Active Ingredient: Fosdenopterin
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Intravenous, 0.9 milligrams fosdenopterin per kilogram of body weight, once daily.
Regimen B: Intravenous, 0.4 milligrams fosdenopterin, once monthly, over the duration of 1 month. Afterwards, intravenous, 0.7 milligrams fosdenopterin, once daily, over the duration of 1 month. Afterwards, intravenous, 0.9 milligrams fosdenopterin, once daily.
Regimen C: Intravenous, 0.55 milligrams fosdenopterin, once daily, over the duration of 1 month. Afterwards, intravenous, 0.75 milligrams fosdenopterin, once daily, over the duration of 1 month. Afterwards, intravenous, 0.9 milligrams fosdenopterin, once daily.
In patients less than one year of age, the recommended dose of fosdenopterin is titrated based on gestational age.
For patients less than 1 year of age who are preterm neonates (gestational age <37 weeks), the recommended starting dose of fosdenopterin is 0.40 mg/kg/day administered intravenously once daily. The dose is to be titrated to the target dose of 0.90 mg/kg/day over a period of 3 months as shown in Table 1.
For patients less than 1 year of age who are term neonates (gestational age ≥37 weeks), the recommended starting dose of fosdenopterin is 0.55 mg/kg/day administered intravenously once daily. The dose is to be titrated to the target dose of 0.90 mg/kg/day over a period of 3 months as shown in Table 1.
Table 1. Starting dose and titration schedule of fosdenopterin for patients less than one year of age by gestational age:
| Titration schedule | Preterm neonate (gestational age less than 37 weeks) | Term neonate (gestational age 37 weeks and above) |
|---|---|---|
| Initial dose | 0.40 mg/kg once daily | 0.55 mg/kg once daily |
| Dose at month 1 | 0.70 mg/kg once daily | 0.75 mg/kg once daily |
| Dose at month 3 | 0.90 mg/kg once daily | 0.90 mg/kg once daily |
The recommended dose is 0.90 mg/kg (based on actual body weight) administered intravenously once daily.
If a dose is missed, the missed dose is to be administered as soon as possible. The next scheduled dose must be given at least 6 hours after the administration of the missed dose.
Fosdenopterin is intended for administration at an infusion rate of 1.5 mL/min after reconstitution with 5 mL of sterile water for injection. Dose volumes below 2 mL may require syringe administration by slow intravenous push.
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