Mirdametinib (Oral)
Mirdametinib is used to treat neurofibromatosis (a genetic disorder that causes tumors to develop on the nerves) with plexiform neurofibromas that cannot be surgically removed in patients at least 2 years old.
Mirdametinib may also be used for purposes not listed in this medication guide.
uses
What is Mirdametinib (Oral) used for?
- Neurofibromatosis
warnings
What is the most important information I should know about Mirdametinib (Oral)?
Tell your doctor if you have ever had:
- eye problems; or
- heart problems.
Mirdametinib may affect fertility in women.
May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while using mirdametinib and for at least 6 weeks after your last dose. Tell your doctor if you are pregnant or plan to become pregnant.
Men using mirdametinib should use condoms during treatment, and for at least 3 months after treatment ends.
Do not breastfeed while using this medicine, and for at least 1 week after your last dose.
Side Effects
What are the side effects of Mirdametinib (Oral)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- eye problems--blurred vision, severe vision problems, including vision loss;
- heart problems--swelling, rapid weight gain, feeling short of breath, tiredness, fast heart rate, coughing and wheezing; or
- skin problems--skin rash, peeling, itching, bumps, and redness.
Common side effects may include:
- diarrhea, vomiting, nausea, stomach pain;
- headache and tiredness;
- muscle, joint or bone pain;
- skin redness, swelling, pain around fingernail or toenail; or
- abnormal lab results including low white blood cell (WBC) counts.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Mirdametinib (Oral) if I’m pregnant or breastfeeding?
Mirdametinib may affect fertility in women.
May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while using mirdametinib and for at least 6 weeks after your last dose. Tell your doctor if you are pregnant or plan to become pregnant.
Do not breastfeed while using this medicine, and for at least 1 week after your last dose.
Interactions
What drugs and food should I avoid while taking Mirdametinib (Oral)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Mirdametinib (Oral)?
Use Mirdametinib (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Mirdametinib is usually taken twice per day (about 12 hours apart) with or without food. Mirdametinib is taken in a 28-day treatment cycle. You may need to take the medicine only during certain days of each cycle. Your doctor will determine how long to treat you with this medicine.
In case of tablet for oral suspension, follow the instructions provided with this medicine or ask your doctor or pharmacist if you don't understand how to use this medication.
If more than one capsule or tablet for oral suspension is needed for a dose, swallow each capsule or tablet one at a time.
Doses are based on body surface area (height and weight). Your dose may change if you gain or lose weight or if you are still growing.
If you vomit shortly after taking mirdametinib, do not take another dose. Take your next dose as scheduled.
Mirdametinib can cause your heart to pump less blood than normal. You may need medical tests to check your heart function before treatment and every 3 months while you are taking this medicine.
Mirdametinib can also cause eye problems that may lead to blindness. You will need frequent vision exams, and your next dose may be delayed based on the results.
Do not change your dose or dosing schedule without your doctor's advice.
Swallow the capsule whole and do not crush, chew, break, or open it.
Store at room temperature away from moisture, heat, and light.
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
Overdose Signs
What happens if I overdose on Mirdametinib (Oral)?
Images
MIR 1 mg
Color: green
Shape: capsule
Imprint: MIR 1 mg
MIR 2 mg
Color: blue/green
Shape: capsule
Imprint: MIR 2 mg
S
Color: white
Shape: oval
Flavor: grape
Imprint: S