Shingrix (varicella-zoster virus glycoprotein E,rec/AS01B adjuvant/PF)

Varicella Vaccines Intramuscular Kit; Intramuscular Syringe (ML)

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Last reviewed · Source: First Databank (FDB) drug data

Overview

Zoster vaccine recombinant, adjuvanted contains recombinant varicella zoster virus (VZV) surface glycoprotein E (gE) and an adjuvant (i.e., AS01B) and is used to boost active immunity to VZV.

Zoster vaccine recombinant, adjuvanted is an inactivated (recombinant) vaccine used to boost immunity to varicella zoster virus (VZV), thereby reducing the risk of reactivation of VZV and development of herpes zoster (also known as zoster or shingles) and complications of the disease. Zoster vaccine recombinant, adjuvanted is commercially available as a prefilled syringe and as a kit containing single-dose vials of lyophilized VZV surface glycoprotein E (gE) antigen (sterile white powder) and single-dose vials of AS01B adjuvant suspension (opalescent, colorless to pale brown liquid). The recombinant gE antigen component of the kit is prepared using recombinant DNA technology and Chinese hamster ovary (CHO) cells in media containing amino acids (without albumin, antibiotics, or animal-derived proteins) and then purified using chromatography.

The adjuvant component of the kit is a liposomal formulation of AS01B composed of 3-O-desacyl-4'-monophosphoryl lipid A (MPL) (produced from Salmonella minnesota) and QS-21 (a saponin purified from plant extract Quillaja saponaria Molina). The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in phosphate-buffered saline solution and water for injection. The AS01B adjuvant enhances the immune response to the recombinant VZV gE antigen.

Following reconstitution of a single-dose vial of the VZV gE antigen component with a single-dose vial of the AS01B adjuvant component, each 0.5-mL dose of zoster vaccine recombinant contains 50 mcg of recombinant gE antigen, 50 mcg of MPL, and 50 mcg of QS-21. In addition, each 0.5-mL dose of the vaccine contains 20 mg of sucrose (as stabilizer) and also contains 4.4 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.16 mg of sodium dihydrogen phosphate dihydrate, 0.15 mg of disodium phosphate anhydrous, 0.12 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80. The vaccine may contain residual amounts of host cell proteins (3% or less) and DNA (2.1 picograms or less) from the manufacturing process.

Administration of a 2-dose vaccination series of zoster vaccine recombinant, adjuvanted in adults 50 years of age or older boosts VZV-specific cell-mediated immune responses and VZV-specific humoral immunity resulting in a reduced risk of zoster and postherpetic neuralgia (PHN) in vaccinees. The minimum immune response that correlates with protection against zoster has not been established.

USES: This vaccine is used to help prevent zoster (shingles) in adults. Zoster is caused by the same virus that causes chickenpox. After you have been infected with chickenpox (usually in childhood), the virus can live in your body's nerve roots in an inactive form.

Later in life, the virus may become active again and cause shingles. Symptoms of shingles include a painful rash and blisters. Shingles may also rarely cause serious problems such as blindness, hearing problems, and long-term nerve pain.

Vaccination is the best way to protect against this infection. This vaccine works by increasing the body's natural defense (immunity) against the zoster virus so that symptoms of shingles do not occur. Vaccines may not fully protect everyone who receives them.

Generic name: varicella-zoster virus glycoprotein E,rec/AS01B adjuvant/PF
Pronunciation: (VAR-i-SEL-a)
Drug class: Varicella Vaccines
Therapeutic class: Biologicals

Reference product & biosimilars

No reference, biosimilar or interchangeable associated with this drug.

Today’s intelligence on Shingrix

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Indications

The following indications are listed for Shingrix:

  • Shingles Vaccination

Also known as: Herpes Zoster Vaccination, Vaccination To Prevent Varicella-Zoster Virus Reactivation.

Dosing

No dosing information is available for this tab.

Drug interactions

There is no enhanced messaging for this drug.

Contraindications

*History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or a previous dose of the vaccine.

Adverse reactions

The most common adverse reactions to zoster vaccine recombinant, adjuvanted in patients >=50 years of age are injection site reactions, including pain (78%), redness (38%), and swelling (26%), and systemic reactions, including myalgia (45%), fatigue (45%), headache (38%), shivering (27%), fever (21%), and GI symptoms (17%).

The most common adverse reactions to zoster vaccine recombinant, adjuvanted in autologous HSCT patients (18-49 and >=50 years of age, respectively) are pain (88 and 83%), redness (30 and 35%), and swelling (21 and 18%), and systemic reactions, including fatigue (64 and 54%), myalgia (58 and 52%), headache (44 and 30%), GI symptoms (21 and 28%), shivering (31 and 25%), and fever (28 and 18%).

Precautions

No enhanced messaging available.

ICD codes

CodeTypeDescription
Shingles vaccination
Z23ICD10CMEncounter for immunization

ICD code information from First Databank (FDB).

Formulary status

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Last reviewed · Source: First Databank (FDB) drug data