Anthrax Vaccine Adsorbed Adjuvanted

Anthrax Vaccine Adsorbed, Adjuvanted is a vaccine indicated for postexposure prophylaxis of anthrax disease following suspected or confirmed exposure to Bacillus anthracis in adults aged 18 to 65 years in combination with recommended antibacterial drugs. 

• Anthrax Vaccine Adsorbed, Adjuvanted is available under the following different brand names: Cyfendus

Common side effects of Anthrax Vaccine Adsorbed, Adjuvanted include: 

• pain/tenderness, warmth, hardness, itching, swelling, redness, and bruising at the injection site
• trouble moving the arm wherein the vaccine was injected
• muscle aches
• tiredness
• headache
• fever

Serious side effects of Anthrax Vaccine Adsorbed, Adjuvanted include:

• rash
• hives
• itching
• redness or swelling
• blisters or peeling of skin with or without fever
• wheezing and tightness in the chest or throat
• trouble breathing, swallowing, or talking
• unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat

Rare side effects of Anthrax Vaccine Adsorbed, Adjuvanted include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Suspension for injection

• 5 mL multidose vial containing 10 doses of 0.5 mL each

Anthrax disease prophylaxis

Adult dosage

• 2-dose primary series: 0.5 mL IM each 2 weeks apart (at weeks 0 and 2) postexposure combined with antibacterial therapy

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Anthrax Vaccine Adsorbed, Adjuvanted has severe interactions with no other drugs
• Anthrax Vaccine Adsorbed, Adjuvanted has serious interactions with the following drugs:
  • elivaldogene autotemcel
  • teplizumab
• Anthrax Vaccine Adsorbed, Adjuvanted has moderate interactions with the following drugs:
  • satralizumab
  • ublituximab
• Anthrax Vaccine Adsorbed, Adjuvanted has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of a severe allergic reaction (eg, anaphylaxis) following a previous dose of Cyfendus, BioThrax, or any component of the vaccine

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Anthrax Vaccine Adsorbed, Adjuvanted?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Anthrax Vaccine Adsorbed, Adjuvanted?”

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 women

Pregnancy and Lactation

• There are no adequate and well-controlled studies on the drug’s use in pregnant women
• Available human data on the drug’s use in pregnant women do not establish the presence or absence of vaccine-associated risks in pregnancy
• NOTE: Available data on BioThrax (anthrax vaccine adsorbed) administered to pregnant women are relevant because both vaccines contain the same active ingredient and are manufactured similarly
• Lactation
  • Unknown whether the 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