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(ZOS ter vak SEEN)
- Herpes Zoster Vaccine
- Shingles Vaccine
- VZV Vaccine (Zoster)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Reconstituted, Subcutaneous [preservative free]:
Zostavax: 19,400 units/0.65 mL (1 ea)
Brand Names: U.S.
- Vaccine, Live (Viral)
A decline in VZV-specific immunity increases the risk of developing zoster infection. As a live, attenuated vaccine (Oka/Merck strain of varicella-zoster virus), zoster virus vaccine stimulates active immunity to disease caused by the varicella-zoster virus. Administration has been demonstrated to protect against the development of herpes zoster, with the highest efficacy in patients 60-69 years of age. It may also reduce the severity of complications, including postherpetic neuralgia, in patients who develop zoster following vaccination.
Zoster vaccine reduced the incidence of zoster by ~70% in those 50 to 59 years of age, 64% in those 60-69 years of age, 41% in those 70-79 years of age, and 18% in those 80 years and older. The overall efficacy for those 60 years and older was 51%. Additional benefit was afforded to vaccine recipients who developed zoster by reduction in the incidence of PHN: 5% for those 60-69 years of age, 55% for those 70-79 years of age, and 26% for those 80 years and older. Other prespecified zoster-related complications were reported less frequently in subjects who received zoster vaccine compared with subjects who received placebo.
Onset of Action
Seroconversion: ~6 weeks (CDC/ACIP [Harpaz, 2008])
Duration of Action
Not established; protection has been demonstrated for at least 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 all patients ≥60 years of age, including patients who report a previous episode of zoster; patients with chronic medical conditions (eg, chronic renal failure, diabetes mellitus, rheumatoid arthritis, chronic pulmonary disease) unless those conditions are contraindications; and residents of nursing homes and other long-term care facilities ≥60 years of age without contraindications (CDC/ACIP [Harpaz, 2008]).
Limitations of use: Not indicated for treatment of zoster or postherpetic neuralgia (PHN); not indicated for prophylaxis of primary varicella infection (chickenpox).
History of anaphylactic/anaphylactoid reaction to gelatin, neomycin (excluding contact dermatitis to neomycin), or any other component of the vaccine; immunosuppression or immunodeficiency, including individuals with leukemia, lymphomas, or other malignant neoplasms affecting the bone marrow or lymphatic systems; primary and acquired immunodeficiency states; AIDS or clinical manifestations of HIV; those receiving immunosuppressive therapy (including high-dose corticosteroids); pregnancy
In addition, ACIP recommends that the following immunocompromised patients should not receive zoster vaccine (CDC/ACIP [Harpaz, 2008]):
Patients undergoing hematopoietic stem cell transplant (limited data; assess risk:benefit, if needed, administer ≥24 months after transplantation).
Patients receiving recombinant human immune modulators, particularly antitumor necrosis factor agents (eg, adalimumab, infliximab, etanercept). Safety and efficacy of concurrent administration is unknown and not recommended. Defer vaccination for ≥1 month after discontinuation.
Patients with unspecified cellular immunodeficiency (exception, patients with impaired humoral immunity may receive vaccine).
Manufacturer labeling: Adults ≥50 years: SubQ: 0.65 mL administered as a single dose
ACIP recommendation: Adults ≥60 years: SubQ: 0.65 mL administered as a single dose; there are no data to support readministration of the vaccine (CDC/ACIP [Harpaz, 2008])
Dosage adjustment for concomitant chronic use of acyclovir, famciclovir, or valacyclovir: Discontinue acyclovir, famciclovir, or valacyclovir ≥24 hours before administration of zoster vaccine. Do not use acyclovir, famciclovir, or valacyclovir for ≥14 days after vaccination (CDC/ACIP [Harpaz 2008]).
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.
Reconstitute with supplied diluent only, immediately upon removal from the freezer; use only sterile syringes free of preservatives, antiseptics, and detergents. Withdraw entire contents of the vial containing the provided diluent to reconstitute vaccine. Gently agitate to mix thoroughly. Withdraw entire contents of reconstituted vaccine vial for administration. Discard if reconstituted vaccine is not used within 30 minutes.
Inject SubQ into the deltoid region of the upper arm. Do not administer IV or IM; inject immediately after reconstitution. To prevent syncope related injuries, patients should be vaccinated while seated or lying down (NCIRD/ACIP, 2011). US federal law requires that the name of medication, 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.
To maintain potency, the lyophilized vaccine must be stored frozen between -50°C to -15°C (-58°F to 5°F). Temperatures below -50°C (-58°F) may occur if stored in dry ice. Protect from light. Store diluent separately at room temperature of 20°C to 25°C (68°F to 77°F) or in refrigerator at 2°C to 8°C (36°F to 46°F). The lyophilized vaccine may also be stored and/or transported under refrigeration at temperatures of 2°C to 8°C (36°F to 46°F) for 72 continuous hours prior to reconstitution; discard if not used within 72 hours.
Acyclovir-Valacyclovir: May diminish the therapeutic effect of Zoster Vaccine. Management: When possible, discontinue antiviral agents with anti-zoster activity (i.e., acyclovir, valacyclovir, famciclovir) for at least 24 hours prior to and 14 days after receiving a live attenuated zoster vaccine. Avoid combination
AzaTHIOprine: May enhance the adverse/toxic effect of Vaccines (Live). AzaTHIOprine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose azathioprine (3 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of azathioprine should be avoided. Consider therapy modification
Belimumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination
Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Doses equivalent to less than 2 mg/kg or 20 mg per day of prednisone administered for less than 2 weeks are not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses and longer durations should be avoided. Consider therapy modification
Daclizumab: May enhance the adverse/toxic effect of Vaccines (Live). Daclizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination
Dimethyl Fumarate: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, Dimethyl Fumarate may increase the risk of vaccinal infection. Dimethyl Fumarate may diminish the therapeutic effect of Vaccines (Live). Management: Canadian labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. U.S. labeling does not mention this. Consider therapy modification
Dupilumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination
Famciclovir: May diminish the therapeutic effect of Zoster Vaccine. Management: When possible, discontinue antiviral agents with anti-zoster activity (i.e., acyclovir, valacyclovir, famciclovir) for at least 24 hours prior to and 14 days after receiving a live attenuated zoster vaccine. Avoid combination
Fingolimod: May enhance the adverse/toxic effect of Zoster Vaccine. The risk of herpes zoster infection may be increased. Fingolimod may diminish the therapeutic effect of Zoster Vaccine. Management: Wait 1 month after zoster vaccine administration to initiate fingolimod therapy. Avoid the use of the zoster vaccine during fingolimod treatment, and for 2 months following treatment discontinuation. Consider therapy modification
Immunosuppressants: May enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Exceptions: AzaTHIOprine; Beclomethasone (Oral Inhalation); Betamethasone (Systemic); Budesonide (Systemic); Corticotropin; Cortisone; Cytarabine (Liposomal); Deflazacort; Dexamethasone (Systemic); Fludrocortisone; Fluticasone (Oral Inhalation); Hydrocortisone (Systemic); Leflunomide; Mercaptopurine; Methotrexate; MethylPREDNISolone; PrednisoLONE (Systemic); PredniSONE; Triamcinolone (Systemic). Avoid combination
Leflunomide: May enhance the adverse/toxic effect of Vaccines (Live). Leflunomide may diminish the therapeutic effect of Vaccines (Live). Management: The ACIP guidelines state that live-attenuated vaccines should generally be avoided for at least 3 months after cessation of immunosuppressant therapy. However, the ACR does not recommend avoiding live vaccines in patients being treated with leflunomide. Consider therapy modification
Mercaptopurine: May enhance the adverse/toxic effect of Vaccines (Live). Mercaptopurine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose 6-mercaptopurine (1.5 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of mercaptopurine should be avoided. Consider therapy modification
Methotrexate: May enhance the adverse/toxic effect of Vaccines (Live). Methotrexate may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose methotrexate (0.4 mg/kg/week or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses of methotrexate should be avoided. Consider therapy modification
Ocrelizumab: May enhance the adverse/toxic effect of Vaccines (Live). Ocrelizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination
Pneumococcal Polysaccharide Vaccine (23-Valent): May diminish the therapeutic effect of Zoster Vaccine. Monitor therapy
Rabies Immune Globulin (Human): May diminish the therapeutic effect of Vaccines (Live). Management: Avoid administering the measles vaccine within 4 months after administration of rabies immune globulin. Avoid administering other live vaccines within 3 months after administration of rabies immune globulin. Consider therapy modification
Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: If a parenteral live vaccine has been recently administered, a scheduled PPD skin test should not be administered for at least 4-6 weeks following the administration of the vaccine. Consider therapy modification
Vaccines (Live): May diminish the therapeutic effect of other Vaccines (Live). Management: Two or more injectable or nasally administered live vaccines not administered on the same day should be separated by at least 28 days (ie, 4 weeks). If not, the vaccine administered second should be repeated at least 4 week later. Exceptions: Adenovirus (Types 4, 7) Vaccine; Cholera Vaccine; Rotavirus Vaccine. Monitor therapy
Venetoclax: May enhance the adverse/toxic effect of Vaccines (Live). Venetoclax may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live, attenuated vaccines before, during, or after (prior to B-cell recovery) venetoclax treatment. Avoid combination
All serious adverse reactions must be reported to the U.S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967 or online at https://vaers.hhs.gov/esub/index.
>10%: Local: Pain at injection site (≤34 to 54%), erythema at injection site (36% to 48%), swelling at injection site (26% to 40%), localized tenderness (≤34%), itching at injection site (7% to 11%)
1% to 10%:
Cardiovascular: Congestive cardiac failure (≤2%)
Central nervous system: Headache (1% to 9%)
Gastrointestinal: Diarrhea (2%)
Local: Warm sensation at injection site (2% to 4%), hematoma at injection site (2%), induration at injection site (1%)
Neuromuscular & skeletal: Weakness (1%), limb pain (1%)
Respiratory: Pulmonary edema (≤2%), respiratory tract disease (1%)
<1% (Limited to important or life-threatening): Exacerbation of asthma, fever, herpes zoster, hypersensitivity reaction, lymphadenopathy (transient), necrotizing retinitis (patients on immunosuppressive therapy), polymyalgia rheumatica
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 (NCIRD/ACIP, 2011).
• 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 (NCIRD/ACIP, 2011).
• 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. Consider deferring 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) (NCIRD/ACIP, 2011).
• Tuberculosis: Defer treatment in patients with active untreated tuberculosis.
• 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:
• Antiviral drugs: Medications active against the herpesvirus family (eg, acyclovir, famciclovir, valacyclovir) may interfere with the zoster vaccine; avoid zoster vaccination to a patient who has received these antivirals 24 hours before vaccination; avoid use of these antiviral agents for 14 days after zoster vaccination (ACIP [Kim 2016]; CDC/ACIP [Harpaz, 2008]).
• 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 (NCIRD/ACIP, 2011).
• Adults: Not for use in patients <50 years of age.
• Altered immunocompetence: In patients where immunosuppressant therapy is anticipated, zoster vaccine should be given at least 14 days to 1 month prior to beginning therapy when possible. Use is contraindicated in severely immunocompromised patients (eg, patients receiving chemo-/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]); may have a reduced response to vaccination. Persons with AIDS or manifestations of HIV with CD4+ T-lymphocyte counts ≤200 cells/microliter or CD4+ T-lymphocyte percentages ≤15% should not be vaccinated. Patients receiving corticosteroids in low-to-moderate doses, topical (inhaled, nasal, skin), local injection (intra-articular, bursal, tendon) may receive vaccine. In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines (CDC/ACIP [Harpaz, 2008]; NCIRD/ACIP, 2011).
• 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]).
Dosage form specific warnings:
• Gelatin: Contains gelatin; do not use in patients with a history of anaphylactic/anaphylactoid reaction to gelatin.
• Neomycin sensitivity: Contains neomycin; do not use in patients with a history of anaphylactic/anaphylactoid reaction to neomycin. Contact dermatitis to neomycin is not a contraindication to the vaccine.
• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the ACIP Recommended Adult Immunization Schedule (ACIP [Kim 2016]). Specific recommendations for use of this vaccine in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions as well as contacts of immunocompromised patients are available from the IDSA (Rubin, 2014).
• 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 (NCIRD/ACIP, 2011).
• Transmission of virus: Although transmission of the vaccine virus may occur between vaccinees and susceptible contacts, vaccinated individuals do not need to take precautions against spreading varicella following vaccination; transmission of virus is rare following vaccination unless rash develops. In case of rash, standard contact precautions should be followed. Persons with rash should avoid contact with persons at high risk for severe varicella infection until lesions have crusted (CDC/ACIP [Harpaz, 2008])
Fever, rash; monitor for syncope for 15 minutes following administration (NCIRD/ACIP, 2011). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion (NCIRD/ACIP, 2011).
Use during pregnancy is contraindicated. Women should avoid becoming pregnant for 3 months after vaccination (4 weeks per CDC). Risk to the fetus following exposure to wild-type varicella zoster virus is small, and risk following exposure from the attenuated vaccine is probably even less (CDC/ACIP [Harpaz 2008]). Based on information collected from the manufacturer’s pregnancy registry, of women who received a varicella-containing vaccine within 3 months of pregnancy or any time during pregnancy and who were available for analysis, there were no infants born with abnormalities consistent with congenital varicella syndrome. Information specific to exposure following zoster vaccine was limited. Due to the rare incidence of congenital varicella syndrome and the low rates of varicella vaccine exposure in women of reproductive potential, the pregnancy registry has been closed. Although zoster vaccine is not licensed for use in women within traditional reproductive ages, inadvertent exposures will still be monitored. Any exposures to the vaccine during pregnancy or within 3 months prior to pregnancy should continue to be reported to the manufacturer (Merck & Co, 877-888-4231) or to VAERS (800-822-7967) as suspected adverse reactions (Marin 2014).
• Discuss specific use of vaccine 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 injection site pain or irritation, itching, or headache (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.
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Other brands: Zostavax