ACAM2000

Generic name: Smallpox (vaccinia) Vaccine, Live
Drug class: Viral vaccines

Usage of ACAM2000

ACAM2000 is a prescription vaccine used to protect people against smallpox disease. It is for use in people who have a high chance of getting the disease.

ACAM2000 contains live vaccinia virus (a "pox"-type virus) to protect against smallpox disease.

ACAM2000 may also be used to prevent monkeypox under the FDA’s Expanded Access Investigational New Drug (IND) mechanism.

ACAM2000 side effects

ACAM2000 may cause serious heart problems, including myocarditis and pericarditis. This can happen within 3 to 4 weeks after you get the vaccine.

Call your healthcare provider or get emergency help right away if you have:

  • chest pain or pressure
  • fast or irregular heartbeat
  • breathing problems

    • Most people who get myocarditis and/or pericarditis seem to get better after a few weeks. But heart problems may last longer in some people, and in rare cases, could lead to death.

    Other serious side effects include:

  • swelling of the brain or spinal cord
  • problems with the vaccination site blister, such as it becoming infected
  • spreading of the vaccine virus to other parts of your body or to another person
  • severe allergic reaction after vaccination
  • accidental infection of the eye (which may cause swelling of the cornea causing watery painful eyes and blurred vision, scarring of the cornea, and blindness)
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    • Common side effects include:

  • itching
  • swollen lymph nodes
  • sore arm
  • fever
  • headache
  • body ache
  • mild rash
  • fatigue

    • The risks for serious vaccine side effects are greater for people who:

  • have skin problems called eczema or atopic dermatitis
  • have skin problems, such as burns, impetigo, contact dermatitis, chickenpox, shingles, psoriasis, or uncontrolled acne
  • have had heart problems
  • have serious heart or blood vessel problems including angina, previous heart attack, artery disease, congestive heart failure, stroke, or other cardiac problems
  • smoke or have high blood pressure, high cholesterol, diabetes, high blood sugar, or a family history of heart problems
  • are breastfeeding
  • are pregnant, could be pregnant, or plan to become pregnant
  • are less than 1 year old
  • are taking steroid eye drops or ointment
  • have had problems after previous doses or are allergic to ACAM2000 or any part of ACAM2000 such as antibiotics neomycin or polymixin B

    • Tell your healthcare provider if you have any of the above conditions.

    The virus from your vaccination can spread to other people and cause serious side effects. It is important to tell your healthcare provider if you:

  • live or work with a person who has skin problems (like eczema, dermatitis, burns, psoriasis, bad acne) or is suffering from impetigo, chicken pox or shingles
  • live or have close contact with a baby, or a person who is pregnant or breastfeeding
  • live or have close contact with a person who has an immune deficiency or cardiac disease

    • See How do I care for the ACAM2000 vaccination site?

    Tell your healthcare provider about any side effect that bothers you or that does not go away.

    To report SUSPECTED ADVERSE REACTIONS, contact your health provider and Acambis Inc. at 866-440-9440 (toll free) or 617-866-4500 or VAERS at 800-822-7967 and http://vaers.hhs.gov

    Before taking ACAM2000

    In an emergency, you should be vaccinated if you are at high risk for getting smallpox disease even if you have health problems (except if you have certain problems with your immune system as discussed below).

    Your healthcare provider may not give you ACAM2000 if you have problems with your immune system. You may have immune system problems if you:

  • have leukemia
  • have lymphoma
  • have had a bone marrow or organ transplant
  • have cancer that has spread
  • have HIV, AIDS
  • have cellular or humoral immune deficiency
  • are being treated with radiation
  • are being treated with steroids, prednisone, or cancer drugs
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    Warnings

    If you are at a high risk for being exposed to smallpox, you should be vaccinated even if you have health problems, unless you have certain problems with your immune system. People who have health problems may have a higher chance of getting serious side effects from vaccination but are also those who have a higher chance of dying from the smallpox disease.

    ACAM2000 may cause serious heart problems called myocarditis and pericarditis, or swelling of the heart tissues. In studies, about 1 in every 175 persons who got the vaccine for the first time may have experienced myocarditis and/or pericarditis. On rare occasions these conditions can result in an irregular heart beat and death. Your chances of getting heart problems from the vaccine are lower if you have already had this vaccine before. You can have myocarditis and/or pericarditis even if you have no symptoms. Call your healthcare provider or get emergency help right away if you have:

  • chest pain or pressure
  • fast or irregular heartbeat
  • breathing problems

    • See ACAM2000 side effects.

    Because the vaccine has a live virus, it can spread to other parts of your body or to other people if you touch the vaccination site and then touch other parts of your body or other people. The vaccine 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. See How do I care for the smallpox vaccination site?

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

    The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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