Version May 2024
Note : Zostavax will no longer be available in the United States, effective July 1, 2020.
Shingles prevention:
Manufacturer labeling: Adults ≥50 years of age: SubQ: 0.65 mL administered as a single dose.
ACIP recommendation: Adults ≥60 years of age: SubQ: 0.65 mL administered as a single dose; there are no data to support readministration of the vaccine (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
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.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Local: Pain at injection site (≤54%), erythema at injection site (36% to 48%), swelling at injection site (26% to 40%), localized tenderness (≤34%), injection site pruritus (7% to 11%)
1% to 10%:
Cardiovascular: 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: Asthenia (1%), limb pain (1%)
Respiratory: Pulmonary edema (≤2%), respiratory tract disease (1%)
<1%, postmarketing, and/or case reports: Anaphylaxis, arthralgia, exacerbation of asthma, facial nerve paralysis, fever, Guillain-Barre syndrome, herpes zoster infection, hypersensitivity reaction, lymphadenopathy (transient), myalgia, nausea, necrotizing retinitis (patients on immunosuppressive therapy), polymyalgia rheumatica, rash at injection site, skin rash, urticaria at injection site, varicella zoster infection (in immunocompromised patients)
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 live (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).
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Canadian labeling: Additional contraindications (not in US labeling): Untreated tuberculosis (TB) disease (active TB).
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 2021]).
• 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 2021]).
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 2021]).
• Tuberculosis: Defer treatment in patients with untreated tuberculosis (TB) disease (active TB).
• Zoster infection: Not for use in the treatment of active zoster outbreak; delay vaccination until after acute stage of illness and symptoms are no longer present (CDC/ACIP [Dooling 2018]). 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 live (ZVL); avoid ZVL vaccination to a patient who has received these antivirals 24 hours before vaccination; avoid use of these antiviral agents for 14 days after ZVL vaccination (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 (ACIP [Kroger 2021]).
Special populations:
• Adults: Not for use in patients <50 years of age.
• Altered immunocompetence: In patients where immunosuppressant therapy is anticipated, zoster vaccine live 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 or may have an adverse event secondary to replication. 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 (ACIP [Kroger 2021]); CDC/ACIP [Harpaz 2008]).
• Pediatric: Zoster vaccine live 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 vaccine live for patients of any age who have received the varicella vaccine (CDC/ACIP [Harpaz 2008]). Patients can receive recombinant zoster vaccine (RZV) regardless of prior varicella vaccination (CDC/ACIP [Dooling 2018]).
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.
Other warnings/precautions:
• 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 annual ACIP Recommended Immunization Schedules (refer to CDC schedule for detailed information). 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 (ACIP [Kroger 2021]).
• 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])
Merck will no longer sell Zostavax in the United States, effective July 1, 2020. All remaining product has an expiry date of November 2020. Further information is available at https://www.merckvaccines.com/wp-content/uploads/sites/8/2020/06/US-CIN-00033.pdf.
Zostavax contains porcine gelatin
Zostavax, a live vaccine, is supplied as a vial of lyophilized preparation of live, attenuated varicella zoster virus.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Suspension Reconstituted, Subcutaneous [preservative free]:
Zostavax: 19,400 units/0.65 mL (1 ea [DSC]) [contains albumin bovine, beef extract (bovine), gelatin (pork), neomycin]
No
Suspension (reconstituted) (Zostavax Subcutaneous)
19400 units/0.65 mL (per each): $267.74
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Suspension Reconstituted, Subcutaneous:
Zostavax II: 19,400 units/0.65 mL ([DSC])
SubQ: Inject SubQ into the deltoid region of the upper arm. Do not administer IV or IM; inject immediately after reconstitution. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection (Ref). To prevent syncope related injuries, patients should be vaccinated while seated or lying down (Ref). 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.
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.html.
Herpes zoster prevention: Prevention of herpes zoster (shingles) in patients ≥50 years of age
The Advisory Committee on Immunization Practices (ACIP) recommends zoster vaccine for the prevention of herpes zoster and related complications in immunocompetent adults. Recombinant zoster vaccine (RZV) is preferred for adults ≥50 years. However, zoster vaccine live (ZVL) remains an option for immunocompetent adults ≥60 years (CDC/ACIP [Dooling 2018]).
Limitations of use: Not indicated for treatment of active herpes zoster infection or postherpetic neuralgia (PHN); not indicated for prophylaxis of primary varicella infection (chickenpox).
Zoster Vaccine (Live) may be confused with Zoster Vaccine (Recombinant)
Zostavax (zoster vaccine [live]) may be confused with Shingrix (zoster vaccine [recombinant])
Zostavax may be confused with Varivax
ZVL (zoster vaccine [live]) may be confused with RZV (zoster vaccine [recombinant])
RZV (zoster vaccine [recombinant]), ZVL (zoster vaccine [live]), or HZV (herpes zoster vaccine) may be confused with VAR (varicella vaccine)
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.
Carefully review product labeling to ensure appropriate use of RZV (Shingrix) and ZVL (Zostavax); each vaccine has different components, routes of administration, dosage, and storage requirements.
Both varicella vaccine and zoster vaccine are live, attenuated strains of varicella-zoster virus. Their indications, dosing, and composition are distinct. Varicella vaccine is indicated for the prevention of chickenpox, while zoster vaccine live is indicated in older individuals to prevent reactivation of the virus which causes shingles. Zoster vaccine is not a substitute for varicella vaccine and should not be used in children; it contains 14 times more antigen than varicella vaccine.
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
Acyclovir-Valacyclovir: May diminish the therapeutic effect of Zoster Vaccine (Live/Attenuated). Risk X: Avoid combination
Anti-CD20 B-Cell Depleting Therapies: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Brivudine: May diminish the therapeutic effect of Zoster Vaccine (Live/Attenuated). Risk X: Avoid combination
Cladribine: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Cladribine may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live vaccines during and for 1 month after therapy with immunosuppressive doses of corticosteroids (equivalent to prednisone > 2 mg/kg or 20 mg/day in persons over 10 kg for at least 2 weeks). Give live vaccines 4 weeks prior to therapy if possible. Risk D: Consider therapy modification
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: Non-US labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. US labeling states that safety and effectiveness of live vaccines administered with dimethyl fumarate has not been assessed. Risk C: Monitor therapy
Dupilumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
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
Etrasimod: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Etrasimod may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Famciclovir: May diminish the therapeutic effect of Zoster Vaccine (Live/Attenuated). Risk X: Avoid combination
Fingolimod: May enhance the adverse/toxic effect of Zoster Vaccine (Live/Attenuated). The risk of herpes zoster infection may be increased. Fingolimod may diminish the therapeutic effect of Zoster Vaccine (Live/Attenuated). 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. Risk X: Avoid combination
Immunosuppressants (Cytotoxic Chemotherapy): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Immunosuppressants (Miscellaneous Oncologic Agents): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Immunosuppressants (Therapeutic Immunosuppressant Agents): May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Therapeutic Immunosuppressant Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Leniolisib: May diminish the therapeutic effect of Vaccines (Live). Risk C: Monitor therapy
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. Risk D: Consider therapy modification
Pneumococcal Polysaccharide Vaccine (23-Valent): May diminish the therapeutic effect of Zoster Vaccine (Live/Attenuated). Risk C: Monitor therapy
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
Teplizumab: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccines-associated infection may be increased. Teplizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Tezepelumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Tildrakizumab: May enhance the adverse/toxic effect of Vaccines (Live). The risk for contracting an infection from the vaccine may be increased. Tildrakizumab may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Tralokinumab: May enhance the adverse/toxic effect of Vaccines (Live). Risk X: Avoid combination
Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: It is preferable to administer live vaccines simultaneously with tuberculin tests. If a live vaccine has been recently administered, the tuberculin skin test should be administered 4 to 6 weeks following the administration of the vaccine. Risk D: 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. Risk C: Monitor therapy
Per the manufacturer, women should avoid becoming pregnant for 3 months after vaccination (4 weeks per CDC) (CDC/ACIP [Harpaz 2008]).
Use during pregnancy is contraindicated.
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 live 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 live is not licensed for use in women within traditional reproductive ages, inadvertent exposures will still be monitored (Marin 2014).
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).
It is not known if virus from this vaccine is present in breast milk. Administration does not affect the safety of breastfeeding for the mother or the infant (ACIP [Kroger 2021]). 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 of treatment to the mother.
Fever, rash; monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2021]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
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. It may also reduce the severity of complications, including postherpetic neuralgia, in patients who develop zoster following vaccination.
Zoster vaccine live reduced the incidence of zoster by ~70% in those 50 to 59 years of age, 64% in those 60-69 years of age, and 38% in those ≥70 years of age (CDC/ACIP [Dooling 2018]). 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: Duration of protection decreases over time with substantial decrease after 1 year. Effectiveness of ZVL in preventing herpes zoster decreased to 32% after 8 years in individuals ≥50 years (Baxter 2017; CDC/ACIP [Dooling 2018]).
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