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Nulibry Generic Name & Formulations
Legal Class
Rx
General Description
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.
Pharmacological Class
Cyclic pyranopterin monophosphate (cPMP).
How Supplied
Single-dose vial (5mL)—1
Manufacturer
Generic Availability
NO
Nulibry Indications
Indications
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 Contraindications
Not Applicable
Nulibry Boxed Warnings
Not Applicable
Nulibry Warnings/Precautions
Warnings/Precautions
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.
Nulibry Pharmacokinetics
See Literature
Nulibry Interactions
Interactions
Do not mix or administer with other drugs.
Nulibry Adverse Reactions
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
See Literature
Nulibry Note
Not Applicable
Nulibry Patient Counseling
See Literature
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