ACAM2000

It works by causing your immune system to produce its own protection (antibodies) against the virus .

This vaccine should only be administered by or under the supervision of your doctor or another health care professional .

This medicine is available only with a doctor`s prescription .

This product is available in the following dosage forms:

• Powder for Suspension


• Powder for Solution

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 smallpox vaccine in children less than 16 years of age. Safety and efficacy have not been established .

Geriatric

No information is available on the relationship of age to the effects of smallpox vaccine in geriatric patients .

Pregnancy

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

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.

• Aclarubicin


• Adalimumab


• Aldesleukin


• Alemtuzumab


• Altretamine


• Amonafide


• Amsacrine


• Asparaginase


• Azacitidine


• Azathioprine


• Bleomycin


• Broxuridine


• Busulfan


• Capecitabine


• Carboplatin


• Carmustine


• Certolizumab Pegol


• Chlorambucil


• Cisplatin


• Cladribine


• Cyclophosphamide


• Cytarabine


• Cytarabine Liposome


• Dacarbazine


• Dactinomycin


• Daunorubicin


• Daunorubicin Citrate Liposome


• Decitabine


• Docetaxel


• Doxifluridine


• Doxorubicin Hydrochloride


• Doxorubicin Hydrochloride Liposome


• Edatrexate


• Eflornithine


• Epirubicin


• Estramustine


• Etanercept


• Etoposide


• Floxuridine


• Fludarabine


• Fluorouracil


• Fotemustine


• Gallium Nitrate


• Gemcitabine


• Golimumab


• Hydroxyurea


• Idarubicin


• Ifosfamide


• Irinotecan


• Lomustine


• Mechlorethamine


• Melphalan


• Mercaptopurine


• Methotrexate


• Mitolactol


• Mitomycin


• Mitotane


• Mitoxantrone


• Mycophenolic Acid


• Oxaliplatin


• Paclitaxel


• Pegaspargase


• Pentostatin


• Pipobroman


• Pirarubicin


• Plicamycin


• Procarbazine


• Raltitrexed


• Rilonacept


• Rituximab


• Sirolimus


• Streptozocin


• Tacrolimus


• Teceleukin


• Tegafur


• Temsirolimus


• Teniposide


• Thioguanine


• Thiotepa


• Topotecan


• Treosulfan


• Trimetrexate


• Trofosfamide


• Uracil Mustard


• Vinblastine


• Vincristine


• Vincristine Liposome


• Vindesine


• Vinorelbine

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept


• Cytomegalovirus Immune Globulin, Human


• Hepatitis B Immune Globulin


• Immune Globulin


• Leflunomide


• Rabies Immune Globulin


• Respiratory Syncytial Virus Immune Globulin, Human


• Rho(D) Immune Globulin


• Tetanus Immune Globulin


• Vaccinia Immune Globulin, Human


• Varicella-Zoster Immune Globulin

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:

• Bone marrow transplant or


• Cancer or


• HIV or AIDS or


• Immune deficiency conditions or


• Leukemia (cancer of the blood) or


• Lymphoma (cancer of the lymph nodes)


• Organ transplanta€”Should not use in patients with these conditions .

• Burns, severe or


• Chest pain or


• Chickenpox or


• Congestive heart failure or


• Dermatitis or


• Diabetes or


• Eczema or


• Eye disease or


• Heart attack, history of or


• Heart disease (or family history of) or


• High blood pressure or


• High cholesterol in the blood or


• Impetigo or


• Psoriasis or


• Shingles or


• Strokea€”May increase the chance and severity of side effects .

Proper Use

A nurse or other trained health professional will give you this vaccine . This vaccine is given by using a needle to poke or jab the skin on your upper arm .

You may need a booster dose of this vaccine every three years to maintain protection against smallpox. Ask your doctor if you will need another dose of this vaccine .

This vaccine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions .

Precautions

It is very important that your doctor check your progress at regular visits to make sure this vaccine is working properly and to check for unwanted effects .

This vaccine may cause serious heart problems in some patients. Check with your doctor right away if you are having chest pain or discomfort; dizziness; fast or irregular heartbeat; fever and chills; shortness of breath; sweating, weakness; or trouble breathing .

Tell your doctor if you smoke cigarettes or other tobacco products . The risk of heart problems is increased in people who smoke .

You should not receive this vaccine if you are using medicines that weaken your immune system, such as steroids, radiation, or cancer medicines .

You should not become pregnant for at least 3 months after receiving this vaccine without first checking with your doctor . There is a chance that this vaccine may cause problems during pregnancy. If you think you have become pregnant, tell your doctor right away .

This vaccine contains neomycin and polymyxin B. Make sure your doctor knows if you have had an allergic reaction to these medicines .

This vaccine contains a live virus. The virus can cause an infection in other parts of your body or in other people if you touch the vaccination site and then touch your body or other people . Always cover the vaccination site with a bandage. Wash your hands thoroughly after changing the bandage or after touching the vaccination site . Your doctor will tell you how to care for the vaccination site . Make sure you understand the directions and follow them carefully. Avoid contact with people who are sick or have infections until the scab falls off (usually 2 to 4 weeks after vaccination). Talk to your doctor about this if you have concerns .

You must wait at least 30 days before you can donate blood, use a hot tub or swim, handle a baby, or breastfeed .

Before you have any medical tests for syphilis or a tuberculin (TB) skin test, tell the medical doctor in charge that you have received this vaccine . The results of these tests may be affected by this vaccine .

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 immediately if any of the following side effects occur:

More common

• Feeling unusually cold


• Shivering


• Swollen, painful, or tender lymph glands in the neck, armpit, or groin

Less common

• Agitation


• Anxiety


• Back pain


• Blindness


• Blistering, peeling, or loosening of skin


• Blue or pale skin


• Blurred vision


• Changes in vision


• Chest discomfort


• Chest pain, possibly moving to the left arm, neck, or shoulder


• Confusion


• Convulsions (seizures)


• Cough


• Diarrhea


• Difficult or labored breathing


• Dizziness


• Drowsiness


• Fast heartbeat


• Fever and chills


• Hallucinations


• Headache


• Irritability


• Itching


• Joint or muscle pain


• Loss of consciousness


• Mood or mental changes


• Red skin lesions, often with a purple center


• Red, irritated eyes


• Shortness of breath


• Skin rash that is encrusted, scaly, and oozing


• Sore throat


• Sores, ulcers, or white spots in the mouth or on the lips


• Stiff neck


• Tightness in the chest


• Trouble breathing


• Unusual tiredness or weakness


• Vomiting


• Wheezing

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

• Decreased ability to exercise


• Difficulty having a bowel movement (stool)


• Difficulty with moving


• Flushing or redness of the skin


• General feeling of discomfort or illness


• Itching, pain, redness, or swelling at the vaccine site


• Muscle aching or cramping


• Muscle stiffness


• Nausea


• Rash


• Swollen joints


• Unusually warm skin

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.