Description
Mirdametinib is used to treat patients with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas that cause symptoms and 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
- Tablet for Suspension
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 mirdametinib 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 mirdametinib 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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—Use with caution. May make these conditions worse.
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 and patient instructions. 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 drinking water. Do not open, break, or chew it.
You may swallow the tablet for suspension whole with drinking water or disperse the tablet into drinking water.
To use the tablet for suspension:
- Wash and dry your hands before using this medicine.
- Add about 5 to 10 milliliters (mL) of drinking water to the dosing cup. Add the prescribed number of tablets to the water.
- Gently swirl the dosing cup to disperse the tablets until no lumps remain. Wait for 2 to 4 minutes until the tablets have fully dispersed. The liquid should be white and cloudy and may contain small pieces.
- Swallow the mixture right away or within 30 minutes after preparing.
- If there are small pieces left in the cup, you may add another 5 to 10 mL of drinking water to the dosing cup. Gently swirl the dosing cup and drink the mixture right away.
- You may also take or give this medicine from an oral dosing syringe. Place the tip of the oral syringe inside the mouth pointing toward inside of either cheek. Slowly push the plunger all the way down to give the full dose. If you are giving this medicine to a child, make sure they are sitting upright until all the liquid has been swallowed.
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 or tablets for suspension):
- For neurofibromatosis type 1 (NF1):
- Adults and 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 2 milligrams per square meter (mg/m[2]) of body surface area, taken 2 times a day about 12 hours apart for 21 days, followed by 7 days off treatment, to complete a 28-day cycle. Your doctor may adjust your dose as needed and tolerated.
- BSA of 1.50 meter squared (m2) or more—4 mg 2 times a day.
- BSA of 1.05 to 1.49 m2—3 mg 2 times a day.
- BSA of 0.70 to 1.04 m2—2 mg 2 times a day.
- BSA of 0.40 to 0.69 m2—1 mg 2 times a day.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- Adults and 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 2 milligrams per square meter (mg/m[2]) of body surface area, taken 2 times a day about 12 hours apart for 21 days, followed by 7 days off treatment, to complete a 28-day cycle. 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, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you vomit after taking your medicine, do not take an extra dose.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
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.
Throw away unused oral liquid 30 minutes after preparing the mixture.
Precautions
It is very important that a doctor check your or your child's 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 tests, and other tests, will be needed before you start treatment, every 3 months during your first year of treatment, and as 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 using this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 6 weeks 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 3 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
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 to be checked by an ophthalmologist (eye doctor).
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.
This medicine may cause serious skin reactions (eg, dermatitis acneiform, eczema). Check with your doctor right away if you have blistering, crusting, irritation, itching, or reddening of the skin, cracked, dry, scaly skin, skin rash, encrusted, scaly and oozing, or swelling.
Some women 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.
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:
Less common
- Agitation
- bladder pain
- blistering, crusting, irritation, itching, or reddening of the skin
- bloody or cloudy urine
- blurred vision
- burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
- change in vision
- chest pain or tightness
- coma
- confusion
- cough
- cracked, dry, scaly skin
- decreased urine output
- depression
- diarrhea
- difficult, burning, or painful urination
- dilated neck veins
- dizziness
- ear congestion
- fever or chills
- frequent urge to urinate
- headache, severe and throbbing
- hostility
- inability to speak
- irregular heartbeat
- irritability
- lethargy
- loss of voice
- lower back or side pain
- muscle or bone pain
- muscle or body aches
- muscle twitching
- nausea or vomiting
- nerve pain
- nervousness
- new loss of taste or smell
- pounding in the ears
- scaling of the skin on hands and feet
- seizures
- skin rash, encrusted, scaly and oozing
- slow or fast heartbeat
- slurred speech
- sneezing
- sore throat
- stuffy or runny nose
- stupor
- swelling
- swelling of the face, fingers, feet, or lower legs
- temporary blindness
- tingling of the hands and feet
- trouble breathing
- unsteadiness or awkwardness
- unusual tiredness or weakness
- weakness in the arms, hands, legs, or feet
- weight gain
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:
Less common
- Arm or leg pain
- back pain
- difficulty in moving
- double vision
- dry mouth
- loss or thinning of the hair
- loosening of the fingernails
- muscle aches, cramps, or stiffness
- redness or soreness around the fingernails
- seeing double
- stomach pain
- sunken eyes
- swelling or inflammation of the mouth
- swollen joints
- thirst
- wrinkled skin
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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