Description
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.
This product is available in the following dosage forms:
- Suspension
Before Using
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.
Pediatric
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.
Geriatric
Anthrax vaccine is not indicated for use in the patients older than 65 years of age.
Breastfeeding
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.
Drug Interactions
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
- 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
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
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
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.
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