REGKIRONA 60 mg/mL concentrate for infusion solution

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:

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:

Calculation to determine the total number of Regkirona vials 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

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.