AdultPediatricGeriatricDosage Forms & Strengths suspension for injection 5mL multidose vial containing ten 0.5mL doses Anthrax Disease Prophylaxis Indicated for postexposure prophylaxis (PEP) of disease following suspected or confirmed exposure to Bacillus anthracis in adults aged 18-65 years in combination with recommended antibacterial drugs Efficacy for PEP is based solely on studies in animal models of inhalational anthrax 2-dose primary series: 0.5 mL IM each 2 weeks apart (at Week 0 and 2) postexposure combined with antibacterial therapy Dosing Considerations Inform healthcare provider if receiving steroid or cancer treatments<18 years: Safety and efficacy not established>65 years: Safety and efficacy not establishedInteraction CheckerEnter a drug name and anthrax vaccine adsorbed, adjuvantedNo Results No Interactions Found Interactions FoundContraindicatedSerious - Use AlternativeSignificant - Monitor CloselyMinorAll Interactions Sort By: SeverityName Contraindicated (0)Serious - Use Alternative (2)elivaldogene autotemcelelivaldogene autotemcel, anthrax vaccine adsorbed, adjuvanted. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .teplizumabteplizumab decreases effects of anthrax vaccine adsorbed, adjuvanted by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.Monitor Closely (2)satralizumabsatralizumab decreases effects of anthrax vaccine adsorbed, adjuvanted by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .ublituximabublituximab decreases effects of anthrax vaccine adsorbed, adjuvanted by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines at least 4 weeks before initiating ublituximab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiating for non-live vaccines. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Do not administer live or live-attenuated vaccines to infants of mothers exposed to ublituximab during pregnancy, before confirming recovery of B-cell counts as measured by CD19+ B cells.Minor (0)elivaldogene autotemcelSerious - Use Alternative (1)elivaldogene autotemcel, anthrax vaccine adsorbed, adjuvanted. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .satralizumabMonitor Closely (1)satralizumab decreases effects of anthrax vaccine adsorbed, adjuvanted by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines. At least 2 weeks before initiating for non-live vaccines. .teplizumabSerious - Use Alternative (1)teplizumab decreases effects of anthrax vaccine adsorbed, adjuvanted by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Inactivated or mRNA vaccines are not recommended within 2 weeks before teplizumab treatment, during treatment, or 6 weeks after completion of treatment.ublituximabMonitor Closely (1)ublituximab decreases effects of anthrax vaccine adsorbed, adjuvanted by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines at least 4 weeks before initiating ublituximab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiating for non-live vaccines. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Do not administer live or live-attenuated vaccines to infants of mothers exposed to ublituximab during pregnancy, before confirming recovery of B-cell counts as measured by CD19+ B cells. >10% All grades Injection-site reaction (93%) Tenderness (88.1%) Pain (86.3%) Any systemic reaction (84.3%) Muscle ache (75.2%) Tiredness (67.1%) Arm motion limitation (63.7%) Headache (58%) Warmth (51.2%) Induration (37.5%) Itching (21.9%) Swelling (19.7%) Erythema/redness (17.9%) Bruising (17.2%) 1-10% H3 All grades Fever (6.8%) Grade 3 or 4 Any systemic reaction (6.6%) Injection-site reaction (3.8%) Muscle ache (3.5%) Headache (3.2%) Tiredness (2.9%) Pain (2.1%) Tenderness (1.7%) Arm motion limitation (1.7%) <1% Grade 3 or 4 Erythema/redness (0.9%) Warmth (0.7%) Fever (0.7%) Itching (0.4%) Swelling (0.4%) Induration (0.3%) Bruising (0.3%) Postmarketing Reports Blood and lymphatic system disorders: Lymphadenopathy Gastrointestinal disorders: Nausea Immune system disorders: Allergic reactions (including anaphylaxis, angioedema, rash, urticaria, pruritus, erythema multiforme, anaphylactoid reaction, and Stevens-Johnson syndrome) Nervous system disorders: Paresthesia, syncope, dizziness, tremor, ulnar nerve neuropathy Musculoskeletal, connective tissue, and bone disorders: Arthralgia, arthropathy, myalgia, rhabdomyolysis, alopecia General disorders and administration-site conditions: Malaise, pain, cellulitis, flu like symptoms Psychiatric disorders: Insomnia Skin and SC tissue disorders: Pruritus, rash, urticaria Vascular disorders: Flushing Contraindications History of a severe allergic reaction (eg, anaphylaxis) following a previous dose of Cyfendus, BioThrax or any component of vaccine Cautions Appropriate medical treatment must be available to manage possible anaphylactic reactions following administration Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to the vaccine Can cause fetal harm when administered to pregnant female Pregnancy There are no adequate and well-controlled studies in pregnant females Available human data administered to pregnant individuals do not establish the presence or absence of vaccine-associated risks in pregnancy NOTE: Available data on BioThrax (anthrax vaccine adsorbed), administered to pregnant individuals are relevant because both vaccines contain the same active ingredient and are manufactured similarly Lactation Unknown whether vaccine is excreted in human milk Human data are not available to assess the impact of the vaccine on milk production, its presence in breast milk, or its effects on breastfed childrenPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Vaccine induces antibodies against protective antigen protein that may contribute to protection by neutralizing the actions of cytotoxic lethal toxin and edema toxin of B anthracis IM Preparation Gently swirl or roll vial to ensure suspension is homogeneous milky-white To avoid foaming, DO NOT shake Visually inspect vial before administering; discard if particulate matter and discoloration are present Do not mix with any other product in the same syringe or vial IM Administration IM administration only Storage Store at 2-8ºC (36-46ºF) Protect vials from light Do NOT shake Do not freeze; discard if product is frozen No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. 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