Fosdenopterin

Generic name: Fosdenopterin
Brand names: Nulibry
Dosage form: intravenous powder for injection (9.5 mg)
Drug class: Miscellaneous metabolic agents

Usage of Fosdenopterin

Fosdenopterin is used to reduce the risk of death in children with molybdenum cofactor deficiency (MoCD) Type A.

Molybdenum (moe-LIB-den-um) cofactor deficiency is a rare condition in newborn babies that affects brain function and gets worse over time. Babies with MoCD begin to show symptoms within a week after birth, and this condition can lead to severe developmental delays and life-threatening health problems.

Fosdenopterin may also be used for purposes not listed in this medication guide.

Fosdenopterin side effects

Get emergency medical help if your child has signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Call your doctor at once if your child has:

a fever;

severe or ongoing vomiting or diarrhea;

bruising, swelling, discomfort, or skin changes around the catheter;

cough with mucus, trouble breathing;

a seizure; or

signs of an ear infection--fever, ear pain, drainage from the ear, fussiness.

Seek emergency medical attention if your child has a skin rash or symptoms of serious sunburn such as skin redness, burning, or blisters.

Common side effects of fosdenopterin may include:

problems with the catheter or IV line;

fever;

vomiting, diarrhea; or

cold symptoms such as stuffy nose, sneezing, cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Fosdenopterin

Your doctor will perform a genetic test to make sure your baby has MoCD.

Fosdenopterin is sometimes given before genetic testing results are available. Treatment will be stopped if the test shows that your baby does not have MoCD.

Relate drugs

How to use Fosdenopterin

Usual Adult Dose for Combined Molybdoflavoprotein Enzyme Deficiency:

0.9 mg/kg IV once a dayComments:-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 ageGestational 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 dayGestational 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 dayPatients 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.

Warnings

Follow all directions on your medicine label and package. Tell each of your child's healthcare providers about all the child's medical conditions, allergies, and medicines.

What other drugs will affect Fosdenopterin

Other drugs may affect fosdenopterin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your child's current medicines and any medicines the child starts or stops using.

Disclaimer

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