Arexvy

Package leaflet: Information for the user

Arexvy powder and suspension for injectable suspension

Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted)
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 taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you use this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. 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 administered
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 diseases – infections of the lungs and other parts of the body involved in breathing. RSV infection usually causes mild flu-like symptoms in healthy adults. However, it can also:
• cause more serious respiratory diseases and complications, such as lung infections (pneumonia) in elderly individuals and adults with pre-existing medical conditions
• worsen certain long-term conditions, such as respiratory or heart diseases.

How Arexvy works
Arexvy helps the body's natural defenses to produce antibodies and specialized white blood cells. These protect against RSV. Arexvy does not contain the virus. Therefore, 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 substance or to any of the other components of this vaccine (listed in section 6).

If any of the conditions described above apply to you, do not use Arexvy. If you have any doubts, consult your
doctor or pharmacist.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before receiving Arexvy if:

• you have had a severe allergic reaction after an injection of any other vaccine
• you have a serious infection with high fever. In such cases, vaccination may be postponed until you recover. A minor infection such as a cold should not be a problem, but discuss this with your doctor first
• you have bleeding disorders or bruise easily
• you have fainted after a previous injection – fainting can occur before or after any injection with a needle. If any of the conditions described above apply to you or if you are unsure, speak with your doctor or pharmacist before receiving Arexvy. Like all vaccines, Arexvy may not fully protect all vaccinated individuals. Other medicines/vaccines and Arexvy Inform your doctor or pharmacist if:
• you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
• you have recently received another vaccine. Arexvy may be administered at the same time as an influenza vaccine, conjugate pneumococcal vaccine, herpes zoster vaccine, or an mRNA COVID-19 vaccine. If Arexvy is administered simultaneously with 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, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before receiving this vaccine. Arexvy is not recommended during pregnancy or breastfeeding. Driving and using machines Some of the effects mentioned 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 if you do not feel well. Arexvy contains sodium and potassium This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’. This medicine contains less than 1 mmol (39 mg) of potassium per dose, i.e., essentially ‘potassium-free’.

3. How Arexvy is administered

Arexvy is administered as a single 0.5 mL dose into the muscle. The injection is usually given in the upper arm.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Very rare (may occur in up to 1 in 10,000 doses of vaccine):

• 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 (Guillain-Barré syndrome)

Inform your doctor immediately if you notice signs of this serious side effect.
The following side effects may occur after administration of Arexvy:
Very common (may affect more than 1 in 10 doses of vaccine):

• pain at the injection site
• feeling tired
• headache
• muscle pain (myalgia)
• joint pain (arthralgia)

Common (may affect up to 1 in 10 doses of vaccine):

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

Uncommon (may affect up to 1 in 100 doses of vaccine):

• itching at the injection site
• pain
• general feeling of being unwell (malaise)
• swollen lymph nodes or swelling of the glands in the neck, armpits or groin (lymphadenopathy)
• allergic reaction such as skin rash
• nausea
• vomiting
• stomach ache

Not known (cannot be estimated from the available data):

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

Inform your doctor or pharmacist if you experience any of the side effects listed above. Most of these side effects are mild or moderate in intensity and do not last for a long time.
If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 carton following EXP. The expiry date refers to the last day of that month.
• Store in a refrigerator (2 °C - 8 °C).
• Do not freeze.
• Keep in the original packaging to protect the medicine from light.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Arexvy contains

• The active substance is:

After reconstitution, one dose (0.5 mL) contains:
RSVPreF3 antigen 120 micrograms
recombinant fusion glycoprotein F of Respiratory Syncytial Virus stabilized in the pre-fusion
conformation = RSVPreF3
RSVPreF3 produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology
adjuvanted with AS01 containing:
Quillaja saponaria Molina extract, fraction 21 (QS-21) 25 micrograms
3-O-desacyl-4’-monophosphoryl lipid A (MPL) from Salmonella minnesota 25 micrograms
RSVPreF3 is a protein found in the Respiratory Syncytial Virus. This protein is not
infectious.
The adjuvant is used to enhance the body's immune response to the vaccine.

• Other components are:

o Powder (antigen RSVPreF3): Trehalose dihydrate, polysorbate 80 (E 433), potassium
dihydrogen phosphate (E 340), dipotassium phosphate (E 340)
o Suspension: Dioleoyl phosphatidylcholine (E 322), cholesterol, sodium chloride, anhydrous
sodium phosphate (E 339), potassium dihydrogen phosphate (E 340), water for
injections

See section 2 “Arexvy contains sodium and potassium”

Description of the appearance of Arexvy and package contents

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

One Arexvy pack consists of:

• One vial of powder (antigen) for 1 dose
• One vial of suspension (adjuvant) for 1 dose

Arexvy is available in packs containing 1 vial of powder and 1 vial of suspension, or in packs containing 10 vials of powder and 10 vials of suspension.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
GlaxoSmithKline Biologicals SA
Rue de l’Institut 89
1330 Rixensart
Belgium
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals s.a./n.v GlaxoSmithKline Biologicals SA
Tél/Tel: + 32 (0) 10 85 52 00 Tel: +370 80000334

България Luxembourg/Luxemburg
GlaxoSmithKline Biologicals SA GlaxoSmithKline Pharmaceuticals s.a./n.v
Тел. +359 80018205 Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 52 00

Česká republika Magyarország
GlaxoSmithKline s.r.o. GlaxoSmithKline Biologicals SA
Tel: + 420 222 001 111 Tel.: +36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Biologicals SA
Tlf: + 45 36 35 91 00 Tel: +356 80065004
[email protected]

Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel: + 49 (0)89 360448701 Tel: + 31 (0)33 2081100
[email protected]

Eesti Norge
GlaxoSmithKline Biologicals SA GlaxoSmithKline AS
Tel: +372 8002640 Tlf: + 47 22 70 20 00

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Tηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (22) 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tél: + 33 (0) 1 39 17 84 44 Tel: + 351 21 412 95 00
[email protected] [email protected]

Hrvatska România
GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA
Tel.: +385 800787089 Tel: +40 800672524

Ireland Slovenija
GlaxoSmithKline (Ireland) Ltd GlaxoSmithKline Biologicals SA
Tel: + 353 (0)1 495 5000 Tel: +386 80688869

Ísland Slovenská republika
Vistor hf. GlaxoSmithKline Biologicals SA
Sími: +354 535 7000 Tel.: +421 800500589

Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: + 39 (0)45 7741 111 Puh/Tel: + 358 10 30 30 30

Κύπρος Sverige
GlaxoSmithKline Biologicals SA GlaxoSmithKline AB
Τηλ: +357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
GlaxoSmithKline Biologicals SA
Tel: +371 80205045

Other 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.
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The following information is intended for healthcare professionals only:
Arexvy is supplied as a vial with a 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 before administration.

Antigen Adjuvant
Powder Suspension

1 dose (0.5 mL)
The powder and suspension should be visually inspected for the presence of foreign particles and/or changes in appearance. If either condition is observed, do not reconstitute the vaccine.

How to prepare Arexvy:
Arexvy must be reconstituted before administration.

1. Using a syringe, withdraw the entire contents of the vial containing the suspension.
2. Add the entire 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, colourless to pale brown.
The reconstituted vaccine must be visually inspected for the presence of foreign particles and/or changes in appearance. If either condition is observed, do not administer the vaccine.

Chemical and physical stability in use has been demonstrated for 4 hours at 2 °C – 8 °C or at room temperature up to 25 °C.
From a microbiological standpoint, the product should be used immediately. Otherwise, the user is responsible for the storage duration after first opening and the conditions prior to use, and the product must be used within a maximum of 4 hours.

Before administration:

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

Administer the vaccine by intramuscular injection.
Unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.