Rezzayo 200 mg powder for concentrate for solution for infusion
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
REZZAYO 200 mg powder for concentrate for solution for infusion
rezafungin
This medicinal product is subject to additional monitoring, which will facilitate the rapid identification of new information on its safety. You can help by reporting any adverse reactions you may experience. Section 4 at the end includes information on how to report these adverse reactions.
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are possible adverse reactions not listed in this leaflet. See section 4.
- What REZZAYO is and what it is used for
- What you need to know before being administered REZZAYO
- How REZZAYO is administered
- Possible adverse reactions
- How to store REZZAYO
- Contents of the pack and other information
1. What REZZAYO is and what it is used for
What REZZAYO is
REZZAYO contains the active substance rezafungin, which is an antifungal agent. 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 tissues or organs caused by a type of yeast called Candida.
How REZZAYO works
This medicine blocks the action of an enzyme (a type of protein) that fungal cells need to produce a molecule which strengthens their cell walls. This causes the fungal cells to become fragile and prevents fungal growth. As a result, the spread of the infection is stopped, giving the body's natural defenses the opportunity to clear the infection.
2. What you need to know before REZZAYO is administered to you
Do not receive REZZAYO
- if you are allergic to rezafungin, other echinocandins (such as caspofungin, anidulafungin), or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before REZZAYO is administered to you.
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 skin redness (flushing), feeling of warmth, nausea (feeling unwell), 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 the infusion rate if an infusion-related reaction occurs.
Sensitivity to light
REZZAYO may increase the risk of phototoxicity (a condition in which the skin and eyes become highly 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 sunlight or use of artificial tanning lamps without protection (such as sunscreen).
Other medicines and REZZAYO
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breast-feeding, and fertility
You must not use this medicine unless specifically instructed by your doctor. If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine. If you are a woman of childbearing age, your doctor may advise you to use contraceptive methods during treatment with REZZAYO.
The effect of REZZAYO in pregnant or breastfeeding women is unknown.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate machinery.
REZZAYO contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose; essentially, “sodium-free”.
3. How REZZAYO is administered
This medicine will be prepared and administered by a doctor or healthcare professional.
Recommended dose
Your treatment will start with a "loading dose" (an initial medicine dose higher than the maintenance dose) of 400 mg on Day 1. Then, a maintenance dose of 200 mg will be given on Day 8 of treatment, and thereafter once weekly.
REZZAYO should be administered once weekly by intravenous infusion (drip into a vein). The infusion will last at least 1 hour. Your doctor will determine the infusion duration and may extend it up to 3 hours to help prevent infusion-related reactions.
Your doctor will decide how long you should continue treatment, depending 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 Candida was detected in the blood.
If your symptoms of invasive candidiasis return, inform your doctor or another healthcare professional immediately.
If you are given more REZZAYO than you should
You must not receive this medicine 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 medicine 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 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 determine when to stop treatment with this medicine. You should not experience any adverse effects after stopping.
If you have any further 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 everyone gets them.
Serious side effects – inform your doctor or another healthcare professional immediately if you experience any of the following side effects:
- skin redness, feeling of warmth, nausea (feeling unwell), chest tightness – these may be signs that you are having an infusion-related reaction (frequent – may affect up to 1 in 10 people).
Other side effects
Very common (may affect more than 1 in 10 people)
- low blood potassium levels (hypokalaemia)
- diarrhoea
- fever (pyrexia)
- decrease in red blood cells (anaemia)
Common (may affect up to 1 in 10 people)
- low blood magnesium levels (hypomagnesaemia)
- low blood phosphate levels (hypophosphataemia)
- low blood pressure (hypotension)
- wheezing
- vomiting
- feeling unwell (nausea)
- (abdominal) stomach pain
- constipation
- skin redness (erythema)
- skin rash
- increased levels of alkaline phosphatase in blood, an enzyme (protein) produced by the liver, bones, kidneys, and intestine
- increased levels of liver enzymes in blood (including alanine aminotransferase and aspartate aminotransferase)
- increased levels of bilirubin in blood, a product of red blood cell breakdown
Uncommon (may affect up to 1 in 100 people)
- high levels of phosphates in blood (hyperphosphataemia)
- low blood sodium levels (hyponatraemia)
- increased sensitivity of the skin or eyes to sunlight or other types of light (photosensitivity)
- tremor
- high levels of eosinophils in blood (a type of white blood cells)
Frequency not known (cannot be estimated from the available data)
- hives (urticaria)
Reporting of side effects
If you experience any type of side effect, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included 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 label of the vial after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 25 °C.
Keep the vial in the outer carton to protect it from light.
Only a qualified healthcare professional who has read the complete instructions should prepare this medicine for use. Once REZZAYO has been prepared, it should normally be used immediately. However, the reconstituted and diluted solution for infusion may be stored for up to 24 hours in a refrigerator.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Pack contents and other information
Composition of REZZAYO
- The active substance is rezafungin. Each vial contains 200 mg of rezafungin (as acetate).
- The other components are mannitol, histidine, polysorbate 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 (powder for concentrate) in a glass vial with a rubber stopper and an aluminium seal 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
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
The Netherlands
Date of the latest 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.
This patient information leaflet is available on the European Medicines Agency website in all languages of the European Union/European Economic Area.
This information is intended for healthcare professionals only:
REZZAYO must be administered as a single agent by 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 standpoint, the reconstituted solution and the diluted infusion solution should be used immediately. If not used immediately, the conditions of storage prior to use are the responsibility of the user and normally should not exceed 24 hours at 2 to 8 °C from the first opening, unless reconstitution and dilution have been carried out under controlled and validated aseptic conditions.
Using aseptic techniques, reconstitute each vial with 9.5 ml of 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; use only water for injections.
To minimize foam formation, do not shake or mix vigorously. The white to pale yellow powder will dissolve completely. Gently mix by swirling for up to 5 minutes until the reconstituted solution is a clear, colourless to pale yellow solution. The reconstituted solution should be inspected visually for particles or discoloration. If any irregularities are observed, do not use the vial.
The vial is for single use only. Therefore, any unused reconstituted concentrate must be discarded immediately.
For the 400 mg loading dose, the reconstitution step must be repeated for the additional REZZAYO vial (see dosing table).
The total volume to be infused must be 250 ml; therefore, the volume of the infusion bag (or bottle) must be adjusted accordingly, as shown in the dosing table. Aseptically transfer 10 ml from each reconstituted vial into an intravenous infusion bag (or bottle) containing 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 infusion bag or bottle is indicated in the dosing table. Gently mix the solution by inverting the intravenous infusion bag (or bottle) several times. Avoid excessive agitation.
After dilution, the solution must be discarded if particles or discoloration are observed.
DOSING TABLE: PREPARATION OF INFUSION SOLUTION IN ADULTS
Dose (mg) | Number of vials | Volume to withdraw into a 250 ml intravenous infusion bag/bottle (ml) | Volume of water for injectable preparations to add to each vial (ml) | Total reconstituted volume to add to the infusion bag/bottle (ml) | Total infusion volume (ml) | Final concentration of infusion solution (mg/ml) |
400 | 2 | 20 | 9.5 | 20* | 250 | 1.6 |
200 | 1 | 10 | 9.5 | 10 | 250 | 0.8 |
- 10 ml from each of the two vials, for a total of 20 ml.