Fosdenopterin

Fosdenopterin is a prescription medication used to reduce the risk for mortality in patients with molybdenum cofactor deficiency (MoCD) type A.

• Fosdenopterin is available under the following different brand names: Nulibry

Common side effects of Fosdenopterin include:

• catheter-related complications
• fever
• viral infection
• pneumonia
• middle ear infection
• vomiting
• cough
• sneezing
• viral upper respiratory infection
• gastroenteritis
• bacteremia
• diarrhea

Serious side effects of Fosdenopterin include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• fever
• severe or ongoing vomiting or diarrhea
• bruising, swelling, discomfort, or skin changes around the catheter
• cough with mucus
• seizure
• signs of an ear infection--fever, ear pain, drainage from the ear, fussiness

Rare side effects of Fosdenopterin include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Pediatric dosage

• Injection, lyophilized powder for reconstitution
• 9.5 mg (single-dose vial)

Molybdenum cofactor deficiency

Pediatric dosage

• Doses are based on actual body weight
• Children younger than 1 year (by gestational age)
• Preterm neonates (gestational age below 37 weeks)
  • Initial dose: 0.4 mg/kg IV once a day
  • Month 1: 0.7 mg/kg IV once a day
  • Month 3: 0.9 mg/kg IV once a day
• Term neonates (gestational age of 37 weeks and more)
  • Initial dose: 0.55 mg/kg IV once a day
  • Month 1: 0.75 mg/kg IV once a day
  • Month 3: 0.9 mg/kg IV once a day
• Children aged 1 year and older
  • 0.9 mg/kg IV once a day

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Fosdenopterin has no noted severe interactions with any other drugs.
• Fosdenopterin has no noted serious interactions with any other drugs.
• Fosdenopterin has no noted moderate interactions with any other drugs.
• Fosdenopterin has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Fosdenopterin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Fosdenopterin?”

Cautions

• Potential for photosensitivity
  • Animal studies have observed that Fosdenopterin has phototoxic potential
  • Advise avoiding or minimizing exposure to direct sunlight and artificial UV light exposure (ie, UVA or UVB phototherapy) and adopt precautionary measures (eg, wearing protective clothing and hats, using a broad-spectrum sunscreen with high sun protection factor in patients with more than 6 months, wearing sunglasses)
  • If photosensitivity occurs, advise seeking medical attention immediately and consider a dermatological evaluation
• Drug interaction overview
  • Weak MATE2-K and OAT1 inhibitor; weak MATE1 substrate

Pregnancy and Lactation

• No data are available on the drug’s use in pregnant women to evaluate for a drug-associated risk for major birth defects, miscarriage, or adverse maternal/fetal outcomes
• Lactation
  • No human or animal data are available to assess the presence of the drug or its metabolites in human milk, its effects on breastfed infants, or on milk production