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Zoster Vaccine (Recombinant)

Pronunciation

(ZOS ter vak SEEN ree KOM be nant)

Index Terms

  • HZ/su

Dosage Forms

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

Suspension Reconstituted, Intramuscular:

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

Brand Names: U.S.

  • Shingrix

Pharmacologic Category

  • Vaccine
  • Vaccine, Recombinant

Pharmacology

Stimulates active immunity to disease caused by the varicella-zoster virus thereby protecting again zoster disease (shingles) and associated complications (ie, 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.

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

Limitations of use: Not indicated for prevention of primary varicella infection (chickenpox)

Contraindications

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

Dosing: Adult

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

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

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

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. To prevent syncope related injuries, adolescents and adults 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

Belimumab: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Patients should receive inactivated vaccines prior to initiation of belimumab therapy whenever possible, due to the risk for an impaired response to the vaccine during belimumab therapy. Consider therapy modification

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

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% (Limited to important or life-threatening): 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 outbreak. May be used in patients with previous history of zoster unless other contraindications to the vaccine exist (CDC/ACIP [Harpaz 2008]).

Concurrent drug therapy issues:

• Vaccines: 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: Limited data on administration to patients with HIV or autologous hematopoietic cell transplant recipients.

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

• Varicella vaccine recipients: The ACIP does not recommend zoster vaccination in patients of any age who have received the varicella vaccine (CDC/ACIP [Harpaz 2008]).

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 Considerations

Adverse events were not observed in animal reproduction studies.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience muscle pain, loss of strength and energy, headache, shivering, nausea, vomiting, diarrhea, abdominal pain, or injection site pain, redness, or swelling (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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