Patient leaflet - Regkirona
B. PACKAGE LEAFLET
Package leaflet: Information for the patient
Regkirona 60 mg/mL concentrate for solution for infusion regdanvimab
This medicine is subject to additional monitoring. This will allow quick identification of new safetyinformation. You canhelp by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or nurse.
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– If you get any side effects, talk to your doctor or nurse.This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
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1. What Regkirona is and what it is used for
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2. What you need to know before you are given Regkirona
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3. How Regkirona is given to you
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4. Possible side effects
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5. How to store Regkirona
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6. Contents of the pack and other information
1. What Regkirona is and what it is used for
he active substance of Regkirona is regdanvimab. It is a monoclonal antibody used for the treatment of COVID-19, a disease caused by a virus called SARS-CoV-2.
Regkirona is given to adult patients with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
his medicine stops the virus from entering human cells by binding to the spike protein of SARS-CoV-2. When it attaches to the spike protein, the interaction between the virus and the cellular receptor is blocked and the ability of the virus to enter the body’s cells is reduced.This can help your body to resist the virus infection, and may help to prevent the disease from getting worse.
2. What you need to know before you are given Regkirona
Do not use Regkirona:
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– if you are allergic to regdanvimab or any of the other ingredients of this medicine (listed in
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section 6).
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→ Talk to your doctor or nurse as soon as possible, if this applies to you.
Warnings and precautions
Reactions after receiving the medicine
his medicine can cause allergic reactions or other reactions after the medicine is given to you. See also section 4, “Possible side effects”. Symptoms can include:
- Fever
- Difficulty breathing
- Shortness of breath, rapid breathing or rapid heartbeat
- Chills
- Feeling tired
- Irregular, rapid or slow heart rate
- Chest discomfort or pain
- Weakness
- Confusion
- Feeling sick (nausea)
- Headache
- Shortness of breath, wheezing
- Low or high blood pressure
- Swelling of the face, lips, or throat (angioedema)
- Rash including nettle rash
- Itching
- Muscle aches
- Feeling faint
- Dizziness
- Sweating
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→ Seek urgent medical advice if you get any of these symptoms.
Children and adolescents
This medicine is not to be given to children and adolescents under 18 years of age because there are no data to show that this medicine is safe and works in this age group.
Other medicines and Regkirona
Tell your doctor or nurse about any other medicines you are taking, or have recently taken.
It is not yet known if this medicine affects other medicines, or if it is affected by them. Your healthcare team will monitor you for signs of medicines affecting each other.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving Regkirona. Your doctor will advise you whether the benefits of treatment with Regkirona are greater than any likely risks for you and your baby.
It is not known whether the ingredients of Regkirona can pass into breast milk. If you are breast-feeding, you must check with your doctor before you receive Regkirona.
Driving and using machines
Regkirona is not expected to have any effect on your ability to drive or use tools or machines.
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3. How Regkirona is given to you
This medicine will be given to you by a nurse or doctor, as a drip into a vein (an intravenous infusion) lasting 60 minutes.
The recommended dose is a single dose of 40 mg/kg. This medicine should be given within 7 days of symptom onset.
This medicine can cause infusion reactions after the medicine is given to you. You will be closely monitored during your treatment and for at least 1 hour after infusion is complete.
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.
Tell your doctor or nurse if you notice any of the following side effects:
- Uncommon: may affect up to 1 in 100 people
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– Allergic reactions due to an infusion (e.g. fever, difficulty breathing, irregular, rapid or slow heart rate, high blood pressure, rash including nettle rash, itching, feeling faint)
In general, these types of reactions occur within minutes to several hours following completion of the infusion.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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. How to store Regkirona
Keep this medicine out of sight and reach of children
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Keep the container in the outer carton in order to protect from light. Do not freeze.
Do not use this medicine if you notice any particulate matter or discoloration prior to administration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines that you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Regkirona contains
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– The active ingredient is called regdanvimab. The vial contains 960 mg of regdanvimab in 16 mL
(60 mg/mL).
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– The other ingredients are l-histidine, l-histidine monohydrochloride monohydrate, polysorbate
80, l-arginine monohydrochloride and water for injections.
What Regkirona looks like and contents of the pack
This medicine is a clear to opalescent, colourless to pale yellow liquid solution in a glass vial with a rubber stopper and flip-off aluminium seal supplied as a concentrate for solution for infusion.
Regkirona is available in packs containing 1 vial.
Marketing Authorisation Holder
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1–3. WestEnd Office Building B torony
Hungary
Manufacturer
NUVISAN GmbH
Wegenerstr. 13,
Neu-Ulm, Bayern, 89231
GERMANY
NUVISAN FRANCE SARL
2400 route des Colles,
06410 BIOT,
FRANCE
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
Celltrion Healthcare Belgium BVBA
Tél/Tel: + 32 1528 7418
Efcnrapua
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1–3. WestEnd Office Building B torony
YwrapuM
Ten.: +36 1 231 0493
Česká republika
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1–3. WestEnd Office Building B torony
Maďarsko
Tel: +36 1 231 0493
Danmark
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1–3. WestEnd Office Building B torony
Ungarn
Tlf: +36 1 231 0493
Deutschland
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1–3. WestEnd Office Building B torony
Ungarn
Tel: +36 1 231 0493
Lietuva
Celltrion Healthcare Hungary Kft.
1062 Budapest
Vaci ut 1–3. WestEnd Office Building B torony
Vengrija
Tel: +36 1 231 0493
Luxembourg/Luxemburg
Celltrion Healthcare Belgium BVBA
Tel/Tel: +32 1528 7418
Magyarorszag
Celltrion Healthcare Hungary Kft.
1062 Budapest
Vaci ut 1–3. WestEnd Office Building B torony
Magyarorszag
Tel.: +36 1 231 0493
Malta
Celltrion Healthcare Hungary Kft.
1062 Budapest
Vaci ut 1–3. WestEnd Office Building B torony
Vengrija
Tel: +36 1 231 0493
Nederland
Celltrion Healthcare Netherlands B.V.
Tel: +31 20 888 7300
Eesti
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1–3. WestEnd Office Building B torony
Ungari
Tel: +36 1 231 0493
EMáóa
BLANES A.E.
Tql: +30 210 8009111 – 120
España
OMFE SA
Carretera Fuencarral-Alcobendas N° 6 28049
Madrid
Tel: +34 917408700
France
CELLTRION HEALTHCARE FRANCE SAS 14 rue Cambacérès 75008 Paris
Tél: +33 (0)1 71 25 27 00
Hrvatska
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1–3. WestEnd Office Building B torony
Vengrija
Tel: +36 1 231 0493
Ireland
Celltrion Healthcare Ireland Ltd.
26, Arrow Building, Old Belgard Road, Tallaght, Dublin D24 ND70, Ireland
Tel: +353–1–223–4026
Ísland
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1–3. WestEnd Office Building B torony Ungverjaland
Sími: +36 1 231 0493
Norge
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1–3. WestEnd Office Building B torony
Ungarn
Tlf: +36 1 231 0493
Ö sterreich
Astro-Pharma GmbH
Tel.: +43 1 97 99 860
Polska
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1–3. WestEnd Office Building B torony
W?gry
Tel.: +36 1 231 0493
Portugal
PharmaKERN Portugal – Produtos
Farmacéuticos,
Sociedade Unipessoal, Lda.
Tel: +351 214 200 290
Romania
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1–3. WestEnd Office Building B torony Ungaria
Tel: +36 1 231 0493
Slovenija
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1–3. WestEnd Office Building B torony Vengrija
Tel: +36 1 231 0493
Slovenská republika
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1–3. WestEnd Office Building B torony
Maďarsko
Tel: +36 1 231 0493
Italia
Celltrion Healthcare Italy S.R.L.
Tel: +39 0247 927040
Kûnpoç
Celltrion Healthcare Hungary Kft.
1062 Budapest
Vaci ut 1–3. WestEnd Office Building B torony
Vengrija
Tel: +36 1 231 0493
Latvija
Celltrion Healthcare Hungary Kft.
1062 Budapest
Vaci ut 1–3. WestEnd Office Building B torony
Ungarija
Tel: +36 1 231 0493
Suomi/Finland
Celltrion Healthcare Hungary Kft.
1062 Budapest
Vaci ut 1–3. WestEnd Office Building B torony
Unkari
Puh/Tel: +36 1 231 0493
Sverige
Celltrion Healthcare Hungary Kft.
1062 Budapest
Vaci ut 1–3. WestEnd Office Building B torony
Ungern
Tel: +36 1 231 0493
United Kingdom (Northern Ireland)
Celltrion Healthcare Hungary Kft.
1062 Budapest
Vaci ut 1–3. WestEnd Office Building B torony
Hungary
Tel: +36 1 231 0493
This leaflet was last revised in {MM/YYYY }.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http : //.
This leaflet is available in all EU/EEA languages on the European Medicines Agency website. This leaflet is available electronically in all EU/EEA languages if scanning this code.
URL:
The following information is intended for healthcare professionals only.
Please refer to the Summary of Product Characteristics for further information.
Instructions for healthcare professionals
Regkirona 60 mg/mL concentrate for solution for infusion regdanvimab
Each single-use vial contains 960 mg of regdanvimab in 16 mL.
Regdanvimab should only be administered in settings in which health care providers have immediate access to appropriate resuscitation equipment and medicinal products to treat a severe infusion reaction, including anaphylaxis.
Monitor the patient for side effects during and at least 1 hour after the infusion is complete.
If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medicinal products and/or supportive therapy.
Dilute the concentrate with sodium chloride solution for infusion
Regkirona solution for infusion should be prepared by a qualified healthcare professional using aseptic technique:
- Remove Regkirona vial(s) from refrigerated storage and allow to equilibrate to room
temperature (not exceeding 30°C) for approximately 20 minutes before preparation. Do not expose to direct heat. Do not shake the vial(s).
- Regkirona is a clear to opalescent, colourless to pale yellow solution for infusion. Inspect
Regkirona vial(s) visually for particulate matter and discolouration prior to dilution. Should either be observed, the vial(s) must be discarded, and new vial(s) should be used for preparation.
- Calculate total volume of Regkirona to be administered. The volume of Regkirona is calculated
as follows.
Calculation to determine the total volume of Regkirona to be administered:
Patient’s body weight (kg) x Regkirona dose (40 mg/kg)
= Volume of Regkirona (mL)
Vial concentration (60 mg/mL)
Calculation to determine the total number of Regkirona vials needed:
Total Regkirona volume (mL) to be administered
= Number of Regkirona vials needed
Total volume per vial (16 mL/vial)
Table 1: Sample calculations for patients receiving the recommended dose of 40 mg/kg
of Regkirona for weights ranging from 40 kg to 120 kg
| Body weight (kg) | Total dose (mg) | Volume (mL) | Vials (n) |
| 40 | 1,600 | 27 | 2 |
| 60 | 2,400 | 40 | 3 |
| 80 | 3,200 | 53 | 4 |
| 100 | 4,000 | 67 | 5 |
| 120 | 4,800 | 80 | 5 |
Note: If a patient’s weight is more than 200 kg, the dose calculation should use 200 kg. The maximal recommended dose is 8,000 mg.
Dilute Regkirona in a bag containing sodium chloride 9 mg/mL (0.9%) solution for infusion.
The total volume of the medicinal product and sodium chloride should be 250 mL.
o In a 250 mL bag of sodium chloride, withdraw and discard the required volume (which is identical to the calculated volume of Regkirona) of sodium chloride 9 mg/mL (0.9%) from the infusion bag.
o Withdraw the calculated volume of Regkirona from the vial(s) using a sterile syringe.
o Transfer Regkirona to the infusion bag.
- Gently invert IV bag by hand approximately 10 times to mix. Do not shake.
- This product is preservative-free and therefore, the diluted solution for infusion should be
administered immediately. After aseptic dilution in sodium chloride 9 mg/mL (0.9%) solution for infusion, the prepared infusion solution of Regkirona in sodium chloride 9 mg/mL (0.9%) solution for infusion is physically and chemically stable for 72 hours at 2°C – 8°C or 4 hours at <30°C.
- From a microbiological point of view, the prepared infusion solution should be used
immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C – 8°C, unless dilution has taken place in controlled and validated aseptic conditions. If refrigerated, allow the solution for infusion to equilibrate to room temperature (not exceeding 30°C) for approximately 20 minutes prior to administration.
Administer the infusion
Regkirona solution for infusion should be administered by a qualified healthcare professional.
- Gather the recommended materials for infusion: Infusion set with in-line filter (PES
(Polyethersulfone) filter with a pore size of 1.2 gm or less would be recommended).
- Attach the infusion set to the IV bag.
- Prime the infusion set.
- Administer as an IV infusion via pump over 60 minutes.
- The prepared solution for infusion should not be administered simultaneously with any other