Description
Encorafenib is used in combination with binimetinib to treat melanoma (skin cancer) that has spread or cannot be removed by surgery. It is only used if the melanoma cells have the BRAF V600E or V600K mutations. Your doctor will use a special test to look for these mutations.
Encorafenib is also used in combination with cetuximab to treat cancer of the colon and rectum that has spread and have the BRAF V600E mutations. Your doctor will use a special test to look for these mutations. Encorafenib belongs to the group of medicines, called antineoplastics (cancer medicines).
Encorafenib is also used in combination with binimetinib to treat non-small cell lung cancer (NSCLC) that has spread in patients who have BRAF V600E mutations. Your doctor will use a special test to look for these mutations.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of encorafenib in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of encorafenib in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Atazanavir
- Bepridil
- Cisapride
- Dronedarone
- Fluconazole
- Ketoconazole
- Levoketoconazole
- Mesoridazine
- Pimozide
- Piperaquine
- Posaconazole
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Adagrasib
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apalutamide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atorvastatin
- Avacopan
- Azithromycin
- Bedaquiline
- Boceprevir
- Bosentan
- Buprenorphine
- Buserelin
- Carbamazepine
- Cenobamate
- Ceritinib
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clothiapine
- Clozapine
- Cobicistat
- Conivaptan
- Crizotinib
- Cyclobenzaprine
- Cyclosporine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Eye problem (eg, iritis, iridocyclitis, uveitis) or
- Heart rhythm problems (eg, QT prolongation)—Use with caution. May make these conditions worse.
- Hypokalemia or (low potassium level) or
- Hypomagnesemia (low magnesium level)—These conditions must be corrected first before using this medicine.
- Kidney disease, severe or
- Liver disease, moderate or severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine usually comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For colorectal cancer:
- Adults—300 milligrams (mg) (four 75 mg capsules) once a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For melanoma and non-small cell lung cancer:
- Adults—450 milligrams (mg) (six 75 mg capsules) once a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For colorectal cancer:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose, take it as soon as you remember. If it is 12 hours or less until your next scheduled dose, skip the missed dose and go back to your regular dosing schedule. Do not take extra medicine to make up for a missed dose. If you vomit after taking a dose, do not take an extra dose. Take your next dose at your regular time.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep the medicine in its original container.
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests will be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, spermicide). Use an effective form of birth control during treatment and for at least 2 weeks after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
Some men who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
This medicine may increase your risk of having cutaneous squamous cell carcinoma (cuSCC) or other skin cancers. Check with your doctor right away if you develop any skin changes, including a new wart, change in size or color of a mole, or a skin sore or reddish bump that does not heal. Your doctor may want your skin be checked for new skin lesions before treatment, during treatment, and for up to 6 months after the last dose.
This medicine may cause hemorrhage (severe bleeding) in the stomach and bowel areas or in the brain. Call your doctor right away if you have any unusual or unexplained bleeding.
This medicine may cause heart problems (eg, cardiomyopathy). Check with your doctor right away if you have chest discomfort or pain, dizziness, faintness, fast, irregular, or pounding heartbeat, swelling of the feet or lower legs, trouble breathing, or unusual tiredness or weakness.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Check with your doctor right away if eye pain or a change in vision occurs during treatment. This could be a sign of a serious eye problem. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, including QT prolongation.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Black, tarry stools
- bleeding gums
- bloating
- blood in the urine or stools
- chest pain or tightness
- chills
- constipation
- coughing up blood
- dark urine
- difficulty in breathing or swallowing
- dizziness
- fast heartbeat
- fever
- headache
- hives, itching, skin rash
- hoarseness
- increased menstrual flow or vaginal bleeding
- indigestion
- irritation
- joint pain, stiffness, or swelling
- loss of appetite
- lower back or side pain
- nausea
- nosebleed
- painful or difficult urination
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- partial or slight paralysis of the face
- pinpoint red spots on the skin
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark-brown urine
- redness, swelling, or pain of the skin
- scaling of the skin on the hands and feet
- sore throat
- swelling of the eyelids, face, lips, hands, or feet
- swollen glands
- thickening of the skin
- tingling of the hands and feet
- ulcers, sores, or white spots in the mouth
- ulceration of the skin
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- yellow eyes or skin
Rare
- Vomiting of blood or material that looks like coffee grounds
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Back pain
- burning, numbness, tingling, or painful sensations
- change in taste
- difficulty in moving
- dry skin
- hair loss, thinning of hair
- increased sensitivity of the skin to sunlight
- loss of taste
- muscular pain, tenderness, wasting, or weakness
- pain in the arms or legs
- redness or other discoloration of the skin
- severe sunburn
- stomach pain
- unsteadiness or awkwardness
- weakness in the arms, hands, legs, or feet
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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