Arexvy powder and suspension for injectable suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Arexvy powder and solvent for injectable suspension

respiratory syncytial virus vaccine (recombinant, adjuvanted)

This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Section 4 below includes information on how to report side effects.

Read all of this leaflet carefully before you start receiving this vaccine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Arexvy is and what it is used for

Arexvy is a vaccine that helps protect adults aged 18 years and older against a virus called respiratory syncytial virus (RSV).

RSV is a respiratory virus that spreads very easily.

• RSV can cause lower respiratory tract disease—infections in the lungs and other parts of the body involved in breathing.

RSV infection usually causes mild, cold-like symptoms in healthy adults. However, it can also:

• cause more severe respiratory illnesses and complications, such as lung infections (pneumonia), particularly in older adults and adults with underlying medical conditions
• worsen certain chronic conditions, such as long-term respiratory or heart diseases.

How Arexvy works

Arexvy helps your body's natural defenses produce antibodies and special white blood cells that protect you against RSV.

Arexvy does not contain the virus. This means it cannot cause an infection.

2. What you need to know before receiving Arexvy

Do not use Arexvy

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

Do not use Arexvy if any of the above apply to you. If you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before receiving Arexvy if:

• you have ever had a severe allergic reaction after injection of any other vaccine
• you have a serious infection with high fever. If this is the case, vaccination may be postponed until you feel better. A minor infection, such as a cold, should not be a problem, but consult your doctor first
• you have a bleeding disorder or bruise easily
• you have fainted after a previous injection. Fainting can occur before or after any needle injection
• you have a weakened immune system, as this may prevent you from obtaining full benefit from Arexvy.

If any of the above apply to you, or if you are unsure, consult your doctor or pharmacist before receiving Arexvy.

As with all vaccines, Arexvy may not fully protect all individuals who receive it.

Other medicines/vaccines and Arexvy

Inform your doctor or pharmacist if:

• you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription
• you have recently received any other vaccine.

Arexvy may be administered at the same time as an influenza vaccine, a pneumococcal conjugate vaccine, a herpes zoster vaccine, or an mRNA COVID-19 vaccine.

If Arexvy is administered at the same time as another injectable vaccine, a different injection site will be used for each vaccine, i.e., a different arm for each injection.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before receiving this vaccine.

Arexvy is not recommended during pregnancy or breastfeeding.

Driving and using machines

Some of the side effects listed below in section 4 “Possible side effects” (e.g., feeling tired) may temporarily affect your ability to drive or operate machinery. Do not drive or operate machinery or tools if you do not feel well.

Arexvy contains sodium and potassium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; essentially, “sodium-free”.

This medicine contains potassium, less than 1 mmol (39 mg) per dose; essentially, “potassium-free”.

3. How Arexvy is administered

Arexvy is administered as a single 0.5 ml dose injection into a muscle. It is usually given in the upper arm.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

Very rare (may occur in up to 1 in every 10,000 vaccine doses):

• a neurological disorder that usually begins with tingling and weakness in the limbs and may progress to paralysis of part or all of the body (Guillain-Barré syndrome).

Inform your doctor immediately if you notice signs of this serious adverse effect.

The following adverse effects may occur after receiving Arexvy:

Very common (may occur in more than 1 in every 10 vaccine doses):

• pain at the injection site
• tiredness (fatigue)
• headache
• muscle pain (myalgia)
• joint pain (arthralgia)

Common (may occur in up to 1 in every 10 vaccine doses):

• swelling at the injection site
• redness at the injection site
• fever
• chills

Uncommon (may occur in up to 1 in every 100 vaccine doses):

• itching at the injection site
• pain
• general malaise
• enlarged lymph nodes, or swelling of the glands in the neck, armpits, or groin (lymphadenopathy)
• allergic reactions, such as rash
• nausea
• vomiting
• stomach pain

Not known (cannot be estimated from available data):

• death of the skin tissue at the injection site (necrosis at the injection site)

Inform your doctor or pharmacist if you experience any of the adverse effects listed above. The intensity of most of these adverse effects is mild to moderate and they do not last long.

If any of the adverse effects you experience are severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Arexvy

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label and the carton, after EXP. The expiry date is the last day of the month indicated.
• Store in a refrigerator (between 2 °C and 8 °C).
• Do not freeze.
• Keep in the original packaging to protect from light.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Arexvy

• The active substances are:

After reconstitution, one dose (0.5 ml) contains:

1 recombinant respiratory syncytial virus F glycoprotein stabilized in the prefusion conformation = RSVPreF3

2 RSVPreF3 produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology

VRSPreF3 is a respiratory syncytial virus protein. This protein is not infectious.

The adjuvant is used to enhance the body's response to the vaccine.

• Other components are:

• Powder (VRSPreF3 antigen): trehalose dihydrate, polysorbate 80 (E 433), potassium dihydrogen phosphate (E 340), and dipotassium phosphate (E 340).

• Suspension: dioleoyl phosphatidylcholine (E 322), cholesterol, sodium chloride, anhydrous disodium phosphate (E 339), potassium dihydrogen phosphate (E 340), and water for injections.

See section 2, “Arexvy contains sodium and potassium”.

Nature of the product and contents of the container

• Powder and suspension for injectable suspension.
• The powder is white.
• The suspension is an opalescent liquid, colorless to light brown.

An Arexvy pack consists of:

• Powder (antigen) for 1 dose in a vial
• Suspension (adjuvant) for 1 dose in a vial

Arexvy is available in packs of 1 vial with powder and 1 vial with suspension, or in packs of 10 vials with powder and 10 vials with suspension.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

GlaxoSmithKline Biologicals SA
Rue de l’Institut 89
1330 Rixensart
Belgium

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu, and on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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This information is intended for healthcare professionals only:

Arexvy is supplied 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 suspension must be reconstituted prior to administration.

The powder and suspension should be visually inspected for the presence of any foreign particles and/or changes in appearance. If either of these conditions is observed, do not reconstitute the vaccine.

How to prepare Arexvy

Arexvy must be reconstituted before administration.

1. Withdraw the entire contents of the vial containing the suspension using a syringe.
2. Add all the contents of the syringe to the vial containing the powder.
3. Gently shake until the powder is completely dissolved.

The reconstituted vaccine is an opalescent liquid, colorless to light brown.

The reconstituted vaccine should be visually inspected for the presence of any foreign particles and/or changes in appearance. If either of these conditions is observed, do not administer the vaccine.

Physical and chemical stability in use has been demonstrated for 4 hours at 2 °C to 8 °C or at room temperature up to 25 °C.

From a microbiological standpoint, the vaccine should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and must not exceed 4 hours.

Before administration

1. Withdraw 0.5 mL of the reconstituted vaccine using the syringe.
2. Change the needle, using a new one.

Administer the vaccine by intramuscular injection.

Any unused medicine and materials that have come into contact with it should be disposed of in accordance with local regulations.