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.
Arexvy powder and suspension for suspension 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 (rsv) vaccine (recombinant, adjuvanted) 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
Arexvy is a vaccine that helps to protect adults aged 60 years and older against a virus called 'respiratory syncytial virus' (RSV). Arexvy also helps to protect against RSV in adults 50 through 59 years of age at increased risk for RSV disease. RSV is a respiratory virus that spreads very easily.
- RSV can cause lower respiratory tract disease – infections of the lungs and other parts of the body that help you breathe. RSV infection usually causes mild, cold-like signs in healthy adults. But it can also:
- cause more serious respiratory illnesses and complications, such as infections of the lungs (pneumonia), in older adults and adults with underlying medical conditions
- make some illnesses worse, such as long-term respiratory or heart diseases. How Arexvy works Arexvy helps your body's natural defences make antibodies and special white blood cells. These protect you against RSV. Arexvy does not contain the virus. This means it cannot cause an infection.
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What you need to know before you take it
e Arexvy
Do not use Arexvy •
if you are allergic to the active substances or any of the other ingredients of this vaccine (listed in section 6). Do not use Arexvy if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist. Warnings and precautions Talk to your doctor, pharmacist or nurse before you receive Arexvy if:
- you have ever had a severe allergic reaction after the injection of any other vaccine
- you have a severe infection with a high temperature (fever). If this happens, the vaccination may be delayed until you feel better. A minor infection such as a cold should not be a problem but talk to your doctor first
- you have a bleeding problem or bruise easily
- you have fainted with a previous injection – fainting can happen before or after any needle injection. If any of the above apply to you, or you are not sure, talk to your doctor or pharmacist before you have Arexvy. As with all vaccines, Arexvy may not fully protect all people who are vaccinated. Other medicines/vaccines and Arexvy Tell your doctor or pharmacist if:
- you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription.
- you have recently received any other vaccine. Arexvy may be given at the same time as a flu vaccine, pneumococcal conjugate vaccine, shingles (herpes zoster) vaccine or COVID-19 mRNA vaccine. If Arexvy is given at the same time as another injectable vaccine, a different injection site will be used for each vaccine, which means a different arm for each injection. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this vaccine. Arexvy is not recommended during pregnancy or breast-feeding. Driving and using machines Some of the effects mentioned below in section 4 "Possible side effects" (e.g. feeling tired) may temporarily affect the ability to drive or use machines. Do not drive or use machines or tools if you are feeling unwell. Arexvy contains sodium and potassium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodiumfree'. This medicine contains less than 1 mmol (39 mg) potassium per dose, i.e. essentially 'potassium-free'.
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How to take it
Arexvy is given as a single dose injection of 0.5 mL into a muscle. It is usually given into the upper arm. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen after receiving Arexvy: Serious side effects
- Very rare (may affect up to 1 in 10 000 people): Guillain-Barré syndrome (a neurological disorder that usually starts with pins and needles and weakness of the limbs and may progress up to paralysis of part or all of the body). Tell your doctor immediately if you notice signs of this serious side effect. Very common (these may occur with more than 1 in 10 doses of the vaccine):
- pain at the injection site
- feeling tired (fatigue)
- headache
- muscle pain (myalgia)
- joint pain (arthralgia)
- redness where the injection is given Common (these may occur with up to 1 in 10 doses of the vaccine):
- swelling where the injection is given
- fever
- chills Uncommon (these may occur with up to 1 in 100 doses of vaccine):
- itching at the injection site
- pain
- generally feeling unwell (malaise)
- enlarged lymph nodes, or swollen glands in the neck, armpit or groin (lymphadenopathy)
- allergic reactions such as rash
- feeling sick (nausea)
- vomiting
- stomach pain Very rare (may affect up to 1 in 10 000 people):
- Guillain-Barré syndrome (see Serious side effects, above). An increased risk of GuillainBarré syndrome after Arexvy has been observed (estimated 7 additional cases per million doses administered) in a study conducted in the US in people aged 65 years and older Not known (cannot be estimated from the available data):
- death of skin tissue in the injection site (injection site necrosis) Tell your doctor or pharmacist if you get any of the side effects listed above. Most of these side effects are mild to moderate in intensity and do not last long. 3
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: 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
Arexvy • • • • • •
6.
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 label and carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 °C – 8 °C). Do not freeze. Store in the original package in order to protect from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Arexvy contains •
The active substances are: After reconstitution, one dose (0.5 mL) contains: RSVPreF31 antigen2,3 120 micrograms 1
Respiratory Syncytial Virus recombinant glycoprotein F stabilised in the pre-fusion conformation = RSVPreF3 2
RSVPreF3 produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology 3
adjuvanted with AS01E containing: plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 25 micrograms 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota 25 micrograms
The RSVPreF3 is a protein present in the Respiratory Syncytial Virus. This protein is not infectious. The adjuvant is used to improve the body's response to the vaccine.
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The other ingredients are: o Powder (RSVPreF3 antigen): Trehalose dihydrate, polysorbate 80 (E 433), potassium dihydrogen phosphate (E 340), dipotassium phosphate (E 340). o Suspension: Dioleoyl phosphatidylcholine (E 322), cholesterol, sodium chloride, disodium phosphate anhydrous (E 339), potassium dihydrogen phosphate (E 340) and water for injections. See Section 2 "Arexvy contains sodium and potassium".
What Arexvy looks like and contents of the pack • • •
Powder and suspension for suspension for injection. The powder is white. The suspension is an opalescent, colourless to pale brownish liquid.
One pack of Arexvy consists of:
- Powder (antigen) for 1 dose in a vial
- Suspension (adjuvant) for 1 dose in a vial Arexvy is available in a pack size of 1 vial of powder plus 1 vial of suspension or in a pack size of 10 vials of powder plus 10 vials of suspension. Not all pack sizes may be marketed. Marketing Authorisation Holder GlaxoSmithKline UK Limited 79 New Oxford Street London WC1A 1DG United Kingdom Manufacturer GlaxoSmithKline Biologicals SA Rue de l'Institut 89 1330 Rixensart Belgium Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only). Please be ready to give the following information: Product name Arexvy Reference number 19494/0316 This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in October 2025 Trade marks are owned by or licensed to the GSK group of companies © 2025 GSK group of companies or its licensor
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<————————————————————————————————————————> The following information is intended for healthcare professionals only: Arexvy is presented as a vial with a mustard green flip-off cap containing the powder (antigen) and a vial with a brown flip-off cap containing the suspension (adjuvant). The powder and the suspension must be reconstituted prior to administration.
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The powder and suspension should be inspected visually for any foreign particulate matter and/or variation of appearance. If either is observed, do not reconstitute the vaccine. How to prepare Arexvy Arexvy must be reconstituted prior to administration. 1. 2. 3.
Withdraw the entire contents of the vial containing the suspension into the syringe. Add the entire contents of the syringe into the vial containing the powder. Gently swirl until the powder is completely dissolved.
The reconstituted vaccine is an opalescent, colourless to pale brownish liquid. The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of appearance. If either is observed, do not administer the vaccine. Chemical and physical in-use stability has been demonstrated for 4 hours at 2 °C – 8 °C or at room temperature up to 25 °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 and should not be longer than 4 hours. Before administration 1. 2.
Withdraw 0.5 mL of the reconstituted vaccine into the syringe. Change the needle so that you are using a new needle.
Administer the vaccine intramuscularly. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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Frequently asked questions about Arexvy powder and suspension for suspension for injection
How do I take Arexvy powder and suspension for suspension for injection?
Arexvy powder and suspension for suspension for injection comes as oral solution. 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 Arexvy powder and suspension for suspension for injection?
The active substance in Arexvy powder and suspension for suspension for injection is respiratory syncytial virus (rsv) vaccine (recombinant, adjuvanted).
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Arexvy powder and suspension for suspension 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 Arexvy powder and suspension for suspension 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 (rsv) vaccine (recombinant, adjuvanted)
- 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
Arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in:
• adults 60 years of age and older;
• adults 50 through 59 years of age who are at increased risk for RSV disease.
The use of this vaccine should be in accordance with official recommendations.
4.2. Posology and method of administration
Posology
Arexvy is administered as a single dose of 0.5 mL.
The need for revaccination with a subsequent dose has not been established (see section 5.1).
Paediatric population
The safety and efficacy of Arexvy in children have not been established.
No data are available.
Method of administration
For intramuscular injection only, preferably in the deltoid muscle.
For instructions on reconstitution 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.
Prior to immunisation
Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Vaccination should be postponed in individuals suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions may occur in association with the vaccination process itself. It is important that precautions are in place to avoid injury from fainting.
Precautions for use
Do not administer the vaccine intravascularly or intradermally. No data are available on subcutaneous administration of Arexvy.
As with other intramuscular injections, Arexvy should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration to these individuals.
Systemic immunosuppressive medicinal products and immunodeficiency
Safety and immunogenicity data on Arexvy are not available for immunocompromised individuals. Patients receiving immunosuppressive treatment or patients with immunodeficiency may have a reduced immune response to Arexvy.
Guillain-Barré Syndrome
Guillain-Barré syndrome has been reported very rarely following vaccination with Arexvy (see section 4.8). Healthcare professionals should be attentive to signs and symptoms of Guillain-Barré syndrome in Arexvy recipients to ensure correct diagnosis, initiate adequate supportive care and treatment, and rule out other causes.
Excipients
This medicinal product contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially 'potassium-free'.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
Use with other vaccines
Arexvy may be administered concomitantly with a COVID-19 mRNA vaccine, pneumococcal conjugate vaccine, herpes zoster vaccine (recombinant, adjuvanted), inactivated seasonal influenza vaccine (standard dose unadjuvanted, high dose unadjuvanted, or standard dose adjuvanted).
If Arexvy is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.
Concomitant administration of Arexvy with other vaccines than those listed above has not been studied.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no data from the use of Arexvy in pregnant women. After administration of an investigational unadjuvanted RSVPreF3 vaccine to 3 557 pregnant women in a single clinical study, an increase in preterm births was observed compared to placebo. Currently no conclusion on a causal relationship between administration of unadjuvanted RSVPreF3 and preterm birth can be drawn. Results from animal studies with Arexvy or with an investigational unadjuvanted RSVPreF3 vaccine do not indicate direct or indirect harmful effects with respect to developmental and reproductive toxicity (see section 5.3). Arexvy is not recommended during pregnancy.
Breast-feeding
There are no data on the excretion of Arexvy in human or animal milk. Arexvy is not recommended in breast-feeding/lactating women.
Fertility
There are no data on the effects of Arexvy on human fertility. Animal studies with Arexvy or with an investigational unadjuvanted RSVPreF3 vaccine do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
4.7. Effects on ability to drive and use machines
No studies on the effects of Arexvy on the ability to drive and use machines have been performed.
Arexvy has a minor influence on the ability to drive and use machines. Some of the effects mentioned under section 4.8 “Undesirable effects” (e.g. fatigue) may temporarily affect the ability to drive or use machines.
4.8. Undesirable effects
Summary of the safety profile
The safety profile presented in Table 1 is based on a pooled analysis of data generated in two placebo-controlled Phase III clinical studies (conducted in Europe, North America, Asia and Southern hemisphere) in adults ≥ 60, and 50 through 59 years of age, and on post-marketing experience.
In study participants 60 years of age and older (more than 12 000 adults received one dose of Arexvy and more than 12 000 received placebo, with a follow-up period of approximately 12 months), the most commonly reported adverse reactions were injection site pain (61%), fatigue (34%), myalgia (29%), headache (28%), and arthralgia (18%). These adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination.
Most other adverse reactions were uncommon and similarly reported between the study groups.
In study participants 50 through 59 years of age (769 participants, including 386 participants with pre-defined, stable, chronic medical conditions leading to an increased risk for RSV disease), a higher incidence of injection site pain (76%), fatigue (40%), myalgia (36%), headache (32%), and arthralgia (23%) was observed, compared with those 60 years of age and older (381 participants) in the same study. However, the duration and severity of these events were comparable across age groups in the study.
Tabulated list of adverse reactions
Adverse reactions are listed below by MedDRA system organ class and frequency.
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)
Table 1 presents adverse reactions observed in clinical trials as well as adverse reactions which have been spontaneously reported during the post-marketing use of Arexvy worldwide.
Table 1. Adverse reactions
System Organ Class
Frequency
Adverse reactions
Blood and lymphatic system disorders
Uncommon
lymphadenopathy
Immune system disorders
Uncommon
hypersensitivity reactions (such as rash)
Nervous system disorders
Very common
headache
Very rare
Guillain-Barré syndrome
Gastrointestinal disorders
Uncommon
nausea, abdominal pain, vomiting
Musculoskeletal and connective tissue disorders
Very common
myalgia, arthralgia
General disorders and administration site conditions
Very common
injection site pain, injection site erythema, fatigue
Common
injection site swelling, fever, chills
Uncommon
injection site pruritus
pain, malaise
Not known
injection site necrosis1
1Adverse reaction from spontaneous reporting.
Description of selected adverse reactions
Guillain-Barré syndrome
In an open label, phase 3, multi-country study in individuals 60 years of age and older, one case of Guillain-Barré syndrome was reported in a participant enrolled in a study site in Japan with an onset of 9 days after receiving Arexvy and assessed by the investigator as possibly related to the administered vaccine.
In a US post-marketing observational study in individuals aged 65 years or older, an increased risk of Guillain-Barré syndrome (estimated 7 excess cases per million doses administered) was observed during the 42 days following vaccination with Arexvy.
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
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
No case of overdose has been reported in the clinical studies.
🇷🇴 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 (rsv) vaccine (recombinant, adjuvanted). 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 Arexvy powder and suspension for suspension 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.