Shingrix polvo y suspension para suspension inyectable

Prescribing Information: Information for the User

Shingrix Powder and Suspension for Injectable Suspension

Herpes Zoster Vaccine (Recombinant, Adjuvanted)

Read this entire prescribing information carefully before starting to receive this vaccine, as it contains important information for you.

• Keep this prescribing information, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to other people.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prescribing information.See Section 4.

What is Shingrix used for

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

Shingrix is administered to:

• adults aged 50 years and older;
• adults aged 18 years and older who have a higher risk of developing shingles.

Shingrix cannot be used to prevent chickenpox.

What is shingles

• Shingles is a rash with blisters, often painful. It usually appears in a limited area of the body and can last for several weeks.
• Shingles is caused by the same virus that causes chickenpox.
• After having chickenpox, the virus that causes it remains in the body, in nerve cells.
• Occasionally, many years later, if the immune system (the body's natural defenses) weakens (due to age, illness, or a medication being taken), the virus can cause shingles.

Complications related to shingles

Shingles can cause complications.

The most common complication associated with shingles is:

• long-lasting paindue to nerve damage– called postherpetic neuralgia or PHN. Once the shingles blisters have disappeared, you may have pain for months or years and it can be severe.

Other shingles complications are:

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

How Shingrix works

Shingrix allows your body to remember the virus that causes shingles. This helps your immune system (the body's natural defenses) to be prepared to fight the virus and protect you from shingles and its complications.

You should not receive Shingrix if

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

You should not receive Shingrix if you have any of the above. If you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting Shingrix if:

• you have a severe infection with a high temperature (fever). In these 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 problem or easily form bruises.

If you have any of the above (or are unsure), consult your doctor or pharmacist before Shingrix is administered.

You may faint before or after any injection, so inform your doctor or nurse if you have fainted on previous occasions after receiving an injection.

Shingrix cannot be used as treatment if you already have shingles or complications associated with it.

As with all vaccines, Shingrix may not protect everyone fully.

Consult your doctor if, after receiving Shingrix, you experience temporary nerve inflammation that causes pain, weakness, and paralysis (Guillain-Barré syndrome). There has been a slight increase in the risk of developing Guillain-Barré syndrome (estimated at 3 additional cases per million doses administered) after receiving Shingrix in people aged 65 years or older.

Other medications and Shingrix

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including over-the-counter medications, or have recently received any other vaccine.

Shingrix can be administered at the same time as other vaccines such as the seasonal flu inactivated vaccine, the 23-valent pneumococcal polysaccharide vaccine, the 13-valent pneumococcal conjugate vaccine, the reduced antigen content diphtheria, tetanus, and pertussis (acellular) vaccine, or the COVID-19 mRNA vaccine. 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 and digestive problems (including nausea, vomiting, diarrhea, and/or stomach pain), headache, muscle pain, or joint pain when you receive the COVID-19 mRNA vaccine at the same time as Shingrix.

Pregnancy and breastfeeding

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

Driving and operating machinery

Some of the 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 are not feeling well.

Shingrix contains sodium and potassium

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

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

• Shingrix is administered through a muscle injection (usually in the upper arm).
• You will receive 2 injections with a 2-month interval.If flexibility in the vaccination schedule is required, the second dose can be administered between 2 and 6 months after the first dose.

Depending on your health status, your doctor may also recommend that you receive the secondinjection 1 month after the first.

• You will be informed about when to return to receive the second dose of Shingrix.

Make sure to complete the vaccination program. This will maximize the protection offered by Shingrix.

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

Like all medications, this vaccine may produce adverse effects, although not all people will experience them.

Adverse effects reported during clinical trialsand after commercializationof Shingrix:

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

• Headache
• Gastrointestinal symptoms (including nausea, vomiting, diarrhea, and/or stomach pain)
• Muscle pain (myalgia)
• Pain, redness, and swelling at the injection site
• Feeling of fatigue
• Chills
• Fever.

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

• Itching at the injection site (pruritus)
• General discomfort.

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

• Swelling of the lymph nodes in the neck, armpits, or groin
• Joint pain.

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

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

Most of these adverse effects are of mild to moderate intensity and short duration.

Adults with compromised immunity aged 18 to 49 years may experience more adverse effects than adults with compromised immunity aged ≥ 50 years.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, including possible adverse effects not listed in this prospectus. You can also report them directly through the national notification system included in Appendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and packaging. The expiration date is the last day of the month indicated.

Store in the refrigerator (between 2°C and 8°C).Do not freeze.

Store in the original packaging to protect it from light.

Dispose of unused medications and packaging through your pharmacist. This will help protect the environment.

Composition of Shingrix

• The active ingredients are:

• The other components are:

• Dry powder:sucrose, polysorbate 80 (E 433), dihydrogen phosphate dihydrate (E 339), dipotassium phosphate (E 340).
• Lyophilized suspension:dioleoyl phosphatidylcholine (E 322), cholesterol, sodium chloride, anhydrous disodium phosphate (E 339), potassium dihydrogen phosphate (E 340), and water for injection.

See section 2 “Shingrix contains sodium and potassium”.

Appearance of the product and contents of the pack

Dry powder and lyophilized suspension for injection.The powder is white.

The lyophilized suspension is an opalescent, colorless to light brown liquid.

One pack of Shingrix contains:

• Dry powder (antigen) for 1 dose in a vial
• Lyophilized suspension (adjuvant) for 1 dose in a vial.

Shingrix is available in packs of 1 vial with dry powder and 1 vial with lyophilized suspension or in packs of 10 vials with dry powder and 10 vials with lyophilized suspension.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut 89

B-1330 Rixensart

Belgium

For further information about this medicinal product, please consult the representative of the marketing authorization holder in your country:

Last update of this leaflet:

Other sources of information

Further information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

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This information is intended for healthcare professionals only:

Shingrix is presented in a brown cap vial containing the dry powder (antigen) and a blue-green cap vial containing the lyophilized suspension (adjuvant).

The dry powder and lyophilized suspension must be reconstituted before administration.

The dry powder andlyophilized suspensionmust be visually inspected to observe any foreign particles and/or variation in physical appearance.If any of these circumstances are observed, do not reconstitute the vaccine.

How to prepare Shingrix:

Shingrix must be reconstituted before administration.

1. Remove all the contents of the vial containing the lyophilized suspension with the syringe.

2. Add all the contents of the syringe to the vial containing the dry powder.

3. Gently agitate until the dry powder is completely dissolved.

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

The reconstituted vaccine must be visually inspected to observe any foreign particles and/or variation in physical appearance.If any of these circumstances are observed, do not administer the vaccine.

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

Before administration:

1. Remove all the contents of the vial containing the reconstituted vaccine with the syringe.

2. Change the needle so that a new needle is used to administer the vaccine.

The elimination of unused medication and all materials that have been in contact with it will be carried out in accordance with local regulations.