Nulibry (fosdenopterin)

Side effects of Nulibry include:

• catheter-related complications,
• fever,
• viral infection,
• pneumonia,
• middle ear infection,
• vomiting,
• cough,
• sneezing,
• viral upper respiratory infection,
• gastroenteritis,
• bacteremia, and
• diarrhea

Patient Selection

Start Nulibry if the patient has a diagnosis or presumptive diagnosis of MoCD Type A.

In patients with a presumptive diagnosis of MoCD Type A, confirm the diagnosis of MoCD Type A immediately after initiation of Nulibry treatment. In such patients, discontinue Nulibry if the MoCD Type A diagnosis is not confirmed by genetic testing.

Important Administration Information

• Nulibry is intended for administration by a healthcare provider. If deemed appropriate by a healthcare provider, Nulibry may be administered at home by the patient’s caregiver. If Nulibry can be administered by a caregiver/patient, advise them to read the detailed instructions on the preparation, administration, storage, and disposal of Nulibry for caregivers.
• Nulibry is for intravenous infusion only. Administer with non-DEHP tubing with a 0.2 micron filter. Do not mix Nulibry with other drugs (note Nulibry is reconstituted with Sterile Water for Injection, USP). Do not administer as an infusion with other drugs.
• Nulibry is given through an infusion pump at a rate of 1.5 mL per minute.
• Dose volumes below 2 mL may require syringe administration through slow intravenous push.
• Administration of Nulibry must be completed within 4 hours of reconstitution.

Recommended Dosage And Administration

Recommended Dosage And Administration In Patients Less Than One Year Of Age (By Gestational Age)

The recommended dosage regimen of Nulibry in patients less than one year of age (by gestational age) is based on actual body weight as shown in Table 1.

Table 1 Recommended Initial Dosage and Titration Schedule of Nulibry for Patients Less Than One Year of Age by Gestational Age

Recommended Dosage And Administration In Patients One Year Of Age Or Older

• For patients one year of age or older, the recommended dosage of Nulibry is 0.9 mg/kg (based on actual body weight) administered as an intravenous infusion once daily.

Recommendations For A Missed Dose

• If a Nulibry dose is missed, administer the missed dose as soon as possible. Administer the next scheduled dose at least 6 hours after the administration of the missed dose.

• There are no available data on Nulibry use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• There are no human or animal data available to assess the presence of Nulibry or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production for the mother.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Nulibry and any potential adverse effects on the breastfed infant from Nulibry or from the underlying maternal condition.