Shingrix powder and suspension for injectable suspension

Patient Information Leaflet

Introduction

Patient Information Leaflet

Shingrix powder and solvent for suspension for injection

recombinant zoster vaccine (adjuvanted)

Please 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 you should not give it to other people.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Shingrix is and what it is used for

What Shingrix is used for

Shingrix is a vaccine that helps protect adults against herpes zoster (shingles) and postherpetic neuralgia (PHN), the long-lasting pain following herpes zoster due to nerve damage.

Shingrix is administered to:

• adults aged 50 years and older;
• adults aged 18 years and older who are at increased risk of developing herpes zoster.

Shingrix cannot be used to prevent varicella (chickenpox).

What herpes zoster is

• Herpes zoster is a blistering rash, often painful. It usually appears in a limited area of the body and can last several weeks.
• Herpes zoster is caused by the same virus that causes varicella (chickenpox).
• After having had varicella, the virus that caused it remains in your body, lying dormant in nerve cells.
• Sometimes, after many years, if your immune system (the body's natural defenses) becomes weakened (due to aging, illness, or certain medications), the virus can reactivate and cause herpes zoster.

Complications associated with herpes zoster

Herpes zoster can lead to complications.

The most common complication associated with herpes zoster is:

• long-lasting pain due to nerve damage – called postherpetic neuralgia or PHN. After the herpes zoster blisters have healed, you may experience pain for months or even years, which can be severe.

Other complications of herpes zoster include:

• scarring where blisters occurred
• skin infections, muscle weakness, paralysis, and loss of hearing or vision – these are less common.

How Shingrix works

Shingrix enables your body to recognize the virus that causes herpes zoster. This helps your immune system (the body's natural defenses) to be prepared to fight the virus and protect you against herpes zoster and its complications.

2. What you need to know before receiving Shingrix

Do not receive Shingrix if

• you are allergic to the active substance or to any of the other components of this vaccine (listed in section 6). Signs of an allergic reaction may include: itchy skin rash, difficulty breathing, and swelling of the face or tongue.

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

Warnings and precautions

Talk to your doctor or pharmacist before receiving Shingrix if:

• you have a serious infection with a high fever. In such cases, vaccination may need to be postponed until you have recovered. A minor infection, such as a cold, should not be a problem, but consult your doctor first;
• you have a blood clotting disorder or bruise easily.

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

Fainting may occur before or after any injection; therefore, inform your doctor or nurse if you have previously fainted after receiving an injection.

Shingrix cannot be used to treat shingles or associated complications if you already have them.

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

Other medicines and Shingrix

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines, or if you have recently received any other vaccines.

Shingrix can be administered at the same time as other vaccines, such as seasonal influenza vaccine (inactivated, non-adjuvanted), 23-valent pneumococcal polysaccharide vaccine, 13-valent pneumococcal conjugate vaccine, reduced antigen content diphtheria, tetanus and pertussis (acellular) vaccine, mRNA-based COVID-19 vaccine, or respiratory syncytial virus (RSV) vaccine (recombinant, adjuvanted). A different injection site will be used for each vaccine.

You are more likely to experience fever and/or chills when Shingrix is administered at the same time as the 23-valent pneumococcal polysaccharide vaccine.

You are more likely to experience chills, fatigue, fever, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or stomach pain), headache, muscle pain, or joint pain when Shingrix is administered at the same time as an mRNA-based COVID-19 vaccine.

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.

Driving and using machines

Some of the side effects mentioned in section 4 “Possible side effects” may temporarily affect your ability to drive or operate machinery. Do not drive or operate machinery if you do not feel well.

Shingrix contains polysorbate 80, sodium, and potassium

This medicine contains 0.08 mg of polysorbate 80 per dose. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

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

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

3. How Shingrix is administered

• Shingrix is given as an injection into the muscle (usually in the upper arm).
• You will receive 2 injections, 2 months apart. If flexibility in the vaccination schedule is required, the second dose may be administered between 2 and 6 months after the first dose.

Depending on your health status, your doctor may also recommend receiving the second injection 1 month after the first.

• You will be informed about when you should return for your second dose of Shingrix.

Make sure you complete the vaccination schedule. This will maximize the protection provided by Shingrix.

You may be given Shingrix even if you have already been vaccinated with the live attenuated herpes zoster vaccine. For more information, consult your doctor.

4. Possible adverse reactions

Like all medicines, this vaccine may cause adverse reactions, although not everyone experiences them.

Adverse reactions reported during clinical trials and after the marketing of Shingrix:

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

• headache
• stomach and digestive symptoms (including nausea, vomiting, diarrhea and/or stomach pain)
• muscle pain (myalgia)
• pain, redness and swelling at the injection site
• feeling tired
• chills
• fever

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

• itching at the injection site (pruritus)
• general feeling of discomfort

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

• swelling of lymph nodes in the neck, armpits or groin
• joint pain
• hardening of the skin at the injection site

Rare (may occur in up to 1 in every 1,000 doses of vaccine):

• allergic reactions including rash, hives (urticaria), swelling of the face, tongue or throat which may cause difficulty swallowing or breathing (angioedema)

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

• a neurological disorder which usually begins with tingling sensations and weakness in the limbs and may progress to partial or complete paralysis (Guillain-Barré syndrome)

Most of these adverse reactions are mild to moderate in intensity and short-lived.

Immunocompromised adults aged 18 to 49 years may experience more adverse reactions than immunocompromised adults aged ≥ 50 years.

Adults aged 50 to 69 years may experience more adverse reactions than adults aged ≥ 70 years.

Reporting of adverse reactions

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

5. Storage of Shingrix

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 packaging, after EXP. The expiry date refers to 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Shingrix

• The active substances are:

• The other components are:

• Powder: sucrose, polysorbate 80 (E 433), sodium dihydrogen phosphate dihydrate (E 339), 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 “Shingrix contains polysorbate 80, sodium and potassium”.

Appearance 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.

One Shingrix container contains:

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

Shingrix is available in pack sizes of 1 vial with powder and 1 vial with suspension, or in pack sizes 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

For more information about this medicinal product, please contact 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 European Medicines Agency website: https://www.ema.europa.eu.

This information is intended for healthcare professionals only:

Shingrix is supplied as a vial with a brown removable cap containing the powder (antigen) and a vial with a blue-green removable cap containing the suspension (adjuvant).

The powder and suspension must be reconstituted before administration.

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

How to prepare Shingrix

Shingrix must be reconstituted before administration.

1. Withdraw the entire contents of the vial containing the suspension into the syringe, using an appropriate needle (21G to 25G).

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 foreign particles and/or physical changes. If any of these conditions are observed, do not administer the vaccine.

After reconstitution, the vaccine should be used immediately; if this is not possible, it should be stored in the refrigerator (between 2 °C and 8 °C). It must be discarded if not used within 6 hours.

Before administration

1. Withdraw the entire contents of the vial containing the reconstituted vaccine into the syringe.
2. Change the needle, using a new needle to administer the vaccine.

Disposal of waste

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