Pronunciation:

AN-thrax VAX-een ad-SORBD, AD-joo-van-ted

Brand Names:

• Cyfendus

Uses of This Medicine:

Anthrax vaccine adsorbed, adjuvanted is used to prevent infection caused by anthrax bacteria. It is 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 Cyfendus™ in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of Cyfendus™ in patients older than 65 years of age. Safety and efficacy have not been established.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Weak immune system—May decrease the effect of the vaccine and the body's response to it.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given as a shot into one of your muscles.

This vaccine is given in 2 doses, 2 weeks apart after exposure to anthrax, together with antibiotics.

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.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

It is important that your doctor check your progress to make sure the vaccine is working properly. Blood tests may be needed to check for unwanted effects.

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, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, a fast heartbeat, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the vaccine.

Make sure your doctor knows if you are receiving a treatment that may weaken the immune system.

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:

Incidence not known

Blistering, peeling, or loosening of the skin

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

chest tightness

chills

cough

dark colored urine

diarrhea

difficulty in moving

difficulty swallowing

dizziness

fainting

fast heartbeat

feeling of warmth

hives, itching, skin rash

joint pain

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

muscle cramps, pains, spasms, or stiffness

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

red irritated eyes

red skin lesions, often with a purple center

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

shakiness in the legs, arms, hands, or feet

sore throat

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

swollen, painful, or tender lymph glands in neck, armpit, or groin

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

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

fever

headache

muscle aches

Incidence not known

General feeling of discomfort or illness

itching, pain, redness, swelling, tenderness, warmth on skin

loss of appetite

loss or thinning of the hair

runny nose

shivering

trouble sleeping

vomiting

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.