Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Abrysvo powder and solvent for solution for injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Respiratory syncytial virus vaccine (bivalent, recombinant) may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Abrysvo is a vaccine to prevent lung (respiratory tract) disease caused by a virus called respiratory syncytial virus (RSV). Abrysvo is given to: • or • or •
pregnant individuals to protect their infants from birth through 6 months of age individuals 60 years of age and older. individuals 18 through 59 years of age who are at increased risk of lung disease caused by RSV.
RSV is a common virus which, in most cases, causes mild, cold-like symptoms such as a sore throat, cough or a blocked nose. However, in young infants RSV can cause serious lung problems. In older adults and people with chronic medical conditions, RSV can worsen illnesses such as chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). RSV can lead to hospitalisation in severe cases and in some cases it can be fatal. How Abrysvo works This vaccine helps the immune system (the body's natural defences) to make antibodies (substances in the blood that help the body fight infections) which protect against lung disease caused by RSV. In pregnant individuals who are vaccinated between weeks 28 and 36 of pregnancy, these antibodies are passed to the infant through the placenta before birth which protects infants when they are at most risk from RSV. 2.
What you need to know before you take it
e Abrysvo
Abrysvo should not be given
- if you are allergic to the active substances or any of the other ingredients of this vaccine (listed in section 6). Page 1 of 7
Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given this vaccine
- if you have ever had a severe allergic reaction or breathing problems after you received any other vaccine injection or after you were given Abrysvo in the past.
- if you are feeling nervous about getting the vaccine or have ever fainted after any injection. Fainting can happen before or after any injection.
- if you have an infection with a high fever. If this is the case, then vaccination will be postponed. There is no need to delay vaccination for a minor infection, such as a cold, but talk to your doctor first.
- if you have a bleeding problem or bruise easily.
- if you have a weakened immune system which may prevent you from getting the full benefit from Abrysvo.
- if you are less than 28 weeks pregnant. If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Abrysvo. As with any vaccine, Abrysvo may not fully protect all those who receive it. Children and adolescents Abrysvo is not recommended in children and young people below 18 years of age except during pregnancy (see 'Pregnancy' section below). Other medicines and Abrysvo Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines or have recently received any other vaccine. Abrysvo may be given at the same time as a flu vaccine or a COVID-19 vaccine. A gap of at least two weeks is recommended between administration of Abrysvo and administration of a vaccine against tetanus, diphtheria and acellular pertussis (whooping cough). Pregnancy and breast-feeding Pregnant individuals can be given this vaccine in the third trimester (weeks 28 to 36). Talk to your doctor or nurse for advice before getting this vaccine if you are breast-feeding. Driving and using machines Abrysvo is unlikely to affect your ability to drive or use machines. Abrysvo contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'. Abrysvo contains polysorbate 80 One dose of Abrysvo contains 0.08 mg of polysorbate 80. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies. 3.
How to take it
You will be given one injection of 0.5 mL into a muscle of your upper arm. If you have any questions on the use of Abrysvo, ask your doctor, pharmacist or nurse. 4.
Possible side effects
Like all vaccines, this vaccine can cause side effects, although not everybody gets them. Page 2 of 7
Serious side effects Rare (may affect up to 1 in 1 000 people) • Guillain-Barré syndrome (a serious nerve condition that usually starts with pins and needles (an uncomfortable tingling sensation) and weakness of the legs and/or arms that can progress up to paralysis of part or all of the body, and include difficulty breathing. Urgent hospital treatment is required to help prevent the symptoms progressing and improve recovery, however the effects of Guillain-Barré syndrome may sometimes be long-lasting. 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. Seek immediate medical attention if you notice signs of these serious side effects. The following side effects were reported in pregnant individuals Very common (may affect more than 1 in 10 people) • pain where the injection is given • headache • muscle pain (myalgia). Common (may affect up to 1 in 10 people) • redness where the injection is given • swelling where the injection is given. Rare (may affect up to 1 in 1 000 people) • allergic reactions such as rash or hives • swollen glands (lymphadenopathy). No side effects were reported in infants born to vaccinated mothers. The following side effects were reported in individuals 18 years of age and older Very common (may affect more than 1 in 10 people) • tiredness (fatigue) • headache • pain where the injection is given • muscle pain (myalgia). Common (may affect up to 1 in 10 people) • joint pain (arthralgia) • redness where the injection is given • swelling where the injection is given. Uncommon (may affect up to 1 in 100 people) • fever (pyrexia). Rare (may affect up to 1 in 1 000 people) • serious nerve inflammation, which may cause paralysis and difficulty breathing (GuillainBarré syndrome) (see Serious side effects, above)* • allergic reactions such as rash or hives • swollen glands (lymphadenopathy) • bruising where the injection is given (haematoma) • itching where the injection is given (pruritus). Page 3 of 7
*Frequency reported in individuals 60 years of age and older. Very rare (may affect up to 1 in 10 000 people) • severe allergic reactions (see Serious side effects, above) Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
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 refers to the last day of that month. Store in a refrigerator (2oC – 8oC). Do not freeze. Discard if the carton 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.
Contents of the pack and other information
What Abrysvo contains The active substances are: RSV subgroup A stabilised prefusion F antigen1,2 60 micrograms RSV subgroup B stabilised prefusion F antigen1,2 60 micrograms (RSV antigens) 1 glycoprotein F stabilised in the prefusion conformation 2 produced in Chinese Hamster Ovary cells by recombinant DNA technology. The other ingredients are: Powder
- trometamol
- trometamol hydrochloride
- sucrose
- mannitol (E421)
- polysorbate 80 (E433)
- sodium chloride
- hydrochloric acid Solvent
- water for injections What Abrysvo looks like and contents of the pack Abrysvo is provided as
- a white powder in a glass vial
- a solvent in a pre-filled syringe or a vial to dissolve the powder After dissolving the powder in the solvent, the solution is clear and colourless. Page 4 of 7
Abrysvo is available in
- a carton containing 1 vial of powder, 1 pre-filled syringe of solvent, 1 vial adaptor, with 1 needle or without needles (1 dose pack).
- a carton containing 5 vials of powder, 5 pre-filled syringes of solvent, 5 vial adaptors, with 5 needles or without needles (5 dose pack).
- a carton containing 10 vials of powder, 10 pre-filled syringes of solvent, 10 vial adaptors, with 10 needles or without needles (10 dose pack).
- a carton containing 5 vials of powder and 5 vials of solvent (5 dose pack).
- a carton containing 10 vials of powder and 10 vials of solvent (10 dose pack). Not all pack sizes may be marketed. Marketing Authorisation Holder Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ United Kingdom Manufacturer Pfizer Manufacturing Belgium NV Rijksweg 12 2870 Puurs-Sint-Amands Belgium For any information about this medicine, please contact: Medical Information, Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS. Telephone 01304 616161 This leaflet was last revised in 11/2025. Ref: bAB 11_0 ————————————————————————————————————————–The following information is intended for healthcare professionals only: Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Administration Abrysvo is for intramuscular use only. The unopened vial is stable for 5 days when stored at temperatures from 8°C to 30°C. At the end of this period Abrysvo should be used or discarded. This information is used to guide healthcare professionals in case of temporary temperature excursions only. Storage of reconstituted vaccine Abrysvo should be used immediately after reconstitution or within 4 hours. Store the reconstituted vaccine between 15oC and 30oC. Do not freeze reconstituted vaccine.
Page 5 of 7
Chemical and physical in-use stability has been demonstrated for 4 hours between 15°C and 30°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. Preparation for administration For use of vial of antigens for Abrysvo (powder), pre-filled syringe of solvent and vial adaptor The powder must be reconstituted only with the solvent provided in the pre-filled syringe using the vial adaptor. Pre-filled syringe containing solvent for Abrysvo
Vial containing antigens for Abrysvo (powder)
Syringe cap
Vial stopper (with flip off cap removed)
Luer lock adaptor
Vial adaptor
Step 1. Attach vial adaptor
- Peel off the top cover from the vial adaptor packaging and remove the flip off cap from the vial.
- While keeping the vial adaptor in its packaging, centre over the vial's stopper and connect with a straight downward push. Do not push the vial adaptor in at an angle as it may result in leaking. Remove the packaging. Step 2. Reconstitute the powder component (antigens) to form Abrysvo
- For all syringe assembly steps, hold the syringe only by the Luer lock adaptor. This will prevent the Luer lock adaptor from detaching during use.
- Twist to remove the syringe cap, then twist to connect the syringe to the vial adaptor. Stop turning when you feel resistance.
- Inject the entire contents of the syringe into the vial. Hold the plunger rod down and gently swirl the vial until the powder is completely dissolved. Do not shake. Step 3. Withdraw reconstituted vaccine
- Invert the vial completely 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 adaptor.
- Attach a sterile needle suitable for intramuscular injection.
The prepared vaccine is a clear and colourless solution. Visually inspect the vaccine for large particulate matter and discolouration prior to administration. Do not use if large particulate matter or discolouration is found.
Page 6 of 7
For use of vial of antigens for Abrysvo (powder) and vial of solvent The powder must be reconstituted only with the vial of solvent provided.
1. Using a sterile needle and sterile syringe, withdraw the entire contents of the vial containing the solvent and inject the entire contents of the syringe into the vial containing the powder. 2. Gently swirl 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 and colourless solution. Visually inspect the vaccine for large particulate matter and discolouration prior to administration. Do not use if large particulate matter or discolouration is found. Disposal Any unused product or waste material should be disposed of in accordance with local requirements.
Page 7 of 7
Frequently asked questions about Abrysvo powder and solvent for solution for injection
How do I take Abrysvo powder and solvent for solution for injection?
Abrysvo powder and solvent for solution for injection comes as injection. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Abrysvo powder and solvent for solution for injection?
The active substance in Abrysvo powder and solvent for solution for injection is respiratory syncytial virus vaccine (bivalent, recombinant).
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Abrysvo powder and solvent for solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Abrysvo powder and solvent for solution for injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: respiratory syncytial virus vaccine (bivalent, recombinant)
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Abrysvo is indicated for:
• Active immunisation of pregnant individuals to protect infants from birth through 6 months of age against lower respiratory tract disease caused by respiratory syncytial virus (RSV). See sections 4.2 and 5.1.
• Active immunisation for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
• Active immunisation for the prevention of lower respiratory tract disease caused by RSV in individuals 18 through 59 years of age who are at increased risk for lower respiratory tract disease caused by RSV.
The use of this vaccine should be in accordance with official recommendations.
4.2. Posology and method of administration
Posology
Pregnant individuals
A single dose of 0.5 mL should be administered between weeks 28 and 36 of gestation (see sections 4.4, 4.6 and 5.1).
Individuals 18 years of age and older
A single dose of 0.5 mL should be administered.
The need for revaccination has not been established.
Immunocompromised individuals
A single dose of 0.5 mL should be administered. The need for a second dose has not been established (see section 5.1).
Paediatric population
The safety and efficacy of Abrysvo in children (from birth to less than 18 years of age) have not yet been established. Limited data are available in pregnant adolescents and their infants (see section 5.1).
Method of administration
Abrysvo is for intramuscular injection into the deltoid region of the upper arm.
The vaccine should not be mixed with any other vaccines or medicinal products.
For instructions on reconstitution and handling of the medicinal product before administration, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Hypersensitivity and anaphylaxis
Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Anxiety-related reactions
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from fainting.
Concurrent illness
Vaccination should be postponed in individuals suffering from an acute febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Thrombocytopenia and coagulation disorders
Abrysvo should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding or bruising may occur following an intramuscular administration to these individuals.
Immunocompromised individuals
Safety and immunogenicity have been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy (see sections 4.8 and 5.1). The efficacy of Abrysvo may be lower in immunosuppressed individuals.
Individuals less than 28 weeks of gestation
Abrysvo has not been studied in pregnant individuals less than 24 weeks of gestation and should not be used in pregnant individuals less than 28 weeks of gestation (see sections 4.2, 4.6 and 5.1).
Limitations of vaccine effectiveness
As with any vaccine, a protective immune response may not be elicited after vaccination.
Guillain-Barré Syndrome
Guillain-Barré syndrome has been reported rarely following vaccination with Abrysvo in individuals ≥ 60 years (see section 4.8).
Healthcare professionals should be attentive to signs and symptoms of Guillain-Barré syndrome in all Abrysvo recipients to ensure correct diagnosis, in order to initiate adequate supportive care and treatment, and rule out other causes.
Excipients
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium‑free'.
Abrysvo contains polysorbate 80. Polysorbate 80 may cause hypersensitivity reactions.
4.5. Interaction with other medicinal products and other forms of interaction
Abrysvo can be administered concomitantly with:
• seasonal influenza vaccines, either standard dose adjuvanted or high dose unadjuvanted.
• COVID-19 mRNA vaccines, with or without high dose unadjuvanted influenza vaccine administered concomitantly.
A minimum interval of two weeks is recommended between administration of Abrysvo and administration of a tetanus, diphtheria and acellular pertussis vaccine (Tdap). There were no safety concerns when Abrysvo was co‑administered with Tdap in healthy non‑pregnant women. Immune responses to RSV A, RSV B, diphtheria and tetanus on co‑administration were non-inferior to those after separate administration. However, the immune responses to the pertussis components were lower on co‑administration compared to separate administration and did not meet the criteria for non‑inferiority. The clinical relevance of this finding is unknown.
Data on concomitant administration of Abrysvo and vaccines other than those listed is not available.
4.6. Fertility, pregnancy and lactation
Pregnancy
Data on pregnant women (more than 4 000 exposed outcomes) indicate no malformative nor feto/neonatal toxicity.
Results from animal studies with Abrysvo do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
In a phase 3 study (Study 1), maternal adverse events reported within 1 month after vaccination were similar in the Abrysvo group (14%) and the placebo group (13%).
No safety signals were detected in infants up to 24 months of age. The incidences of adverse events reported within 1 month after birth in infants were similar in the Abrysvo group (38%) and the placebo group (35%). Major birth outcomes assessed in the Abrysvo group compared to placebo included premature birth (207 (6%) and 172 (5%), respectively), low birth weight (186 (5%) and 158 (4%), respectively) and congenital anomalies (205 (6%) and 245 (7%), respectively). As a precautionary measure until more data are available, Abrysvo should be administered to pregnant individuals between weeks 28 and 36 of gestation to minimise any potential risk of extremely premature birth (see section 4.2).
Breast-feeding
It is unknown whether Abrysvo is excreted in human milk. No adverse effects of Abrysvo have been shown in breastfed newborns of vaccinated mothers.
Fertility
No human data on the effect of Abrysvo on fertility are available.
Animal studies do not indicate direct or indirect harmful effects with respect to female fertility (see section 5.3).
4.7. Effects on ability to drive and use machines
Abrysvo has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
Pregnant individuals
In pregnant women at 24-36 weeks of gestation the most frequently reported adverse reactions were vaccination site pain (41%), headache (31%) and myalgia (27%). The majority of local and systemic reactions in maternal participants were mild to moderate in severity and resolved within 2-3 days of onset.
Individuals 18 years of age and older
In individuals 18 years of age and older the most frequently reported adverse reactions were fatigue (23%), headache (20%), vaccination site pain (19%) and myalgia (16%). The majority of reactions were mild to moderate in severity and resolved within 1‑2 days of onset.
Tabulated list of adverse reactions
The safety of administering a single dose of Abrysvo to pregnant women at 24-36 weeks of gestation (n=3 698) and to individuals 18 years of age and older (n=20 275) was evaluated in clinical trials.
Adverse reactions are listed according to the following frequency categories:
Very common (≥1/10);
Common (≥1/100 to <1/10);
Uncommon (≥1/1 000 to <1/100);
Rare (≥1/10 000 to <1/1 000);
Very rare (<1/10 000);
Not known (cannot be estimated from the available data).
Adverse reactions reported are listed per system organ class, in decreasing order of seriousness.
Table 1 Adverse reactions following administration of Abrysvo
System organ class
Adverse drug reactions
pregnant individuals
≤49 years
Adverse drug reactions
individuals
≥18 years
Blood and lymphatic system disorders
Lymphadenopathy
Rare
Rare
Immune system disorders
Anaphylaxis
Very rare
Hypersensitivity reactions (includes rash, urticaria)
Rare
Rare
Nervous system disorders
Headache
Very common
Very common
Guillain-Barré syndrome
Rarea
Musculoskeletal and connective tissue disorders
Myalgia
Very common
Very common
Arthralgia
Common
General disorders and administration site conditions
Fatigue
Very common
Vaccination site pain
Very common
Very common
Vaccination site redness
Common
Common
Vaccination site swelling
Common
Common
Pyrexia
Uncommon
Vaccination site pruritus
Rare
Vaccination site bruising
Rare
Vaccination site haematoma
Rare
aFrequency reported in individuals 60 years of age and older
Special populations
Immunocompromised individuals 18 years of age and older
Reactogenicity was consistent with the known profile of Abrysvo. There were no unexpected safety findings.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Overdose with Abrysvo is unlikely due to its single dose presentation.
There is no specific treatment for an overdose with Abrysvo. In the event of an overdose, the individual should be monitored and provided with symptomatic treatment as appropriate.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Respiratory syncytial virus vaccine (bivalent, recombinant). The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- BCG VACCINE prescription partial — not the same combinationVACCIN BCG · injection / infusion
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- Onko BCG 100BCG vaccinum 100 mg
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Abrysvo powder and solvent for solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.