REGKIRONA 60 mg/mL concentrate for infusion solution
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Introduction
Patient Information: Summary of Product Characteristics
Regkirona 60 mg/ml concentrate for solution for infusion
regdanvimab
This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.
Read all of this leaflet carefully before you start receiving this medicine, because it contains important information for you.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- 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.
Contents of the pack
- What is Regkirona and what is it used for
- What you need to know before you are given Regkirona
- How Regkirona is given
- Possible side effects
- Storage of Regkirona
- Contents of the pack and other information
1. What is Regkirona and what is it used for
The active substance of Regkirona is regdanvimab, which 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 are at high risk of severe COVID-19 worsening.
This medicine prevents the virus from entering human cells by binding to the spike protein of SARS-CoV-2. When it binds to the spike protein, it blocks the interaction between the virus and the cell receptor, and this reduces the virus's ability to enter the body's cells. In this way, it helps the body to resist the infection and may help prevent the disease from worsening.
2. What you need to know before you are given Regkirona
You must not be given Regkirona
- if you are allergic to regdanvimab or any of the other ingredients of this medicine
(listed in section 6).
- Tell your doctor or nurse as soon as possible if this applies to you.
Warnings and precautions
Reactions after receiving the medicine
This medicine may cause allergic reactions or other reactions after it is given. See also section 4, "Possible side effects". The symptoms may include:
- Fever
- Difficulty breathing
- Shortness of breath, rapid breathing or rapid heartbeat
- Chills
- Fatigue
- Irregular, rapid or slow heartbeat
- Chest pain or discomfort
- 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 hives
- Itching
- Muscle pain
- Feeling dizzy
- Dizziness
- Sweating
- Seek medical attention immediatelyif you experience any of these symptoms.
Children and adolescents
This medicine must not be given to children and adolescents under 18 years of age, as there are no data to indicate that this medicine is safe and effective in this age group.
Other medicines and Regkirona
Tell your doctor or nurseif you are taking or have recently taken any other medicines.
It is not known if this medicine affects other medicines or if they may have an effect on it. Your healthcare team will monitor you for possible signs of drug interactions.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnantor plan to become pregnant, consult your doctorbefore receiving Regkirona. Your doctor will advise you if the benefits of treatment with Regkirona outweigh the potential risks to you and your baby.
It is not known if the components of Regkirona are excreted in breast milk. If you are breastfeeding, consult your doctorbefore receiving Regkirona.
Driving and using machines
Regkirona is not expected to have any effect on the ability to drive or use tools or machines.
3. How Regkirona is given
A doctor or nurse will give you this medicine by infusion into a vein (intravenous infusion) over 60 minutes.
The recommended dose is a single dose of 40 mg/kg. This medicine should be given within 7 days of the onset of symptoms.
This medicine may cause infusion reactions after it is given. You will be closely monitored during treatment and for at least 1 hour after the end of the infusion.
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 experience any of the following side effects:
- Uncommon:may affect up to 1 in 100 people
- Infusion reactions (e.g. fever; difficulty breathing;
slow, rapid or irregular heartbeat, high blood pressure; rash, including hives; itching or feeling faint)
These types of reactions usually occur within a few minutes to several hours after the infusion is completed.
Reporting of side effects
If you experience any side effects, talk to your doctor or nurse, even if they are 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. Storage of Regkirona
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 after EXP. The expiry date is the last day of the month shown.
Store in a refrigerator (between 2 °C and 8 °C). Keep the container in the outer carton to protect it from light. Do not freeze.
Do not use this medicine if you notice particles or color changes before administration.
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. Container Content and Additional Information
Composition of Regkirona
- The active substance is regdanvimab. The vial contains 960 mg of regdanvimab in 16 ml (60 mg/ml).
- The other components are L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, L-arginine hydrochloride, and water for injectable preparations.
Appearance of the Product and Container Content
This medicine is a transparent to opalescent solution, colorless to pale yellow. It is presented in a glass vial with a rubber stopper and sealed with an aluminum flip-off cap containing concentrate for solution for infusion.
Regkirona is available in packs of 1 vial.
Marketing Authorization Holder
Celltrion Healthcare Hungary Kft.
1062 Budapest
Váci út 1-3. WestEnd Office Building B tower
Hungary
Manufacturers
NUVISAN GmbH
Wegenerstr. 13,
Neu-Ulm, Bayern, 89231
GERMANY
NUVISAN FRANCE SARL
2400 route des Colles,
06410 BIOT,
FRANCE
You can request more information about this medicine by contacting the local representative of the marketing authorization holder:
Belgium Celltrion Healthcare Belgium BVBA Tel: +32 1528 7418 | Lithuania Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Hungary Tel: +36 1 231 0493 |
Bulgaria Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Bulgaria Tel: +36 1 231 0493 | Luxembourg Celltrion Healthcare Belgium BVBA Tel: +32 1528 7418 |
Czech Republic Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Hungary Tel: +36 1 231 0493 | Hungary Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Hungary Tel: +36 1 231 0493 |
Denmark Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Hungary Tel: +36 1 231 0493 | Malta Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Hungary Tel: +36 1 231 0493 |
Germany Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Hungary Tel: +36 1 231 0493 | Netherlands Celltrion Healthcare Netherlands B.V. Tel: +31 20 888 7300 |
Estonia Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Hungary Tel: +36 1 231 0493 | Norway Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Hungary Tel: +36 1 231 0493 |
Greece ΒΙΑΝΕΞ Α.Ε. Tel: +30 210 8009111 – 120 | Austria Astro-Pharma GmbH Tel: +43 1 97 99 860 |
Spain OMFE SA Carretera Fuencarral-Alcobendas Nº 6 28049 Madrid Tel: +34 917408700 | Poland Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Hungary Tel: +36 1 231 0493 |
France CELLTRION HEALTHCARE FRANCE SAS 14 rue Cambacérès 75008 Paris Tel: +33 (0)1 71 25 27 00 | Portugal PharmaKERN Portugal – Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Tel: +351 214 200 290 |
Croatia Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Hungary Tel: +36 1 231 0493 | Romania Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Hungary 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 | Slovenia Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Hungary Tel: +36 1 231 0493 |
Iceland Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Hungary Tel: +36 1 231 0493 | Slovakia Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Hungary Tel: +36 1 231 0493 |
Italy Celltrion Healthcare Italy S.R.L. Tel: +39 0247 927040 | Finland Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Hungary Tel: +36 1 231 0493 |
Cyprus Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Hungary Tel: +36 1 231 0493 | Sweden Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Hungary Tel: +36 1 231 0493 |
Latvia Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Hungary Tel: +36 1 231 0493 | United Kingdom (Northern Ireland) Celltrion Healthcare Hungary Kft. 1062 Budapest Váci út 1-3. WestEnd Office Building B tower Hungary Tel: +36 1 231 0493 |
Date of the last revision of this leaflet: {MM/AAAA}.
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.
This leaflet is available electronically in all EU/EEA languages if you scan this code.
URL: http://www.regkirona-eu.com
--------------------------------------------------------------------------------------------------------------------This information is intended only for healthcare professionals.
Consult the Summary of Product Characteristics or Package Leaflet for more 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 environments where healthcare professionals have immediate access to appropriate resuscitation equipment and medications to treat a severe infusion reaction, including anaphylaxis.
Monitor the patient for potential adverse effects during infusion and for at least 1 hour after the end of the infusion.
If signs and symptoms of a hypersensitivity reaction or anaphylaxis with clinical relevance appear, discontinue treatment immediately and start administering the necessary medications and/or supportive treatment.
Dilution of the concentrate with sodium chloride solution for infusion
A qualified healthcare professional will prepare Regkirona solution for infusion using aseptic techniques:
- Remove the Regkirona vials from the refrigerator and let them stand at room temperature (not exceeding 30 °C) for approximately 20 minutes before preparation. Do not expose to direct heat sources. Do not shake the vials.
- Regkirona is a transparent to opalescent solution, colorless to pale yellow. Visually inspect the Regkirona vials for particles and color changes before dilution. If any are observed, discard the vials and use new vials for preparation.
- Calculate the total administration volume of Regkirona. The volume of Regkirona is calculated as follows.
Calculation to determine the total administration volume of Regkirona:
Patient weight (kg) × Regkirona dose (40 mg/kg) | = Regkirona volume (ml) |
Vial concentration (60 mg/ml) |
Calculation to determine the total number of Regkirona vials needed:
Total administration volume of Regkirona (ml) | = Number of Regkirona vials |
Total volume per vial (16 ml/vial) | needed |
Table 1:Sample calculations for patients treated with the recommended dose of 40 mg/kg of Regkirona for a weight range of 40 to 120 kg
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 the patient's weight is above 200 kg, 200 kg should be used to calculate the dose. The maximum recommended dose is 8,000 mg.
- Dilute Regkirona in a bag with sodium chloride 9 mg/ml (0.9%) solution for infusion. The total volume of the medication and sodium chloride should be 250 ml.
- In a 250 ml bag with sodium chloride, withdraw and discard the necessary volume (equivalent to the calculated volume of Regkirona) of sodium chloride 9 mg/ml (0.9%) from the infusion bag.
- Withdraw the calculated volume of Regkirona from the vials with a sterile syringe.
- Transfer Regkirona to the infusion bag.
- Gently invert the intravenous infusion bag with your hand approximately 10 times to mix. Do not shake.
- This product does not contain preservatives, so the diluted infusion solution should be administered immediately. After aseptic dilution in a sodium chloride 9 mg/ml (0.9%) solution for infusion, the prepared Regkirona infusion solution in sodium chloride 9 mg/ml (0.9%) solution for infusion is physically and chemically stable for 72 hours at 2-8 °C or for 4 hours at ≤ 30 °C.
- From a microbiological point of view, the prepared infusion solution should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not exceed 24 hours at 2-8 °C, unless the dilution has taken place in controlled and validated aseptic conditions. If refrigerated, let the infusion solution stand at room temperature (not exceeding 30 °C) for approximately 20 minutes before administration.
Administration of the infusion
Regkirona solution for infusion will be administered by a qualified healthcare professional.
- Gather the recommended materials for infusion: intravenous infusion equipment with an in-line filter (a PES [polyethersulfone] filter with a pore size of 1.2 μm or less is recommended). Connect the infusion equipment to the intravenous infusion bag.
- Connect the infusion equipment to the intravenous infusion bag.
- Prime the infusion equipment.
- Administer the intravenous infusion with an infusion pump over 60 minutes.
- The prepared infusion solution should not be administered simultaneously with another medication.
The disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.
- Country of registration
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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