Trofinetide (troe-FIN-e-tide)

Treats Rett syndrome.

Brand Name(s):

Daybue

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. Do not use a household measuring cup.
• Your doctor will give you medicines to help prevent diarrhea during treatment with this medicine. Drink extra fluids to help prevent dehydration.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• You may also give this medicine using a gastrostomy tube.
• Missed dose: If you miss a dose or vomit after taking a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• Keep the bottle closed when you are not using it. Keep it in the refrigerator. Do not freeze.
• Throw away any unused medicine 14 days after opening the bottle.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not take laxatives before starting treatment with this medicine.
• Some medicines can affect how trofinetide works. Tell your doctor if you are using midazolam.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease.
• This medicine may cause the following problems:
  • Diarrhea, which can be severe
  • Weight loss
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Decreased appetite, weight loss
• Diarrhea
• Seizures

If you notice these less serious side effects, talk with your doctor:

• Fever, sore throat, stuffy or runny nose
• Tiredness
• Vomiting

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088