This medication is used to treat a certain rare genetic disorder (Rett syndrome). This disorder affects the development of the brain. Trofinetide may help lessen the symptoms of Rett syndrome.

Read the Patient Information Leaflet if available from your pharmacist before you start taking trofinetide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth or through a feeding tube with or without food as directed by your doctor, usually twice daily. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition, weight, and response to treatment.

If you are taking a laxative, your doctor may direct you to stop the laxative before starting trofinetide. Consult your doctor or pharmacist for more details.

If you vomit after taking your dose of trofinetide, do not take an additional dose. Take your next dose at the regular scheduled time. Do not take two doses at the same time.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Tell your doctor if your condition gets worse.

Vomiting or weight loss may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.

Diarrhea is a common side effect that can cause dehydration. Tell your doctor promptly if you have diarrhea. Drink plenty of fluids to reduce the risk of dehydration. Your doctor may prescribe medications to control the diarrhea or stop/adjust the dose of trofinetide. Tell your doctor right away if you develop signs of dehydration (such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, dizziness/lightheadedness).

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking trofinetide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney disease

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as weight) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the refrigerator. Do not freeze. Keep the bottle tightly closed and in an upright position. Once the bottle is opened, this medication expires after 14 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.