Encorafenib capsules for oral use are prescribed for treating adult patients with a specific type of advanced melanoma, a skin cancer with BRAF mutation.
Encorafenib capsules for oral use are prescribed along with binimetinib for treating advanced melanoma which either cannot be removed by surgery or has moved to other parts of the body, in adult patients with BRAF V600E or V600K mutation confirmed by an FDA-approved test.
Tumor specimens should be tested for the presence of BRAF V600E or V600K mutation before starting the treatment with encorafenib.
Encorafenib should not be used in patients with-
• Allergy to encorafenib
• Wild-type BRAF skin cancer
• Pregnancy and breastfeeding
• Men undergoing fertility treatments
Encorafenib should not be used in children as safety and effectiveness studies of encorafenib have not been conducted in these age groups.
Caution is required in treating patients with-
• History of bleeding
• Heart rhythm abnormalities
• Eye disorders
• The recommended adult dose of encorafenib is 450 mg taken one time daily in combination with binimetinib.
• If any serious side effects occur, the dose of encorafenib can be reduced or modified to 300mg first, and then to 200 mg if needed.
• Treatment with encorafenib can permanently be discontinued if the patient cannot tolerate 200 mg of encorafenib given once daily.
• The dose of encorafenib can be reduced to 300 mg taken once daily if binimetinib is discontinued for some reasons and can be maintained at the same dose until binimetinib is initiated.
• Encorafenib comes in a capsule form that can be taken by mouth with or without food. Take encorafenib capsules with food if stomach irritation occurs.
• If a dose of encorafenib is missed, take the missed dose as early as possible. Never take the missed dose of encorafenib if the next scheduled dose is within 12 hours.
• Do not take an additional dose of encorafenib if vomiting occurs while taking encorafenib capsules but continue with the next dose as per the next scheduled time.
• Women of childbearing age should take an effective contraceptive measure during the treatment with encorafenib and continue taking contraceptives for at least two weeks after the last dose of encorafenib.
• Breastfeeding mothers should not breastfeed their children during encorafenib treatment and for at least two weeks from the last dose.
• A pregnancy test should be done on women of childbearing age before the therapy, and the treatment with encorafenib should be started only if the pregnancy test reads negative.
• Men of reproductive potential should plan to store their sperms in a sperm bank before starting encorafenib treatment as it may affect their fertility status.
• Patients should be monitored for any abnormalities in heart rhythm and dose with encorafenib can be reduced, or treatment may be discontinued if the rhythm has a prolongation greater than 500 milliseconds.
• Look for any electrolyte abnormalities during the treatment with encorafenib and correct if any low levels of potassium or magnesium occur.
• Skin examination should be performed before starting treatment with encorafenib that should be followed up every two months during the treatment and six months after stopping the encorafenib treatment.
• Eye disorders including new or worsening of visual disturbances can occur with encorafenib treatment; therefore patients should be advised to meet an eye specialist and to check their eye function at regular intervals.
• Bleeding events can occur during treatment with encorafenib and binimetinib combination. The most common is bleeding in the stomach and worsening of bleeding in hemorrhoids or piles which require treatment modification.
• Gastrointestinal: Nausea, vomiting, pain in the stomach, constipation
• Musculoskeletal: Muscle pain, pain in the joints and extremities
• Nervous system: Headache, dizziness, numbness or pricking sensation in the hands or feet
• Skin: Rashes, itching, hair loss, dry skin
• Others: Weakness, fever, bleeding episodes, allergic reactions, painful nodules in the skin, high sugar level, alterations in sodium and magnesium level, blood disorders and other lab abnormalities.
• Never change the dose or stop the treatment of encorafenib without the advice of the physician.
• Do not take an additional dose of encorafenib to make up for the missed dose as it can cause serious side effects.
• Encorafenib may affect the effectiveness of hormonal contraceptives and should be avoided taken together.
• Do not take drugs that cause heart rhythm abnormalities along with encorafenib as the condition may worsen with encorafenib treatment.
• Avoid taking grapefruit juice with encorafenib as it may increase the amount of encorafenib in the body leading to life-threatening conditions.
• Inform the doctor about taking any prescription, non-prescription or herbal supplements prior to taking encorafenib so as to avoid dangerous drug reactions with the latter.
• Store encorafenib capsules at room temperature between 20°C and 25°C.
• Keep the encorafenib capsules in their original bottle and do not remove the desiccant provided inside the bottle as it protects the capsule from moisture.
• Keep the encorafenib capsules away from children and pets.
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