Description
Selumetinib is used to treat neurofibromatosis type 1 (NF1) in children 2 years of age and older who have plexiform neurofibromas that cannot be removed by surgery.
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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of selumetinib in children 2 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of selumetinib in the elderly. Safety and efficacy have not been established.
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 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
- Abciximab
- Acenocoumarol
- Anagrelide
- Apalutamide
- Aprepitant
- Aspirin
- Atazanavir
- Avacopan
- Boceprevir
- Bosentan
- Carbamazepine
- Cenobamate
- Cilostazol
- Ciprofloxacin
- Clarithromycin
- Clopidogrel
- Cobicistat
- Conivaptan
- Crizotinib
- Cyclosporine
- Diltiazem
- Dipyridamole
- Dronedarone
- Efavirenz
- Enzalutamide
- Eptifibatide
- Erythromycin
- Etravirine
- Fedratinib
- Fexinidazole
- Fluconazole
- Fluvoxamine
- Fosnetupitant
- Fosphenytoin
- Idelalisib
- Imatinib
- Indinavir
- Itraconazole
- Ketoconazole
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 or vision problems or
- Heart disease (eg, cardiomyopathy)—Use with caution. May make these conditions worse.
- 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
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 patient information leaflet. Read and follow the instructions carefully. Ask your doctor or pharmacist if you have any questions.
You may take this medicine with or without food.
Swallow the capsule whole with water. Do not chew, dissolve, or open it.
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 neurofibromatosis type 1 (NF1):
- Children 2 years of age and older—Dose is based on body surface area and must be determined by your doctor. The dose is usually 25 milligrams per square meter (mg/m[2]) of body surface area, taken 2 times a day at least 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
- BSA of 1.90 meter squared (m2) or more—50 mg 2 times a day.
- BSA of 1.70 to 1.89 m2—45 mg 2 times a day.
- BSA of 1.50 to 1.69 m2—40 mg 2 times a day.
- BSA of 1.30 to 1.49 m2—35 mg 2 times a day.
- BSA of 1.10 to 1.29 m2—30 mg 2 times a day.
- BSA of 0.90 to 1.09 m2—25 mg 2 times a day.
- BSA of 0.70 to 0.89 m2—20 mg 2 times a day.
- BSA of 0.55 to 0.69 m2—20 mg in the morning and 10 mg in the evening.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- Children 2 years of age and older—Dose is based on body surface area and must be determined by your doctor. The dose is usually 25 milligrams per square meter (mg/m[2]) of body surface area, taken 2 times a day at least 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
- For neurofibromatosis type 1 (NF1):
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 it is more than 6 hours until the time you normally take a dose, take it as soon as you remember. If it is less than 6 hours until your regular time, skip the missed dose and go back to your regular dosing schedule. If you vomit after taking your medicine, do not take an extra dose.
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 bottle. Do not throw the desiccant (drying agent) packet.
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. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 1 week after your last dose. Males who are taking this medicine, with female partners who can become pregnant must use effective birth control during treatment and for at least 1 week after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may cause heart problems. Check with your doctor right away if you have chest discomfort or pain, dizziness or faintness, fast, irregular, or pounding heartbeat, swelling of the feet or lower legs, trouble with breathing, or unusual tiredness or weakness.
Check with your doctor right away if eye pain or a change in vision occurs during treatment. These could be a sign of a serious eye problem. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).
This medicine may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.
Check with your doctor right away if you have a severe skin rash, acne, or redness, swelling, peeling, or tenderness of the hands or feet. These may be symptoms of a serious skin problem.
Call your doctor right away if you have dark urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.
This medicine may cause bleeding problems. Tell your doctor if you have bleeding gums, coughing up blood, difficulty with breathing or swallowing, dizziness, headache, increased menstrual flow or vaginal bleeding, nosebleeds, prolonged bleeding from cuts, red or dark brown urine, or red or black, tarry stools.
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 (eg, St. John's wort) 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
- Blistering, crusting, irritation, itching, or reddening of the skin
- blood in urine
- cracked, dry scaly skin
- diarrhea
- fast heartbeat
- itching, pain, redness, swelling, tenderness, warmth on the skin
- loosening of the fingernails
- muscle or bone pain
- nosebleeds
- redness or soreness around the fingernails
- swelling
Less common
- Blurred vision
- change in vision
- chest tightness
- difficult or labored breathing
- dizziness
- headache
- nervousness
- overbright appearance of lights
- pounding in the ears
- rapid weight gain
- seeing flashes or sparks of light
- seeing floating spots before the eyes, or a veil or curtain across part of your vision
- slow or fast heartbeat
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
- Constipation
- fever
- hair loss, thinning of the hair
- loss of appetite
- nausea
- stomach pain
- swelling or inflammation of the mouth
- unusual tiredness or weakness
- vomiting
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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