Shingrix (varicella-zoster virus glycoprotein E,rec/AS01B adjuvant/PF)
Varicella Vaccines Intramuscular Kit; Intramuscular Syringe (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Zoster vaccine recombinant, adjuvanted contains recombinant varicella zoster virus (VZV) surface glycoprotein E (gE) and an adjuvant (i.e., AS01B) and is used to boost active immunity to VZV.
Zoster vaccine recombinant, adjuvanted is an inactivated (recombinant) vaccine used to boost immunity to varicella zoster virus (VZV), thereby reducing the risk of reactivation of VZV and development of herpes zoster (also known as zoster or shingles) and complications of the disease. Zoster vaccine recombinant, adjuvanted is commercially available as a prefilled syringe and as a kit containing single-dose vials of lyophilized VZV surface glycoprotein E (gE) antigen (sterile white powder) and single-dose vials of AS01B adjuvant suspension (opalescent, colorless to pale brown liquid). The recombinant gE antigen component of the kit is prepared using recombinant DNA technology and Chinese hamster ovary (CHO) cells in media containing amino acids (without albumin, antibiotics, or animal-derived proteins) and then purified using chromatography.
The adjuvant component of the kit is a liposomal formulation of AS01B composed of 3-O-desacyl-4'-monophosphoryl lipid A (MPL) (produced from Salmonella minnesota) and QS-21 (a saponin purified from plant extract Quillaja saponaria Molina). The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in phosphate-buffered saline solution and water for injection. The AS01B adjuvant enhances the immune response to the recombinant VZV gE antigen.
Following reconstitution of a single-dose vial of the VZV gE antigen component with a single-dose vial of the AS01B adjuvant component, each 0.5-mL dose of zoster vaccine recombinant contains 50 mcg of recombinant gE antigen, 50 mcg of MPL, and 50 mcg of QS-21. In addition, each 0.5-mL dose of the vaccine contains 20 mg of sucrose (as stabilizer) and also contains 4.4 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.16 mg of sodium dihydrogen phosphate dihydrate, 0.15 mg of disodium phosphate anhydrous, 0.12 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80. The vaccine may contain residual amounts of host cell proteins (3% or less) and DNA (2.1 picograms or less) from the manufacturing process.
Administration of a 2-dose vaccination series of zoster vaccine recombinant, adjuvanted in adults 50 years of age or older boosts VZV-specific cell-mediated immune responses and VZV-specific humoral immunity resulting in a reduced risk of zoster and postherpetic neuralgia (PHN) in vaccinees. The minimum immune response that correlates with protection against zoster has not been established.
USES: This vaccine is used to help prevent zoster (shingles) in adults. Zoster is caused by the same virus that causes chickenpox. After you have been infected with chickenpox (usually in childhood), the virus can live in your body's nerve roots in an inactive form.
Later in life, the virus may become active again and cause shingles. Symptoms of shingles include a painful rash and blisters. Shingles may also rarely cause serious problems such as blindness, hearing problems, and long-term nerve pain.
Vaccination is the best way to protect against this infection. This vaccine works by increasing the body's natural defense (immunity) against the zoster virus so that symptoms of shingles do not occur. Vaccines may not fully protect everyone who receives them.
Generic name: varicella-zoster virus glycoprotein E,rec/AS01B adjuvant/PF
Pronunciation: (VAR-i-SEL-a)
Drug class: Varicella Vaccines
Therapeutic class: Biologicals
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Shingrix
Indications
The following indications are listed for Shingrix:
- Shingles Vaccination
Also known as: Herpes Zoster Vaccination, Vaccination To Prevent Varicella-Zoster Virus Reactivation.
Dosing
No dosing information is available for this tab.
Zoster vaccine recombinant, adjuvanted is administered only by IM injection. The vaccine should not be administered subcutaneously, intradermally, or IV.
Zoster vaccine recombinant, adjuvanted is commercially available as a kit containing single-dose vials of lyophilized varicella zoster virus (VZV) surface glycoprotein E (gE) antigen and single-dose vials of AS01B adjuvant suspension that requires reconstitution before use. The vaccine is also available as a single-dose prefilled syringe that does not require reconstitution.
Prior to administration of the prefilled syringe, attach a sterile needle. Administer the prefilled syringe as soon as possible following removal from the refrigerator. The prefilled syringe may be stored between 8-25degreesC for up to 72 hours.
Prior to administration of the kit, reconstitute a single-dose vial of lyophilized VZV gE antigen by adding the entire contents of a single-dose vial of adjuvant suspension from the kit according to the manufacturer's directions. After the adjuvant suspension component is added to the VZV gE antigen component, gently swirl the vaccine to ensure that the powder is completely dissolved; do not shake vigorously. Consult the manufacturer's labeling for additional information regarding preparation of zoster vaccine recombinant.
Following reconstitution, administer zoster vaccine recombinant, adjuvanted immediately or store at 2-8degreesC and administer within 6 hours; discard any reconstituted vaccine not used within 6 hours.
Store the kit containing the components of zoster vaccine recombinant, adjuvanted and the prefilled syringe at 2-8degreesC and protect from light; do not freeze and discard if freezing has occurred.
Zoster vaccine recombinant, adjuvanted does not contain any preservatives.
Zoster vaccine recombinant, adjuvanted may be given concurrently with other age-appropriate vaccines. When multiple vaccines are administered during a single health-care visit, each parenteral vaccine should be given using separate syringes and different injection sites. Injection sites should be separated by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Shingrix Vial Kit | Maintenance | Inject 0.5 milliliter (50 mcg) by intramuscular route once. |
| Shingrix 50 Mcg/0.5 Ml Syringe | Maintenance | Inject 0.5 milliliter (50 mcg) by intramuscular route once. |
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
Non-Live Or Non-Replicating Vaccines/Efalizumab
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: Efalizumab-induced immunosuppression may prevent proper immune response to the vaccine.(1)
CLINICAL EFFECTS: The use of vaccines in patients who have recently received efalizumab may be ineffective.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Patients should receive all appropriate immunizations prior to beginning efalizumab therapy. The use of vaccines in patients who have recently received efalizumab may be ineffective.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2)
DISCUSSION: In a small study with intravenous efalizumab, a single dose of 0.3 mg/kg of efalizumab given before primary immunization with a neoantigen decreased the secondary immune response, and a dose of 1 mg/kg almost completely ablated it. (This dose has comparable pharmacodynamic effects to the recommended subcutaneous dose of 1 mg/kg.) In chimpanzees treated with greater than 10 times the normal clinical exposure level of efalizumab, antibody responses were decreased following immunization with tetanus toxoid compared with untreated control animals.(1)
Non-Live, Non-Replicating Vaccine/Rebisufligene Etisparvovec
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: Rebisufligene etisparvovec therapy may decrease the effectiveness of vaccines. The mechanism is not known.(1)
CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The US manufacturer of rebisufligene etisparvovec states that vaccines should be avoided 30 days prior to rebisufligene etisparvovec administration.(1)
DISCUSSION: Rebisufligene etisparvovec therapy may decrease the effectiveness of vaccines.(1)
Vaccines/Pariglasgene Brecaparvovec
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: Pariglasgene brecaparvovec therapy may decrease the effectiveness of vaccines. The mechanism is not known.(1)
CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The US manufacturer of pariglasgene brecaparvovec states that vaccines should be avoided for 1 month prior to pariglasgene brecaparvovec administration.(1)
DISCUSSION: Pariglasgene brecaparvovec therapy may decrease the effectiveness of vaccines.(1)
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
Non-Live Or Non-Replicating Vaccines/Teplizumab
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: Teplizumab may cause lymphopenia and alter the immune system's response to vaccines.(1)
CLINICAL EFFECTS: Administration of a non-live vaccine within the 2 weeks prior to, during, or for 6 weeks following teplizumab therapy may result in decreased effectiveness of the vaccine.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating teplizumab therapy. The manufacturer of teplizumab states that non-live vaccines (e.g., inactivated or mRNA vaccines) are not recommended within the 2 weeks prior to, during, or for 6 weeks after stopping teplizumab therapy.(1) The immune response to non-live vaccines should be monitored in patients who receive teplizumab within these time frames. The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) For COVID-19 vaccines, the CDC advises planning for vaccination at least 2 weeks before starting or resuming immunosuppressive therapy. Patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted. The CDC states that an age-appropriate mRNA COVID-19 vaccine is preferred over the Janssen COVID-19 vaccine for the primary and booster doses for immunocompromised patients. All immunocompromised patients over 5 years of age should receive at least 1 booster dose if eligible. See the CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for age- and product-specific recommendations.(3)
DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before, during, and for 6 weeks following teplizumab therapy.(1)
Moderate Interaction: Assess the risk to the patient and take action as needed.
Non-Live Or Non-Rep Vaccines/Systemic Corticosteroids; Acth
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: Corticosteroids and corticotropin suppress the immune system and may alter the immune system's response to vaccines.(1)
CLINICAL EFFECTS: Vaccines administered during or within 2 weeks prior to therapy with corticosteroids or corticotropin may result in decreased effectiveness of the vaccine.(1)
PREDISPOSING FACTORS: Patients receiving immunosuppressive doses of corticosteroids or corticotropin for equal to or greater than 14 consecutive days.(1)
PATIENT MANAGEMENT: The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed, including those who are receiving or have received high-dose, systemic steroids for greater than or equal to 14 consecutive days. When initiating immunosuppressives doses of corticosteroids, wait 2 weeks after a non-live vaccines is administered. However, if patients require therapy for chronic inflammatory conditions, do not delay therapy due to past vaccines.(1) The immune response to non-live vaccines should be monitored in patients receiving corticosteroids. Vaccinations given during corticosteroid therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(1)
DISCUSSION: Vaccinations given during and within 2 weeks prior to corticosteroid therapy may be less effective. However they are considered safe to administer.(1) Many clinicians consider a dose equivalent to either 2 mg/kg of body weight or a total of 20 mg/day of prednisone as sufficiently immunosuppressive to raise safety concerns about live-virus vaccines.(1) Immunization procedures may be undertaken in patients receiving corticosteroids when the therapy is short term (less than 2 weeks); low to moderate dose; long-term, alternate-day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or administered topically (skin or eyes), by aerosol, or by intra-articular, bursal, or tendon injection.(1)
Non-Live Or Non-Replicating Vaccines/Etrasimod
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: Etrasimod is an immunosuppressant and may alter the immune system's response to vaccines.(1)
CLINICAL EFFECTS: Administration of a vaccine during and for up to 5 weeks after discontinuation of etrasimod therapy may result in decreased effectiveness of the vaccine. Etrasimod treatment should be paused 5 weeks prior and for 4 weeks after vaccination.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating etrasimod therapy. The immune response to non-live vaccines should be monitored in patients receiving etrasimod or who have received etrasimod in the previous 5 weeks. Vaccinations given during and for up to 5 weeks after discontinuation of etrasimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2)
DISCUSSION: Vaccinations may be less effective if administered during and for up to 5 weeks after etrasimod treatment.(1) However they are considered safe to administer.
Non-Live Or Non-Replicating Vaccines/Fingolimod
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: Fingolimod is an immunosuppressant and may alter the immune system's response to vaccines.(1)
CLINICAL EFFECTS: Administration of a vaccine during and for 2 months following fingolimod therapy may result in decreased effectiveness of the vaccine.(1,2)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating fingolimod therapy. The immune response to non-live vaccines should be monitored in patients receiving fingolimod or who have received fingolimod in the previous two months. Vaccinations given during and for 2 months after stopping fingolimod therapy may need to be repeated.(1,2) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(3)
DISCUSSION: Vaccinations may be less effective during and for 2 months following fingolimod therapy(1) however they are considered safe to administer.(2)
Non-Live Or Non-Replicating Vaccines/Ocrelizumab
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: Ocrelizumab is an immunosuppressant and may alter the immune system's response to vaccines.(1)
CLINICAL EFFECTS: Administration of a non-live vaccine within 2 weeks before or during ocrelizumab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiating ocrelizumab therapy.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Ideally, administer non-live vaccines at least two weeks prior to initiating ocrelizumab therapy. The immune response to non-live vaccines should be monitored in patients receiving ocrelizumab. Vaccinations given during ocrelizumab therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2)
DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before or during ocrelizumab treatment.(1)
Non-Live Or Non-Replicating Vaccines/Ozanimod
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: Ozanimod is an immunosuppressant and may alter the immune system's response to vaccines.(1)
CLINICAL EFFECTS: Administration of a vaccine during and for up to 3 months after discontinuation of ozanimod therapy may result in decreased effectiveness of the vaccine. Ozanimod treatment should be paused 3 months prior and for 1 month after vaccination.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating ozanimod therapy. The immune response to non-live vaccines should be monitored in patients receiving ozanimod or who have received ozanimod in the previous 3 months. Vaccinations given during and for up to 3 months after discontinuation of ozanimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2)
DISCUSSION: Vaccinations may be less effective if administered during and for up to 3 months after ozanimod treatment.(1) However they are considered safe to administer.
Non-Live Or Non-Replicating Vaccines/Ponesimod
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: Ponesimod is an immunosuppressant and may alter the immune system's response to vaccines.(1)
CLINICAL EFFECTS: Administration of a vaccine during and for up to 2 weeks after discontinuation of ponesimod therapy may result in decreased effectiveness of the vaccine. Ponesimod treatment should be paused 1-2 weeks prior and for 4 weeks after vaccination.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating ponesimod therapy. The immune response to non-live vaccines should be monitored in patients receiving ponesimod or who have received ponesimod in the previous 2 weeks. Vaccinations given during and for up to 2 weeks after discontinuation of ponesimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2)
DISCUSSION: Vaccinations may be less effective if administered during and for up to 2 weeks after ponesimod treatment.(1) However they are considered safe to administer.
Non-Live Or Non-Replicating Vaccines/Satralizumab
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: Satralizumab is an immunosuppressant and may alter the immune system's response to vaccines.(1)
CLINICAL EFFECTS: Administration of a vaccine during satralizumab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiation of satralizumab.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Ideally, administer vaccines two weeks prior to initiating satralizumab therapy. The immune response to non-live vaccines should be monitored in patients receiving satralizumab. Vaccinations given during satralizumab therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2)
DISCUSSION: Vaccinations may be less effective if administered during satralizumab treatment.(1)
Non-Live Or Non-Replicating Vaccines/Siponimod
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: Siponimod is an immunosuppressant and may alter the immune system's response to vaccines.(2)
CLINICAL EFFECTS: Administration of a vaccine during and for up to 1 month after discontinuation of siponimod therapy may result in decreased effectiveness of the vaccine. Siponimod treatment should be paused 1 week prior and for 4 weeks after vaccination.(2)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating siponimod therapy. The immune response to non-live vaccines should be monitored in patients receiving siponimod or who have received siponimod in the previous week. Vaccinations given during and for up to 1 month after discontinuation of siponimod therapy may need to be repeated.(2) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(3)
DISCUSSION: Vaccinations may be less effective if administered during and for up to 1 month after siponimod treatment(2) however they are considered safe to administer.(1)
Non-Live Or Non-Replicating Vaccines/Ublituximab
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: Ublituximab is an immunosuppressant and may alter the immune system's response to vaccines.(1)
CLINICAL EFFECTS: Administration of a non-live vaccine within 2 weeks before or during ublituximab therapy may result in decreased effectiveness of the vaccine. If possible, non-live vaccines should be administered at least two weeks prior to initiating ublituximab therapy.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Ideally, administer non-live vaccines at least two weeks prior to initiating ublituximab therapy. The immune response to non-live vaccines should be monitored in patients receiving ublituximab. Vaccinations given during ublituximab therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2)
DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before or during ublituximab treatment.(1)
Non-Live Or Nonreplicating Vaccine/Vusolimogene Oderparepvec
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: The interaction potential of non-live or non-replicating vaccines with vusolimogene oderparepvec is unknown.
CLINICAL EFFECTS: Concurrent administration of non-live or non-replicating vaccines with vusolimogene oderparepvec may alter the effectiveness or toxicities of either agent.
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The manufacturer of vusolimogene oderparepvec states that non-live and non-replicating vaccines should ideally be delayed until the current course of vusolimogene oderparepvec therapy is completed. If vaccination is required during treatment, separate administration of the vaccine and vusolimogene oderparepvec by at least 14 days.(2) Patients should be advised that their cancer gene therapy may be delayed due to administration of vaccines.(3)
DISCUSSION: The concomitant use of non-live or non-replicating vaccines and vusolimogene oderparepvec has not been evaluated. The manufacturer's recommendation is intended to minimize potential interactions and confounding factors in the safety assessments of vaccines and vusolimogene oderparepvec therapy.(2)
Vaccines/Hepatitis B Vaccine (Fendrix)
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: No data is available on the concurrent administration of the hepatitis B vaccine Fendrix and other vaccines.(1)
CLINICAL EFFECTS: It is unknown if concurrent administration of the hepatitis B vaccine Fendrix and other vaccines will affect the efficacy of either vaccine.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The Swedish manufacturer of Fendrix states that since there is no data available for the concurrent administration of Fendrix with other vaccines, the administration of Fendrix and other vaccines should be separated by 2 to 3 weeks.(1)
DISCUSSION: No data is available on the concurrent administration of the hepatitis B vaccine Fendrix with other vaccines.(1)
Contraindications
*History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or a previous dose of the vaccine.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- No disease contraindications
Adverse reactions
The most common adverse reactions to zoster vaccine recombinant, adjuvanted in patients >=50 years of age are injection site reactions, including pain (78%), redness (38%), and swelling (26%), and systemic reactions, including myalgia (45%), fatigue (45%), headache (38%), shivering (27%), fever (21%), and GI symptoms (17%).
The most common adverse reactions to zoster vaccine recombinant, adjuvanted in autologous HSCT patients (18-49 and >=50 years of age, respectively) are pain (88 and 83%), redness (30 and 35%), and swelling (21 and 18%), and systemic reactions, including fatigue (64 and 54%), myalgia (58 and 52%), headache (44 and 30%), GI symptoms (21 and 28%), shivering (31 and 25%), and fever (28 and 18%).
Rare or Very Rare
- Acute gouty arthritis
- Angioedema
- Guillain-barre syndrome
- Hypersensitivity drug reaction
- Optic neuropathy
More Frequent
- Chills
- Erythema
- Fatigue
- Fever
- Gastrointestinal irritation
- Headache disorder
- Injection site pain
- Injection site sequelae
- Localized edema
Less Frequent
- Acute abdominal pain
- Arthralgia
- Diarrhea
- Dizziness
- Malaise
- Myalgia
- Nausea
- Pruritus of skin
- Vomiting
Rare or Very Rare
- Injection site erythema
- Lymphadenopathy
- Paresthesia
- Skin rash
- Syncope
- Urticaria
Precautions
No enhanced messaging available.
Safety and efficacy of zoster vaccine recombinant, adjuvanted have not been established in pediatric patients and the vaccine is not indicated for prevention of primary varicella infection (chickenpox).
Data are insufficient to establish a vaccine-associated risk with use of zoster vaccine recombinant, adjuvanted in pregnant women. In animal studies, there was no evidence that zoster vaccine recombinant or the AS01B adjuvant component of the vaccine affected fetal development or caused fetal harm.
The US Public Health Service Advisory Committee on Immunization Practices (ACIP) states that consideration should be given to delaying administration of zoster vaccine recombinant, adjuvanted in pregnant women.
It is not known whether zoster vaccine recombinant, adjuvanted is distributed into human milk, affects milk production, or affects the breast-fed infant.
The benefits of breast-feeding and the importance of zoster vaccine recombinant, adjuvanted to the woman should be considered along with the potential adverse effects on the breast-fed child from the vaccine or from the underlying maternal condition (i.e., susceptibility to reactivation of varicella zoster virus (VZV) infection).
ACIP states that administration of a non-live vaccine to a woman who is breast-feeding does not pose risks for the woman or her breast-fed infant. However, these experts state that consideration should be given to deferring administration of zoster vaccine recombinant, adjuvanted in women who are breast-feeding.
The manufacturer makes no specific dosage recommendations for geriatric patients.
In the ZOE-50 and ZOE-70 clinical trials of zoster vaccine recombinant, adjuvanted, 15% of study participants were 60-69 years of age, 47% were 70-79 years of age, and 13% were >=80 years of age. There were no clinically meaningful differences in efficacy of the vaccine across these age groups; however, adverse effects were reported less frequently in vaccine recipients 70 years of age or older compared with those 50-69 years of age. Among geriatric patients who enrolled into the long-term follow-up study, 17% were 60-69 years of age, 46% were 70-79 years of age, and 9% were >=80 years of age. From a median of 5.6 to 11.4 years after vaccination, incidence rates of herpes zoster were higher in older age groups (70-79 and >80 years of age) compared with younger age groups (50-59 and 60-69 years of age).
In the clinical trial of zoster vaccine recombinant, adjuvanted in adults who underwent autologous hematopoietic stem cell transplantation (HSCT), 18.7% of study participants were >=65 years of age. No clinically meaningful differences in efficacy of the vaccine were observed between geriatric patients and younger adults. In the 6 clinical trials of zoster vaccine recombinant, adjuvanted in immunocompromised patients, 21.2% were >=65 years of age. The frequencies of solicited local and general adverse reactions among geriatric patients were similar to or lower than those reported in younger adults.
ICD codes
| Code | Type | Description |
|---|---|---|
| Shingles vaccination | ||
| Z23 | ICD10CM | Encounter for immunization |
ICD code information from First Databank (FDB).
Formulary status
Search health-plan coverage for this drug by ZIP code.
Choose the first character of a health plan name.
Last reviewed · Source: First Databank (FDB) drug data
On this page
Actions
Sign in to save favorites
Saving this drug requires a free Physicians Office Resource account.