Drug information of Anthrax vaccine

Anthrax vaccine

Drug group: Vaccines

Anthrax is a disease caused by infection with spore-forming bacteria called Bacillus anthracis, which occur naturally in soil. These bacteria most often infect animals such as sheep, goats, cattle, deer, antelope, and other herbivores. Anthrax disease can occur in people who are exposed to an infected animal or other source of anthrax bacteria.

Anthrax is most common in agricultural regions lacking in good veterinary prevention programs, especially in Africa, Asia, Central and South America, the Caribbean, the Middle East and Southeastern Europe. Although less common, anthrax does occur in the United States among both wild game animals and domestic livestock.

Anthrax is spread to a human through the skin, the stomach, or the lungs. The bacteria can enter the skin through a cut or wound that comes into contact with products from an infected animal (such as meat, wool, hide, or hair). Infection can also occur through the lungs when a person inhales the bacterial spore, or through the stomach when a person eats undercooked meat from an infected animal. Anthrax is a serious disease that can spread quickly throughout the body and it is fatal in a high number of cases, especially when acquired through the lungs.

Anthrax vaccine is used to help prevent anthrax disease in adults. Anthrax vaccine will not treat an active infection that has already developed in the body.

Anthrax vaccine is used before exposure in people who may come into contact with anthrax bacteria in certain work settings, while traveling, or during military service. Anthrax vaccine is used together with antibiotics after exposure in people who have already come into contact with anthrax bacteria.

This vaccine works by exposing you to an antigen protein that causes your body to develop immunity to the disease. Anthrax vaccine does not contain live or killed forms of the bacteria that causes anthrax.

Like any vaccine, the anthrax vaccine may not provide protection from disease in every person.

Mechanism of effect

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.

Drug indications

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

Dosage

Usual Adult Dose for Anthrax Prophylaxis
Pre-Exposure Prophylaxis:
Primary series: 0.5 mL intramuscularly at 0, 1, and 6 months
Booster series: 0.5 mL intramuscularly 6 and 12 months after primary series and at 12-month intervals thereafter
Pre-Exposure Prophylaxis in patients at risk of hematoma from intramuscular injection:
Primary series: 0.5 mL subcutaneously at 0, 2, and 4 weeks and 6 months
Booster series: 0.5 mL subcutaneously 6 and 12 months after primary series and at 12-month intervals thereafter
Post-Exposure Prophylaxis:
Primary series: 0.5 mL subcutaneously at 0, 2, and 4 weeks post-exposure combined with antimicrobial therapy

Drug contraindications

Severe hypersensitivity (e.g. anaphylaxis) to any of the ingredients

Safety and efficacy have not been established in patients younger than 18 years or older than 65 years; this drug is not recommended for use in these patients

Side effects

>10%:
Central nervous system: Burning sensation, fatigue, headache
Endocrine & metabolic: Edema at insertion site
Local: Tenderness at injection site, erythema at injection site, warm sensation at injection site, injection site nodule, induration at injection site, itching at injection site, pain at injection site
Neuromuscular & skeletal: Decreased range of motion, myalgia
1%
 to 10%:
Hematologic & oncologic: Lymphadenopathy
Local: Bruising at injection site
<1%, postmarketing, and/or case reports: Alopecia, anaphylactoid reaction, anaphylaxis, angioedema, arthralgia, arthropathy, cellulitis, dizziness, erythema multiforme, flu-like symptoms, flushing, hypersensitivity reaction, insomnia, lymphadenopathy, malaise, nausea, pain, paresthesia, pruritus, rhabdomyolysis, skin rash, Stevens-Johnson syndrome, syncope, tremor, ulnar nerve neuropathy, urticaria

Fingolimod, Immunosuppressants, Siponimod, Venetoclax

Alerts

Persons with a history of anthrax disease may have an increased risk for severe local adverse reactions from the vaccine

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 2017]). For patients at risk of hemorrhage following IM injection, the vaccine can be administered SubQ

Vaccination is not recommended after cutaneous or gastrointestinal exposures that pose no risk of inhalational exposure to Bacillus anthracis spores; antimicrobial postexposure prophylaxis may be considered in these patients

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

Points of recommendation

To make sure anthrax vaccine is safe for you, tell your doctor if you have:
an allergy to latex, aluminum hydroxide, benzothonium chloride, or formaldehyde
a weak immune system caused by receiving certain medicines such as steroids, chemotherapy or radiation
if you take a blood thinner (warfarin, Coumadin, Jantoven

Vaccines may be harmful to an unborn baby and generally should not be given to a pregnant woman. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that this vaccine could prevent. Your doctor will decide whether you should receive this vaccine, especially if you have a high risk of infection with anthrax
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of anthrax vaccine on the baby.

It is not known whether anthrax vaccine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby

This vaccine is given as an injection (shot) into a muscle or under the skin

Anthrax vaccine is recommended before exposure for adults age 18 through 65 in the following situations:
people who handle anthrax bacteria in a laboratory or other work setting
people who handle animal hides or furs imported from areas where anthrax is common
people who handle meat or other animal products in areas where anthrax is common
veterinarians who travel to countries where anthrax is common
military personnel at risk of exposure through potential biological warfare when anthrax may be used as a weapon

When used after exposure, anthrax vaccine is given in combination with antibiotic medicine. Be sure to use the antibiotic for the full prescribed length of time, even if you feel fine

The anthrax vaccine is given in a series of shots. An annual booster shot is also recommended every year during possible exposure to anthrax. Follow your doctor's instructions or the booster schedule recommended by the health department of the state where you live

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over

Be sure you receive all recommended doses of this vaccine. You may not be fully protected against disease if you do not receive the full series

Store at 2°C to 8°C ; do not freeze

Pregnancy level

D

Pregnancy Category: D

Breast feeding warning

Lactation: Not known whether distributed in breast milk (use caution

Drug forms

BioThrax

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