Fosdenopterin Dosage
Medically reviewed by Drugs.com. Last updated on Mar 6, 2024.
Applies to the following strengths: 9.5 mg
Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Combined Molybdoflavoprotein Enzyme Deficiency
0.9 mg/kg IV once a day
Comments:
- Dosing is based on actual body weight; infuse at a rate of 1.5 mL/min with non-DEHP tubing and a 0.2-micron filter.
- Safety and effectiveness for use of this drug in adults with of molybedenum cofactor deficiency (MoCD) Type A have been established based on adequate and well-controlled clinical investigation in pediatric patients.
Use: To reduce the risk of mortality in patients with MoCD Type A.
Usual Pediatric Dose for Combined Molybdoflavoprotein Enzyme Deficiency
Patients less than 1 year: Dosing is based on gestational age
Gestational age less than 37 weeks (preterm neonates):
- Initial Dosage: 0.4 mg/kg IV once a day
- Dose at one month: 0.7 mg/kg IV once a day
- Dose at three months: 0.9 mg/kg IV once a day
Gestational age 37 weeks and above (term neonates):
- Initial Dosage: 0.55 mg/kg IV once a day
- Dose at one month: 0.75 mg/kg IV once a day
- Dose at three months: 0.9 mg/kg IV once a day
Patients 1 year or older: 0.9 mg/kg IV once a day
Comments:
- Dosing is based on actual body weight; infuse at a rate of 1.5 mL/min with non-DEHP tubing and a 0.2-micron filter (volumes below 2 mL may require syringe administration through slow intravenous push).
- Therapy may be started upon diagnosis or presumptive diagnosis of molybedenum cofactor deficiency (MoCD) Type A; for a presumptive diagnosis, confirm with genetic testing and discontinue this drug if diagnosis is not confirmed.
Use: To reduce the risk of mortality in patients with MoCD Type A.
Renal Dose Adjustments
Use with caution; the effect of renal impairment is unknown
Liver Dose Adjustments
Use with caution; the effect of hepatic impairment is unknown
Precautions
CONTRAINDICATIONS: None
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Administer via IV infusion at a rate of 1.5 mL/minute once a day; an infusion pump should be used unless the dose volume is below 2 mL; for dose volume less than 2 mL, administer slow IV push with a syringe
- Administer using non-DEHP tubing with a 0.2-micron filter
- This drug is intended for administration by a healthcare provider, although may be administered at home with proper training and instructions.
Missed dose: If dose is missed, administer as soon as possible; administer next scheduled dose at least 6 hours after the administration of the missed dose
Storage requirements:
- Unopened vials should be stored frozen (-13F to 14F [-25C to -10C]) in its original carton to protect from light
- Reconstituted solution may be stored at room temperature (59F to 77F [15C to 25C]) or refrigerated (36F to 46F 2C to 8C]) for up to 4 hours including infusion time; if refrigerated allow to come to room temperature as noted below; do not re-freeze
Reconstitution/preparation techniques:
- Remove vials from freezer and allow to reach room temperature by hand warning (3 to 5 minutes) or exposing to ambient air (approximately 30 minutes); do not heat
- Reconstitute each vial with 5 mL sterile water for injection; gently swirl until powder is completely dissolved; do not shake; reconstituted solution 9.5 mg/5 mL (1.9 mg/mL)
IV compatibility: Do not administer as an infusion with other drugs
Patient advice:
- Patients should be instructed to read the US FDA-approved patient labeling (Instructions for Use)
- Patients/caregivers should be advised of the potential for photosensitivity reactions and measures to be taken to minimize exposure to sunlight and artificial UV light exposure; if a rash or other symptoms of photosensitivity reactions develop (redness, burning sensation of the skin, blisters), seek medical attention immediately.
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