Abrysvo

Patient Information Leaflet: Information for the User

Abrysvo Powder and Solvent for Injectable Solution

Respiratory syncytial virus vaccine (bivalent, recombinant)

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 receiving this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before receiving this vaccine, as it contains important information for you.

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

Contents of this leaflet

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

1. What is Abrysvo and what is it used for?

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

• pregnant women to protect their newborns from birth up to 6 months of age, or
• individuals aged 18 years and older.

RSV is a common virus that in most cases causes mild, flu-like symptoms such as sore throat, cough, or nasal congestion. However, in young children, RSV can cause serious lung problems. In older adults and individuals with chronic conditions, RSV can worsen diseases such as chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). In severe cases, RSV may require hospitalization and, in some instances, can be fatal.

How Abrysvo works
This vaccine helps the immune system (the body’s natural defenses) 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 gestation, these antibodies are transferred to the newborn through the placenta before birth, thereby protecting the infant when most vulnerable to RSV.

2. What you need to know before receiving Abrysvo

Do not receive Abrysvo

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving this vaccine

• if you previously had a severe allergic reaction or breathing problems after receiving an injection of any vaccine or after being administered Abrysvo in the past;
• if the thought of receiving a vaccine makes you anxious or if you have previously fainted after an injection. Fainting can occur before or after any injection;
• if you have an infection with high fever. In this case, vaccination will be postponed. Vaccination does not need to be delayed for a minor infection, such as a cold, but you should consult your doctor;
• if you have bleeding disorders or bruise easily;
• if your immune system is weakened, which might prevent you from getting the full benefit of Abrysvo;
• if you are less than 24 weeks pregnant.

If any of the conditions described above apply to you (or you are unsure), speak with your doctor,
pharmacist, or nurse before receiving Abrysvo.
As with all vaccines, Abrysvo may not fully protect all vaccinated individuals.
Children and adolescents
Abrysvo is not recommended for children and young people under 18 years of age, except for
adolescents during pregnancy (see section “Pregnancy” below).
Other medicines and Abrysvo
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other
medicines, or if you have recently received another vaccine.
Abrysvo may be administered at the same time as an influenza vaccine or a COVID-19 vaccine. An interval of at least two weeks is recommended between vaccination with Abrysvo and vaccination with a tetanus, diphtheria, and acellular pertussis (whooping cough) vaccine.
Pregnancy and breastfeeding
Pregnant women may receive this vaccine during the late second or third trimester (weeks 24 to 36). If you are breastfeeding, consult your doctor or nurse before receiving this vaccine.
Driving and using machines
It is unlikely that Abrysvo will affect your ability to drive or operate machinery.
Abrysvo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.
Abrysvo contains polysorbate 80
One dose of Abrysvo contains 0.08 mg of polysorbate 80. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergy.

3. How Abrysvo is administered

You will be given a 0.5 mL injection into a muscle in the upper arm.
If you have any questions about the use of Abrysvo, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, this vaccine may cause side effects, although not everyone experiences them.
Serious side effects
Very rare (may affect up to 1 in 10,000 people)

• severe allergic reactions: 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 may progress to paralysis of part or all of the body).

Inform your doctor immediately if you notice any 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
• swollen glands (lymphadenopathy)

No side effects have been reported in newborns born to vaccinated mothers.
The following side effects have been reported in individuals 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
• swollen glands (lymphadenopathy)
• bruising at the injection site (haematoma)
• itching at the injection site (pruritus)

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

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

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 Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Abrysvo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after "Exp.". The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C–8 °C).
Do not freeze. Discard if the product has been frozen.
After reconstitution, Abrysvo must be administered immediately or within 4 hours if stored at a temperature between 15 °C and 30 °C. Do not freeze.

6. Package contents and other information

What Abrysvo contains
The active substances are:
Stabilized prefusion F antigen of RSV subgroup A 60 micrograms
Stabilized prefusion F antigen of RSV subgroup B 60 micrograms
(RSV antigens)
Stabilized F glycoprotein in prefusion conformation
produced in Chinese hamster ovary cells using recombinant DNA technology.

The other components are:
Powder

• tromethamine
• tromethamine hydrochloride
• sucrose
• mannitol (E421)
• polysorbate 80 (E433)
• sodium chloride
• hydrochloric acid
  Solvent
• water for injections

Description of the appearance of Abrysvo and contents of the pack
Abrysvo is supplied as:

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

After dissolving the powder in the solvent, the resulting solution is clear and colourless.
Abrysvo is available in the following pack sizes:

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

Not all 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Luxembourg/Luxemburg Pfizer Luxembourg SARL
Pfizer NV/SA filialas Lietuvoje
Tél/Tel: + 32 (0)2 554 62 11 Tel: +370 5 251 4000

България Magyarország
Пфайзер Люксембург САРЛ, Pfizer Kft
Клон България Tel: + 36 1 488 37 00
Teл: +359 2 970 4333

Česká republika Malta
Pfizer, spol. s r.o. Vivian Corporation Ltd.
Tel: +420 283 004 111 Tel: + 356 21344610

Danmark Nederland
Pfizer ApS Pfizer bv
Tlf: + 45 44 20 11 00 Tel: +31 (0)800 63 34 636

Deutschland Norge
PFIZER PHARMA GmbH Pfizer AS
Tel: +49 (0)30 550055-51000 Tlf: +47 67 52 61 00

Eesti Österreich
Pfizer Luxembourg SARL Eesti Pfizer Corporation Austria
filiaal Ges.m.b.H
Tel: +372 666 7500 Tel: +43 (0)1 521 15-0

Ελλάδα Polska
Pfizer Ελλάς A.E. Pfizer Polska Sp. z o.o.
Τηλ.: +30 210 6785800 Tel.: +48 22 335 61 00

España Portugal
Pfizer, S.L. Laboratórios Pfizer, Lda.
Télf: +34 91 490 99 00 Tel: +351 21 423 5500

France România
Pfizer Pfizer Romania S.R.L
Tél +33 (0)1 58 07 34 40 Tel: +40 (0) 21 207 28 00

Hrvatska Slovenija
Pfizer Croatia d.o.o. Pfizer Luxembourg SARL
Tel: + 385 1 3908 777 Pfizer, podružnica za
svetovanje s področja
farmacevtske dejavnosti,
Ljubljana
Tel.: +386 (0)1 52 11 400

Ireland Slovenská republika
Pfizer Healthcare Ireland Unlimited Pfizer Luxembourg SARL,
Company organizačná zložka
Tel: +1800 633 363 (toll free) Tel: + 421 2 3355 5500
Tel: +44 (0)1304 616161

Ísland Suomi/Finland
Icepharma hf. Pfizer Oy
Simi: + 354 540 8000 Puh/Tel: +358 (0)9 430 040

Italia Sverige
Pfizer S.r.l. Pfizer AB
Tel: +39 06 33 18 21 Tel: +46 (0)8 550 520 00

Kύπρος United Kingdom (Northern Ireland)
Pfizer Ελλάς Α.Ε. (Cyprus Branch) Pfizer Limited
Tηλ: +357 22817690 Tel: + 44 (0) 1304 616161

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel.: + 371 670 35 775

Further 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 exclusively for healthcare professionals:

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

Administration
Abrysvo is for intramuscular use only.
The unopened vial is stable for 5 days if stored at temperatures between 8 °C and 30 °C. After this period, Abrysvo must either be used or discarded. These data are intended as guidance for healthcare professionals in the case of temporary temperature excursions only.

Storage of reconstituted vaccine
Abrysvo must be used immediately after reconstitution or within 4 hours. Store the reconstituted vaccine at a temperature between 15 ºC and 30 ºC. Do not freeze the reconstituted vaccine.
Chemical and physical stability in use has been demonstrated for 4 hours at a temperature between 15 °C and 30 °C. From a microbiological standpoint, the product should be used immediately.
Otherwise, the duration and conditions of storage prior to use are the responsibility of the user.

Preparation for administration
For use with the vial of Abrysvo antigens (powder), pre-filled syringe of solvent, and vial adapter

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

Vial containing Abrysvo
Vial adapter
Pre-filled syringe containing solvent for
antigens (powder)
Abrysvo

Syringe cap Vial adapter Luer Lock Vial stopper (with cap
of syringe removed)
removable cap

Step 1. Attach the vial adapter

• Remove the top cover from the vial adapter packaging and remove the removable cap from the vial.
• While keeping the vial adapter in its packaging, center it over the vial stopper and attach by pushing straight down. Do not push the vial adapter on at an angle, as this may cause leakage. Remove the packaging.

Step 2. Reconstitute the powder component (antigens) to prepare Abrysvo

• During all syringe assembly steps, hold the syringe only by the Luer Lock adapter to prevent accidental disconnection during use.
• Twist off the syringe cap, then continue twisting to connect the syringe to the vial adapter. Stop twisting when resistance is felt.
• Inject the entire contents of the syringe into the vial. Press and hold the plunger while gently rotating the vial until the powder is completely dissolved. Do not shake.

Step 3. Withdraw the reconstituted vaccine

• Completely invert the vial and slowly withdraw the entire contents into the syringe to ensure a 0.5 mL dose of Abrysvo.
• Twist to disconnect the syringe from the vial adapter.
• Attach a sterile needle suitable for intramuscular injection.

The prepared vaccine is a clear, colourless solution. Visually inspect the vaccine before administration to exclude the presence of large particulate matter or discoloration. Do not use if either of these characteristics is observed.

For use with the vial of Abrysvo antigens (powder) and the solvent vial

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

1. Using a sterile needle and syringe, withdraw the entire contents of the solvent vial and inject the full contents into the vial containing the powder.
2. Gently rotate the vial in a circular motion until the powder is completely dissolved. Do not shake.
3. Withdraw 0.5 mL from the vial containing the reconstituted vaccine.

The prepared vaccine is a clear, colourless solution. Visually inspect the vaccine before administration to exclude the presence of large particulate matter or discoloration. Do not use if either of these characteristics is observed.

Disposal
Any unused medicinal product and waste material derived from such medicinal product must be disposed of in accordance with local requirements.

ANNEX IV
CONCLUSIONS RELATING TO THE ANNUAL CONFIDENTIALITY PROTECTION REQUEST SUBMITTED BY THE EUROPEAN MEDICINES AGENCY
Conclusions submitted by the European Medicines Agency on:

• one-year confidentiality protection

In consideration of the provisions of Article 14(11) of Regulation (EC) No 726/2004, the Committee for Human Medicinal Products (CHMP) has reviewed the data submitted by the marketing authorization holder and considers that the new therapeutic indication provides a significant clinical benefit compared to currently available therapies, as further described in the European Public Assessment Report (EPAR).