Pronunciation:

AN-thrax VAX-een ad-SORBD

Brand Names:

• Biothrax

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Anthrax vaccine is used to prevent infection caused by anthrax bacteria. It is used before exposure to anthrax to protect people at high risk of getting the disease. It is also used after exposure to anthrax, together with antibiotics, to protect people from getting the disease. The vaccine works by causing the body to produce its own protection (antibodies) against anthrax.

Anthrax is a serious disease that may cause death. It is spread by touching or eating something that is infected with the anthrax germ, such as animals, or by breathing in the anthrax germ.

This vaccine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of anthrax vaccine in the pediatric population. Safety and efficacy have not been established.

Older adults—

Anthrax vaccine is not indicated for use in the patients older than 65 years of age.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atidarsagene Autotemcel
• Elivaldogene Autotemcel
• Ocrelizumab
• Teplizumab-mzwv
• Ublituximab-xiiy

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anthrax infection, history of—May increase risk for more serious side effects.

• Blood clotting problems or
• Thin blood from medicines (eg, warfarin, Coumadin®)—The vaccine will be given as a shot under the skin.

• Weak immune system—The vaccine may not work as well in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this vaccine. The vaccine is given as a shot under your skin or into a muscle.

You will receive a total of 3 doses (0, 1, and 6 months) as primary series of shots, if the vaccine is given into a muscle. If you are at risk for hematoma (bruise) formation, you may receive the vaccine under your skin, with a total of 4 doses (0, 2, 4 weeks, and 6 months) as primary series of shots. You will also receive 2 additional doses (booster doses) at 12 and 18 months after the last shot in the primary series followed by a yearly booster dose thereafter if you are still at risk for anthrax infection.

In order for this vaccine to work properly, it is very important that you not miss any doses. Keep all of your appointments with your doctor.

This vaccine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

It is very important that you return to your doctor’s office at the right time for the next dose of the vaccine. Be sure to tell your doctor about any side effects that occur after you receive this vaccine.

Receiving this vaccine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while receiving the vaccine, tell your doctor right away.

This vaccine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the tongue and throat, or trouble breathing after receiving the vaccine.

This vaccine will not treat an anthrax infection that has already started. Talk to your doctor if you have been exposed to anthrax. You will need medicine to treat the infection.

The stopper of the vial contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start receiving this vaccine.

Make sure your doctor knows if you have cancer or are receiving a treatment that may weaken the immune system (eg, a steroid medicine, radiation treatment, or cancer medicines).

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Pain, redness, tenderness, or limited movement of the arm where the injection is given

Less common

Swollen, painful, or tender lymph glands in the neck, armpit, or groin

Incidence not known

Blistering, peeling, or loosening of the skin

chills

cough

diarrhea

difficulty with swallowing

dizziness

fainting

fast heartbeat

hives or welts, skin rash

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

redness of the skin

shakiness in the legs, arms, hands, or feet

shortness of breath

sores, ulcers, or white spots in the mouth or on the lips

trembling or shaking of the hands or feet

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Headache

muscle aches and pains

Incidence not known

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

dark-colored urine

difficulty with moving

feeling of warmth

hair loss or thinning of the hair

muscle cramps or spasms

muscle pain or stiffness

nausea

redness of the face, neck, arms, and occasionally, upper chest

swollen joints

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.