Kavigale

Package leaflet: Information for the user

KAVIGALE 300 mg solution for injection or infusion

sipavibart
This medicinal product is subject to additional monitoring. This will allow for rapid identification of
new safety information. You can help by reporting any side effects you experience while taking
this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before receiving this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, including those not listed in this leaflet, talk to your doctor or nurse. See section 4.

Contents of this leaflet

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

1. What KAVIGALE is and what it is 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 aged 12 years and older who weigh at least 40 kg and are at increased risk of infection because they have a weakened immune system due to a medical condition or treatments.
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 cells. This may help your body resist infection.

2. What you need to know before receiving KAVIGALE

This medicine must not be administered

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

Warnings and precautions
Talk to your doctor or nurse before receiving KAVIGALE if:

• you have a low platelet count in your blood (components that help blood clotting), clotting disorders, or if you are taking a medicine to prevent blood clots (an anticoagulant).

This medicine may cause an allergic reaction, which could be severe or life-threatening. If
you notice signs or symptoms of an allergic reaction, seek immediate medical help. 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 swollen bumps.

KAVIGALE may cause an infusion reaction (drop by drop). This could occur
immediately or within a few hours after the infusion. Symptoms may include:

• nausea
• joint pain
• headache
• fever and chills
• stomach upset
• pain
• dizziness or feeling faint
• flushed and warm face
• cough
• chest discomfort
• dizziness
• shortness of breath.

Contact a doctor or nurse if you experience any of these symptoms.
You may 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 every circulating
variant of the virus. COVID-19 affects people in different ways, but the most common symptoms
include:

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

More severe symptoms of COVID-19 include:

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

Seek immediate medical attention if you develop symptoms of COVID-19.
Children and adolescents
KAVIGALE must not be administered to children under 12 years of age or to children aged 12 years and older weighing less than 40 kg. It has not been studied in these populations.
Other medicines and KAVIGALE
It is not known whether this medicine interacts with other medicines or is affected by them. Inform your
doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Inform your doctor or nurse if you are pregnant, suspect you may be pregnant, or are planning a
pregnancy.
This medicine has not been studied in pregnant women. It is not known whether it may have effects on
the fetus. Your doctor will administer this medicine only if the potential benefits of treatment for the
mother outweigh the potential risks to the fetus.
Inform your doctor or nurse if you are breastfeeding. It is not yet known whether this medicine passes into
breast milk or what effects it may have on the infant. Your doctor will help you decide whether to continue
breastfeeding.
Driving and using machines
It is unlikely that KAVIGALE will affect your ability to drive or operate machinery.
KAVIGALE contains polysorbate 80
This medicine contains 0.8 mg of polysorbate 80 in each vial. Polysorbates may cause
allergic reactions. Inform your doctor if you have known allergies.

3. How KAVIGALE is administered

The recommended dose is 300 milligrams (mg).
KAVIGALE is administered by a doctor or nurse via injection into the thigh muscle or via intravenous infusion. Depending on the method of infusion, the procedure takes approximately 6 to 20 minutes.
The doctor or nurse will decide how long you will be monitored for adverse reactions after administration of the medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Patients treated with medicines similar to KAVIGALE have experienced severe allergic reactions. If you
experience symptoms of a severe allergic reaction, contact a doctor immediately or go to the
emergency room. Signs and symptoms of an allergic reaction include:

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

Other side effects
Common (may affect up to 1 in 10 people)

• Injection site reactions (reactions near the site where the injection was given into the muscle, such as pain, bruising, redness, bleeding, swelling, blood under the skin, itching, numbness and tingling, rash, skin discoloration, and sensation of warmth on the skin).
• Infusion site reactions (reactions near the site where the infusion was administered into the vein, such as bruising, pain, itching, redness and swelling).
• Infusion-related reactions (reactions affecting the body, such as feeling unwell, joint pain, headache and fever).

Uncommon (may affect up to 1 in 100 people)

• Allergic reaction (hypersensitivity), including itching, skin redness, hives and rash.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 the proper disposal of any unused product. 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 refers to the last day of that month.

Unopened vials:

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

Prepared syringes or infusion bags should be used immediately. If necessary, prepared syringes or infusion bags may be stored for no longer than:

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

6. Package contents 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 components are histidine, monohydrochloride histidine, hydrochloride arginine, polysorbate 80 (E 433),
and water for injections.
Description of the appearance of KAVIGALE and contents of the pack
KAVIGALE is an injectable or infusion solution (injection/infusion), from clear to opalescent,
colourless to slightly yellow, supplied in a clear glass vial with a light green cap.
Each pack contains 1 vial.
Marketing Authorisation Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden
Manufacturer
AstraZeneca AB
Gärtunavägen
SE-152 57 Södertälje
Sweden
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550
България Luxembourg/Luxemburg
АстраЗенека България ЕООД AstraZeneca S.A./N.V
Тел.: +359 24455000 Tél/Tel: +32 2 370 48 11
Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel.: +36 1 883 6500
Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf.: +45 43 66 64 62 Tel: +356 2277 8000
Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 85 808 9900
Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00
Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 210 6871500 Tel: +43 1 711 31 0
España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel.: +48 22 245 73 00
France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00
Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41
Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland), DAC AstraZeneca UK Limited
Tel: +353 1609 7100 Tel.: +386 1 51 35 600
Ísland Slovenská republika
Vistor hf. AstraZeneca AB, o.z.
Sími: +354 535 7000 Tel: +421 2 5737 7777
Italia Suomi/Finland
AstraZeneca S.p.A. AstraZeneca Oy
Tel.: +39 02 00704500 Puh/Tel.: +358 10 23 010
Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel.: +46 8 553 26 000
Latvija
SIA AstraZeneca Latvija
Tel.: +371 67377100
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

The following information is intended for healthcare professionals only:

To improve the traceability of biological medicinal products, the name and batch number of the administered product must be clearly recorded.
KAVIGALE is supplied in single-dose vials. KAVIGALE may be administered via intramuscular injection or by intravenous infusion using an infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) dextrose solution for injection, or via a syringe pump. The injectable or infusion solution must be prepared and administered by a healthcare professional using aseptic technique as follows:

Solution preparation prior to administration

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

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

Intramuscular injection

1. Withdraw 2 mL from the vial into a syringe.
2. Administer the intramuscular injection into the anterolateral thigh.

Intravenous infusion – infusion bag or syringe pump
Solution preparation

1. Withdraw 2 mL from the vial and prepare an infusion mixture by transferring it into a 50 mL or 100 mL infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) dextrose solution for injection, or administer using a syringe pump (see below).
2. Do not freeze or shake the solution.

Administration – infusion bag

1. Do not administer other medicinal products through the same infusion line simultaneously.
2. Administer the infusion solution intravenously via an infusion pump or by gravity over approximately 20 minutes through an intravenous line equipped with a sterile, low-protein-binding in-line filter of 0.2 or 0.22 micron.
3. After completion of the infusion, flush the line with sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) dextrose solution for injection in sufficient volume to ensure delivery of the full dose.

Administration – syringe pump

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

Disposal
Any unused medicinal product and waste materials derived from it must be disposed of in accordance with local legal requirements.