REZZAYO 200 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

2. What you need to know before you are given REZZAYO

Do not be given REZZAYO

• 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.

Liver effects

Your doctor may decide to monitor your liver function more closely if you develop liver problems during treatment.

Infusion-related reactions

REZZAYO may cause infusion-related reactions, which could include flushing of the skin (redness), feeling of warmth, nausea (feeling sick), and chest tightness. Your doctor may decide to monitor you during the infusion to detect signs of an infusion-related reaction. Your doctor may decide to slow down the infusion (drip) if an infusion-related reaction occurs.

Sensitivity to light

REZZAYO may increase the risk of phototoxicity (a disorder in which the skin and eyes become very sensitive to sunlight or other types of light). During treatment and for 7 days after receiving the last dose of this medicine, you should avoid exposure to the sun or use of sunlamps without protection (such as sunscreen).

Other medicines and REZZAYO

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding, and fertility

You should not use this medicine unless your doctor specifically tells you to. If you are pregnant or breastfeeding, or think you may be pregnant, talk to your doctor or pharmacist before using this medicine. If you are a woman of childbearing age, your doctor may tell you to use birth control methods during treatment with REZZAYO.

The effect of REZZAYO on pregnant or breastfeeding women is not known.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use machines.

REZZAYO contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

3. How REZZAYO is given

This medicine will be prepared and given to you by a doctor or healthcare professional.

Recommended dose

Your treatment will start with a "loading dose" (an initial dose of a medicine that is higher than the maintenance dose) of 400 mg on the first day. You will then be given a maintenance dose of 200 mg on Day 8 of treatment and then once a week.

REZZAYO should be given once a week, by infusion (drip) into a vein. The infusion will last at least 1 hour. Your doctor will decide the duration of the infusion and may extend it up to 3 hours to avoid infusion-related reactions.

Your doctor will decide how long you should 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 that Candidawas detected in your blood.

If your symptoms of invasive candidiasis come back, tell your doctor or another healthcare professional immediately.

If you are given too much REZZAYO

You should not receive this medicine more than once a week. If you are concerned that you have been given too much REZZAYO, tell your doctor or another healthcare professional immediately.

If you miss a dose of REZZAYO

Since this medicine is given to you under close medical supervision, it is unlikely that you will miss a dose. However, if you cannot attend 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 treatment with REZZAYO

Your doctor will monitor your response and condition to decide when to stop treatment with this medicine. You should not experience any side effects after this.

If you have any other questions about 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 if you have any of the following side effects:

• flushing of the skin, feeling of warmth, nausea (feeling sick), chest tightness - these may be signs that 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 potassium levels in the blood (hypokalemia)
• diarrhea
• fever (pyrexia)
• decrease in red blood cells (anemia)

Common(may affect up to 1 in 10 people)

• low magnesium levels in the blood (hypomagnesemia)
• low phosphate levels in the blood (hypophosphatemia)
• low blood pressure (hypotension)
• wheezing
• vomiting
• feeling sick (nausea)
• stomach pain (abdominal pain)
• constipation
• redness of the skin (erythema)
• rash
• increased levels of alkaline phosphatase in the blood, an enzyme (protein) produced by the liver, bones, kidneys, and intestine
• increased levels of liver enzymes in the blood (including alanine aminotransferase and aspartate aminotransferase)
• increased levels of bilirubin in the blood, a product of the breakdown of red blood cells

Uncommon(may affect up to 1 in 100 people)

• high phosphate levels in the blood (hyperphosphatemia)
• low sodium levels in the blood (hyponatremia)
• sensitivity of the skin or eyes to sunlight or other types of light (phototoxicity)
• shaking (tremor)
• high levels of eosinophils in the blood (a type of white blood cell)

Frequency not known(cannot be estimated from the available data)

• hives (urticaria)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if you think they are not related to the medicine. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 is the last day of the month shown.

Do not store above 25°C.

Store the vial in the outer carton to protect it from light.

Only a qualified healthcare professional who has read the complete instructions can prepare this medicine for use. Once prepared, REZZAYO should normally be used immediately. However, the reconstituted and diluted infusion solution can be stored for up to 24 hours in the refrigerator.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

What REZZAYO contains

• The active substance is rezafungin. Each vial contains 200 mg of rezafungin (as acetate).
• The other ingredients are mannitol, histidine, polysorbate 80, hydrochloric acid, sodium hydroxide (see section 2 "REZZAYO contains sodium").

Appearance and pack contents

REZZAYO is a powder for concentrate for solution for infusion (powder for concentrate) in a glass vial with a rubber stopper and an aluminum cap with a plastic "flip-off" cap. It is a white to pale yellow paste or powder.

Each pack contains 1 vial.

Marketing authorization holder

Mundipharma GmbH,

De-Saint-Exupery-Strasse 10,

Frankfurt Am Main,

60549

Germany

Tel.: +49 69506029-000

Email: [email protected]

Manufacturer

Fareva Mirabel

Route de Marsat Riom

Clermont-Ferrand

63963

France

Or

Mundipharma DC B.V.

Leusderend 16

Leusden

Utrecht

3832 RC

Netherlands

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

The leaflet can be found in all languages of the European Union/European Economic Area on the European Medicines Agency website.

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This information is intended only for healthcare professionals:

REZZAYO should be administered as a single agent by intravenous infusion in sodium chloride 9 mg/ml (0.9%) injection solution, sodium chloride 4.5 mg/ml (0.45%) injection solution, or glucose 5%.

INSTRUCTIONS FOR USE IN ADULT PATIENTS

REZZAYO should be reconstituted and diluted before administration.

From a microbiological point of view, the reconstituted solution and the diluted infusion solution should be used immediately. If not used immediately, the storage conditions prior to use are the responsibility of the user and would normally not exceed 24 hours between 2 and 8°C from the first opening, unless the reconstitution and dilution are performed in controlled and validated aseptic conditions.

Using aseptic techniques, reconstitute each vial with 9.5 ml of water for injection. The concentration of the reconstituted vial will be 20 mg/ml. Do not use sterile sodium chloride 9 mg/ml (0.9%) injection solution to reconstitute the vial; use only water for injection.

To minimize foam formation, do not shake or mix vigorously. The white to pale yellow powder will dissolve completely. Gently mix with circular movements for a maximum of 5 minutes until the reconstituted solution is a clear, colorless to pale yellow solution. The reconstituted solution should be inspected visually for particles or color changes. If irregularities are detected, do not use the vial.

The vial is for single use only. Therefore, the reconstituted concentrate not used should be discarded immediately.

For the 400 mg loading dose, the reconstitution step should be repeated for the additional vial of REZZAYO (see dosing table).

The total volume to be infused should be 250 ml; therefore, the volume of the infusion bag (or bottle) should be adjusted accordingly, as shown in the dosing table. Aseptically transfer 10 ml from each of the reconstituted vials to an infusion bag (or bottle) containing sodium chloride 9 mg/ml (0.9%) injection solution, sodium chloride 4.5 mg/ml (0.45%) injection solution, or glucose 5%. The total reconstituted volume to be added to the infusion bag or bottle is indicated in the dosing table. Mix the solution by gently inverting the infusion bag (or bottle). Avoid excessive agitation.

After dilution, the solution should be discarded if particles or color changes are detected.

DOSING TABLE: PREPARATION OF THE INFUSION SOLUTION IN ADULTS

• 10 ml from each of the two vials, for a total of 20 ml.