Smallpox (Vaccinia) Vaccine, Injection

What are other names for this medicine?

Type of medicine: vaccine

Generic and brand names: smallpox (vaccinia) vaccine, injection; ACAM2000

What is this medicine used for?

This medicine is given by injection (a shot) to protect people against smallpox disease. It is for use in people who have a high chance of getting the disease. This injection contains live vaccinia virus.

What should the healthcare provider know before I take this medicine?

Before taking this medicine, tell the healthcare provider if you have ever had:

• an allergic reaction to any medicine or vaccine, or to eggs
• a weakened immune system from diseases such as HIV/AIDS, from cancer chemotherapy or radiation therapy, or from taking immunosuppressant medicines to prevent organ transplant rejection or steroid medicines to treat arthritis
• diabetes
• eye disease treated with steroid medicines
• heart disease, high blood pressure, a stroke, or heart attack
• skin problems such as eczema, psoriasis, acne, or contact dermatitis

Tell the healthcare provider if you currently have an infection of any kind. Also tell your provider if a close family member had heart problems before the age of 50.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. Use an effective birth control method one month before and after the vaccination. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

How do I use it?

This medicine must be given by a healthcare provider. Your healthcare provider will make 15 pokes in the skin of your upper arm with a needle containing the virus. The pokes are not deep, but will cause a drop of blood to form. This is called the vaccination site.

It is important to care for the vaccination site properly so that the virus doesn't spread. Follow your healthcare provider's instructions exactly. You may need to change the bandage every 1 to 3 days. You can infect another part of your body or other people until the scab falls off. To prevent this:

• Wear bandages or Band-Aids to cover the entire vaccination site. Wear gloves when you change the bandage. Throw away gloves and used bandages in sealed or double plastic bags. A small amount of bleach put in the bag will kill the virus.
• Wear sleeves to cover the site.
• Wash your hands often with alcohol-based cleansers or soap and water. Wash your hands each time you change your bandage or if you touch the vaccination site. Do not touch your eyes, any part of your body, or another person until you have washed your hands.
• Do not scrub the vaccination site. Cover the vaccination site with a waterproof bandage when bathing. Do not use creams or lotions on the vaccination site because they will delay healing and can spread the virus.
• Do not scratch or pick at the vaccination site or let others touch the vaccination site.
• Wash clothing, towels, bedding or other items that may have come in contact with the vaccination site separately from other wash. Use hot water with detergent and bleach.
• When the scab falls off, throw it away in a sealed plastic bag with a small amount of bleach. Wash your hands afterwards.

What should I watch out for?

Because the vaccine has a live virus, it can spread if you touch the vaccination site and then touch other parts of your body or other people. The virus can spread until the vaccination scab falls off (2 to 4 weeks after vaccination). If the virus is spread to a person who should not get the vaccine, the side effects can be very serious and life-threatening.

Until the vaccination site has healed, do NOT:

• have close personal contact with infants less than 12 months old, pregnant women, people with a skin condition such as eczema, or anyone who has a weakened immune system
• donate blood for at least 30 days
• swim or use a hot tub
• share clothes, towels, or bedding with anyone who has not been vaccinated
• get pregnant or breast-feed
• have a TB test

If you need emergency care, surgery, or dental work in the month after your vaccination, tell the healthcare provider or dentist that you just got a smallpox vaccination.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical treatment or call 911 for help): Allergic reaction (hives; itching; rash; tightness in your chest; swelling of your lips, tongue, or throat; trouble breathing).

Serious (report this to your healthcare provider right away): Chest pain, fast or irregular heartbeat, severe shortness of breath, confusion, seizures, blisters, severe rash, fever that lasts more than 1 day, eye infection or vision problems, vaccination site that is not healing, rash or sore on other parts of your body.

Other: Soreness, redness, or mild swelling where the shot was given, tiredness, muscle pain, headache, nausea, diarrhea, constipation, vomiting.

What products might interact with this medicine?

When you receive this medicine while you are taking other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Tell the healthcare provider if you are taking:

• immunosuppressants such as azathioprine (Imuran), basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), daclizumab (Zenapax), glatiramer (Copaxone), mycophenolate (CellCept), tacrolimus (Prograf), and sirolimus (Rapamune)
• corticosteroids such as cortisone, dexamethasone, fludrocortisone (Florinef), hydrocortisone (Cortef), methylprednisolone (Medrol), prednisolone (Prelone), prednisone (Prednisone Intensol, Sterapred), and triamcinolone (Aristocort)
• other live vaccines
• radiation treatment or chemotherapy (this vaccine may not be effective)

Keep a record of all vaccines received and when you received them.

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.