Dabrafenib (Tafinlar®)

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About This Drug

Dabrafenib is used to treat cancer. It is given orally (by mouth).

Possible Side Effects

  • Headache
  • Fever
  • Pain in the joints
  • Hair loss. Hair loss is often temporary, although with certain medicine, hair loss can sometimes be permanent. Hair loss may happen suddenly or gradually. If you lose hair, you may lose it from your head, face, armpits, pubic area, chest, and/or legs. You may also notice your hair getting thin.
  • Hand-and-foot syndrome. The palms of your hands or soles of your feet may tingle, become numb, painful, swollen, or red.
  • Thickening of the skin
  • New skin growths

Note: Each of the side effects above was reported in 20% or greater of patients treated with dabrafenib. Not all possible side effects are included above. You may experience different side effects if you take dabrafenib in combination with trametinib.

Warnings and Precautions

  • Blurred vision or other changes in eyesight which can rarely cause blindness.
  • Severe allergic skin reaction. You may develop blisters on your skin that are filled with fluid or a severe red rash all over your body that may be painful.
  • Changes in your heart function
  • Serious fever reactions. This may be accompanied by dehydration (lack of water in the body from losing too much fluid), low blood pressure and changes in your kidney function which can cause kidney failure.
  • Blood sugar levels may change. If you have diabetes, changes may need to be made to your diabetes medication.
  • Increased tumor growth with specific tumor types
  • This drug may raise your risk of getting a second cancer and the development of skin lesions that may or may not be cancer
  • Breakdown of your red blood cells which can cause anemia (decreased red blood cells) in people with a G6PD deficiency
  • Serious bleeding events

Note: Some of the side effects above are very rare, or occur when dabrafenib and trametinib are given together. If you have concerns and/or questions, please discuss them with your medical team.

How to Take Your Medication

  • Take this drug by mouth without food, 12 hours apart, at least 1 hour before you eat or 2 hours after you eat. Do not open, crush or break the capsules.
  • Missed dose: If you miss a dose, take it as soon as you think about it ONLY if your next dose is due in more than 6 hours. If your next dose is due in LESS than 6 hours, then skip the missed dose and contact your physician.
  • If you vomit a dose, take your next dose at the regular time, and contact your physician. Do not take 2 doses at the same time and do not double up on the next dose.
  • Handling: Wash your hands after handling your medicine, your caretakers should not handle your medicine with bare hands and should wear latex gloves.
  • This drug may be present in the saliva, tears, sweat, urine, stool, vomit, semen, and vaginal secretions. Talk to your doctor and/or your nurse about the necessary precautions to take during this time.
  • Storage: Store this medicine in the original container at room temperature. Discuss with your nurse or your doctor how to dispose of unused medicine.

Treating Side Effects

  • If you have diabetes, keep good control of your blood sugar level. Tell your nurse or your doctor if your glucose levels are higher or lower than normal.
  • Keeping your pain under control is important to your well-being. Please tell your doctor or nurse if you are experiencing pain.
  • Avoid sun exposure and apply sunscreen routinely when outdoors.
  • If you get a rash, do not put anything on it unless your doctor or nurse says you may. Keep the area around the rash clean and dry. Ask your doctor for medicine if your rash bothers you.
  • To help with hair loss, wash with a mild shampoo and avoid washing your hair every day.
  • Avoid rubbing your scalp, pat your hair or scalp dry.
  • Avoid coloring your hair.
  • Limit your use of hair spray, electric curlers, blow dryers, and curling irons.
  • If you are interested in getting a wig, talk to your nurse. You can also call the American Cancer Society at 800-ACS-2345 to find out information about the “Look Good, Feel Better” program close to where you live. It is a free program where women getting chemotherapy can learn about wigs, turbans and scarves as well as makeup techniques and skin and nail care.
  • Examine your skin often for new skin lesions/growth.

Food and Drug Interactions

  • Do not eat grapefruit or drink grapefruit juice while taking this medicine.Grapefruit and grapefruit juice may raise the levels of dabrafenib in your body. This could make side effects worse.
  • Check with your doctor or pharmacist about all other prescription medicines and over-the-counter medicines and dietary supplements (vitamins, minerals, herbs and others) you are taking before starting this medicine as there are known drug interactions with dabrafenib. Also, check with your doctor or pharmacist before starting any new prescription or over-the-counter medicines, or dietary supplement to make sure that there are no interactions.

When to Call the Doctor

Call your doctor or nurse if you have any of these symptoms and/or any new or unusual symptoms:

  • Fever of 100.5 F (38 C) or higher
  • Chills
  • Trouble breathing
  • Swelling of legs, ankles, or feet
  • Weight gain of 5 pounds in one week (fluid retention)
  • Feeling that your heart is beating in a fast or not normal way (palpitations)
  • Blurred vision or other changes in eyesight
  • Red or painful eye
  • Headache that does not go away
  • Feeling dizzy or weak
  • Blood in your urine, vomit (bright red or coffee-ground) and/or stools (bright red, or black/tarry)Pain that does not go away or is not relieved by prescribed medicine
  • Abnormal blood sugar
  • Unusual thirst, passing urine often, headache, sweating, shakiness, irritability
  • Painful, red, or swollen areas on your hands or feet.
  • Numbness and/or tingling of your hands and/or feet
  • A new rash or a rash that is not relieved by prescribed medicines
  • New skin lesions
  • If you think you may be pregnant

Reproduction Warnings

  • Pregnancy warning: This drug can have harmful effects on the unborn baby. Women of childbearing potential should use effective non-hormonal methods of birth control during your cancer treatment and for 2 weeks (or 4 months if taken with trametinib) after treatment. Let your doctor know right away if you think you may be pregnant. Birth control pills (oral contraceptives) may not be effective with this medication.
  • Breastfeeding warning: Women should not breastfeed during treatment and for 2 weeks (or 4 months if taken with trametinib) after treatment because this drug could enter the breast milk and cause harm to a breastfeeding baby.
  • Fertility warning: In men and women both, this drug may affect your ability to have children in the future. Talk with your doctor or nurse if you plan to have children. Ask for information on sperm or egg banking.

Revised February 2018

This information is intended to provide helpful health information to the general public and is not to be used in place of any medical, health, psychological, or any other kind of personal professional services. The information herein does not cover all possible uses, actions, precautions, side effects, or interactions of the medicines mentioned, nor is the information intended as medical advice for individual problems or for making an evaluation as to the risks and benefits of taking a particular medication. The dose, method of administration and contraindications for any administered medication should be confirmed before use. UPMC specifically disclaims all responsibility for any liability, loss or risk, personal or otherwise, which is incurred as a consequence, directly or indirectly, of the use and application of any medication mentioned herein.