Acam2000

Name: ACAM2000

Before Using ACAM2000

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

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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.

Interactions with 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. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may decide not to use this vaccine or change some of the other medicines you take.

  • Deflazacort
  • Thiotepa

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.

  • Adalimumab
  • Alemtuzumab
  • Antithymocyte Globulin Rabbit
  • Azathioprine
  • Bendamustine
  • Bortezomib
  • Bosutinib
  • Brodalumab
  • Cabazitaxel
  • Capecitabine
  • Carboplatin
  • Carfilzomib
  • Carmustine
  • Certolizumab Pegol
  • Chlorambucil
  • Cisplatin
  • Cladribine
  • Clofarabine
  • Cyclophosphamide
  • Cyclosporine
  • Cytarabine
  • Cytarabine Liposome
  • Dacarbazine
  • Dasatinib
  • Daunorubicin
  • Daunorubicin Citrate Liposome
  • Docetaxel
  • Doxorubicin
  • Dupilumab
  • Epirubicin
  • Etanercept
  • Etoposide
  • Everolimus
  • Fingolimod
  • Fludarabine
  • Fluorouracil
  • Gemcitabine
  • Gemtuzumab Ozogamicin
  • Golimumab
  • Guselkumab
  • Hydroxyurea
  • Idarubicin
  • Ifosfamide
  • Imatinib
  • Immune Globulin
  • Infliximab
  • Interferon Alfa
  • Irinotecan
  • Irinotecan Liposome
  • Leflunomide
  • Lomustine
  • Mechlorethamine
  • Melphalan
  • Mercaptopurine
  • Methotrexate
  • Mitomycin
  • Mitoxantrone
  • Mycophenolic Acid
  • Nelarabine
  • Nilotinib
  • Ofatumumab
  • Oxaliplatin
  • Paclitaxel
  • Paclitaxel Protein-Bound
  • Pemetrexed
  • Pentostatin
  • Ponatinib
  • Procarbazine
  • Rilonacept
  • Rituximab
  • Sarilumab
  • Secukinumab
  • Sirolimus
  • Temozolomide
  • Teniposide
  • Teriflunomide
  • Tocilizumab
  • Topotecan
  • Tositumomab
  • Trabectedin
  • Ustekinumab
  • Vinblastine
  • 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
  • Rabies Immune Globulin
  • Respiratory Syncytial Virus Immune Globulin, Human
  • Tetanus Immune Globulin
  • Vaccinia Immune Globulin, Human
  • Varicella-Zoster Immune Globulin

Interactions with Food/Tobacco/Alcohol

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 transplant—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
  • Stroke—May increase the chance and severity of side effects .

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 .

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.

Dosing & Uses

Dosage Forms & Strengths

lyophilized powder for reconstitution

  • Following reconstitution: 2.5-12.5 x 10^5 plaque forming units/0.0025mL
  • Both the vaccine and provided diluent vial stoppers do not contain latex material

Smallpox Immunization

Indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection

A droplet is administered by the percutaneous route (scarification) using 15 jabs of a bifurcated needle (see Administration for complete preparation and scarification instructions)

Immunization Schedules

Up-to-date vaccination schedules available at http://www.cdc.gov/vaccines/schedules/hcp/index.html

Dosage Forms & Strengths

lyophilized powder for reconstitution

  • Following reconstitution: 2.5-12.5 x 10^5 plaque forming units/0.0025mL
  • Both the vaccine and provided diluent vial stoppers do not contain latex material

Smallpox Immunization

<16 years: Safety and efficacy not established; use of the vaccine in all pediatric age groups is supported by evidence from the adequate and well-controlled studies in adults and with additional historical data with use of live vaccinia virus smallpox vaccine in pediatrics

No longer recommended for routine immunization since smallpox disease has been eradicated

Indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection

A droplet is administered by the percutaneous route (scarification) using 15 jabs of a bifurcated needle (see Administration for complete preparation and scarification instructions)

Dosing Considerations

Before the eradication of smallpox disease, live vaccinia virus smallpox vaccine was administered routinely in all pediatric age groups, including neonates and infants, and was effective in preventing smallpox disease

During that time, live vaccinia virus was occasionally associated with serious complications in children, the highest risk being in infants aged ≤1 yr

Adverse Effects

>10%

Injection site pruritus (82-92%)

Injection site erythema (61-74%)

Injection site pain (37-67%)

Blood and lymphatic system disorders (22-59%)

Lymph node pain (19-57%)

Headache (32-50%)

Injection site swelling (28-48%)

Fatigue (34-48%)

Myalgia (27-46%)

Malaise (28-37%)

Feeling hot (20-32%)

GI disorders (23-31%)

Erythema (22-24%)

Rigors (12-21%)

Nausea (10-19%)

Diarrhea (12-16%)

Decreased exercise tolerance (8-11%)

Rash (6-11%)

1-10%

Constipation (6%)

Vomiting (3-5%)

Dyspnea (3-4%)

Lymphadenopathy (6-8%)

Pregnancy & Lactation

Pregnancy

Pregnancy Category: D; has not been studied in pregnant women

The only setting in which vaccination of pregnant women should be considered is when exposure to smallpox is considered likely

Live vaccinia virus vaccines can cause fetal harm when administered to a pregnant woman; congenital infection, principally occurring during the first trimester, has been observed after vaccination with live vaccinia smallpox vaccines, although the risk may be low

Generalized vaccinia of the fetus, early delivery of a stillborn infant, or a high risk of perinatal death has been reported

If this vaccine is used during pregnancy, or if the vaccinee lives in the same household with or has close contact with a pregnant women, the vaccinee should be apprised of the potential hazard to the fetus

Lactation

Not known if excreted in breast milk, not recommended for nursing women in non-emergency situations

Live vaccinia virus can be inadvertently transmitted from a lactating mother to her infant

Infants are at high risk of developing serious complications from live vaccinia smallpox vaccination

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

How do I receive ACAM2000?

ACAM2000 smallpox vaccine is not a shot like other vaccines. Your healthcare provider will make 15 pokes in the skin of your upper arm with a needle containing ACAM2000. 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 to other parts of your body or to other people. You can infect another part of your body or other people until the scab falls off.

Liver Dose Adjustments

Data not available

Dialysis

Data not available

Administrative Information

LactMed Record Number

244

Last Revision Date

20130907

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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