Shingrix (Lyophilisate) Instructions for Use

Marketing Authorization Holder

GlaxoSmithKline Trading, JSC (Russia)

Manufactured By

GlaxoSmithKline Biologicals, S.A. (Belgium)

ATC Code

J07BK03 (Purified herpes zoster antigen)

Active Substance

Herpes zoster vaccine (recombinant, adjuvanted)

Herpes zoster vaccine (recombinant, adjuvanted)

Dosage Form

Shingrix

Lyophilisate for preparation of suspension for intramuscular administration in set with suspension for intramuscular administration 1 dose: vial.

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of suspension for intramuscular administration in set with suspension for intramuscular administration.

Lyophilisate: white powder. Suspension: opalescent liquid from colorless to light brown. Reconstituted vaccine: opalescent liquid from colorless to light brown.

* after reconstitution, 1 dose (0.5 ml) of the herpes zoster vaccine (recombinant, adjuvanted) contains 50 mcg of Varicella Zoster virus glycoprotein E (gE) antigen¹ with the AS01_B adjuvant system².

¹ Varicella Zoster virus glycoprotein E (gE), derived from a Varicella Zoster virus strain in Chinese hamster ovary (CHO) cells using recombinant DNA technology.
² The AS01_B adjuvant system consists of purified saponins Quillaja, obtained from the plant extract Quillaja saponaria Molina, fraction 21 (QS-21) (50 mcg) and 3-O-desacyl-4′-monophosphoryl lipid A (MPL) derived from Salmonella minnesota (50 mcg).

Excipients:
Lyophilisate sucrose, polysorbate 80, sodium dihydrogen phosphate dihydrate – 0.160 mg, dipotassium hydrogen phosphate.
Suspension 3-O-desacyl-4′-monophosphoryl lipid A (MPL), purified Quillaja saponins (QS-21), dioleoyl phosphatidylcholine, cholesterol, disodium hydrogen phosphate anhydrous – 150 mcg, potassium dihydrogen phosphate – 0.54 mg, sodium chloride – 4.385 mg, water for injections.

1 dose of lyophilisate – neutral glass type I vials (1) in a set with 1 vial of suspension for intramuscular administration (0.5 ml) – cardboard packs with first-opening control.

Clinical-Pharmacological Group

Vaccine for the prevention of herpes infection

Pharmacotherapeutic Group

Vaccines; viral vaccines; vaccines against chickenpox and herpes zoster

Pharmacological Action

Recombinant adjuvanted herpes zoster virus (HZ/su) subunit vaccine.

It is derived from a Varicella Zoster strain in Chinese hamster ovary (CHO) cells using recombinant DNA technology.

The vaccine is intended to induce antigen-specific cellular and humoral immune responses in individuals with pre-existing immunity to the Varicella zoster virus.

Results from preclinical studies demonstrate that the AS01_B adjuvant system induces local and temporary activation of the innate immune system through specific molecular pathways. This facilitates the mobilization and activation of antigen-presenting cells carrying glycoprotein E in the draining lymph node, which, in turn, leads to the production of glycoprotein E-specific CD4⁺ T cells and antibodies.

Indications

For the prevention of herpes zoster and its associated complications, such as postherpetic neuralgia: in adults aged 50 years and older, in adults aged 18 years and older with an increased risk of developing herpes zoster.

ICD codes

Dosage Regimen

The vaccine is administered according to the standard schedule in accordance with official recommendations.

For intramuscular administration, preferably into the deltoid muscle.

It can be used in individuals previously vaccinated with a live attenuated herpes zoster vaccine, using the standard vaccination schedule.

The vaccine is not indicated for the prevention of chickenpox.

Adverse Reactions

Nervous system disorders very common – headache.

Gastrointestinal disorders very common – nausea, vomiting, diarrhea and/or abdominal pain.

Musculoskeletal and connective tissue disorders very common – myalgia; uncommon – arthralgia.

General disorders and administration site conditions very common – injection site reactions (such as pain, redness, swelling), fatigue, chills, fever; common – injection site pruritus, malaise.

Contraindications

Hypersensitivity to this vaccine.

Use in Pregnancy and Lactation

There are no data on the use of the vaccine during pregnancy.

The effect of the vaccine on breastfed infants when administered to their mothers has not been studied. It is not known whether the vaccine is excreted in human breast milk.

Pediatric Use

The vaccine is intended for use in adults over 18 years of age.

Geriatric Use

Use with caution in elderly patients over 65 years of age.

Special Precautions

Good clinical practice includes taking a medical history prior to vaccination (especially regarding previous vaccinations and possible occurrence of adverse reactions) and performing a clinical examination.

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following administration of the vaccine.

As with any vaccination, a protective immune response may not be elicited in all vaccinated individuals.

Improper administration technique (subcutaneous administration) of the vaccine may lead to an increase in transient local reactions.

As with other vaccines administered intramuscularly, this vaccine should be used with caution in patients with thrombocytopenia or coagulation disorders, as intramuscular injection may cause bleeding in such patients.

Fainting (loss of consciousness) can occur following, or even before, any vaccination as a psychogenic response to the injection. It is important to ensure that the patient does not injure themselves in case of fainting.

Effect on ability to drive and use machines

After administration, it is not recommended to drive vehicles or operate machinery in case of feeling unwell.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.