Acam2000 Generic Name & Formulations
Smallpox (vaccinia) vaccine, live; contains 2.5–12.5×10^5 plaque forming units; per 0.0025mL dose; lyophilized pwd for percutaneous scarification after reconstitution; contains trace amounts of neomycin, polymyxin B.
Multiple-dose vial (3mL)—1 (w. bifurcated needles, tuberculin syringes)
Active immunization against smallpox disease for persons determined to be at high risk for smallpox infection.
Acam2000 Dosage and Administration
See full labeling. ≥17yrs: Give by percutaneous route (scarification) into the upper arm (deltoid) only after proper training. Clean the inj site area using an alcohol swab(s), if necessary. Allow skin to dry thoroughly to prevent inactivation of the live vaccine virus by the alcohol. Pick up a droplet (0.0025mL) of reconstituted vaccine soln using a bifurcated needle and deposit onto the vaccination site. Rapidly make 15 jabs of the needle perpendicular to the skin through the droplet to puncture skin, within a diameter of about 5mm. Vaccination site may be covered with loose gauze bandage or semipermeable dressing. Repeat vaccination every 3yrs in those at continued high risk of exposure.
<17yrs: not established.
Severe immunodeficiency, including those who are undergoing bone marrow transplantation or those with primary or acquired immunodeficiency who require isolation.
Acam2000 Boxed Warnings
Risk for serious complications including: myocarditis and/or pericarditis in healthy adults; 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, ocular complications, blindness, and fetal death following either primary vaccination or revaccination. Increased risk of these complications, which may result in severe disability, permanent neurological sequelae and/or death, with the following conditions: cardiac disease or history of, eye disease treated with topical steroids, congenital or acquired immune deficiency disorders (including those taking immunosuppressants), eczema or history of, other exfoliative skin conditions, infants <12mos of age, pregnancy. Risk of transmitting live vaccinia virus to persons who have close contact with the vaccinee; the risks in close contacts are the same as the vaccinee. Weigh risk of serious vaccination complications against the risk of a potentially fatal smallpox infection.
See Boxed Warning. Known cardiac disease (eg, previous MI, angina, CHF, cardiomyopathy, chest pain, shortness of breath with activity, stroke or TIA, other heart conditions). Diagnosed with ≥3 risk factors for ischemic coronary disease (eg, high BP, elevated blood cholesterol, diabetes, family history of heart condition <50yrs of age, smokers). Accidental infection of the eye may result in ocular complications (eg, keratitis, corneal scarring, blindness). Do not inject by the intradermal, SC, IM, or IV route. Avoid contact with skin, eyes, or mucous membranes. Avoid blood and organ donation for at least 30 days after vaccination. Vaccination may not protect all recipients. Elderly (>65yrs): not studied. Pregnancy (Cat. D): may cause fetal vaccinia or fetal death. Nursing mothers: can be transmitted to infants.
Concomitant use with corticosteroid eye drops may increase risk of ocular complications. May induce false (+) tests for syphilis. May induce false (–) results for tuberculin skin test, and possibly, blood tests for tuberculosis; if possible, delay tuberculin test for 1 month after vaccination. Do not put salves or ointments on the vaccination site.
Acam2000 Adverse Reactions
Inoculation site signs/symptoms, lymphadenitis, constitutional symptoms (eg, malaise, fatigue, fever, myalgia, headache), urticaria, folliculitis.
Acam2000 Clinical Trials
Acam2000 Patient Counseling