Rezzayo 200 mg powder for concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What REZZAYO is and what it is used for
2. What you need to know before you are given REZZAYO
3. How REZZAYO is given
4. Possible side effects
5. How to store REZZAYO
6. Contents of the pack and other information

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

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.

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.

• 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).

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.

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).

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

You should not use this medicine unless specifically told by your doctor. If you are pregnant or breast-feeding, 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.

This medicine is unlikely to have an effect on driving or using machines.

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

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.

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.

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.

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.

• 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).

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)

Not known (frequency cannot be estimated from the available data)

• sudden, severe allergic reaction (anaphylactic reaction)
• Hives (urticaria)

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.

• 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”).

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.

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