Fosdenopterin: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: July 25, 2024🚩 Report this page

Fosdenopterin

Various Alimentary Tract and Metabolism Products

Sold as Nulibry

EU EMA

Drug class: Various Alimentary Tract and Metabolism Products
Availability: See label
Markets covered: 1
Products on record: 1

A16AXVarious Alimentary Tract and Metabolism Products

Overview

Fosdenopterin is an active pharmaceutical ingredient in the Various Alimentary Tract and Metabolism Products group (A16AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
EU European Union	EMA	1	July 25, 2024

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised July 25, 2024[1]

NULIBRY is indicated for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.

How to take

Sources & citations

[1]European Medicines Agency · EMEA/H/C/005378 · revised July 25, 2024

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised July 25, 2024[1]

Summary of the safety profile The adverse drug reactions described in this section were evaluated in 11 patients with MoCD Type A. The most frequent (> 20%) adverse reaction observed during clinical trials were complications 5 associated with device, which have been attributed to the catheter and not to fosdenopterin.
No patients had to have their treatment discontinued due to adverse events. Tabulated list of adverse reactions Adverse drug reactions (ADRs) observed are listed below by MedDRA system organ class and by frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000), not known (cannot be estimated from available data).
Table 2 presents the most common ADRs that occurred in patients treated with NULIBRY. Table 2 Adverse reactions reported by SOC/PT and frequency System Organ Class Very common (≥ 10%) General disorders and administration site conditions Complications associated with device Description of selected adverse reactions Catheter-related complications Eight of ten patients treated with NULIBRY experienced at least one device-related adverse event.
The events reported in more than one patient included complications associated with device (7 patients), device dislocation and catheter site infection (3 patients each), and catheter site extravasation, catheter site pain, central venous catheterization, catheter site discharge, device leakage, device occlusion, bacteraemia, sepsis, and vascular device infection (2 patients each).
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised July 25, 2024[1]

3. , use broad spectrum sunscreen with high sun protection factor, and wear clothing, a hat, and sunglasses that protects against sun exposure). Caregivers/patients must be advised to 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).
Physicians should consider Vitamin D supplementation due to the use of sunscreens and sun protective clothing and advise the caregiver/patients accordingly. Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

EUEuropean Union· EMA

Drugs in the same class

Sources & citations