Trofinetide

Trofinetide is for use in adults and children who are at least 2 years old to treat Rett syndrome.

Trofinetide may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

If you take laxatives, stop taking them before starting trofinetide.

Trofinetide is usually taken twice per day, in the morning and evening, with or without food.

Trofinetide can also be given through a gastrostomy feeding tube. Follow your doctor's instructions.

Doses are based on weight. Your dose may change if you gain or lose weight.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

If you vomit shortly after taking trofinetide, do not take another dose. Take your next dose as scheduled.

Your kidney function may need to be checked often.

Your treatment with trofinetide may be interrupted, changed, or discontinued if you have certain side effects.

Store tightly closed in an upright position in the refrigerator, do not freeze.

Throw the medicine away after 14 days of first opening the bottle, even if there is still medicine left inside.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

Tell your doctor if you have or have ever had:

• if you use a laxative; or
• kidney disease.

It is not known if trofinetide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using trofinetide.

Get emergency medical help if you notice signs of an allergic reaction: hives; trouble breathing; swelling of your face, lips, tongue, or throat.

Trofinetide can cause serious side effects. Contact your doctor immediately if you experience:

• severe diarrhea;
• weight loss; or
• dehydration--dizziness, confusion, feeling very thirsty, or urinating less.

Common side effects may include diarrhea or vomiting.

This is not a complete list of side effects, and others may happen. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Rett Syndrome:

Oral:18 years or older:-Weight 9 to less than 12 kg: 5,000 mg (25 mL) orally twice a day-Weight 12 to less than 20 kg: 6,000 mg (30 mL) orally twice a day-Weight 20 to less than 35 kg: 8,000 mg (40 mL) orally twice a day-Weight 35 to less than 50 kg: 10,000 mg (50 mL) orally twice a day-50 kg or more: 12,000 mg (60 mL) orally twice a dayComments:-This drug can be taken with or without food twice daily, in the morning and evening.-If a dose is missed, an additional dose should not be taken to make up for the missed dose. Instead, wait and continue with the next scheduled dose.-In the event of vomiting, do not take another dose to make up for that dose. Wait and take the following dose as scheduled.Use: For the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older

Usual Pediatric Dose for Rett Syndrome:

Oral:2 to less than 18 years:-Weight 9 to less than 12 kg: 5,000 mg (25 mL) orally twice a day-Weight 12 to less than 20 kg: 6,000 mg (30 mL) orally twice a day-Weight 20 to less than 35 kg: 8,000 mg (40 mL) orally twice a day-Weight 35 to less than 50 kg: 10,000 mg (50 mL) orally twice a day-50 kg or more: 12,000 mg (60 mL) orally twice a dayComments:-This drug can be taken with or without food twice daily, in the morning and evening.-If a dose is missed, an additional dose should not be taken to make up the missed dose. Instead, wait and continue with the next scheduled dose.-In the event of vomiting, do not take another dose to make up for that dose. Wait and take the following dose as scheduled.Use: For the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older

Skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may affect trofinetide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.