smallpox (vaccinia) vaccine, live (Rx)

Brand and Other Names:ACAM2000
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and smallpox (vaccinia) vaccine, live

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            Contraindicated (13)

            • belimumab

              belimumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.

            • certolizumab pegol

              certolizumab pegol decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Do not give live vaccines concurrently with certolizumab.

            • ibrutinib

              ibrutinib decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo after cessation of immunosuppressive therapy.

            • ifosfamide

              ifosfamide decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.

            • ixekizumab

              ixekizumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Ixekizumab may interfere with immune response of live vaccines and increase risk for vaccine adverse effects; prior to initiating ixekizumab, complete all age appropriate immunizations.

            • mechlorethamine

              mechlorethamine decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo after cessation of immunosuppressive therapy.

            • melphalan

              melphalan decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.

            • methotrexate

              methotrexate decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunization with live virus vaccines is generally not recommended.

            • onasemnogene abeparvovec

              onasemnogene abeparvovec decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Adjust vaccinations to accommodate concomitant corticosteroid administration prior to and following onasemnogene abeparvovec infusion. Avoid live vaccines for at least 1 month when initiating or after high-dose systemic corticosteroid therapy administered for =2 weeks.

            • oxaliplatin

              oxaliplatin decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.

            • procarbazine

              procarbazine decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo after cessation of immunosuppressive therapy.

            • secukinumab

              secukinumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Contraindicated. Secukinumab may interfere with immune response of live vaccines and increase risk for vaccine adverse effects; prior to initiating secukinumab, complete all age appropriate immunizations.

            • ustekinumab

              ustekinumab decreases effects of smallpox (vaccinia) vaccine, live by Mechanism: pharmacodynamic antagonism. Contraindicated. Prior initiating therapy, patients should receive all age-appropriate immunizations as recommended by current guidelines. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            Serious - Use Alternative (57)

            • adalimumab

              adalimumab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • alefacept

              alefacept decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • anakinra

              anakinra decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • antithymocyte globulin equine

              antithymocyte globulin equine decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • antithymocyte globulin rabbit

              antithymocyte globulin rabbit decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • atoltivimab/maftivimab/odesivimab

              atoltivimab/maftivimab/odesivimab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .

            • axicabtagene ciloleucel

              axicabtagene ciloleucel decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live virus vaccines for at least 6 weeks before initiating lymphodepleting therapy, during axicabtagene ciloleucel treatment, and after treatment until full immune recovery is achieved.

            • azathioprine

              azathioprine decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • baricitinib

              baricitinib decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines with baricitinib. Update immunizations in agreement with current immunization guidelines before initiating baricitinib.

            • basiliximab

              basiliximab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • budesonide

              budesonide decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • cabazitaxel

              cabazitaxel decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Live attenuated vaccines should not be used in patients receiving immunosuppressive therapy. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects.

            • canakinumab

              canakinumab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • cortisone

              cortisone decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • cyclosporine

              cyclosporine decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Avoid live vaccines in immunocompromised patients due to the risk of developing a clinical infection from the live vaccine. Inadequate immune response to the vaccine may also occur in the presence of immunosuppressants. Avoid live vaccines for at least 3 months after cessation of immunosuppressant therapy unless the benefit of vaccine administration outweighs the potential risk.

            • deflazacort

              deflazacort decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

              deflazacort decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Do not administer live or live attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids.

            • dexamethasone

              dexamethasone decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • dupilumab

              dupilumab, smallpox (vaccinia) vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating dupilumab, complete all age appropriate immunizations. Avoid use of live vaccines in patients treated with dupilumab.

            • etanercept

              etanercept decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • everolimus

              everolimus decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • fingolimod

              fingolimod decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid live attenuated vaccines during and for 2 months after stopping fingolimod.

            • fludrocortisone

              fludrocortisone decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • glatiramer

              glatiramer decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • golimumab

              golimumab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • guselkumab

              guselkumab, smallpox (vaccinia) vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating guselkumab, complete all age appropriate immunizations. No data available on the ability of live or inactive vaccine to elicit an immune response in patients treated with guselkumab.

            • hydrocortisone

              hydrocortisone decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • hydroxychloroquine sulfate

              hydroxychloroquine sulfate decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • hydroxyurea

              hydroxyurea decreases effects of smallpox (vaccinia) vaccine, live by Other (see comment). Avoid or Use Alternate Drug. Comment: Vaccination with live vaccines in a patient receiving hydroxyurea may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection).

            • infliximab

              infliximab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • leflunomide

              leflunomide decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • lomustine

              lomustine decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.

            • mercaptopurine

              mercaptopurine decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • methylprednisolone

              methylprednisolone decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • muromonab CD3

              muromonab CD3 decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • mycophenolate

              mycophenolate decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • ocrelizumab

              ocrelizumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-attenuated or live vaccines is not recommended during ocrelizumab treatment and until B-cell repletion.

            • ofatumumab SC

              ofatumumab SC decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of ofatumumab SC for live or live-attenuated vaccines, and whenever possible.

            • ozanimod

              ozanimod decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live-attenuated vaccines with ozanimod during treatment and for up to 3 months after discontinuing ozanimod. .

            • ponesimod

              ponesimod decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live attenuated vaccines at least 1 month before initiating, during, and for 1-2 weeks after treatment. Coadministration with live attenuated vaccines may increase infection risk.

            • prednisolone

              prednisolone decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • prednisone

              prednisone decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • rilonacept

              rilonacept decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • risankizumab

              risankizumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.

            • rituximab

              rituximab, smallpox (vaccinia) vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

            • rituximab-hyaluronidase

              rituximab-hyaluronidase, smallpox (vaccinia) vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Safety of immunization with live viral vaccines following rituximab therapy has not been studied and vaccination with live virus vaccines is not recommended.

            • sarilumab

              sarilumab, smallpox (vaccinia) vaccine, live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.

            • siponimod

              siponimod decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Pause vaccinations beginning 1 week before initiating siponimod and for 4 weeks after stopping treatment. Coadministration with live attenuated vaccines may increase infection risk.

            • sirolimus

              sirolimus decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • tacrolimus

              tacrolimus decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • temsirolimus

              temsirolimus decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • tildrakizumab

              tildrakizumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.

            • tisagenlecleucel

              tisagenlecleucel decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live-virus vaccines is not recommended for at least 2 weeks before starting lymphodepleting chemotherapy, during tisagenlecleucel treatment, and until immune recovery afterwards.

            • tocilizumab

              tocilizumab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • triamcinolone acetonide injectable suspension

              triamcinolone acetonide injectable suspension decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.

            • upadacitinib

              upadacitinib decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • ustekinumab

              ustekinumab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Prior initiating therapy, patients should receive all age-appropriate immunizations as recommended by current guidelines. Immunosuppressants also increase risk of infection with concomitant live vaccines.

            • vedolizumab

              vedolizumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live virus vaccines while receiving vedolizumab; live vaccines may be administered concurrently with vedolizumab only if the benefits outweigh the risks.

            Monitor Closely (12)

            • anthrax immune globulin

              anthrax immune globulin decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Immune globulin administration may impair the efficacy of live attenuated vaccines. Defer vaccination with live virus vaccines until ~3 months after administration of anthrax IG. Revaccinate people who received anthrax IG shortly after live virus vaccination following 3 months after the administration of anthrax IG.

            • belatacept

              belatacept decreases effects of smallpox (vaccinia) vaccine, live by Other (see comment). Use Caution/Monitor. Comment: The use of live vaccines should be avoided during treatment with belatacept. Inform patients that vaccinations may be less effective while they are being treated with belatacept.

            • cytomegalovirus immune globulin (CMV IG)

              cytomegalovirus immune globulin (CMV IG) decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.

            • hepatitis B immune globulin (HBIG)

              hepatitis B immune globulin (HBIG) decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.

            • immune globulin IM (IGIM)

              immune globulin IM (IGIM) decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.

            • immune globulin IV (IGIV)

              immune globulin IV (IGIV) decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.

            • immune globulin SC

              immune globulin SC decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor.

            • obinutuzumab

              obinutuzumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunization with live virus vaccines is not recommended during obinutuzumab treatment and until after B-cell recovery.

            • rabies immune globulin, human (RIG)

              rabies immune globulin, human (RIG) decreases effects of smallpox (vaccinia) vaccine, live by Other (see comment). Use Caution/Monitor. Comment: High dose rabies immunoglobulin may impair response to active immunization.

            • tecovirimat

              tecovirimat, smallpox (vaccinia) vaccine, live. Other (see comment). Use Caution/Monitor. Comment: No vaccine-drug interaction studies have been performed in humans. Some animal studies suggest a reduced immune response to smallpox vaccine if coadministered with tecovirimat. The clinical impact of this interaction on vaccine efficacy is unknown.

            • tetanus immune globulin (TIG)

              tetanus immune globulin (TIG) decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.

            • vaccinia immune globulin intravenous

              vaccinia immune globulin intravenous decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor. Defer live vaccines for 3 months after immune globulin administration.

            Minor (2)

            • chloroquine

              chloroquine decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Minor/Significance Unknown.

            • Rho(D) immune globulin

              Rho(D) immune globulin decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Minor/Significance Unknown. Separate by 3 months.

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            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%)

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            Warnings

            Black Box Warnings

            Suspected cases of myocarditis and/or pericarditis have been observed in healthy adult primary vaccinees

            Encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson syndrome), and eczema resulting in permanent sequelae or death, ocular complications, blindness, and fetal death have occurred following either primary vaccination or revaccination with smallpox vaccines

            This is a live vaccinia virus that can be transmitted to persons who have close contact with the recipient of the vaccine, and the risks in contacts are the same as those for the vaccinated patient

            The risk for experiencing serious vaccination complications must be weighed against the risks for experiencing a potentially fatal smallpox infection

            Risks increased with the following conditions

            • These risks of severe adverse effects are increased with the following conditions and may result in severe disability, permanent neurologic sequelae, and/or death
              • Cardiac disease or a history of cardiac disease
              • Eye disease treated with topical steroids
              • Congenital or acquired immune deficiency disorders, including those taking immunosuppressive medications
              • Eczema and persons with a history of eczema or other acute or chronic exfoliative skin conditions
              • Infants aged <1 yr
              • Pregnancy

            Contraindications

            There are very few absolute contraindications to the vaccine for those who are at high risk for smallpox

            The risk for experiencing serious vaccination complications must be weighed against the risks for experiencing a potentially fatal smallpox infection; see Cautions for persons who are at higher risk of experiencing serious vaccination complications

            Severe immune deficiency

            • Severe localized or systemic infection with vaccinia (progressive vaccinia) may occur in persons with weakened immune systems
            • Individuals with severe immunodeficiency who are not expected to benefit from the vaccine should not receive ACAM2000
            • These individuals may include those who are undergoing bone marrow transplantation or individuals with primary or acquired immunodeficiency who require isolation

            Cautions

            Serious complications may follow vaccination and may include myocarditis and/or pericarditis, encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia (vaccinia necrosum), generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson syndrome), eczema vaccinatum, blindness, and fetal death in pregnant women; these complications may rarely lead to severe disability, permanent neurological sequelae, and death

            Ischemic cardiac events and nonischemic, dilated cardiomyopathy have been reported following smallpox vaccination; relationship to the vaccine is unknown

            Accidental infection of the eye (ocular vaccinia) may result in ocular keratitis, corneal scarring, and blindness

            Severe localized or systemic infection with vaccinia (progressive vaccinia) may occur in persons with weakened immune systems, including those with leukemia, lymphoma, organ transplantation, generalized malignancy, HIV/AIDS, cellular or humoral immune deficiency, radiation therapy, or treatment with antimetabolites, alkylating agents, high-dose corticosteroids (>10 mg prednisone/day or equivalent for ≥2 weeks), or other immunomodulatory drugs; contraindicated in individuals with severe immunodeficiency (see Contraindications)

            Persons with eczema of any description such as, atopic dermatitis, neurodermatitis, and other eczematous conditions, regardless of severity of the condition, or persons who have a history of these conditions at any time in the past, are at higher risk of developing eczema vaccinatum

            Not studied in infants or children; risk of serious adverse events is higher in infants; vaccinated persons who have close contact with infants (eg, breastfeeding women), must take precautions to avoid inadvertent transmission of live vaccinia virus to infants

            Not studied in pregnant women; live vaccinia virus vaccines can cause fetal vaccinia and fetal death; if administered during pregnancy, the vaccinee should be apprised of the potential hazard to the fetus; pregnant women who are close contacts of vaccinees may be at increased risk because live vaccinia virus can shed and be transmitted to close contacts

            Contains neomycin and polymyxin B; caution with history of allergy to these components on

            Vaccinia immune globulin (VIG) is indicated for certain complications of vaccination live vaccinia virus smallpox vaccine; if VIG is needed or additional information is required, physicians should contact the CDC at (404) 639-3670 (M-F) or (404) 639-2888 evenings/weekends

            The most important measure to prevent inadvertent auto-inoculation and contact transmission from vaccinia vaccination is thorough hand washing after changing the bandage or after any other contact with the vaccination site

            Avoid blood and organ donation for at least 30 days following vaccination

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            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.

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            Pharmacology

            Mechanism of Action

            Lyophilized preparation of live vaccinia virus; vaccinia virus is similar to the variola (smallpox) virus; immunity to both virus achieved with induced vaccinia virus infection by stimulating the production of neutralizing antibodies

            Conveys active immunity via stimulation of production of endogenously produced antibodies

            Pharmacokinetics

            Onset: Neutralizing antibodies appear 15-20 days after vaccination; appearance of neutralizing antibodies may occur 7 days following vaccination

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            Administration

            Vaccine Preparation

            Reconstitution

            • Reconstitute only with diluent provided
            • Removed vial from cold storage and bring to room temperature before reconstitution
            • Remove the flip cap seals of the vaccine and diluent vials and wipe each rubber stopper with an isopropyl alcohol swab and allowed to dry thoroughly
            • Using aseptic technique and a sterile 1 mL syringe fitted with a 25 gauge x 5/8” needle (provided), draw up 0.3 mL of diluent and transfer the entire content of the syringe to the vaccine vial
            • Note: this 0.3 mL of diluent is not the entire content of the diluent vial
            • Gently swirl to mix but try not to get product on the rubber stopper
            • Reconstituted liquid should appear clear to slightly hazy, colorless to straw-colored, and free from extraneous matter
            • Inspect visually for particulate matter and discoloration prior to administration; if particulate matter or discoloration is observed, the vaccine should not be used and the vial should be disposed of according to biocontaminant regulations

            Handling precautions and disposal

            • Personnel preparing and administering the vaccine should wear surgical or protective gloves and avoid contact of vaccine with skin, eyes or mucous membranes
            • The vaccine vial, its stopper, the diluent syringe, the vented needle used for reconstitution, the bifurcated needle used for administration, and any gauze or cotton that came in contact with the vaccine should be discarded in leak-proof, puncture-proof biohazard containers
            • These containers should then be disposed of appropriately

            Percutaneous (Scarification) Administration

            The site of vaccination is the upper arm over the insertion of the deltoid muscle

            No skin preparation should be performed unless the skin at the intended site of vaccination is obviously dirty, in which case an alcohol swab(s) may be used to clean the area; the skin must be allowed to dry thoroughly to prevent inactivation of the live vaccine virus by the alcohol

            Remove the vaccine vial cap and bifurcated needle from individual wrapping; submerge bifurcated end of needle in reconstituted vaccine solution; the needle will pick up a droplet of vaccine (0.0025 mL) within the fork of the bifurcation

            Use aseptic technique; ie, do not insert the upper part of the needle that has been in contact with fingers into the vaccine vial, and never redip the needle into the vaccine vial if the needle has touched skin

            Deposit the droplet of vaccine onto clean, dry skin of the arm prepared for vaccination; the needle is held between thumb and first finger perpendicular to the skin; the wrist of the hand holding the needle of the vaccinator rests against the patient’s arm; rapidly make 15 jabs of the needle perpendicular to the skin through the vaccine droplet to puncture the skin, within a diameter of about 5 mm; the jabs should be vigorous enough so that a drop of blood appears at the vaccination site

            Any excess droplets of vaccine and blood should be wiped off the skin using a dry gauze pad and discarded in a biohazard container; discard the needle in a biohazard sharps container

            Close the vaccine vial by reinserting the rubber cap and return to a refrigerator or place on ice unless it will be used immediately to vaccinate another subject (see Storage)

            Cover the vaccination site loosely with a gauze bandage, using first aid adhesive tape to keep it in place; this bandage provides a barrier to protect against spread of the vaccinia virus

            If the vaccinee is involved in direct patient care, the gauze should be covered with a semipermeable (semiocclusive) dressing as an additional barrier; a semipermeable dressing is one that allows for the passage of air but does not allow for the passage of fluids

            Wash hands with soap and warm water or with alcohol-based hand rubs such as gels or foams after direct contact with the vaccination site, the bandage or clothes, towels or sheets that might be contaminated with virus from the vaccination site; this is vital in order to remove any virus from your hands and prevent contact spread

            Put the contaminated bandages in a sealed plastic bag and throw them away in the trash

            Wash separately clothing, towels, bedding, or other items that may have come in direct contact with the vaccination site or drainage from the site, using hot water with detergent and/or bleach; wash hands afterwards

            Don’t use a bandage that blocks air from the vaccination site; this may cause the skin at the vaccination site to soften and wear away; use loose gauze secured with medical tape to cover the site

            Don’t put salves or ointments on the vaccination site

            See ACAM2000 prescribing information for visual photos on how to interpret vaccination response

            Storage

            Lyophilized powder

            • Store in freezer with an average temperature of -15°C to -25°C (+5°F to -13°F)
            • Prior to reconstitution, smallpox vaccine retains a potency of ≥1 x 10^8 PFU per dose for at least 18 months when stored at refrigerated temperatures of +2-8°C (36-46°F)
            • During shipment: Maintain temperature of -10°C or colder

            Reconstituted solution

            • After reconstitution, vaccine may be administered within 6-8 hr if kept at room temperature (20-25°C, 68-77°F)
            • Unused, reconstituted vaccine may be refrigerated (2-8°C, 36-46°F) for up to 30 days, after which it should be discarded as a biohazardous material
            • Exposure of reconstituted vaccine to room temperature during vaccination sessions should be minimized by placing it in refrigerator or on ice between patient administrations
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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.