Fosdenopterin Hydrobromide
Generic Name: fosdenopterin hydrobromide
Brand Names:
Nulibry
11 DESCRIPTION NULIBRY (fosdenopterin) for injection is cyclic pyranopterin monophosphate (cPMP). Fosdenopterin is present as a dihydrate of the hydrobromide salt with the chemical name (4a R ,5a R ,11a R ,12a S )-8-amino-4a,5a,6,9,11,11a,12,12a-octahydro-2,12,12-trihydroxy-1,3,2-dioxaphosphorino[4',5':5,6]pyrano[3,2- g ]pteridin-10(4 H )-one 2-oxide. Fosdenopterin hydrobromide as a dihydrate is a crystalline solid.
Overview
11 DESCRIPTION NULIBRY (fosdenopterin) for injection is cyclic pyranopterin monophosphate (cPMP). Fosdenopterin is present as a dihydrate of the hydrobromide salt with the chemical name (4a R ,5a R ,11a R ,12a S )-8-amino-4a,5a,6,9,11,11a,12,12a-octahydro-2,12,12-trihydroxy-1,3,2-dioxaphosphorino[4',5':5,6]pyrano[3,2- g ]pteridin-10(4 H )-one 2-oxide. Fosdenopterin hydrobromide as a dihydrate is a crystalline solid.
Uses
1 INDICATIONS AND USAGE NULIBRY is indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A. NULIBRY is cyclic pyranopterin monophosphate (cPMP) indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Start NULIBRY if known or presumed MoCD Type A. Promptly discontinue if MoCD Type A is not confirmed by genetic testing. ( 2.1 ) Reconstitute before use and complete infusion within 4 hours of reconstitution. ( 2.2 , 2.4 ) Administer as an intravenous infusion once daily at a rate of 1.5 mL/minute with non-DEHP tubing with a 0.2 micron filter. Volumes below 2 mL may require syringe administration through slow intravenous push. ( 2.2 ) See Full Prescribing Information for additional important preparation instructions and administration instructions. ( 2.2 ) See the table below for the recommended dosage in patients less than one year of age.
Side Effects
6 ADVERSE REACTIONS The most common adverse reactions (>25%) were catheter-related complications, pyrexia, viral infection, pneumonia, otitis media, vomiting, cough/sneezing, viral upper respiratory infection, gastroenteritis, bacteremia, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sentynl Therapeutcis, Inc. at 888-507-5206 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Warnings
5 WARNINGS AND PRECAUTIONS Potential for Photosensitivity : Advise patients/caregivers to avoid patient exposure to sunlight, and to have the patient wear sunscreen, protective clothing, and sunglasses when exposed to the sun. If photosensitivity occurs, advise caregivers/patients to seek medical attention immediately and consider a dermatological evaluation. ( 5.1 , 13.2 ) 5.1 Potential for Photosensitivity Animal studies have identified that NULIBRY has phototoxic potential [see Nonclinical Toxicology ( 13.2 )]. 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on NULIBRY use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction toxicology studies have not been conducted with fosdenopterin. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
Storage
Storage Store NULIBRY frozen between -25°C and -10°C (-13°F and 14°F). Store the vial in its original carton to protect from light. For storage recommendations for the reconstituted solution [see Dosage and Administration ( 2.5 )] .
Frequently Asked Questions
What is Fosdenopterin Hydrobromide used for?▼
1 INDICATIONS AND USAGE NULIBRY is indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A. NULIBRY is cyclic pyranopterin monophosphate (cPMP) indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A. ( 1 )
What are the side effects of Fosdenopterin Hydrobromide?▼
6 ADVERSE REACTIONS The most common adverse reactions (>25%) were catheter-related complications, pyrexia, viral infection, pneumonia, otitis media, vomiting, cough/sneezing, viral upper respiratory infection, gastroenteritis, bacteremia, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sentynl Therapeutcis, Inc. at 888-507-5206 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Can I take Fosdenopterin Hydrobromide during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on NULIBRY use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction toxicology studies have not been conducted with fosdenopterin. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
What are the important warnings for Fosdenopterin Hydrobromide?▼
5 WARNINGS AND PRECAUTIONS Potential for Photosensitivity : Advise patients/caregivers to avoid patient exposure to sunlight, and to have the patient wear sunscreen, protective clothing, and sunglasses when exposed to the sun. If photosensitivity occurs, advise caregivers/patients to seek medical attention immediately and consider a dermatological evaluation. ( 5.1 , 13.2 ) 5.1 Potential for Photosensitivity Animal studies have identified that NULIBRY has phototoxic potential [see Nonclinical Toxicology ( 13.2 )]. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.