NULIBRY is indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A.
WARNINGS AND PRECAUTIONS
Potential for Photosensitivity
NULIBRY can make the patient oversensitive to sunlight. NULIBRY-treated patients or their caregivers are advised to avoid or minimize patient exposure to sunlight and artificial UV light and adopt precautionary measures when exposed to the sun, including wearing protective clothing and sunglasses, and use broad-spectrum sunscreen with high SPF in patients 6 months of age and older. If photosensitivity occurs, caregivers/patients are advised to seek medical attention immediately and consider a dermatological evaluation.
The most common side effects in NULIBRY-treated patients were infusion catheter–related complications, pyrexia (fever), viral infection, pneumonia, otitis media (ear infection), vomiting, cough/sneezing, viral upper respiratory infection (common cold/flu-like infection), gastroenteritis (stomach flu-like symptoms), diarrhea, and bacteremia (bacteria in the blood). Side effects for rcPMP-treated patients were similar to the NULIBRY-treated patients.
PATIENT COUNSELING INFORMATION
Please read the FDA-approved NULIBRY Prescribing Information and Instructions for Use and follow the instructions on how to prepare and administer NULIBRY.
NULIBRY has a potential for photosensitivity; see Warnings and Precautions. Seek medical attention immediately if the patient develops a rash or if they notice symptoms of photosensitivity reactions (redness, burning sensation of the skin, blisters).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call