KAVIGALE 300 MG INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

KAVIGALE 300mg solution for injection and infusion

sipavibart

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you are given 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, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is KAVIGALE and what is it used for

KAVIGALE is a medicine called a monoclonal antibody. It contains the active substance sipavibart.

KAVIGALE is used to help prevent COVID-19 (pre-exposure prophylaxis). It is used in adults and adolescents from 12 years of age who weigh at least 40 kg and are at greater risk of infection because they have a weakened immune system due to a disease or treatment.

The active substance in KAVIGALE (sipavibart) is designed to recognize and bind to a specific protein of the SARS-CoV-2 virus that causes COVID-19. This prevents the virus from entering cells and spreading between them. This can help your body fight the infection.

2. What you need to know before you are given KAVIGALE

You should not be given this medicine

• if you are allergicto sipavibart or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or nurse before you are given KAVIGALE

• if you have a low number of platelets (components that help blood clot), any blood clotting problems, or if you are taking any medicine to prevent blood clots (an anticoagulant).

This medicine may cause an allergic reaction that can be serious or life-threatening. If you notice any signs or symptoms of an allergic reaction, seek medical attention immediately. The signs and symptoms of an allergic reaction include:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• severe itching of the skin, with red rash or raised bumps.

KAVIGALE may cause an infusion reaction (drip). This could happen immediately or a few hours after the infusion. The symptoms may include:

• feeling sick (nausea)
• joint pain
• headache
• fever and chills
• stomach upset
• pain
• feeling dizzy or faint
• red and hot face
• cough
• chest discomfort
• dizziness
• shortness of breath.

Talk to your doctor or nurse if you notice any of these symptoms.

You can still get COVID-19 after receiving KAVIGALE. The SARS-CoV-2 virus that causes COVID-19 changes over time, and KAVIGALE may not protect you against all variants of the virus in circulation. COVID-19 affects different people in different ways, but the most common symptoms include:

• fever
• chills
• sore throat
• cough
• fatigue
• recent loss of taste or smell.

The most severe symptoms of COVID-19 include:

• difficulty breathing or shortness of breath
• loss of speech or movement
• confusion
• chest pain.

Talk to your doctor or nurse if you notice any of the symptoms of COVID-19.

Children and adolescents

KAVIGALE should not be given to children under 12 years of age or children from 12 years of age who weigh less than 40 kg. It has not been studied in these populations.

Other medicines and KAVIGALE

It is not known if this medicine affects other medicines or if it is affected by them. Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, talk to your doctor or nurse.

This medicine has not been studied in pregnant women. It is not known if it can affect the fetus. Your doctor will only give you this medicine if the potential benefits of treatment for the mother are greater than the potential risks to the fetus.

Tell your doctor or nurse if you are breastfeeding. It is not known if this medicine passes into breast milk and what effects it may have on the baby. Your doctor will help you decide if you can breastfeed or not.

Driving and using machines

KAVIGALE is unlikely to affect your ability to drive or use machines.

KAVIGALE contains polysorbate 80

This medicine contains 0.8 mg of polysorbate 80 in each vial. Polysorbates can cause allergic reactions. Tell your doctor if you have any known allergy.

3. How KAVIGALE is given

The recommended dose is 300 milligrams (mg).

Your doctor or nurse will give you KAVIGALE by injection into the muscle of the thigh or by infusion into a vein. Depending on how the infusion is given, the procedure takes approximately 6 to 20 minutes.

Your doctor or nurse will decide how long you will be under supervision in case of any side effects after you are given the medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some patients who have taken medicines similar to KAVIGALE have experienced severe allergic reactions. If you experience symptoms of a severe allergic reaction, contact your doctor immediately or go to an emergency room. The signs and symptoms of an allergic reaction include:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• severe itching of the skin, with red rash or raised bumps.

Other side effects:

Common(may affect up to 1 in 10 people)

• Reactions at the injection site (near the site where the injection was given in the muscle, such as pain, bruising, redness, bleeding, swelling, blood under the skin, itching, numbness, tingling, rash, discoloration, feeling of warmth on the skin).
• Reactions at the infusion site (near where the infusion was given in the vein, such as bruising, pain, itching, redness, swelling).
• Reactions related to the infusion (reactions that affect the body, such as feeling sick, joint pain, headache, fever).

Uncommon(may affect up to 1 in 100 people)

• Allergic reactions (hypersensitivity) that may include: itching, redness, hives, and rash.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through 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 KAVIGALE

Keep this medicine out of the sight and reach of children.

Your doctor, pharmacist, or nurse is responsible for the storage of this medicine and for disposing of any unused product properly. The following information is intended for healthcare professionals.

Do not use this medicine after the expiry date which is stated on the carton and on the label of the vial after EXP. The expiry date is the last day of the month stated.

Unopened vials:

• Store in a refrigerator (between 2°C and 8°C).
• Do not freeze.
• Do not shake.
• Keep the vial in the outer packaging to protect it from light.

Prepared syringes or prepared infusion bags should be used immediately. If necessary, store prepared syringes or prepared infusion bags for no more than:

• 24 hours at a temperature of 2°C to 8°C, and
• 4 hours at room temperature up to 25°C.

6. Contents of the pack and other information

What KAVIGALE contains

• The active substance is sipavibart. Each vial contains 300 mg of sipavibart in 2 ml of solution.

The other ingredients are histidine, histidine monohydrochloride, arginine hydrochloride, polysorbate 80 (E 433), and water for injections.

Appearance and pack of KAVIGALE

KAVIGALE is a solution for injection and infusion (injectable/for infusion) that is clear to opalescent, colorless to slightly yellow, and comes in a clear glass vial with a light green stopper.

Each carton contains 1 vial.

Marketing authorisation holder

Astrazeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

Astrazeneca AB

Gärtunavägen

SE-152 57 Södertälje

Sweden

You can ask for more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu

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This information is intended for healthcare professionals only:

In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

KAVIGALE is supplied in a single-dose vial. KAVIGALE can be administered by intramuscular injection or by intravenous infusion using an infusion bag containing a solution for injection of sodium chloride 9 mg/ml (0.9%) or a solution for injection of dextrose 50 mg/ml (5%) or a syringe pump. The solution for injection and infusion must be prepared and administered by a healthcare professional, using an aseptic technique as follows:

Preparation of the solution before administration

1. Remove the vial from the refrigerator.
2. Visually inspect the vial for particles and discoloration. The solution is clear to opalescent, colorless to slightly yellow. Discard the vial if the solution is cloudy, discolored, or visible particles are observed. Do not shake the vial.

For the storage conditions of the prepared syringe or prepared infusion bag, see section 6.3 of the Summary of Product Characteristics.

Intramuscular injection

1. Draw up 2 ml from the vial with a syringe.
2. Administer the intramuscular injection in the anterolateral thigh.

Intravenous infusion - infusion bag or syringe pump

Preparation of the solution

1. Draw up 2 ml from the vial and prepare an infusion mixture by transferring it to a 50 ml or 100 ml infusion bag containing a solution for injection of sodium chloride 9 mg/ml (0.9%) or a solution for injection of dextrose 50 mg/ml (5%) for solution for injection or administer with a syringe pump (see below).
2. Do not freeze or shake the solution.

Administration - infusion bag

1. Do not administer other medicines concomitantly through the same infusion line.
2. Administer the infusion solution intravenously over approximately 20 minutes through an intravenous line containing a sterile, low-protein-binding in-line filter of 0.2 or 0.22 microns.
3. Once the infusion is complete, flush the tubing with sufficient solution for injection of sodium chloride 9 mg/ml (0.9%) or a solution for injection of dextrose 50 mg/ml (5%) to ensure administration of the required dose.

Administration - syringe pump

1. Administer 2 ml (300 mg) as an intravenous infusion undiluted using a syringe pump over at least 6 minutes.
2. After administering the entire contents of the syringe, flush the administration equipment with a sufficient volume of solution for injection of sodium chloride 9 mg/ml (0.9%) or a solution for injection of dextrose 50 mg/ml (5%) to ensure that the full dose has been administered.

Disposal

Disposal of the unused medicinal product and all materials that have come into contact with it should be done in accordance with local regulations.