ABRYSVO powder and solvent for injectable solution

Introduction

Package Leaflet: Information for the User

Abrysvo Powder and Solvent for Solution for Injection

vaccine against respiratory syncytial virus (bivalent, recombinant)

This medicine is subject to additional monitoring, which will allow for the rapid detection of new safety information. You can help by reporting any side effects you may have. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you start receiving this vaccine 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 experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Abrysvo and what is it used for
2. What you need to know before you receive Abrysvo
3. How Abrysvo is administered
4. Possible side effects
5. Storage of Abrysvo
6. Contents of the pack and further information

1. What is Abrysvo and what is it used for

Abrysvo is a vaccine to prevent lung disease (of the respiratory tract) caused by a virus called respiratory syncytial virus (RSV). Abrysvo is administered to:

• pregnant women to protect their babies from birth up to 6 months of age,

or

• people aged 18 years and older.

RSV is a common virus that, in most cases, causes mild symptoms similar to those of a cold, such as sore throat, cough, or runny nose. However, in small infants, RSV can cause serious lung problems. In older adults and people with chronic conditions, RSV can worsen diseases such as chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). RSV can lead to hospitalization in severe cases and, in some circumstances, can be fatal.

How Abrysvo works

This vaccine helps the immune system (the body's natural defenses) to produce antibodies (substances in the blood that help the body fight infections) that protect against lung disease caused by RSV. In pregnant women vaccinated between 24 and 36 weeks of pregnancy, these antibodies pass to the baby through the placenta before birth, protecting the babies when they are most at risk of contracting RSV.

2. What you need to know before you start receiving Abrysvo

Abrysvo must not be administered

• if you are allergic to the active substances or to any of the other components of this vaccine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you are given this vaccine

If any of the above situations apply to you (or you are not sure), talk to your doctor, pharmacist, or nurse before you are given Abrysvo.

As with any vaccine, it is possible that Abrysvo may not completely protect everyone who receives it.

Children and adolescents

Abrysvo is not recommended in children and young people under 18 years of age, except during pregnancy (see section "Pregnancy" below).

Other medicines and Abrysvo

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine or have recently received any other vaccine.

Abrysvo can be administered at the same time as the flu vaccine or the COVID-19 vaccine. It is recommended to leave an interval of at least two weeks between the administration of Abrysvo and the tetanus, diphtheria, and pertussis vaccine.

Pregnancy and breastfeeding

Pregnant women can receive this vaccine at the end of the second or third trimester (weeks 24 to 36). If you are breastfeeding, talk to your doctor or nurse before receiving this vaccine.

Driving and using machines

It is unlikely that Abrysvo will affect your ability to drive or use machines.

Abrysvo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; i.e., it is essentially "sodium-free".

Abrysvo contains polysorbate 80

A dose of Abrysvo contains 0.08 mg of polysorbate 80. Polysorbates can cause allergic reactions. Tell your doctor if you have any known allergy.

3. How Abrysvo is administered

You will be given an injection of 0.5 ml into a muscle in the upper arm.

If you have any questions about the use of Abrysvo, talk to your doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, this vaccine can cause side effects, although not everybody gets them.

Serious side effects

Very rare(may affect up to 1 in 10,000 people)

• severe allergic reactions: the signs of a severe allergic reaction include swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, and dizziness. See also section 2.
• Guillain-Barré syndrome (a neurological disorder that usually starts with tingling and weakness in the limbs and can progress to paralysis of part or all of the body).

Tell your doctor immediately if you notice signs of these serious side effects.

The following side effects have been reported in pregnant women

Very common(may affect more than 1 in 10 people)

• pain at the injection site
• headache
• muscle pain (myalgia).

Common(may affect up to 1 in 10 people)

• redness at the injection site
• swelling at the injection site.

Rare(may affect up to 1 in 1,000 people)

• allergic reactions such as rash or hives
• inflammation of the glands (lymphadenopathy).

No side effects have been reported in infants born to vaccinated mothers.

The following side effects have been reported in people aged 18 years and older

Very common(may affect more than 1 in 10 people)

• fatigue
• headache
• pain at the injection site
• muscle pain (myalgia).

Common(may affect up to 1 in 10 people)

• joint pain (arthralgia)
• redness at the injection site
• swelling at the injection site.

Uncommon(may affect up to 1 in 100 people)

• fever (pyrexia).

Rare(may affect up to 1 in 1,000 people)

• allergic reactions such as rash or hives
• inflammation of the glands (lymphadenopathy)
• bruising at the injection site (hematoma)
• itching at the injection site (pruritus).

Very rare(may affect up to 1 in 10,000 people)

• severe allergic reactions (see Serious side effects above)
• Guillain-Barré syndrome (see Serious side effects above).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are 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 Abrysvo

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 and label after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C).

Do not freeze. Discard if the pack has been frozen.

After reconstitution, Abrysvo should be administered immediately or within 4 hours if stored between 15°C and 30°C. Do not freeze.

6. Container Contents and Additional Information

Composition of Abrysvo

The active ingredients are:

Stabilized F antigen in pre-fusion of subgroup A of VRS1,2 60 micrograms

Stabilized F antigen in pre-fusion of subgroup B of VRS1,2 60 micrograms

(VRS antigens)

1stabilized F glycoprotein in the pre-fusion conformation.

2produced in Chinese hamster ovary (CHO) cells using recombinant DNA technology.

The other components are:

Powder

• tromethamine
• hydrochloride tromethamine
• sucrose
• mannitol (E421)
• polysorbate 80 (E433)
• sodium chloride
• hydrochloric acid

Solvent

• water for injectable preparations

Appearance of the Product and Container Contents

Abrysvo is provided as:

• white powder in a glass vial
• solvent in a pre-filled syringe or a vial for dissolving the powder.

After dissolving the powder in the solvent, the solution is transparent and colorless.

Abrysvo is available in:

• a pack with 1 vial of powder, 1 pre-filled syringe of solvent, 1 vial adapter with 1 needle or without needles (1-dose pack);
• a pack with 5 vials of powder, 5 pre-filled syringes of solvent, 5 vial adapters with 5 needles or without needles (5-dose pack);
• a pack with 10 vials of powder, 10 pre-filled syringes of solvent, 10 vial adapters with 10 needles or without needles (10-dose pack);
• a pack with 5 vials of powder and 5 vials of solvent (5-dose pack).
• a pack with 10 vials of powder and 10 vials of solvent (10-dose pack).

Only some pack sizes may be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs-Sint-Amands

Belgium

Pfizer Ireland Pharmaceuticals

Grange Castle Business Park

Clondalkin, Dublin 22

Ireland

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:04/2025.

Other Sources of Information

Detailed information on this medicinal product 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:

Traceability

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

Administration

Abrysvo can only be administered via the intramuscular route.

The unopened vial is stable for 5 days when stored at temperatures between 8 °C and 30 °C. At the end of this period, Abrysvo must be used or discarded. This information is used to guide healthcare professionals only in case of temporary deviations from the temperature.

Storage of the Reconstituted Vaccine

Abrysvo should be administered immediately after reconstitution or within 4 hours. Store the reconstituted vaccine between 15 °C and 30 °C. Do not freeze the reconstituted vaccine.

Chemical and physical stability has been demonstrated for 4 hours between 15 °C and 30 °C. From a microbiological point of view, the vaccine should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user.

Preparation for Administration

For use with the Abrysvo antigen vial (powder), pre-filled syringe with solvent, and vial adapter

The powder must be reconstituted only with the solvent provided in the pre-filled syringe using the vial adapter.

The prepared vaccine is a clear and colorless solution. Visually inspect the vaccine for particulate matter and color changes before administration. Do not use if you observe particulate matter or color changes.

For use with the Abrysvo antigen vial (powder) and the solvent vial

The powder must be reconstituted only with the solvent vial provided.

1. Using a sterile needle and syringe, withdraw all the contents of the solvent vial and inject all the contents of the syringe into the powder vial.
2. Gently shake the vial with circular movements until the powder is completely dissolved. Do not shake.
3. Withdraw 0.5 ml from the vial with the reconstituted vaccine.

The prepared vaccine is a clear and colorless solution. Visually inspect the vaccine for particulate matter and color changes before administration. Do not use if you observe particulate matter or color changes.

Disposal

Disposal of the unused product and all materials that have come into contact with it will be carried out in accordance with local regulations.