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  • Generic Name: (dabrafenib)
    Other Brands: N/A
  • Last Revised: 07/2016
    • What is this medication and its most common uses?

      Tafinlar is a medicine used alone or with another medicine called trametinib, to treat certain people with a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery.

    • What should I know when beginning and continuing on this medication?

      How does this medication work?

      Tafinlar works by blocking the action of an abnormal protein that signals cancer cells to multiply, thereby stopping the growth of cancer cells.

      What are the beneficial effects of this medication and when should I begin to have results?

      What: Tafinlar, when taken alone or with trametinib, has been shown to improve progression-free survival (the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse).

      When: Everyone responds differently to treatment, so try to be patient and follow your healthcare provider's directions. It is important that you take Tafinlar exactly as your healthcare provider has prescribed.

      How do I know it is working?

      Your healthcare provider may order tests regularly to check how well this medication is working.

    • What are the possible side effects of this medication?

      The following is not a full list of side effects. Side effects cannot be anticipated. If any develop or change in intensity, tell your healthcare provider as soon as possible. Only your healthcare provider can determine if it is safe for you to continue taking this medication.

      More common side effects of Tafinlar when used without trametinib may include: thickening of the outer layers of the skin, headache, fever, joint pain, warts, hair loss, hand-foot syndrome (redness, swelling, and pain on the palms of the hands and/or the soles of the feet).

      More common side effects of Tafinlar when used with trametinib may include: fever, rash, chills, headache, joint pain, cough.

      Less common side effects of Tafinlar may include:

      Risk of new cancers, with symptoms such as a new wart, a skin sore or reddish bump that bleeds or does not heal, and change in size or color of a mole. Your healthcare provider should check your skin before treatment with Tafinlar, every two months during treatment with Tafinlar, and for up to 6 months after you stop taking Tafinlar to look for any new skin cancers. Your healthcare provider should also check for cancers that may not occur on the skin.

      Serious, life-threatening bleeding problems (especially in your brain or stomach) when taken with trametinib, with symptoms such as headache, dizziness, or weakness; coughing up blood or blood clots; vomiting blood or your vomit looks like coffee grounds; and red or black, tarry stools.

      Heart problems (including heart failure), with symptoms such as feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles or feet, and lightheadedness. Your healthcare provider should check your heart function before and during treatment with Tafinlar.

      Eye problems that can lead to blindness, with symptoms such as blurred vision, loss of vision, or other vision changes; seeing color dots; seeing halos (blurred outline around objects); and eye pain, swelling, or redness.

      Fever that may happen more often or may be more severe when Tafinlar is taken with trametinib. In some cases, chills or shaking chills, dehydration (too much fluid loss), low blood pressure, dizziness, or kidney problems may happen with the fever.

      Skin reactions, with symptoms such as a skin rash that bothers you or does not go away; acne; redness, swelling, peeling, or tenderness of hands or feet; or skin redness.

      High blood sugar or worsening diabetes, with symptoms such as increased thirst, urinating more often than normal, or urinating an increased amount of urine. If you are diabetic, your healthcare provider should check your blood sugar levels closely during treatment with Tafinlar alone or with trametinib.

      Tafinlar may cause healthy red blood cells to break down too early in people with glucose-6-phosphate dehydrogenase (G6PD) deficiency. This may lead to a type of anemia called hemolytic anemia where the body does not have enough healthy red blood cells. Symptoms may include jaundice (yellow skin), weakness or dizziness, and shortness of breath.

      Tafinlar may also harm your unborn baby if used during pregnancy. Tell your healthcare provider immediately if you are pregnant or plan to become pregnant.

    • Who should not take this medication?

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

    • What should I tell my healthcare provider before I take the first dose of this medication?

      Tell your healthcare provider about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Tafinlar. Also, talk to your healthcare provider about your complete medical history, especially if you have bleeding, diabetes, G6PD deficiency, or heart, eye, liver, or kidney problems; plan to have surgery or dental or other medical procedures; or if you are pregnant, plan to become pregnant, or are breastfeeding.

    • What is the usual dosage?

      The information below is based on the dosage guidelines your healthcare provider uses. Depending on your condition and medical history, your healthcare provider may prescribe a different regimen. Do not change the dosage or stop taking your medication without your healthcare provider's approval.

      Adults: The recommended dose is 150 milligrams twice a day (about 12 hours apart). Your healthcare provider may adjust your dose as needed.

    • How should I take this medication?

      Take Tafinlar exactly as prescribed by your healthcare provider.

      Take Tafinlar at least 1 hour before or 2 hours after a meal.

      Do not open, crush, or break the capsules.

      Birth control methods that contain hormones (such as birth control pills, injections, or patches) may not work as well during treatment with Tafinlar alone or Tafinlar and trametinib. You should use another effective method of birth control during treatment with Tafinlar alone or Tafinlar and trametinib. Talk to your healthcare provider about birth control methods that may be right for you during this time.

    • What should I avoid while taking this medication?

      Do not change your dose or stop taking Tafinlar without first talking to your healthcare provider.

    • What are the possible food and drug interactions associated with this medication?

      If Tafinlar is taken with certain other drugs, the effects of either could be increased, decreased, or altered. Tafinlar may interact with numerous medications. Therefore, it is very important that you tell your healthcare provider about any other medications you are taking.

    • May I receive this medication if I am pregnant or breastfeeding?

      Tafinlar can harm your unborn baby if taken during pregnancy. Women who are able to become pregnant should use effective birth control during treatment and for 2 weeks after the last dose of Tafinlar. The effects of Tafinlar during breastfeeding are unknown. Do not breastfeed during treatment and for 2 weeks after your last dose of Tafinlar. Tell your healthcare provider immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

      Tafinlar may cause fertility problems in women. This could affect your ability to become pregnant. Talk to your healthcare provider if this is a concern for you.

      Tafinlar may also cause lower sperm counts in men. This could affect the ability to father a child. Talk to your healthcare provider if this is a concern for you.

    • What should I do if I miss a dose of this medication?

      If you miss a dose of Tafinlar, take it as soon as you remember. However, if it is within 6 hours of your next scheduled dose, skip the missed dose and take your next dose at your regular time. Do not take two doses at once.

    • How should I store this medication?

      Store at room temperature.

    • Who should I contact in case of emergency or overdose?
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      In the event of a medical emergency call your doctor or 9-1-1 immediately. In the event of overdose, call your doctor or poison control for further instructions.
      National Poison Control#: Call 1-800-222-1222

      This PDR+ drug information has been developed by the Physicians’ Desk Reference Network (PDRN), a source of medication information trusted by doctors for over 65 years.

      This monograph summarizes the most important information about your medication and does not cover all the information you may need. If you have any questions or concerns or want to learn more about your medication, ask your healthcare provider; he/she will be able to provide answers to your questions. This medication should only be used by the patient for whom it was prescribed and should not be shared with other people.
    • Additional patient resources.
      back to top Use your PDR® Pharmacy Discount Card when you or a family member fills a prescription and ask for your PDR® Discount every
      time!
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    This discount plan is NOT insurance or a Medicare prescription drug plan. The plan is not intended as a substitute for insurance and does not meet creditable coverage requirements under state or federal law. The plan provides discounts at participating pharmacies on certain pharmaceutical supplies, prescription drugs, or medical equipment and supplies. The range of discounts will vary depending on the products received. Members are obligated to pay the pharmacy the entire amount of the discounted rate for such products at the point of sale. The plan does not pay pharmacies for products provided to members. No enrollment or periodic fees apply. The pharmacy may pay the plan a fee from amounts the pharmacy collects from the member. The discount plan organization is ProCare Pharmacy Benefit Manager, Inc.,1267 Professional Parkway, ProCare Office Park, Gainesville, GA 30507, 1-888-299-5383. Customer service is provided by PDR, LLC., 5 Paragon Drive, Montvale, NJ, 07645, 1-800-232-7379, www.pdr.net/DiscountCard, customerservice@pdr.net.