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Zoster Vaccine (Recombinant)

Medically reviewed by Drugs.com. Last updated on Apr 29, 2020.

Pronunciation

(ZOS ter vak SEEN ree KOM be nant)

Index Terms

  • Herpes Zoster Vaccine
  • HZ/su
  • Recombinant zoster vaccine
  • RZV
  • Shingles Vaccine

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension Reconstituted, Intramuscular [preservative free]:

Shingrix: 50 mcg/0.5 mL (1 ea) [contains polysorbate 80]

Brand Names: U.S.

  • Shingrix

Pharmacologic Category

  • Vaccine
  • Vaccine, Recombinant

Pharmacology

Stimulates active immunity to disease caused by reactivation of the varicella-zoster virus, thereby protecting against zoster disease (shingles) and associated complications (eg, postherpetic neuralgia [PHN]).

Zoster vaccine (recombinant) reduced the incidence of zoster by ~97% in those 50 to <70 years of age and ~91% in those ≥70 years of age. Additional benefit was afforded to vaccine recipients who developed zoster by reduction in the incidence of PHN: ~89% for those ≥70 years of age.

Duration of Action

~85% to 93% vaccine efficacy after 4 years

Use: Labeled Indications

Herpes zoster prevention: Prevention of herpes zoster (shingles) in patients ≥50 years of age

The Advisory Committee on Immunization Practices (ACIP) recommends:

Routine vaccination of immunocompetent patients ≥50 years of age, including those who previously received varicella vaccine or zoster vaccine (live) or who report a previous episode of zoster; and patients with chronic medical conditions (eg, chronic renal failure, diabetes, rheumatoid arthritis, chronic pulmonary disease). Recombinant zoster vaccine is preferred over zoster vaccine (live) in immunocompetent patients (CDC/ACIP [Dooling 2018]).

Limitations of use: Not indicated for prevention of primary varicella infection (chickenpox) or for the treatment of zoster or postherpetic neuralgia (PHN) (CDC/ACIP [Dooling 2018]).

Contraindications

Severe hypersensitivity (eg, anaphylaxis) to recombinant zoster vaccine or any component of the formulation.

Dosing: Adult

Note: Immunization during coronavirus disease 2019 (COVID-19) pandemic: Routine vaccination should not be delayed because of the COVID-19 pandemic (CDC 2020; WHO 2020). In general, simultaneous administration of all vaccines for which a patient is eligible (according to current immunization schedules/guidelines) is recommended (ACIP [Ezeanolue 2020]). However, vaccination of patients with suspected or confirmed COVID-19 infection (regardless of symptoms) should be postponed to avoid exposure to health care personnel and other patients (CDC 2020). Additional information is available from the CDC, the American Academy of Pediatrics, and the Immunization Action Coalition.

Shingles prevention: Adults ≥50 years: IM: 0.5 mL administered as a 2-dose series at 0 and 2 to 6 months

CDC/ACIP recommendations: If the primary series is delayed or interrupted, the series does not need to be restarted. If the interval between dose 1 and 2 is <4 weeks, then the second dose should be repeated (CDC/ACIP [Dooling 2018]).

Dosing: Geriatric

Refer to adult dosing.

Reconstitution

Reconstitute the vaccine using the supplied adjuvant suspension by withdrawing the entire contents of the adjuvant vial and slowly transferring to the vaccine vial. Gently shake until powder is completely dissolved. Suspension should be an opalescent, colorless to pale brownish liquid.

Administration

IM: Administer IM, preferably in the deltoid muscle. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. Zoster vaccine (recombinant) should not be administered within 2 months of zoster vaccine (live) (CDC/ACIP [Dooling 2018]). To prevent syncope-related injuries, patients should be vaccinated while seated or lying down (ACIP [Ezeanolue 2020]). If purchased under Centers for Disease Control and Prevention contract, US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.

For patients at risk of hemorrhage following IM injection, the vaccine should be administered IM if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia therapy or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23 gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for ≥2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (ACIP [Ezeanolue 2020]).

Storage

Store intact vials of vaccine and adjuvant between 2°C and 8°C (36°F and 46°F). Protect vials from light. After reconstitution, may store under refrigeration for up to 6 hours; discard if not used within 6 hours. Do not freeze. Discard if frozen.

Drug Interactions

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Consider therapy modification

Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Consider therapy modification

Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy

Adverse Reactions

>10%:

Central nervous system: Fatigue (37% to 57%), headache (29% to 51%), shivering (20% to 36%)

Gastrointestinal: Gastrointestinal adverse effects (14% to 24%)

Local: Pain at injection site (69% to 88%), erythema at injection site (38% to 39%), swelling at injection site (23% to 31%)

Neuromuscular & skeletal: Myalgia (35% to 57%)

Miscellaneous: Fever (14% to 28%)

1% to 10%:

Central nervous system: Chills (4%), malaise (2%), dizziness (1%)

Dermatologic: Injection site pruritus (2%)

Gastrointestinal: Nausea (1%)

Neuromuscular & skeletal: Arthralgia (2%)

<1%, postmarketing, and/or case reports: Gout, high fever, lymphadenitis, optic neuropathy

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Ezeanolue 2020]).

• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis or tendinitis) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).

• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Ezeanolue 2020]).

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Defer administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Ezeanolue 2020]).

• Zoster infection: Not for use in the treatment of active zoster symptoms or postherpetic neuralgia. Vaccination with zoster vaccine (recombinant) should be delayed during an acute herpes zoster infection; may administer after acute illness is over and symptoms have resolved (CDC/ACIP [Dooling 2018]).

Concurrent drug therapy issues:

• Vaccines: Zoster vaccine (recombinant) should not be administered within 2 months of zoster vaccine (live) (CDC/ACIP [Dooling 2018]). In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist (ACIP [Ezeanolue 2020]).

• Immunosuppressive agents: May reduce the effectiveness of the vaccine.

Special populations:

• Adults: Not for use in patients <50 years of age.

• Altered immunocompetence: Effectiveness of any vaccine can be reduced by immunosuppressive therapies or immunocompromising conditions (ACIP [Ezeanolue 2020]). The Advisory Committee on Immunization Practices (ACIP) recommends zoster vaccination in patients receiving low-dose immunosuppressants (eg, <20 mg/day prednisone [or equivalent], inhaled or topical corticosteroids), and patients anticipating immunosuppression or who have recovered from an immunocompromising condition (CDC/ACIP [Dooling 2018]). In a study of 1,721 adults post-autologous hematopoietic stem cell transplant, patients who received recombinant zoster vaccine 50 to 70 days posttransplant, with a second dose 1 to 2 months later, had a significantly lower incidence of herpes zoster in the 21-month median follow-up period as compared to placebo recipients; vaccine efficacy was 68.2%. Incidences of postherpetic neuralgia and herpes zoster-related complications and hospitalizations were also significantly lower in vaccine versus placebo recipients. Overall, vaccine doses were well tolerated with no significant safety concerns (Bastidas 2019). Immunogenicity of recombinant herpes zoster vaccine has been demonstrated in adults with HIV, solid tumor malignancies, hematologic malignancies, and post-renal transplant; physiologic parameters of underlying conditions were generally unchanged (eg, HIV viral load, allograft function) and adverse events were similar to those in immunocompetent patients (Berkowitz 2015; Dagnew 2019; Vink 2019; Vink 2020). In patients with hematologic malignancies, post-hoc analysis demonstrated 87.2% efficacy in preventing shingles over a median 11-month follow-up period. (Dagnew 2019). While immunosuppression is not listed as a contraindication in the prescribing information, the ACIP has not yet evaluated the studies cited above or made recommendations for use of recombinant herpes zoster vaccine in immunosuppressed populations.

• Pediatric: Zoster vaccine is not a substitute for varicella vaccine and should not be used in children and adolescents.

Other warnings/precautions:

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Ezeanolue 2020]).

Monitoring Parameters

Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Ezeanolue 2020]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy Considerations

Based on the lack of data in pregnant women, the ACIP recommends that consideration be given to delaying vaccination with zoster vaccine (recombinant) during pregnancy (CDC/ACIP [Dooling 2018]).

Patient Education

What is this drug used for?

• It is used to prevent shingles.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Muscle pain

• Loss of strength and energy

• Headache

• Shivering

• Nausea

• Vomiting

• Diarrhea

• Abdominal pain

• Injection site pain, redness, or swelling

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

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