Tafinlar

Generic name: Dabrafenib
Drug class: Multikinase inhibitors

Usage of Tafinlar

Tafinlar is a type of targeted cancer drug that works by interfering with the growth and spread of cancer cells in the body.

Tafinlar is only used for the treatment of certain cancers that have a mUTAtion in the BRAF gene.

Tafinlar works by targeting certain proteins made by the mutated BRAF gene that help cancer cells to grow. By blocking these proteins, Tafinlar stops or slows down the growth of the cancer cells.

Tafinlar side effects

Get emergency medical help if you have signs of an allergic Reaction to Tafinlar: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects are more likely to occur if you take Tafinlar and trametinib together. Call your doctor at once if you have:

little or no urination;

fever, chills, feeling light-headed or short of breath;

pale or yellowed skin, dark colored urine, fever, confusion or weakness;

eye pain or swelling, vision changes, seeing halos around lights, seeing color "dots" in your vision;

severe skin rash, skin pain or swelling, redness and peeling skin on your hands or feet;

increased thirst or urination;

signs of bleeding - weakness, dizziness, headache, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

signs of a heart problem - shortness of breath (even with mild exertion), pounding heartbeats, swelling in your feet or ankles.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Tafinlar side effects in adults may include:

headache, muscle or joint pain;

bleeding;

fever, chills, tiredness;

dry skin, thickened skin, warts, rash;

swelling in the legs, arms, and face;

redness, swelling, peeling, or tenderness of hands or feet;

nausea, vomiting, diarrhea, decreased appetite;

cough, shortness of breath; or

hair loss.

Common Tafinlar side effects in children may include:

headache, muscle or joint pain;

bleeding;

fever or tiredness;

dry skin or rash;

nausea, diarrhea, or vomiting;

constipation;

cough;

acne;

skin infection around fingernails or toenails; or

stomach-area (abdomen) pain

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Tafinlar

You should not use Tafinlar if you are allergic to Dabrafenib.

To make sure Tafinlar is safe for you, tell your doctor if you have ever HAD:

heart problems;

bleeding problems;

liver or kidney problems;

diabetes (dabrafenib may raise your blood sugar);

eye problems (especially a problem with your retina); or

a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Using dabrafenib with trametinib may increase your risk of developing a certain type of skin cancer. Ask your doctor about your specific risk. Tell your doctor if you notice any new skin symptoms such as redness, warts, sores that will not heal, or a mole that has changed in size or color.

Pregnancy

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Dabrafenib can harm an unborn baby or cause birth defects if the mother or father is using this medicine.

Keep using birth control for at least 2 weeks after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Tafinlar.

If you use Tafinlar and trametinib together: Keep using birth control for at least 4 months after your last dose of these two medicines.

Tafinlar can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using Tafinlar, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because dabrafenib can harm an unborn baby.

Breastfeeding

You should not breastfeed while using this medicine and for at least 2 weeks after your last dose (or 4 months after your last dose of dabrafenib with trametinib).

Relate drugs

How to use Tafinlar

COnfirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to treatment initiation with FDA-approved tests: http://www.fda.gov/CompanionDiagnostics. Usual Adult Dose for Melanoma, Non-Small Cell Lung Cancer, Thyroid Cancer, and Solid Tumors

150 mg (two 75 mg capsules) orally twice daily.

Uses:

as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation.

in combination with trametinib: - for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations. - for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations and involvement of lymph node(s), following complete resection. - for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation. - for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options. - for the treatment of patients with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Recommended duration of treatment: - for patients with unresectable or metastatic melanoma or solid tumors, metastatic NSCLC, or locally advanced or metastatic anaplastic thyroid cancer is until disease progression or uNACceptable toxicity. - for patients in the adjuvant melanoma setting is until disease recurrence or unacceptable toxicity for up to 1 year.

Usual Pediatric Dose for Solid Tumors and Low-Grade Glioma

Capsules

Body Weight Recommended DoSage 26 to 37 kg 75 mg orally twice daily 38 to 50 kg 100 mg orally twice daily 51 kg or greater 150 mg orally twice daily

Tablets for Oral Suspension

Body Weight Recommended Dosage 8 to 9 kg 20 mg twice daily 10 to 13 kg 30 mg twice daily 14 to 17 kg 40 mg twice daily 18 to 21 kg 50 mg twice daily 22 to 25 kg 60 mg twice daily 26 to 29 kg 70 mg twice daily 30 to 33 kg 80 mg twice daily 34 to 37 kg 90 mg twice daily 38 to 41 kg 100 mg twice daily 42 to 45 kg 110 mg twice daily 46 to 50 kg 130 mg twice daily ≥ 51 kg 150 mg twice daily

Uses:

in combination with trametinib: - for the treatment of pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). - for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.

Recommended duration of treatment: - for pediatric patients with solid tumors is until disease progression or unacceptable toxicity. - for pediatric patients with LGG is until disease progression or until unacceptable toxicity.

Warnings

Using Tafinlar with trametinib may increase your risk of developing a certain type of skin cancer. Ask your doctor about your specific risk. Tell your doctor if you notice any new skin symptoms.

Your healthcare provider should check your skin before you start treatment, and every two months while taking this medicine to look for any new skin cancers.

Your healthcare provider may continue to check your skin for six months after you stop treatment.

What other drugs will affect Tafinlar

Sometimes it is not safe to use certain medications at the SAMe time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with dabrafenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Disclaimer

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