Fosdenopterin: uses, dosing, side effects & brands
Fosdenopterin is a cyclic pyranopterin monophosphate sold in the U.S. under one brand, for inborn errors metal metabolism. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Cyclic Pyranopterin Monophosphate
- Treats
- Inborn Errors Metal Metabolism
- Available as
- Injectable
- Sold as
- Nulibry
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How fosdenopterin is dosed
From the FDA label for Nulibry (application NDA214018). Other fosdenopterin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Start NULIBRY if known or presumed MoCD Type A. Promptly discontinue if MoCD Type A is not confirmed by genetic testing. ( 2.1 ) 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. ( 2.2 ) See the table below for the recommended dosage in patients less than one year of age. Administer NULIBRY by intravenous infusion once daily. For dose volumes less than 2 mL, consider administering by slow intravenous push. ( 2.3 ) Titration Duration Preterm Neonates (Gestational Age Less than 37 Weeks) Term Neonates (Gestational Age 37 weeks and Above) Initial Dosage 0.4 mg/kg once daily 0.55 mg/kg once daily Dosage at Month 1 and Month 2 0.7 mg/kg once daily 0.75 mg/kg once daily Dosage at Month 3 to Month 12 0.9 mg/kg once daily 0.9 mg/kg once daily Recommended Dosage in Patients One Year of Age or Older: 0.9 mg/kg given as an intravenous infusion once daily. ( 2.3 ) 2.1 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. 2.2 Important Recommendation Prior to NULIBRY…
Fosdenopterin side effects
The most common adverse reactions (>25%) were catheter-related complications, pyrexia, viral infection, pneumonia, otitis media, vomiting, cough/sneezing, viral upper respiratory infection, gastroenteritis, bacteremia, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sentynl Therapeutcis, Inc. at 888-507-5206 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Overview of Safety Evaluation The safety of NULIBRY was assessed in 37 pediatric patients and healthy adults who received at least one intravenous infusion of NULIBRY or an E. coli derived non-salt, anhydrous form of cPMP (recombinant cPMP or rcPMP, which has the same active moiety and therefore the same biologic activity as NULIBRY). Of these 37 patients/healthy adults, 13 were pediatric patients with MoCD Type A in Studies 1, 2, and 3 [ see Clinical Studies ( 14 )] , 6 were pediatric patients with presumptive MoCD Type A but who were later confirmed to not have MoCD Type A, and 18 were healthy adults (without MoCD Type A) in a Phase 1 study. Adverse Reactions Assessment of adverse reactions for NULIBRY is based…
Who shouldn’t take fosdenopterin
None. None. ( 4 )
Every fosdenopterin product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Nulibry.
Related calculators
Frequently asked questions
What is fosdenopterin?
NULIBRY (fosdenopterin) for injection is cyclic pyranopterin monophosphate (cPMP).
What kind of drug is fosdenopterin?
The FDA classifies fosdenopterin as a cyclic pyranopterin monophosphate. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take fosdenopterin with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run fosdenopterin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does fosdenopterin come in?
Across the brands we track, fosdenopterin is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic fosdenopterin?
We do not currently list a generic-labelled fosdenopterin product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Fosdenopterin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/fosdenopterin
- MLA
- “Fosdenopterin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/fosdenopterin.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for fosdenopterin on DailyMed (NIH) ↗.