Shingles prevention:
Adults ≥18 years of age (immunocompromised [current or future]): IM: 0.5 mL administered as a 2-dose series at 0 and 1 to 2 months.
Adults ≥50 years of age (immunocompetent): IM: 0.5 mL administered as a 2-dose series at 0 and 2 to 6 months.
CDC/ACIP recommendations: If the second dose 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 [Anderson 2022]; CDC/ACIP [Dooling 2018]).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
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]
No
Shingrix, a recombinant subunit vaccine, is supplied as a vial of lyophilized recombinant varicella zoster virus surface glycoprotein E antigen which is to be reconstituted with the accompanying vial of AS01B adjuvant suspension.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Reconstituted, Intramuscular:
Shingrix: 50 mcg/0.5 mL (1 ea) [contains polysorbate 80]
In the United States, the appropriate Centers for Disease Control and Prevention (CDC)-approved Vaccine Information Statement (VIS) should be provided to the patient/caregiver before administering each dose of this vaccine. If purchased under CDC contract, the VIS must be provided and the VIS edition date and date it was provided to the patient/caregiver should be recorded. VIS is available at http://www.cdc.gov/vaccines/hcp/vis/vis-statements/shingles-recombinant.html.
IM: Administer IM, preferably in the deltoid muscle. Use proper injection technique 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). 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 [Kroger 2022]). If purchased under CDC 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 [Kroger 2022]).
Herpes zoster prevention: Prevention of herpes zoster (shingles) in patients ≥50 years of age and in patients ≥18 years of age who are or will be at increased risk for herpes zoster due to immunodeficiency or immunosuppression caused by disease or therapy.
The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination in the following patient populations:
• 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 (CDC/ACIP [Dooling 2018]).
• Patients ≥19 years of age who are or will become immunocompromised (CDC/ACIP [Anderson 2022]).
Limitations of use: Not indicated for prevention of primary varicella infection (chickenpox) or for the treatment of zoster or postherpetic neuralgia (PHN) (CDC/ACIP [Anderson 2022]; CDC/ACIP [Dooling 2018]).
Zoster Vaccine (Recombinant) may be confused with Zoster Vaccine (Live) (Canadian product).
Shingrix (zoster vaccine [recombinant]) may be confused with Zostavax II (zoster vaccine [live]; Canadian product).
RZV (zoster vaccine [recombinant]) may be confused with ZVL (zoster vaccine [live]; Canadian product).
RZV (zoster vaccine [recombinant]), ZVL (zoster vaccine [live]; Canadian product), or HZV (herpes zoster vaccine) may be confused with VAR (varicella [-zoster] vaccine).
Carefully review product labeling and the Canadian National Advisory Committee on Immunization (NACI) recommendations to ensure appropriate use of the recombinant zoster vaccine (RZV; Shingrix). The RZV vaccine may be confused with the live zoster vaccine (ZVL/LZV; Zostavax), which remains available in Canada but not in the United States; vaccines differ (eg, components, administration routes, recommended uses, dosages) and cannot be used interchangeably
Zoster vaccine (recombinant) contains recombinant varicella-zoster virus glycoprotein E (gE) antigen component with an adjuvant (ASO1B). Zoster vaccine live and varicella vaccine live contain live, attenuated varicella-zoster viruses. Their indications, dosing, and composition are distinct. Zoster vaccines are indicated in older individuals to prevent reactivation of the virus that causes shingles, whereas varicella vaccine is indicated for the primary prevention of chickenpox. Zoster vaccines are not a substitute for varicella vaccine and should not be used in children.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Gastrointestinal: GI adverse effects (13% to 24%)
Local: Erythema at injection site (20% to 39%), pain at injection site (69% to 88%), swelling at injection site (10% to 31%)
Nervous system: Fatigue (37% to 57%), headache (15% to 51%), shivering (11% to 36%)
Neuromuscular & skeletal: Myalgia (35% to 57%)
Miscellaneous: Fever (6% to 28%; including high fever)
1% to 10%:
Dermatologic: Injection site pruritus (2%)
Gastrointestinal: Nausea (1%)
Nervous system: Chills (4%), dizziness (1%), malaise (2%)
Neuromuscular & skeletal: Arthralgia (2%)
Respiratory: Flu-like illness (1%), pneumonia (2%)
<1%:
Endocrine & metabolic: Gout (including gouty arthritis)
Hematologic & oncologic: Lymphadenitis
Ophthalmic: Optic neuropathy
Postmarketing:
Dermatologic: Skin rash, urticaria
Hypersensitivity: Angioedema, hypersensitivity reaction
Nervous system: Guillain-Barre syndrome (FDA Safety Communication, March 24, 2021), impaired mobility (of injected arm)
Severe hypersensitivity (eg, anaphylaxis) to recombinant zoster vaccine or any component of the formulation.
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 [Kroger 2022]).
• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis or tendinopathy) 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 [Kroger 2022]).
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 [Kroger 2022]).
• Guillain-Barré syndrome: An increased risk of Guillain-Barré syndrome was reported within 6 weeks following administration.
• 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 [Anderson 2022]; CDC/ACIP [Dooling 2018]).
Concurrent drug therapy issues:
• Immunosuppressive agents: May reduce the effectiveness of the vaccine.
• 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 [Kroger 2022]).
Special populations:
• Altered immunocompetence: Effectiveness of any vaccine can be reduced by immunosuppressive therapies or immunocompromising conditions (ACIP [Kroger 2022]). The Advisory Committee on Immunization Practices recommends zoster vaccination for persons ≥19 years of age who are or will become immunocompromised. Administration should be prior to anticipated immunosuppression (when possible) or when patient will be most immunocompetent (eg, periods of lower immunosuppression) (CDC/ACIP [Anderson 2022]).
• 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 [Kroger 2022]).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Cladribine: May diminish the therapeutic effect of Zoster Vaccine (Recombinant). Management: Vaccination with recombinant zoster vaccine is permitted for seropositive patients. Seronegative patients should be vaccinated prior to cladribine therapy. Consider revaccination 3 months after therapy for patients vaccinated during cladribine therapy. Risk D: Consider therapy modification
Corticosteroids (Systemic): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). 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. Risk D: Consider therapy modification
Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Methotrexate: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to methotrexate initiation, if possible. If patients are vaccinated less than 14 days prior to or during methotrexate therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
RiTUXimab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of rituximab when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 6 months after therapy is complete. Risk D: Consider therapy modification
Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider therapy modification
Teplizumab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccination with inactivated or non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification
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]).
It is not known if components of this vaccine are present in breast milk. In general, administration of recombinant vaccines does not affect the safety of breastfeeding for the mother or the infant (ACIP [Kroger 2022]). However, based on the lack of data in lactating women, the Advisory Committee on Immunization Practices recommends that consideration be given to delaying vaccination with zoster vaccine (recombinant) to breastfeeding mothers (CDC/ACIP [Dooling 2018]). According to the manufacturer, the decision to breastfeed following immunization should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits to the mother.
Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2022]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
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. In adults post–autologous hematopoietic stem cell transplant, vaccine efficacy against herpes zoster was ~68% in patients who received zoster vaccine (recombinant) 50 to 70 days post-transplant, with a second dose 1 to 2 months later (Bastidas 2019). In another study of patients with hematologic malignancies, the vaccine demonstrated ~87% efficacy against herpes zoster (Dagnew 2019).
Duration: ~85% to 93% vaccine efficacy after 4 years
Suspension (reconstituted) (Shingrix Intramuscular)
50 mcg/0.5 mL (per each): $205.88
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