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The following safety information contains crucial warnings about the use of Tafinlar (dabrafenib). It is important to read these details carefully and discuss any concerns with your healthcare provider.

• Risk of New Cancers: Some patients using Tafinlar (dabrafenib) have developed new types of cancer, including various skin cancers. Regular monitoring by your healthcare provider for any signs of cancer is essential during treatment.

• Not Suitable for Certain Cancers: Tafinlar (dabrafenib) should not be used in individuals with cancers lacking a BRAF mutation, as this medication may promote cancer cell growth in such cases. Confirming the presence of a BRAF mutation is necessary before starting treatment.

• Bleeding Risks: The combination of Tafinlar (dabrafenib) and Mekinist (trametinib) can lead to bleeding issues, such as nosebleeds or internal bleeding. Report any unusual bleeding to your provider immediately. Treatment adjustments or discontinuation may be required based on severity.

• Heart Health Concerns: Some patients on Tafinlar (dabrafenib) with Mekinist (trametinib) have experienced heart problems where the heart's pumping ability is reduced. Regular heart function monitoring through echocardiograms is recommended every 2 to 3 months. Alert your provider if you notice symptoms like fatigue, breathing difficulties, or leg swelling.

• Eye Issues: Rarely, patients have developed uveitis, causing symptoms like vision changes and eye pain. An eye examination may be necessary, and treatment may include pausing Tafinlar (dabrafenib) and using eye drops.

• Serious Fever: A significant fever reaction may occur, with or without additional symptoms like chills and low blood pressure. Contact your provider if you develop a fever of 100.4°F or higher. Temporary discontinuation of Tafinlar (dabrafenib) may be advised.

• Severe Skin Reactions: While rashes are common, severe skin reactions like Stevens-Johnson syndrome (SJS) or DRESS can occur. Immediate medical attention is required if you experience painful blisters, skin wounds, or peeling.

• Elevated Blood Sugar: Patients with diabetes may experience increased blood sugar levels, sometimes necessitating changes in diabetes medication. Regular blood sugar monitoring is advised.

• Consideration for G6PD Deficiency: Individuals with G6PD deficiency are at risk for hemolytic anemia while taking Tafinlar (dabrafenib). Seek medical advice if you experience symptoms like extreme fatigue or stomach tenderness.

• Serious Blood Condition: Rare cases of hemophagocytic lymphohistiocytosis (HLH) have been reported, characterized by fever and organ damage. Immediate medical evaluation is necessary if symptoms arise.

• Potential Harm to Unborn Baby: Tafinlar (dabrafenib) may harm an unborn child or increase miscarriage risks. Women who can become pregnant should use non-hormonal birth control during treatment and for two weeks after the last dose. Men should use condoms during treatment and for two weeks post-treatment if their partner can become pregnant. Notify your provider if pregnancy occurs.

By understanding these warnings, you can help ensure safe and effective use of Tafinlar (dabrafenib). Always consult your healthcare provider with any questions or concerns regarding your treatment.

When using this medication, some common side effects may occur. These include high blood sugar, increased liver enzymes, fever, tiredness, changes in blood test results, and rash. Nausea, headache, chills, diarrhea, vomiting, cough, and muscle or joint pain are also possible, along with constipation. Most of these effects are mild, but if they persist or worsen, it's advisable to consult a healthcare provider.

Other side effects that might be experienced include skin thickening, dry skin, rash on hands and feet, papilloma, lower appetite, swelling in the legs, bleeding, hair loss, and trouble breathing. If these occur, especially if they are severe, consulting a healthcare provider is recommended.

There is also a risk of serious side effects, which, although rare, require immediate medical attention. These include unusual skin changes or new skin growths, symptoms of high blood sugar like increased thirst or urination, easy bruising or bleeding, and signs of heart failure such as shortness of breath and unusual fatigue. Other serious effects can be dizziness, fainting, kidney problems, serious eye problems, and severe skin reactions. In very serious cases, there may be signs of bleeding in the brain or stomach/intestinal bleeding.

A rash is common with this medication, and while usually not serious, seek medical help if one develops, as it may be a sign of a severe reaction. Although a very serious allergic reaction is rare, immediate medical help is necessary if symptoms such as fever, swollen lymph nodes, rash, itching, swelling, severe dizziness, or trouble breathing occur.

When taking dabrafenib, certain drug interactions need to be considered. This medication can reduce the effectiveness of hormonal birth control methods like pills, patches, or rings, potentially leading to pregnancy. It's essential to discuss with your doctor or pharmacist about using additional reliable contraceptive methods while on dabrafenib. If you experience new spotting or breakthrough bleeding, inform your healthcare provider, as it may indicate your birth control is not functioning properly.

Additionally, some medications can influence how dabrafenib is eliminated from your body, affecting its efficacy. These include azole antifungals (e.g., itraconazole, ketoconazole), gemfibrozil, macrolide antibiotics (e.g., clarithromycin, erythromycin), nefazodone, St. John's Wort, and certain seizure medications (e.g., phenobarbital, phenytoin).

Dabrafenib can also accelerate the removal of other drugs from your system, impacting their effectiveness. Examples include daridorexant, elacestrant, mavacamten, midazolam, quizartinib, revumenib, and warfarin.

Moreover, some medications should generally not be used with dabrafenib unless deemed necessary by your doctor, who may adjust dosages or frequencies. Examples include fluconazole, ketoconazole, azithromycin, erythromycin, and many others. Always keep your healthcare provider informed about all medications and supplements you are taking to manage potential interactions effectively.