Drug Detail:Nulibry (Fosdenopterin [ fos-den-op-ter-in ])
Generic Name: fosdenopterin hydrobromide 9.5mg
Dosage Form: injection, powder, for solution
Drug Class: Miscellaneous metabolic agents
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 [see Instructions for Use].
- 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 [see Dosage and Administration (2.5)].
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.
| Titration Schedule | 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 | 0.7 mg/kg once daily | 0.75 mg/kg once daily |
| Dosage at Month 3 | 0.9 mg/kg once daily | 0.9 mg/kg once daily |
Preparation and Administration Instructions
NULIBRY must be reconstituted prior to use. Use aseptic technique during preparation and follow these instructions:
- Determine the total dose, number of vials needed, and total reconstituted dose volume based on the patient's weight and prescribed dose.
- Remove the required number of vials from the freezer to allow them to reach room temperature (by hand warming for 3 to 5 minutes or exposing to ambient air for approximately 30 minutes).
- Reconstitute each required NULIBRY vial with 5 mL of Sterile Water for Injection, USP. Gently swirl the vial continuously until the powder is completely dissolved. DO NOT shake. After reconstitution, the final concentration of NULIBRY reconstituted solution is 9.5 mg/5 mL (1.9 mg/mL).
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Reconstituted NULIBRY is a clear and colorless to pale yellow solution. Do not use if there are particles present or if the solution is discolored.
- Administer the total reconstituted dose.
Storage of Reconstituted Solution
Reconstituted NULIBRY may be stored at room temperature [15°C to 25°C (59°F to 77°F)] or refrigerated [2°C to 8°C (36°F to 46°F)] for up to 4 hours including infusion time. If reconstituted NULIBRY is refrigerated, allow it to come to room temperature (by hand warming for 3 to 5 minutes or exposing to ambient air for approximately 30 minutes) before administration. Do not heat. Do not re-freeze NULIBRY after reconstitution. Do not shake.
Discard all unused reconstituted NULIBRY solution 4 hours after reconstitution.
