Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Rezzayo 200 mg powder for concentrate for solution for infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Rezafungin acetate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
What REZZAYO is REZZAYO contains the active substance rezafungin, which is an antifungal. Rezafungin belongs to a group of medicines called echinocandins. What REZZAYO is used for This medicine is given to adults to treat invasive candidiasis, a serious fungal infection in your tissues or organs that is caused by a type of yeast called Candida. How REZZAYO works This medicine blocks the action of an enzyme (a type of protein) that is needed by fungal cells to make a molecule that strengthens their cell walls. This makes the fungal cells fragile and stops the fungus from growing. This stops the infection from spreading and gives the body's natural defences a chance to remove the infection. 2.
What you need to know before you take it
REZZAYO
REZZAYO must not be given if you are allergic to rezafungin, other echinocandins (such as caspofungin, anidulafungin), or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given REZZAYO. REZZAYO may cause sudden, severe allergic reaction (anaphylactic reaction) with breathing difficulty, swelling, lightheadness, fast heartbeat, sweating and loss of consciousness. Your doctor will observe you closely while you are being given Rezzayo. If you experience a serious allergic reaction your doctor will permanently stop your treatment. 1
Infusion-related reactions REZZAYO may cause infusion-related reactions, which could include reddening of the skin (flushing), sensation of warmth, nausea (feeling sick) and chest tightness. Your doctor may decide to monitor you during the infusion for signs of an infusion-related reaction. Your doctor may decide to slow down your infusion (drip) if an infusion-related reaction occurs. Effects on the liver Your doctor may decide to monitor you for liver function more closely if you develop liver problems during your treatment. Light sensitivity REZZAYO may increase your risk of phototoxicity (condition in which the skin or eyes become very sensitive to sunlight or other forms of light). During your treatment, and for 7 days after you have been given the last dose of this medicine, you should avoid being out in the sun or using artificial sun tanning lights without protection (like sunscreen). Other medicines and REZZAYO Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy, breast-feeding and fertility You should not use this medicine unless specifically told by your doctor. If you are pregnant or breastfeeding, or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine. If you are a woman of childbearing potential, you may be advised by your doctor to use contraception during your therapy with REZZAYO. The effect of REZZAYO in pregnant or breast-feeding women is not known. Driving and using machines This medicine is unlikely to have an effect on driving or using machines. REZZAYO contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'. 3.
How to take it
This medicine will be prepared and given to you by a doctor or a healthcare professional Recommended dose Your treatment will start with a 'loading dose' (an initial dose of a medicine which is higher than the maintenance dose) of 400 mg on the first day. This will be followed by a maintenance dose of 200 mg on day 8 of your treatment and once weekly thereafter. REZZAYO should be given to you once a week, by infusion (a drip) into your vein. This will take at least 1 hour. Your doctor will determine how long the infusion time will be and may increase it to up to 3 hours to avoid infusion-related reactions. Your doctor will determine how long you need to receive treatment based on your response to the medicine and your condition. In general, your treatment will continue for at least 14 days after the last day Candida was found in your blood. If symptoms of invasive candidiasis come back, tell your doctor or another healthcare professional immediately. 2
If you have been given more REZZAYO than you should You should not receive this medicine more than once a week. If you are concerned that you may have been given too much REZZAYO, tell your doctor or another healthcare professional immediately. If you miss a dose of REZZAYO As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed. However, if you miss an appointment to receive this medicine, contact your doctor or another healthcare professional as soon as possible to schedule a new appointment. If you stop using REZZAYO Your doctor will monitor your response and condition to determine when to stop your treatment with this medicine. You should not experience any side effects after this. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects – tell your doctor or another healthcare professional immediately should you experience any of the following side effects: reddening of the skin, sensation of warmth, nausea (feeling sick), chest tightness – these may be signs you are having an infusion-related reaction (common – may affect up to 1 in 10 people). Other side effects Very common (may affect more than 1 in 10 people) low blood potassium level (hypokalaemia) diarrhoea fever (pyrexia) decreased red blood cells (anaemia) Common (may affect up to 1 in 10 people) low blood magnesium level (hypomagnesaemia) low blood phosphate level (hypophosphataemia) low blood pressure (hypotension) wheezing vomiting feeling sick (nausea) stomach (abdominal) pain constipation redness of the skin (erythema) rash increased blood levels of alkaline phosphatase, an enzyme (protein) made in the liver, bones, kidney and gut increased levels of liver enzymes (including alanine aminotransferase and aspartate aminotransferase) increased blood levels of bilirubin, a breakdown product of red blood cells Uncommon (may affect up to 1 in 100 people) high blood phosphate levels (hyperphosphataemia) low blood sodium level (hyponatraemia) skin or eyes become very sensitive to sunlight or other forms of light (phototoxicity) shaking (tremor) high blood levels of eosinophils (a type of white blood cell) 3
Not known (frequency cannot be estimated from the available data)
- sudden, severe allergic reaction (anaphylactic reaction)
- Hives (urticaria) Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine. 5.
How to store it
REZZAYO
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP. The expiry date refers to the last day of that month. Do not store above 25 °C. Keep the vial in the outer carton in order to protect from light. Only a trained healthcare professional who has read the complete directions can prepare this medicine for use. Once REZZAYO has been prepared, it should normally be used immediately. However, the reconstituted and diluted infusion solution may be stored up to 24 hours in a refrigerator. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What REZZAYO contains The active substance is rezafungin. Each vial contains 200 mg rezafungin (as acetate). The other ingredients are mannitol, histidine, polysorbate 80, hydrochloric acid, sodium hydroxide (see section 2 "REZZAYO contains sodium"). What REZZAYO looks like and contents of the pack REZZAYO is a powder for concentrate for solution for infusion in a glass vial with a rubber stopper and an aluminium seal with plastic flip-off cap. It is a white to pale yellow cake or powder. Each pack contains 1 vial. Marketing Authorisation Holder Napp Pharmaceuticals Ltd Cambridge Science Park Milton Road Cambridge CB4 0GW Manufacturer Fareva Mirabel Route de Marsat Riom Clermont-Ferrand 63963 France
4
OR Mundipharma DC B.V. Leusderend 16 Leusden Utrecht 3832 RC Netherlands This leaflet was last revised in 05/2026 ———————————————————————————————————————–The following information is intended for healthcare professionals only: REZZAYO should be administered as a single agent via intravenous infusion in sodium chloride 9 mg/mL (0.9 %) solution for injection, sodium chloride 4.5 mg/mL (0.45 %) solution for injection, or 5 % glucose. INSTRUCTIONS FOR USE IN ADULT PATIENTS REZZAYO must be reconstituted and diluted prior to administration. From a microbiological point of view, the reconstituted solution and the diluted solution for infusion should be used immediately. If not used immediately, in-use storage conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C from first opening, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions. Using aseptic techniques, reconstitute each vial with 9.5 mL water for injections. The concentration of the reconstituted vial will be 20 mg/mL. Do not use sterile sodium chloride 9 mg/mL (0.9 %) solution for injection to reconstitute the vial, only use water for injections. To minimise foaming, do not shake or mix vigorously. The white to pale yellow powder will dissolve completely. Mix using a gentle swirling motion for up to 5 minutes until the reconstituted solution is a clear, colourless to pale yellow solution. The reconstituted solution should be visually inspected for particulate matter or discolouration. If irregularities are found, do not use the vial. The vial is for single use only. Therefore, unused reconstituted concentrate must be discarded immediately. For the 400 mg loading dose, the reconstitution step should be repeated for the additional vial of REZZAYO (refer to dosing table). The infused total volume should be 250 mL, therefore, the volume of the intravenous infusion bag (or bottle) should be adjusted accordingly, as shown in the dosing table. Aseptically transfer 10 mL from each of the reconstituted vials into an intravenous infusion bag (or bottle) containing either sodium chloride 9 mg/mL (0.9 %) solution for injection, sodium chloride 4.5 mg/mL (0.45 %) solution for injection, or 5 % glucose. The total reconstituted volume to be added to the intravenous bag or bottle is shown in the dosing table. Mix the solution by gentle inversion of the intravenous bag (or bottle). Avoid excessive agitation. After dilution, the solution is to be discarded if particulate matter or discolouration is identified. DOSING TABLE – PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS 5
Dose (mg)
Number of vials
Volume to be removed from 250 mL intravenous bag/bottle (mL)
Volume of Total water for reconstituted injections to be volume to add added to each to intravenous vial (mL) bag/bottle (mL)
400 2 20 9.5 200 1 10 9.5
- 10 mL from each of two vials totalling 20 mL.
20* 10
6
Total infusion volume (mL)
Final infusion solution concentration (mg/mL)
250 250
1.6 0.8
Frequently asked questions about Rezzayo 200 mg powder for concentrate for solution for infusion
How do I take Rezzayo 200 mg powder for concentrate for solution for infusion?
Rezzayo 200 mg powder for concentrate for solution for infusion comes as infusion containing 200mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Rezzayo 200 mg powder for concentrate for solution for infusion?
The active substance in Rezzayo 200 mg powder for concentrate for solution for infusion is rezafungin acetate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Rezzayo 200 mg powder for concentrate for solution for infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Rezzayo 200 mg powder for concentrate for solution for infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: rezafungin acetate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
REZZAYO is indicated for the treatment of invasive candidiasis in adults.
Consideration should be given to official guidance on the appropriate use of antifungal agents.
4.2. Posology and method of administration
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.
Special populations
Elderly
No dose adjustment is required in elderly patients aged 65 years or more (see section 5.2).
Hepatic impairment
No dose adjustment is required for patients with hepatic impairment (see section 5.2).
Renal impairment
No dose adjustment is required for patients with renal impairment. This medicinal product can be given without regard to the timing of haemodialysis (see section 5.2).
Other populations
No dose adjustment is required based on patients' weight (see section 5.2).
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.
After reconstitution and dilution (see section 6.6), the solution should be administered by slow intravenous infusion over approximately 1 hour, infusion time may be increased up to 180 minutes to manage any evolving symptoms of infusion‑related reaction (see section 4.4).
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Hypersensitivity to other medicinal products of the echinocandin class.
4.4. Special warnings and precautions for use
The efficacy of rezafungin has only been evaluated in a limited number of neutropenic patients (see section 5.1).
Anaphylactic reactions
Cases of anaphylactic reaction were reported with the use of rezafungin. If an anaphylactic reaction occurs, rezafungin should be discontinued and appropriate treatment administered.
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.
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.
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'.
4.5. Interaction with other medicinal products and other forms of interaction
The drug‑drug interaction potential of rezafungin with a number of probe substrates of cytochrome P450 enzymes and/or transporter proteins has been assessed clinically. The need for dose adjustments is considered unlikely for medicinal products that are substrates for the CYP2C8, CYP3A4, CYP1A2, and CYP2B6 enzymes and P‑gp, BCRP, OATP, OCT1, OCT2, MATE1, and MATE2 transporter proteins, when administered with rezafungin.
The drug‑drug interaction potential of rezafungin with a number of co‑administered medicinal products has also been assessed clinically. The need for dose adjustments is considered unlikely for tacrolimus, cyclosporine, ibrutinib, mycophenolate mofetil, and venetoclax when administered with rezafungin.
In vitro rezafungin is metabolically stable and was found not to be a substrate for BCRP, P‑gp, MRP2, OATP1B1, OATP1B3, OCT1, OCTN1, and OCTN2 transporter proteins. Therefore, the need for dose adjustments of rezafungin is considered unlikely when rezafungin is co‑administered with other medicinal products.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no data from the use of rezafungin in pregnant women.
Studies in animals did not show reproductive or developmental toxicity (see section 5.3). 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.
Breast‑feeding
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 (see section 5.3).
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.
Fertility
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 (see section 5.3).
4.7. Effects on ability to drive and use machines
REZZAYO has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
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).
Transient infusion‑related reactions have occurred with rezafungin, characterised by flushing, sensation of warmth, nausea, and chest tightness (see section 4.4).
Tabulated list of adverse reactions
The following table includes adverse reactions from173 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
Immune system disorders
Anaphylactic reactions*
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
*see section 4.4
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
In the event of overdose, supportive care and symptomatic treatment is advised with maintenance of homeostasis and vital functions.
In a Phase 1 clinical trial, single doses of 600 mg and 1 400 mg were administered with no reported dose‑limiting toxicity. Rezafungin doses of 400 mg once weekly for up to 4 weeks were administered in a Phase 2 clinical trial with no reported dose‑limiting toxicity.
Rezafungin is highly protein‑bound and not expected to be dialysable (see section 5.2).
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- RezzayoRezafunginum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Rezzayo 200 mg powder for concentrate for solution for infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.