Mirdametinib Tablets for Suspension

What is this medication?

MIRDAMETINIB (MIR da ME ti nib) treats neurofibromatosis, a condition that causes tumors to grow along the nerves. It works by blocking a protein that causes tumor cells to grow and multiply.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Gomekli

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Heart disease
• Vision problems
• An unusual or allergic reaction to mirdametinib, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Swallow the tablets whole. You may also dissolve the tablets in water to make a liquid (suspension). You can take it with or without food. If it upsets your stomach, take it with food. Your care team may change your dose or tell you to stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

To make a suspension: Place the tablets in a cup with 5 to 10 mL of water. Swirl the mixture until no lumps remain. Take the dose within 30 minutes of mixing. After you take the dose, add another 5 to 10 mL of water to the cup, swirl, and drink. This ensures you have taken the entire dose and no residue remains.

This medication is taken in cycles. There will be days you do not take it. Talk to your care team if you have questions about when to take your medication. It is very important to follow the exact schedule. Taking it more often than directed can cause serious side effects.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

If you vomit after taking your dose, do not take another dose. Take your next dose at your usual scheduled time.

What may interact with this medication?

Interactions have not been studied.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Report any side effects. Continue your course of treatment even if you have side effects unless your care team tells you to stop.

You may need a test to check your heart before and during treatment. Talk to your care team right away if you have coughing, shortness of breath, swelling of the ankles, feet, or hands, fatigue, or an increased heart rate.

Your vision may be tested before and during use of this medication. Tell your care team right away if you have any change in your eyesight.

This medication can cause skin rashes. These rashes can be severe. Talk to your care team right away if you notice any type of skin problem while taking this medication. This includes itchy, red or dark patches of skin, raised bumps on the skin, skin bumps that look like acne, and peeling skin. Your care team can help you manage these side effects.

Talk to your care team if you or your partner may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 6 weeks after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 6 weeks after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 3 months after the last dose.

Do not breastfeed while taking this medication and for 1 week after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blurry vision, vision loss, seeing wavy or bent objects or blind spots with dark, light, or flashing spots
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Redness, swelling, and blistering of the skin over hands and feet

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Fatigue
• Hair loss
• Headache
• Muscle pain
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix it with cat litter, dirt, coffee grounds, or another unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.