Chemical formula: C₆₃H₈₅N₈O₁₇⁺ Molecular mass: 1,225.603 g/mol PubChem compound: 78318119
There are no data from the use of rezafungin in pregnant women. Studies in animals did not show reproductive or developmental toxicity. Rezafungin has been shown to cross the placental barrier in animal studies. The potential risk for humans is unknown.
Rezafungin is not recommended to be used during pregnancy and in women of childbearing potential not using contraception unless the benefit outweighs the potential risk to the foetus.
There are no data from the use of rezafungin in lactating women. It is unknown whether rezafungin or its metabolites are excreted in human milk. Rezafungin excretion into milk was observed in rats.
A risk to the breastfed child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from rezafungin therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
No data on the effect of rezafungin on human fertility are available. Rezafungin did not affect fertility in female rats or reproductive performance in male rats, despite reversible testicular effects in male rats.
Rezafungin has no or negligible influence on the ability to drive and use machines.
Based on clinical trial experience, the most frequently reported adverse reactions for rezafungin were hypokalaemia, pyrexia, and diarrhoea (very common adverse reactions).
Transient infusion-related reactions have occurred with rezafungin, characterised by flushing, sensation of warmth, nausea, and chest tightness.
The following table includes adverse reactions from 151 subjects that received rezafungin 400/200 mg listed by system organ class (SOC) and MedDRA preferred terms with frequency corresponding to 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) and from spontaneous reports with frequency not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table of adverse reactions:
| System organ class | Very common ≥1/10 | Common ≥1/100 to <1/10 | Uncommon ≥1/1 000 to <1/100 | Not known |
|---|---|---|---|---|
| Blood and lymphatic system disorders | Anaemia | |||
| Metabolism and nutrition disorders | Hypokalaemia | Hypomagnesaemia, hypophosphataemia | Hyperphosphataemia, hyponatraemia | |
| Vascular disorders | Hypotension | |||
| Respiratory, thoracic and mediastinal disorders | Wheezing | |||
| Gastrointestinal disorders | Diarrhoea | Vomiting, nausea, abdominal pain, constipation | ||
| Skin and subcutaneous tissue disorders | Erythema, rash | Phototoxicity | Urticaria | |
| Musculoskeletal and connective tissue disorders | Tremor | |||
| General disorders and administration site conditions | Pyrexia | |||
| Investigations | Blood alkaline phosphatase increased, hepatic enzymes increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased | Eosinophil count increased | ||
| Injury, poisoning and procedural complications | Infusion-related reactions |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
