Rezzayo 200 mg polvo para concentrado para solucion para perfusion

Prospect: information for the patient

REZZAYO 200mg powder for concentrate for solution for infusion

rezafungina

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this prospect. See section4.

1.What isREZZAYOand how it is used

2.What you need to know before REZZAYO is administered to you

3.How REZZAYO is administered

4.Possible adverse effects

5.Storage of REZZAYO

6.Contents of the package and additional information

What is REZZAYO

REZZAYO contains the active ingredient rezafungin, which is an antifungal. Rezafungin belongs to a group of medicines called echinocandins.

What is REZZAYO used for

This medicine is administered to adults to treat invasive candidiasis, a severe fungal infection in tissues or organs caused by a type of yeast calledCandida.

How REZZAYO works

This medicine blocks the action of an enzyme (a type of protein) that fungal cells need to produce a molecule that strengthens their cell walls. Thismakes fungal cells fragile and prevents the growth of the fungus. This prevents the infection from spreading and gives the body's natural defenses the opportunity to eliminate the infection.

You should not be givenREZZAYO

• if you are allergic to rezafungina, other echinocandins (such as caspofungin, anidulafungin), or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before receiving REZZAYO.

Liver effects

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

Perfusion-related reactions

REZZAYO may cause perfusion-related reactions, which could include skin redness (rubefaction), feeling of heat, nausea (feeling of discomfort), and chest tightness. Your doctor may decide to monitor you during perfusion to detect signs of a perfusion-related reaction. Your doctor may decide to slow down the infusion (drip) if a perfusion-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 7days after receiving the last dose of this medication, you should avoid exposure to the sun or use artificial tanning lamps without protection (such as sunscreen).

Other medications and REZZAYO

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregnancy, breastfeeding, and fertility

You should not use this medication unless your doctor specifically tells you to. If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. If you are a fertile woman, your doctor may instruct you to use contraceptive methods during treatment with REZZAYO.

The effect of REZZAYO on pregnant women or breastfeeding women is unknown.

Driving and operating machines

It is unlikely that this medication will affectyour ability to drive or operate machines.

REZZAYO contains sodium

This medication contains less than 1mmol of sodium (23mg) per dose; it is essentially “sodium-free”.

This medication will be prepared and administered by a doctor or healthcare professional.

Recommended dose

Your treatment will begin with a "loading dose" (an initial dose of a medication that is higher than the maintenance dose) of 400 mg on the first day. Subsequently, a maintenance dose of 200 mg will be administered on Day 8 of treatment and, thereafter, once a week.

REZZAYO should be administered once a week, via intravenous infusion (drip). The infusion will last at least 1 hour. Your doctor will determine the duration of the infusion and may increase it up to 3 hours to prevent infusion-related reactions.

Your doctor will determine how long you should receive treatment based on your response to the medication and your condition.

Generally, your treatment will continue for at least 14 days after the last day on which Candida was detected in the blood.

If your invasive candidiasis symptoms reappear, inform your doctor or another healthcare professional immediately.

If you are given more REZZAYO than you should

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

If you miss a dose of REZZAYO

Since this medication will be administered under strict medical supervision, it is unlikely that a dose will be missed. However, if you are unable to attend an appointment to receive this medication, contact your doctor or another healthcare professional as soon as possible to schedule a new appointment.

If you interrupt treatment with REZZAYO

Your doctor will monitor your response and condition to determine when to discontinue treatment with this medication. You should not experience any adverse effects after this.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects‑Inform your doctor or another healthcare professional immediately if you experience any of the following side effects:

• skin redness, feeling of heat, nausea (feeling of discomfort), chest tightness – these may be signs of a reaction related to perfusion (frequent – may affect up to 1 in 10 people).

Other side effects

Very frequent (may affect more than 1 in 10 people)

• low potassium levels in the blood (hypokalemia)
• diarrhea
• fever (pyrexia)

Frequent(may affect up to 1 in 10 people)

• decreased red blood cells (anemia)
• low magnesium levels in the blood (hypomagnesemia)
• low phosphate levels in the blood (hypophosphatemia)
• low blood pressure (hypotension)
• whistling sounds
• vomiting
• feeling of discomfort (nausea)
• abdominal pain
• constipation
• skin redness (erythema)
• skin rash
• increased levels of alkaline phosphatase in the blood, an enzyme (protein) produced by the liver, bones, kidneys, and intestines
• increased levels of liver enzymes in the blood (including alanine aminotransferase and aspartate aminotransferase)
• increased levels of bilirubin in the blood, a product of red blood cell degradation

Rare(may affect up to 1in 100 people)

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

Unknown frequency(cannot be estimated from available data)

• urticarial hives (urticaria)

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the vial label after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

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

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

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of empty containers and unused medications. This will help protect the environment.

Composition of REZZAYO

• The active ingredient is rezafungin. Each vial contains 200 mg of rezafungin (in the form of acetate).
• The other components are mannitol, histidine, polisorbate 80, hydrochloric acid, sodium hydroxide (see section 2 “REZZAYO contains sodium”).

Appearance of the product 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 aluminum cap with a plastic “flip-off” cap. It is a white to pale yellow paste or powder.

Each pack contains 1 vial.

Marketing authorisation holder

Mundipharma GmbH,

De-Saint-Exupery-Strasse 10,

Frankfurt Am Main,

60549 Germany

Phone: +49 69506029-000

Email: [email protected]

Responsible person for manufacturing

Fareva Mirabel

Route de Marsat Riom

Clermont-Ferrand

63963 France

Or

Mundipharma DC B.V.

Leusderend 16

Leusden

Utrecht

3832 RC Netherlands

Date of the last review of this leaflet:December 2023.

Other sources of information

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

This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

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This information is intended solely for healthcare professionals:

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

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 before use are the responsibility of the user and will normally not exceed 24 hours between 2 and 8°C from the first opening, unless the reconstitution and dilution have been performed in controlled and validated aseptic conditions.

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

To minimize foam formation, do not shake or mix vigorously. The white to pale yellow powder will dissolve completely. Mix gently with circular movements for a maximum of 5 minutes until the reconstituted solution is a transparent, colorless to pale yellow solution. The reconstituted solution should be visually inspected 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.

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

The total infusion volume should be 250 ml; therefore, the volume of the infusion bag (or bottle) should be adjusted accordingly, as shown in the dosage table.Aspirate aseptically 10 ml from each of the reconstituted vials into 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 5% glucose injection solution.The total reconstituted volume to be added to the infusion bag (or bottle) is indicated in the dosage 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 identified.

TABLE OF DOSAGE: PREPARATION OF INFUSION SOLUTION IN ADULTS

* 10 ml from each of the two vials with a total of 20 ml.