Binimetinib tablets for oral use in combination with encorafenib capsules are prescribed for treating melanoma in adult patients with a specific gene mutation.
Binimetinib tablets are prescribed in combination with encorafenib for treating adult patients with a specific type of skin cancer known as melanoma which either cannot be removed by surgery or has moved to other parts of the body.
Binimetinib should be used to treat melanoma with a BRAF V600E or V600K gene mutation as confirmed by an FDA approved test.
Binimetinib should not be used in patients
Allergic to binimetinib
Pregnancy and breastfeeding
Binimetinib should not be used in children as safety and effectiveness of binimetinib has not been studied for their age groups.
Caution is required while treating patients with
History of bleeding
The recommended adult dose of binimetinib is 45 mg taken two times daily in combination with encorafenib capsules.
The dose of binimetinib can either be reduced or modified based on the side effects that occur in patients treated with binimetinib.
Treatment with binimetinib can permanently be discontinued or stopped if the side effects are severe or life-threatening.
Do not continue the treatment with binimetinib alone if encorafenib is withdrawn from the treatment schedule. The treatment with binimetinib should also be stopped.
Binimetinib tablets should be taken by mouth twice daily with a precise gap of 12 hours between the two doses.
Binimetinib can be taken either with or without food. If gastric irritation occurs take binimetinib tablets with food.
If a dose of binimetinib is missed, take the missed dose as early as possible. Do not take the missed dose if the next scheduled dose is close to 6 hours.
Never take an extra dose if vomiting occurs while taking binimetinib tablets but continue with the next dose as per the next scheduled time.
Women of childbearing age should take effective contraceptive measures during the treatment with binimetinib and should continue that for at least 30 days after the last dose of binimetinib.
Breastfeeding mothers should not breastfeed their children during binimetinib treatment and for at least three days after the last dose.
Patients must confirm for the presence of BRAF V600E or V600K gene mutation with an FDA approved test before starting treatment with binimetinib.
A MUGA (Multigated Acquisition) scan to find hearts pumping function or an ECG should be taken before starting treatment with binimetinib, a month after treatment and continued every two or three months during the treatment.
Blood clots can occur deep in the blood vessels while treating with binimetinib. Some clots can travel to the lungs resulting in blockade of blood supply to the lungs. In such situations, the dose of binimetinib can be reduced or treatment can be discontinued.
Various eye disorders including new or worsening of visual disturbances can occur with binimetinib treatment; therefore patients should be advised to meet an eye specialist and to check their eye function at regular intervals.
Airway disease including pneumonitis, heart problems, liver toxicity and severe muscle weakness may occur during binimetinib treatment. So, patients must be monitored for any signs and symptoms and should be treated accordingly.
Bleeding events can occur during treatment with binimetinib and encorafenib combination. The most common place of bleeding is in stomach and worsening of bleeding in hemorrhoids or piles which require treatment modification.
Gastrointestinal: Nausea, pain in the stomach, loose stools, vomiting, bleeding events in the stomach or rectum
Nervous system: Dizziness, fatigue or weakness
Eye: Visual disturbances, eye damage, blood clot in the eye
Cardiovascular system: High blood pressure
Skin: Rashes, bumps or painful nodules
Others: Anemia, fever, allergic reactions, low levels of sodium in the blood, increased levels of creatinine, creatinine phosphokinase, and liver enzymes
Women of childbearing age should perform a pregnancy test and must take binimetinib only when a pregnancy test shows negative.
Patients should inform the doctor if they are taking any prescription, Over-The-Counter medicines or herbal supplements to avoid dangerous drug interactions.
Store binimetinib tablets at room temperature between 20°C and 25°C.
Protect from excess moisture and heat.
Keep binimetinib away from children and pets.
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