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Fosdenopterin Dosage

Medically reviewed by Drugs.com. Last updated on Mar 6, 2023.

Applies to the following strengths: 9.5 mg

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.