Management Tips

Fever

  • Contact your child's health care provider right away if your child gets a fever

  • Give your child plenty of liquids (for example, water, soups, or ice pops)

  • Place a cold cloth on your child's forehead if it feels warm

Dry skin, rash, or acne

For dry skin, consider:

  • Moisturizing skin, especially after bathing

  • Using extra protection from cold, wind, and dry heat

Contact your child's health care provider if your child gets a skin rash or acne that bothers them or worsens. For mild rash or acne, consider:

  • Protecting skin from the sun

  • Choosing a mild soap or shampoo

  • Using a hypoallergenic moisturizer and avoiding anti-acne skin products with alcohol or retinoids

  • Stopping your child from picking at pimples or scratching their skin to prevent infection

Headache

Use over-the-counter headache medication to reduce pain

Upset stomach (including nausea, vomiting, diarrhea, or stomach pain)

  • Contact your child's health care provider if your child has severe diarrhea

  • Give your child cool water to drink between meals

  • Offer smaller meals and bland foods (for example, dry crackers, cereal, or toast)

  • Reduce the number of greasy foods and foods containing dairy in your child's diet

Muscle and bone pain

  • Use over-the-counter medication to reduce pain

  • Encourage gentle exercise, stretching, and breathing techniques

  • Give a simple massage at home and try using hot or cold compresses

Tiredness

  • Encourage extra sleep

  • Provide a healthy diet

  • Recommend exercising when possible

Bleeding

This is a serious problem that requires immediate medical help. Call your child's health care provider right away if you see any signs of bleeding, including:

  • Headaches, dizziness, or feeling weak

  • Coughing up blood or blood clots

  • Vomiting blood or vomit that looks like coffee grounds

  • Red or black stool that looks like tar

Keep track of your child’s side effects and talk to their health care provider right away about any side effects that are tough to deal with or do not go away. This is important for the health care provider to adjust their treatment as needed. When starting treatment with TAFINLAR + MEKINIST, keep a list of all other medications your child is taking and share it with their health care provider; certain medicines may affect each other, resulting in side effects.

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How is TAFINLAR + MEKINIST taken?

TAFINLAR + MEKINIST can be taken in a capsule + tablet form, OR a liquid form. There are specific instructions you will need to follow when giving TAFINLAR + MEKINIST as a liquid—both TAFINLAR and MEKINIST can be given through an oral syringe or feeding tube, and TAFINLAR can also be given in a cup. Our Caregiver's Brochure has additional helpful information, including instructions and tips. Full instructions are available in the Medication Guide for TAFINLAR and Patient Information for MEKINIST.

TAFINLAR oral suspension (prepared by you) + MEKINIST oral solution (prepared by your pharmacist)

Important Safety Information

TAFINLAR and MEKINIST may cause serious side effects, including:

Risk of new cancers. TAFINLAR, when used in combination with MEKINIST, may cause a type of skin cancer called cutaneous squamous cell carcinoma, keratoacanthoma, basal cell carcinoma, or melanoma. Talk with your health care provider about your risk for these cancers. Check your skin and tell your health care provider right away about any skin changes, including a new wart, skin sore, or reddish bump that bleeds or does not heal, or a change in size or color of a mole.

Your health care provider should check your skin before you start treatment, and every 2 months while on treatment, to look for any new skin cancers. Your health care provider should continue to check your skin for 6 months after you stop taking TAFINLAR and MEKINIST.

Approved Uses

TAFINLAR and MEKINIST are prescription medicines that can be used 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” (V600E or V600K mutation-positive) gene

TAFINLAR and MEKINIST are prescription medicines that can be used in combination to help prevent melanoma that has a certain type of abnormal “BRAF” gene from coming back after the cancer has been removed by surgery.

Click or scroll to see IMPORTANT SAFETY INFORMATION AND APPROVED USES