Braftovi

The recommended dose of encorafenib to treat skin cancer is 450 mg (6 × 75 mg capsules), taken by mouth, once a day.

The recommended dose of encorafenib to treat mCRC is 300 mg (4 × 75 mg capsules) taken by mouth, once a day.

Encorafenib may be taken with or without food. The capsules should be swallowed whole with water. Avoid consuming grapefruit or grapefruit juice while you are taking this medication.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is less than 12 hours before your next dose, skip the missed dose and continue with your regular dosing schedule. If you vomit after taking a dose, do not take a second dose, and take your next dose as scheduled. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each hard gelatin capsule, imprinted with a stylized “A” on beige cap and “LGX 75mg” on white body, contains 75 mg of encorafenib.  Nonmedicinal ingredients: colloidal silicon dioxide, copovidone, crospovidone, ferrosoferric oxide, gelatin, iron oxide red, iron oxide yellow, magnesium stearate of vegetable origin, microcrystalline cellulose, pharmaceutical glaze, poloxamer 188, propylene glycol, succinic acid, and titanium dioxide.

Do not take this medication if you are allergic to encorafenib or any ingredients of the medication.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• changed sense of taste

• constipation

• decreased appetite

• diarrhea

• dizziness

• dry, red, or chapped skin

• fatigue

• hair loss or thinning

• headache

• increased sensitivity to sunlight

• inflammation of the fatty layer under the skin (e.g., tender red bumps on the arms and legs, abdomen, breasts, face, or buttocks)

• itching

• joint pain

• muscle weakness or spasm

• nausea

• skin rash

• stomach pain

• symptoms of hand-foot syndrome (e.g., redness, tingling, loss of feeling, skin peeling or blisters on the hands and feet)

• trouble sleeping

• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• acne-like bumps on the chest, upper back, face, or scalp

• fever

• loss of sensation or tingling in the hands and feet

• pain in the arms, legs, hands, or feet

• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)

• signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg)

• signs of bowel inflammation (e.g., fever that appears after starting the medication, watery and severe diarrhea (may also be bloody))

• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don"t stop bleeding)

• signs of kidney problems (e.g., change in the amount or colour of urine, increased urination at night, blood in the urine, swelling in the feet or legs)

• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)

• signs of skin cancer (e.g., open sores that do not heal, growths on the skin that are irregularly shaped or changing colour)

• swelling of the hands and feet

• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)

• symptoms of irregular heartbeat (e.g., chest pain, dizziness, rapid, pounding heartbeat, shortness of breath)

• symptoms of severely increased blood pressure: (e.g., chest pain, blurred vision, dizziness, excessive tiredness, headache, stronger or faster heartbeat)

• thickened outer layers of skin

• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, swelling of the face and throat)

• signs of blood clot in the lungs (pulmonary embolism; e.g., difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)

• signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)

• signs of paralysis of the face (e.g., loss of movement of the face, face muscles appear to droop)

• signs of stroke (bleeding in the brain; e.g., sudden or severe headache; sudden loss of coordination; vision changes; seizures; nausea and vomiting; confusion)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Birth control: Encorafenib may cause harm to the developing baby if it is taken during pregnancy. It is important that people who may become pregnant use effective birth control while taking this medication and for at least 2 weeks after the last dose. Birth control should include a barrier method, such as condoms, as hormonal birth control measures are not effective when used with encorafenib.****

People whose partners are or may become pregnant should use effective barrier birth control while taking encorafenib and for at a least one week after the last dose.

Bleeding: This medication may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Blood clots: This medication may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities. If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.

Diabetes: Encorafenib may cause an increase in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. ****People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drowsiness/reduced alertness: Encorafenib may cause fatigue or vision problems, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how you are affected by this medication.

**Eye inflammation: **This medication may cause eye inflammation. If you experience eye pain, changes in your vision, or eye pain when you are exposed to light, contact your doctor as soon as possible.

Heart rhythm: Encorafenib can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Encorafenib has been reported to cause decreased liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Your doctor may want to test your liver function regularly with blood tests while you are taking this medication. This often allows reduced liver function to be identified before it becomes too severe.

Other cancers: New cancerous lesions on the skin, such as squamous cell cancer or new melanomas can occur while you are taking encorafenib. It is important to have your skin examined before starting this medication, every 2 months while you are taking this medication, and until 6 months after stopping the medication. Signs of squamous cell cancer include sores, warts, or bumps that bleed or do not heal. Signs of melanoma include moles with an irregular shape, border, or colour that are changing shape or are growing. If you notice any of these signs, contact your doctor as soon as possible.

Pregnancy: Encorafenib can cause harm to the developing baby if it is taken during pregnancy. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if encorafenib passes into breast milk. If you are breast-feeding and taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

**For a full list of interactions, use the Drug Interaction Checker **available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Braftovi