Dosing & Uses
Dosage 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 established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (2)
- elivaldogene autotemcel
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. .
- teplizumab
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.
Monitor Closely (2)
- satralizumab
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. .
- ublituximab
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.
Minor (0)
Adverse Effects
>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
Warnings
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 & Lactation
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 children
Pregnancy 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.Pharmacology
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
Administration
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
Images
Formulary
Adding 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.
Adding 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.
