Daybue

About Daybue 

• The US FDA administration granted approval to Daybue on  March 10, 2023.
• Daybue (trofinetide) is a synthetic version of the amino-terminal tripeptide of IGF-1 used to treat Rett syndrome in adults and children aged 2 and above. 
• Rett syndrome is a rare and severe neurological disorder that primarily affects girls. It typically becomes apparent in early childhood and leads to a loss of acquired motor and communication skills, as well as social and cognitive functioning. 
• Symptoms of Rett syndrome can include repetitive hand movements, breathing difficulties, seizures, and developmental regression. It is caused by mutations in the MECP2 gene and requires comprehensive medical and therapeutic support.

Strength

Medicine is available as a Daybue 200 mg/mL oral solution.

Recommended Dosage

The recommended dosage for Daybue should be prescribed by a healthcare professional, as it can vary based on the specific medical condition being treated and the patient’s age and weight. It’s important to follow the healthcare provider’s instructions and the dosing information provided with the medication.

• Daybue is administered orally twice daily, in the morning and evening, for patients 2 years of age and older. 
• Patients weighing 9 kg to less than 12 kg should take 5,000 mg of Daybue twice daily, equivalent to 25 mL each time. 
• For those weighing 12 kg to less than 20 kg, the recommended dosage is 6,000 mg twice daily, corresponding to 30 mL. 
• Patients in the weight range of 20 kg to less than 35 kg should take 8,000 mg twice daily (40 mL each time), and those weighing 35 kg to less than 50 kg should take 10,000 mg twice daily (50 mL each time). 
• Patients weighing 50 kg or more are prescribed 12,000 mg of Daybue twice daily, with a volume of 60 mL each time. 
• Daybue can be taken with or without food as directed by a healthcare provider.

Important

Daybue can be administered orally or through a gastrostomy (G) tube. For doses given via gastrojejunal (GJ) tubes, they should be administered through the G-port. To ensure precise dosing, use a calibrated measuring device, like an oral syringe or dosing cup obtained from the pharmacy, and avoid using a household measuring cup. It’s important to discard any unused Daybue oral solution after 14 days from the bottle’s initial opening.

Warnings & Precautions

• Patients undergoing Daybue oral treatment commonly experience diarrhea. To address this, it’s advisable for patients to discontinue laxatives before starting the medicine. 
• If diarrhea occurs, they should initiate antidiarrheal treatment, increase their oral fluid intake, and promptly inform their healthcare provider. 
• In cases of severe diarrhea or suspected dehydration, it may be necessary to interrupt, reduce the dose, or discontinue Daybue. 
• Additionally, weight loss can be a potential side effect of Daybue. It’s crucial for patients to monitor their weight, and if significant weight loss occurs, they should inform their healthcare provider and be prepared to interrupt, reduce the dose, or discontinue Daybue, especially if they have this condition.
• Before starting the treatment, inform the healthcare provider about pre-existing medical conditions and about the medicine the patients are consuming. 

Common Daybue Side Effects:

• Diarrhea
• Vomiting
• Weight loss
• Fever
• Seizures
• Anxiety
• Decreased appetite
• Fatigue
• Common cold

Use in Specific Population

• Before beginning Daybue treatment, it is crucial to inform the physician if the patient has any kidney-related conditions, as Daybue is not recommended for individuals with moderate to severe renal impairment. 
• Additionally, for patients planning to become pregnant, already pregnant, or breastfeeding, it’s important to consult with their healthcare provider, as there is limited data on the developmental risks of Daybue in pregnant women, and no information is available regarding its presence in human milk or its effects on breastfeeding infants.
• Clinical studies of Daybue did not include patients aged 65 and older, and the drug is known to be primarily eliminated by the kidneys. As a result, it may be advisable to monitor renal function in elderly patients due to their potential for decreased kidney function.

Storage and Handling

• Store Daybue refrigerated between 2°C to 8°C (36°F to 46°F) in an upright position, ensuring it does not freeze. 
• Keep the child-resistant cap securely closed and remember to dispose of any unused Daybue oral solution after 14 days from the initial bottle opening.