Nulibry Generic Name & Formulations
Fosdenopterin 9.5mg (equivalent to 12.5mg fosdenopterin hydrobromide as a dihydrate); per vial; lyophilized pwd or cake for IV infusion after reconstitution; preservative-free; contains mannitol.
Cyclic pyranopterin monophosphate (cPMP).
Single-dose vial (5mL)—1
To reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A.
Nulibry Dosage and Administration
Adults and Children
Initiate treatment if patient has a diagnosis or presumptive diagnosis; discontinue if presumptive diagnosis is not confirmed by genetic testing. Administer by IV infusion pump once daily at a rate of 1.5mL/min. <37 weeks (preterm neonates): initially 0.4mg/kg, then 0.7mg/kg at Month 1, and 0.9mg/kg at Month 3. ≥37 weeks (term neonates): initially 0.55mg/kg, then 0.75mg/kg at Month 1, and 0.9mg/kg at Month 3. ≥1yr: 0.9mg/kg.
Nulibry Boxed Warnings
Avoid or minimize exposure to direct sun or UV light (eg, UVA or UVB phototherapy). Advise use of precautionary measures for photosensitivity (eg, protective clothing, hats, sunscreen). Pregnancy. Nursing mothers.
Do not mix or administer with other drugs.
Nulibry Adverse Reactions
Catheter-related complications, pyrexia, viral infection, pneumonia, otitis media, vomiting, cough/sneezing, viral upper respiratory infection, gastroenteritis, bacteremia, diarrhea; photosensitivity.
Nulibry Clinical Trials
Nulibry Patient Counseling