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]
Pharmacology
Mechanism of Action
Stimulates active immunity to disease caused by the varicella-zoster virus thereby protecting again 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.
Pharmacokinetics/Pharmacodynamics
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
Dosage and Administration
Dosing: Adult
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 [Kroger 2017]). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.
For patients at risk of hemorrhage following intramuscular injection, the vaccine should be administered intramuscularly 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 or other similar therapy, intramuscular 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 at least 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 2017]).
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. Exceptions: Cytarabine (Liposomal). 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 [Kroger 2017]).
- 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 2017]).
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 2017]).
- 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 [Kroger 2017]).
- Immunosuppressive agents: May reduce the effectiveness of the vaccine.
Special populations:
- Adults: Not for use in patients <50 years of age.
- Altered immunocompetence: Vaccination is recommended in patients receiving low-dose immunosuppressives (eg, <20 mg/day prednisone [or equivalent], inhaled or topical corticosteroids), patients anticipating immunosuppression or recovering from an immunocompromising condition (CDC/ACIP [Dooling 2018]).
- 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 2017]).
Monitoring Parameters
Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2017]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Pregnancy
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.
Frequently reported side effects of this drug
- Muscle pain
- Loss of strength and energy
- Headache
- Shivering
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Injection site pain, redness, or swelling
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of 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 brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
