Biothrax (anthrax vaccine adsorbed) dosing, indications, interactions, adverse effects, and more

Sections

Sections anthrax vaccine adsorbed
Dosing & Uses
Adverse Effects
Warnings
Pregnancy
Pharmacology
Administration
Images
Patient Handout
Formulary

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

suspension for injection

5mL multidose vial containing ten 0.5mL doses

Anthrax Immunization

Indicated for active immunization for prevention of disease caused by Bacillus anthracis in individuals aged 18 through 65 yr

Approved in the United States for preexposure prophylaxis in persons at high risk of exposure and for postexposure prophylaxis following suspected or confirmed Bacillus anthracis exposure

Preexposure prophylaxis

3-dose primary series: 0.5 mL IM at 0, 1, and 6 months
Booster series: 0.5 mL IM at 6 and 12 months after primary series initiation and then at 1-year intervals thereafter for persons who remain at risk
Note: Individuals are not considered protected until completion of 3-dose primary series
SC administration for preexposure prophylaxis
- In persons who are at risk for hematoma formation following IM injection, may administer SC
- 4-dose primary series: 0.5 mL SC at 0, 2, 4 weeks, and 6 months
- Booster series: 0.5 mL SC at 6 and 12 months after completion of the primary series, and at 1-year intervals thereafter

Postexposure prophylaxis

0.5 mL SC at 0, 2, and 4 weeks postexposure combined with antimicrobial therapy

Safety and efficacy not established

>65 years: Safety and efficacy not established

>10%

Headache

Fatigue

Tenderness

Erythema

Pain

Edema

Limitation of arm motion

Induration

Warmth

Myalgia

Nasopharyngitis

Pharyngolaryngeal pain

1-10%

Pruritus

Dysmenorrhea

Nausea

Itching

Bruising

Nodule

Back pain

Neck pain

Joint sprain

Rigors

Sinusitis

Upper respiratory tract infection

Sinus headache

Lymphadenopathy

Flu-like illness

Tender/painful axillary adenopathy

<1%

Safety and efficacy not established

Postmarketing Report

Allergic reactions

Alopecia

Anaphylactoid reaction

Arthralgia

Atrthropathy

Erythema multiforme

Injection site

Reactions

Paresthesia

Pyrexia

Rhabdomyolysis

Stevens-Johnson syndrome

Syncope

Tremor

Ulnar

Nerve neuropathy

Contraindications

Documented hypersensitivity

History of anthrax infection

Cautions

Immediate treatment for anaphylactoid reaction should be available during vaccine use

May consider deferring administration in patients with moderate or severe acute illness (with or without fever)

Use with caution in patients with history of bleeding disorders and or anticoagulant therapy

Use caution in patients severely immunocompromised

Pregnancy & Lactation

Pregnancy Category: D

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

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.

Mechanism of Action

Active immunization against Bacillus anthracis prepared from a cell-free filtrate of B anthracis, but no dead or live bacteria

IM or SC Administration

Shake well before use to ensure that the suspension is homogeneous during withdrawal from the vial

May use acetaminophen to provide comfort; routine prophylactic administration of acetaminophen to prevent fever due to vaccine may decrease immune response (significance not established)

Preexposure prophylaxis: Administer IM into the deltoid muscle; if preexposure prophylaxis requires SC administration, administer over the deltoid muscle

Postexposure prophylaxis: Administer SC over the deltoid muscle

Do not mix with any other product in the syringe

Storage

Refrigerate at 2-8°C (36-46°F)

Do not freeze

Images

No images available for this drug.

Patient Handout

ANTHRAX VACCINE - INJECTION

(AN-thrax vak-SEEN)

COMMON BRAND NAME(S): Biothrax

USES: This vaccine is used to help prevent serious, sometimes fatal, infections caused by a certain bacteria (Bacillus anthracis) in people who may be exposed to the bacteria (such as military personnel, laboratory workers who handle the bacteria Bacillus anthracis). It may also be used along with antibiotics to prevent getting the infection after being exposed to the bacteria.This vaccine contains parts from Bacillus anthracis. It works by causing the body to produce its own protection (antibodies) against the bacteria.

HOW TO USE: Read all vaccine information available from your health care professional before receiving the vaccine. If you have any questions, ask your health care professional.This vaccine is given by injection by a health care professional. For preventing the infection before being exposed to the bacteria, it is given into a muscle as directed by your health care professional, usually as a series of 3 doses (1 and 6 months after the first dose), followed by booster shots at 12 and 18 months after the first dose. It may also be given under the skin for certain people (such as people with clotting disorders, people taking "blood thinners"), although this may increase the risk of side effects. When given under the skin, this vaccine is given as directed by your health care professional, usually as a series of 4 doses (2 weeks, 4 weeks, and 6 months after the first dose), followed by booster shots at 12 and 18 months after the first dose.You will need a yearly booster dose if you still remain at risk for anthrax. Ask your health care professional for more details.For preventing the infection after being exposed to the bacteria, it is given under the skin as directed by your health care professional, usually as a series of 3 doses (2 and 4 weeks after the first dose).Follow the dosing schedule closely for the vaccine to be most effective. To help you remember, mark your calendar to keep track of when to receive your next dose.

SIDE EFFECTS: Pain/redness/swelling at the injection site, limited arm movement, muscle ache, headache, or tiredness may occur. If any of these effects last or get worse, tell your health care professional promptly.Rarely, some people have symptoms such as fainting, dizziness, vision changes, or ringing in the ears just after getting a vaccine injection. Tell your health care professional right away if you have any of these symptoms. Sitting or lying down may help, since these symptoms usually don't last long.Remember that this medication has been prescribed because your health care professional has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your health care professional.Contact the health care professional for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018.

PRECAUTIONS: Before you receive this vaccine, tell the health care professional if you are allergic to it; or to latex; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your health care professional for more details.Before receiving this vaccination, tell your health care professional your medical history, especially of: current fever/illness, immune system disorders (such as due to HIV infection, certain cancers such as leukemia/lymphoma, cancer or radiation treatment).This vaccine is not recommended for use during pregnancy. It may harm an unborn baby. Consult your health care professional for more details.It is unknown if this vaccine passes into breast milk. Consult your health care professional before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your health care professional. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this vaccine include: drugs that weaken the immune system (including cyclosporine, tacrolimus, cancer chemotherapy, corticosteroids such as prednisone).

OVERDOSE: Not applicable.

NOTES: As with any vaccine, this vaccine may not fully protect everyone who receives it.

MISSED DOSE: It is important that you receive each vaccination as scheduled. Be sure to ask when each dose should be received, and make a note on a calendar to help you remember.

STORAGE: Store in the refrigerator. Do not freeze. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Formulary

FormularyPatient Discounts

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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.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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