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ACAM2000® [Smallpox and Mpox (Vaccinia) Vaccine, Live]
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all information needed to use ACAM2000 safely and effectively. See full prescribing information for ACAM2000.ACAM2000® [Smallpox and Mpox (Vaccinia) Vaccine, Live] For scarification suspension, for percutaneous use
Initial U.S. Approval: 2007

WARNING: SERIOUS COMPLICATIONS
See full prescribing information for complete boxed warning. Myocarditis and pericarditis (suspect cases observed at a rate of 5.7 per 1000 primary vaccinees (95% CI: 1.9-13.3)), encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including STEVENS-JOHNSON SYNDROME), eczema vaccinatum resulting in permanent sequelae or death, accidental eye infection (ocular vaccinia) which can cause ocular complications that may lead to blindness, and fetal death, have occurred following either primary vaccination or revaccination with ACAM2000 or other live vaccinia virus vaccines that were used historically. These risks are increased in certain individuals and may result in severe disability, permanent neurological sequelae and/or death [see Warnings and Precautions (5)].

------------------------RECENT MAJOR CHANGES---------------------------
Indications and Usage, mpox disease (1) 8/2024
-----------------------INDICATIONS AND USAGE---------------------------
ACAM2000® is indicated for active immunization for the prevention of smallpox and mpox disease in individuals determined to be at high risk for smallpox or mpox infection. (1).

----------------------DOSAGE AND ADMINISTRATION-----------------------
For percutaneous use by scarification. (2) 
• Administer ACAM2000 only after being trained on the safe and effective administration of the vaccine. (2.4) • A droplet of ACAM2000 is administered by scarification percutaneously using 15 jabs of a bifurcated needle. (2.4) 
• The droplet (approximately 0.0025 mL) of reconstituted vaccine is picked up with a bifurcated needle by dipping needle into ACAM2000 vial. (2.4) 
• See full prescribing information for instructions for vaccine preparation (2.2), administration including provision of the Medication Guide to vaccinees and instruction to vaccinees about vaccination site care (2.6) and interpretation of response to vaccination. (2.7)

---------------------DOSAGE FORMS AND STRENGTHS----------------------
• For scarification suspension. (3)
• ACAM2000 is supplied as a multiple dose vial of Lyophilized Antigen Component, Live to be reconstituted with the supplied Diluent Component. After reconstitution, a single dose of
ACAM2000 is approximately 0.0025 mL. (3)
-------------------------------CONTRAINDICATIONS------------------------------
• Individuals with severe immunodeficiency. These individuals may include persons who are undergoing bone marrow transplantation or persons with primary or acquired immunodeficiency states who
require isolation. (4).
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