Chemical formula: C₁₀H₁₄N₅O₈P Molecular mass: 363.223 g/mol
There are no or limited amount of data from the use of fosdenopterin in pregnant women. Animal studies are insufficient with respect to reproductive toxicity.
Fosdenopterin is not recommended during pregnancy and in women of childbearing potential not using contraception.
It is unknown whether fosdenopterin/metabolites are excreted in human milk.
A risk to newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue from fosdenopterin therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility studies have not been conducted with fosdenopterin.
Fosdenopterin has no or negligible influence on the ability to drive and use machines.
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 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.
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).
The following table presents the most common ADRs that occurred in patients treated with fosdenopterin.
Adverse reactions reported by SOC/PT and frequency:
| System Organ Class | Very common (≥10%) |
|---|---|
| General disorders and administration site conditions | Complications associated with device |
Eight of ten patients treated with fosdenopterin 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.
Eight of ten patients treated with fosdenopterin 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).
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