Version May 2024
Preexposure prophylaxis (PrEP): Note: If the vaccination schedule is interrupted, the series does not need to be restarted (Ref). IM administration is preferred; SUBQ administration may be used in persons who are at risk for hematoma formation following IM injection.
Adults ≤65 years of age:
IM (preferred), SUBQ:
Primary immunization: 0.5 mL/dose given as a 3-dose series at day 0, 1 month, and 6 months (Ref).
Booster immunization:
Persons not at high risk for exposure: 0.5 mL/dose given at 6 and 12 months after completion of the primary series and at 3-year intervals thereafter (Ref).
Persons at high risk for exposure: 0.5 mL/dose given 6 and 12 months after completion of the primary series and at 1-year intervals thereafter (Ref).
Note: If the patient has completed the entire priming and booster series but has not received a booster dose in more than 12 months, administer an IM booster dose and wait 2 weeks to enter the high-risk area. If immediate access is required, administer the booster dose and initiate postexposure prophylaxis (PEP) antibiotics for 2 weeks (Ref).
If a person requires immediate access to an area where B. anthracis is suspected to be present in the environment or be in use and they have not completed the primary and initial booster series, a transition from preexposure prophylaxis (PrEP) to postexposure prophylaxis (PEP) with anthrax vaccine adsorbed, in conjunction with antibiotics, should occur as follows (Ref):
|
Previous PrEP doses |
Interval since last dose |
PEP vaccine |
PEP antibiotics |
|---|---|---|---|
|
a For use in persons who have not completed primary and initial booster vaccination who must access an area with high risk of B. anthracis exposure. | |||
|
0 |
— |
Dose 1 (week 0) |
Administer until 42 days after first dose of anthrax vaccine adsorbed or 14 days after last dose, whichever occurs later. |
|
Dose 2 (week 2) | |||
|
Dose 3 (week 4) | |||
|
1 |
— |
Dose 2 (week 0) |
Administer until 28 days after second dose of anthrax vaccine adsorbed or 14 days after the last dose, whichever occurs later. |
|
Dose 3 (week 2) | |||
|
2 |
— |
Dose 3 (week 0) |
Administer until 14 days after last dose. |
|
3 or 4 |
>6 months |
Booster dose |
Administer until 14 days after booster dose. |
|
3 or 4 |
≤6 months |
No booster dose |
No antimicrobials needed. |
Postexposure prophylaxis (inhalation exposure): Initiation: Vaccination should begin within 10 days of exposure (Ref). Antibody titers among vaccinated persons peak at 14 days after the last administered dose and all dosing schedules maintain a high level of predicted survival through week 9 (Ref). Route of administration: SUBQ route is preferred for PEP. In the event of a wide-area aerosolized release of B. anthracis, IM administration may be considered to allow for rapid and efficient administration (Ref). Concomitant antibiotics: Administer with a course of appropriate antibiotics; see guidelines for details (Ref).
SUBQ (preferred), IM: 0.5 mL/dose given at day 0, 2 weeks, and 4 weeks postexposure.
Alternative dose-sparing schedules: Note: If demand were to exceed supply, alternative dose-sparing regimens should be utilized (Ref).
SUBQ (preferred), IM:
Two-full-dose regimen: 0.5 mL/dose given as a 2-dose series at day 0 and 2 to 4 weeks postexposure (Ref).
Three-half-dose regimen: 0.25 mL/dose given as a 3-dose series at day 0, 2 weeks, and 4 weeks postexposure (Ref).
Note: Additional considerations for postexposure prophylaxis following occupational exposures (Ref):
Fully vaccinated: Personnel who have completed the primary vaccination series and booster injections do not require postexposure prophylaxis if wearing protective equipment. If respiratory protection is disrupted, an appropriate course of antimicrobial therapy is recommended.
Previously unvaccinated: Workers should receive the vaccine as directed per postexposure prophylaxis along with the recommended course of antimicrobial therapy.
Partially vaccinated: Any person who started but did not complete the primary vaccination series should receive antibiotics to continue until 28 days after the second dose of PEP vaccine or 14 days after the last dose of PEP vaccine, whichever occurs later; and continue with the primary vaccination schedule.
Safety and efficacy have not been established in persons >65 years of age.
(For additional information see "Anthrax vaccine adsorbed (United States: Availability limited to request from manufacturer [individual patient] or CDC distribution from Strategic National Stockpile via local health department): Pediatric drug information")
Note: Routine preexposure immunization with anthrax vaccine in pediatric patients is not recommended; use in pediatric patients is determined on an event-by-event basis (Ref). Due to increased risk of adverse effects postvaccination and unknown effects on immunogenicity, anthrax vaccine should not be administered at the same time as routine childhood immunizations. Postexposure immunization with anthrax vaccine should take priority over routine childhood immunizations; any routine childhood immunization should be postponed until 4 weeks after completion of the anthrax series (Ref).
Postexposure prophylaxis: Use should be in conjunction with public health official guidance and recommendations on an event-by-event basis; refer to guidelines provided as part of emergency use authorization (EUA) or investigational new drug (IND) application at the time of the event. Use in combination with a 60-day systemic antimicrobial course; vaccination should begin within 10 days of exposure (Ref).
Infants ≥6 weeks, Children, and Adolescents <18 years of age: Very limited data available; use in pediatric patients extrapolated from adult experience (Ref). SubQ: 0.5 mL as a 3-dose series administered at 0, 2, and 4 weeks after exposure (Ref).
Adolescents ≥18 years: SubQ: 0.5 mL as a 3-dose series administered at 0, 2, and 4 weeks after exposure (Ref).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Percentages reported with IM and SUBQ administration in adults unless otherwise specified.
>10%:
Local: Burning sensation at injection site (45% to 97%), erythema at injection site (SUBQ: 53% to 71%; IM: 15% to 48%), induration at injection site (SUBQ: 26% to 40%; IM: 7% to 23%), injection-site nodule (SUBQ: 21% to 42%; IM: 3% to 9%), injection-site pruritus (SUBQ: 3% to 26%; IM 1% to 10%), pain at injection site (12% to 22%), swelling at injection site (SUBQ: 17% to 46%; IM: 5% to 30%), tenderness at injection site (SUBQ: 48% to 72%; IM: 41% to 51%), warm sensation at injection site (SUBQ: 29% to 51%; IM: 4% to 19%)
Nervous system: Fatigue (6% to 13%), headache (2% to 11%)
Neuromuscular & skeletal: Decreased range of motion (5% to 15%; arm), myalgia (3% to 13%)
1% to 10%:
Local: Bruising at injection site (6% to 7%)
Neuromuscular & skeletal: Axillary pain (2%; including tenderness)
Postmarketing:
Cardiovascular: Flushing, syncope
Dermatologic: Alopecia, cellulitis, pruritus, skin rash, urticaria
Gastrointestinal: Nausea
Hematologic & oncologic: Lymphadenopathy
Hypersensitivity: Hypersensitivity reaction (including anaphylaxis, angioedema, erythema multiforme, nonimmune anaphylaxis, Stevens-Johnson syndrome)
Nervous system: Dizziness, insomnia, malaise, neuropathy (ulnar nerve), pain, paresthesia, tremor
Neuromuscular & skeletal: Arthralgia, arthropathy, rhabdomyolysis, rheumatoid arthritis (Vasudev 2006)
Ophthalmic: Optic neuritis (Kerrison 2002)
Respiratory: Flu-like symptoms
Anaphylactic or anaphylactic-like reaction following a previous dose of anthrax vaccine or any component of the formulation including aluminum, benzethonium chloride, and formaldehyde.
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 2023]).
• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis or tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).
• 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 2023]).
Disease-related concerns:
• Acute illness: Postpone administration in patients with moderate or severe acute illness (with or without fever) in preexposure vaccination programs; may administer to patients with mild acute illness (with or without fever). When used for postexposure prophylaxis, consider the benefits versus risks in patients with moderate or severe acute illness (CDC [Wright 2010]).
• Anthrax disease: Persons with a history of anthrax disease may have an increased risk for severe local adverse reactions from the vaccine.
• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2023]). For patients at risk of hemorrhage following IM injection, the vaccine can be administered SUBQ.
Concurrent drug therapy issues:
• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2023]). For patients at risk of hemorrhage following IM injection, the vaccine can be administered SUBQ.
• Vaccines: Anthrax vaccine should not be administered with routine childhood immunization doses due to increased potential for adverse reactions and unknown effects on immunogenicity; routine childhood immunizations should be postponed until 4 weeks after completion of anthrax series (AAP [Bradley 2014]).
Special populations:
• Altered immunocompetence: Consider deferring preexposure vaccination during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]) if appropriate; may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age-appropriate vaccines. Nonlive vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; nonlive vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2023]; IDSA [Rubin 2014]).
• Older adult: Safety and efficacy have not been established in adults ≥65 years of age.
Dosage form specific issues:
• Latex: Packaging may contain natural latex rubber.
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 (ACIP [Kroger 2023]).
Safety data in pediatric patients are lacking; adverse effects are anticipated to be similar to those in adult patients; local adverse reaction may occur due to aluminum hydroxide excipient based on experience with other vaccines; local reactions are not a contraindication for further doses; however, they should be administered at a different site (AAP [Bradley 2014]; CDC [Wright 2010]).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Intramuscular:
BioThrax: Bacillus anthracis proteins (5 mL) [contains formaldehyde solution]
No
For ordering information contact the manufacturer at 866-300-7602 or http://biothrax.com/forhealthpros/clinicalInfo/ordering.aspx. A supply is also maintained in the Strategic National Stockpile for post-exposure prophylaxis in the event of a terrorist attack with anthrax. Additional information from the CDC is available at https://www.cdc.gov/laboratory/drugservice/formulary.html.
Shake well before use. Do not use if discolored or contains particulate matter. Do not use the same site for more than one injection. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope related injuries, patients should be vaccinated while seated or lying down (Ref). If purchased under CDC 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.
Preexposure prophylaxis: For IM administration into the deltoid muscle; do not inject IV or intradermally. Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). For patients at risk of bleeding/hematoma following IM injection, the vaccine can be administered SUBQ over the deltoid muscle.
Postexposure prophylaxis: Administer SUBQ over the deltoid muscle. Under normal circumstances, the SUBQ route is preferred for PEP due to the faster induction of antibody production and higher subsequent antibody concentrations and 4-week survival estimates following this route of administration (Wright 2014). In the event of a wide-area aerosolized release of B. anthracis, IM administration may be considered to allow for rapid and efficient administration (Ref).
Shake well before use. Do not use if discolored or contains particulate matter. Do not use the same site for more than 1 injection. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection; routine childhood immunizations should be delayed during anthrax series. To prevent syncope-related injuries, adolescents should be vaccinated while seated or lying down (Ref). If purchased under CDC 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.
SubQ: Postexposure prophylaxis: Administer SubQ over the deltoid muscle.
In the US, the appropriate 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/anthrax.html.
Anthrax prevention: Active immunization against Bacillus anthracis in persons 18 to 65 years of age.
Preexposure: For preexposure prophylaxis (PrEP) of disease in persons whose occupation or other activities place them at high risk of exposure.
The Department of Defense requires anthrax vaccination for designated active duty and reserve personnel (DoD [Work 2015]).
The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination (preexposure vaccination) for the following (CDC/ACIP [Bower 2019]); CDC/ACIP [Wright 2010]):
• Persons who work directly with B. anthracis in a laboratory
• Persons who handle animals or animal products if they meet ≥1 of the following criteria:
- they are handling potentially infected animals in research settings,
- incidence of enzootic anthrax in work area is high, or
- when animal or animal product handling standards and restrictions are not sufficient to prevent exposure
• Persons engaged in environmental investigations or remediation efforts
• Military personnel as directed by the Department of Defense
Routine immunization for the general population is not recommended. Vaccination may be offered to emergency and other responders (eg, police and fire departments, National Guard response teams) on a voluntary basis under the direction of a comprehensive occupational health and safety program (CDC/ACIP [Bower 2019]); CDC/ACIP [Wright 2010]).
Postexposure: For postexposure prophylaxis (PEP) of disease following suspected or confirmed B. anthracis exposure, administered in conjunction with recommended antibiotics.
The ACIP recommends PEP after known or suspected exposure to aerosolized B. anthracis spores in adults 18 to 65 years of age who did not previously complete a preexposure vaccination schedule (CDC/ACIP [Bower 2019]).
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
Anti-CD20 B-Cell Depleting Therapies: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider therapy modification
Cladribine: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of cladribine when possible. Patients vaccinated less than 14 days before initiating or during cladribine should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Corticosteroids (Systemic): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
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
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). 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. Risk D: Consider therapy modification
Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 2 to 3 months after therapy is complete. Risk D: Consider therapy modification
Methotrexate: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to methotrexate initiation, if possible. If patients are vaccinated less than 14 days prior to or during methotrexate therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider therapy modification
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
Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider therapy modification
Teplizumab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccination with inactivated or non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification
Male fertility is not affected by vaccine administration (Catherino 2005).
Initial data from the Department of Defense suggest the vaccine may be linked with a slightly increased number of atrial septal defects when given during the first trimester of pregnancy; however, when premature infants are excluded from analysis, the association was not statistically significant (Ryan 2008). Additional data from the Department of Defense registry has not found an increased risk of adverse pregnancy outcomes following maternal vaccination with anthrax vaccine adsorbed (CDC [Bower 2019]; Conlin 2015; Conlin 2017).
Information related to anthrax infection in pregnancy is limited; however, maternal infection may be associated with preterm labor and an increased risk of maternal and fetal death (Meaney-Delman 2012).
Although anthrax vaccine may be administered during pregnancy, use in pregnant women in a preanthrax event setting, where the risk to anthrax exposure is low, is not recommended. Vaccination is not a contraindication for pregnant women at high risk for exposure (Meaney-Delman 2014). Postexposure prophylaxis is recommended using anthrax vaccine adsorbed (in combination with appropriate antibiotic therapy) in pregnant women following inhalation exposure to aerosolized Bacillus anthracis (CDC [Bower 2019]).
Data collection to monitor pregnancy and infant outcomes following exposure to anthrax vaccine adsorbed is ongoing. Health care providers are encouraged to enroll pregnant women exposed to this vaccine in Emergent’s vaccination pregnancy registry (1-619-553-9255).
It is not known if components of this vaccine are present in breast milk.
The manufacturer recommends that caution be used if administered to nursing women. Breastfeeding is not considered a contraindication to vaccination with anthrax vaccine adsorbed (Meaney-Delman 2014).
Observe for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2023]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Active immunization against Bacillus anthracis. The vaccine is prepared from a cell-free filtrate of B. anthracis, but no dead or live bacteria. Completion of the entire vaccination series is required for full protection; annual boosters are required to maintain immunity.
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