Smallpox (Vaccinia) Vaccine, Injection

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KEY POINTS

• This medicine is given by injection to protect against smallpox disease. Because this is a live virus vaccine, you can spread the virus to other people for 2 to 4 weeks after you get the vaccine.
• This medicine may cause serious or life-threatening heart problems, swelling of the brain or spinal cord, or other life-threatening side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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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
• A stroke or transient ischemic attack (TIA)
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Diabetes
• Eye disease treated with steroid medicines
• Heart disease, angina (chest pain), heart failure, high blood pressure, or heart attack
• High cholesterol
• Skin problems such as burns, eczema, psoriasis, acne, or contact dermatitis

Tell your healthcare provider if you have close contact with:

• A person who has skin problems (such as eczema, dermatitis, burns, psoriasis, bad acne impetigo, chickenpox, or shingles)
• A baby or a person who is pregnant or breast-feeding
• A person who has a weakened immune system or heart problems

Tell the healthcare provider if you currently have an infection of any kind. Also tell your provider if you smoke or have a family history of heart problems.

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 for at least 1 month after the vaccination. If you become pregnant, contact your healthcare provider right away. Do not breast-feed for at least 1 month after the vaccination.

How do I use it?

Read the Medication Guide that is given to you by your healthcare provider when you receive this vaccine. If you are at high risk for smallpox, you may need a booster every 3 years.

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 that contains 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. Keep the site dry. Cover the site with a waterproof bandage when bathing. If the vaccination site gets wet, dry the site with toilet paper, then flush the toilet paper (do not use a cloth towel). Cover the vaccination site with a loose gauze bandage (not a tight bandage) after bathing to allow it to dry out.
• If you exercise enough to sweat or drip, use a waterproof bandage on the vaccination site when exercising.
• 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?

This vaccine may cause serious or life-threatening heart problems, including myocarditis and pericarditis (swelling of the heart tissues). This can happen within 3 to 4 weeks after getting the vaccine. Contact your healthcare provider right away if you experience chest pain, a fast or irregular heartbeat, or breathing problems. These may be signs of a heart problem.

This vaccine may cause other serious side effects, such as swelling of the brain or spinal cord, severe vaccination site infection, spreading of the vaccine virus to other parts of your body or to another person, severe allergic reaction, and accidental eye infection (which may cause vision problems or blindness). Talk with your healthcare provider about this.

Infants less than 12 months of age should not receive this vaccine. Adults over the age of 65 are at a higher risk of side effects and should not receive this vaccine in non-emergency situations. Talk with your healthcare provider about this.

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.

For 4 weeks after the vaccination AND 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
• 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, lab tests, or dental work in the month after your vaccination, tell the healthcare provider or dentist that you have received this medicine.

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 care 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 these to your healthcare provider right away.): Chest pain; fast or irregular heartbeat; severe shortness of breath; confusion; seizures; numbness; stiff neck; loss of coordination or balance; severe vomiting; severe weakness; severe redness, blisters, peeling or rash; fever that lasts more than 1 day; sore throat; eye infection or vision problems; severe sensitivity to light; vaccination site that is not healing.

Other: Soreness, redness, itching, or mild swelling on your skin 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:

• Cancer medicines such as cisplatin, doxorubicin (Doxil), hydroxyurea (Droxia, Hydrea), vinblastine, and vincristine (Marqibo)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol) and triamcinolone (Aristospan, Kenalog)
• Corticosteroids used in the eyes such as dexamethasone, fluorometholone (Flarex, FML Forte), and prednisolone (Omnipred, Orapred, Prelone)
• Immune globulin
• Immunosuppressants such as azathioprine (Azasan, Imuran), basiliximab (Simulect), cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as adalimumab (Humira), anakinra (Kineret), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), leflunomide (Arava), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Multiple sclerosis medicines such as fingolimod (Gilenya), glatiramer (Copaxone), natalizumab (Tysabri), and teriflunomide (Aubagio)
• Radiation therapy
• Varicella (chickenpox) vaccine or varicella zoster (shingles) vaccine

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

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. 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.

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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.