Rezzayo

Treatment with REZZAYO should be initiated by a physician experienced in the management of invasive fungal infections. Posology A single 400 mg loading dose on Day 1, followed by 200 mg on Day 8 and once weekly thereafter. The duration of treatment should be based upon the patient's clinical and microbiological response.

In general, antifungal therapy should continue for at least 14 days after the last positive culture. During clinical trials patients were treated with rezafungin for up to 28 days. The safety information on rezafungin treatment durations longer than 4 weeks is limited.

If a scheduled dose is missed (not given on the assigned day) the missed dose should be administered as soon as possible. • If the missed dose is administered within 3 days of the assigned day, the next weekly dose may be given on schedule.

• If the missed dose is administered more than 3 days after the assigned day, the dosing schedule should be revised to ensure there are at least 4 days before the next dose. • If administration is restarted after at least 2 weeks of missed dosing, the dosing should be started again at the 400 mg loading dose.

2). 2). Renal impairment No dose adjustment is required for patients with renal impairment. 2). 2). Paediatric population The safety and efficacy of REZZAYO in children below 18 years have not yet been established. No data are available.

Method of administration For intravenous use only. 4). 6.

Summary of the safety profile Based on clinical trial experience, the most frequently reported adverse reactions for rezafungin were hypokalaemia, pyrexia, anaemia, and diarrhoea (very common adverse reactions). 4). Tabulated list of adverse reactions The following table includes adverse reactions from 173 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 1. 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 6 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 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.

1). Hepatic effects In clinical trials, elevations in liver enzymes have been seen in some patients treated with rezafungin. In some patients with serious underlying medical conditions who were receiving multiple concomitant medications along with rezafungin, clinically significant hepatic dysfunction has occurred; a causal relationship to rezafungin has not been established.

Patients who develop elevations in liver enzymes during rezafungin therapy should be monitored and the risk/benefit of continuing rezafungin therapy should be re-evaluated. 4 Infusion-related reactions Transient infusion-related reactions have occurred with rezafungin, characterised by flushing, sensation of warmth, nausea, and chest tightness.

In clinical trials, infusion reactions resolved within minutes, some without interruption or discontinuation of the infusion. Patients should be monitored during the infusion. If the infusion is stopped due to a reaction, consideration may be given to restarting the infusion at a slower rate after the symptoms have resolved.

Phototoxicity Rezafungin may cause increased risk of phototoxicity. Patients should be advised to avoid sun exposure and other sources of UV radiation without adequate protection during treatment and for 7 days after the last administration of rezafungin.

Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

1. Hypersensitivity to other medicinal products of the echinocandin class.