Renal Dose Adjustment
- Renal impairment: Dose adjustments not defined
Hepatic Dosage Adjustment
- Hepatic impairment: Dose adjustments not defined
See Supplemental Patient Information
- Serious complications, which may occur after primary vaccination or revaccination with live vaccinia virus smallpox vaccine 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; these complications may rarely lead to severe disability, permanent neurological sequelae and death [US Black Box Warning]
- Vaccinees with conditions including 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 <12 months of age; and pregnancy are at increased risk of developing such complications [US Black Box Warning]
- Ischemic cardiac events, which can be fatal have been reported following smallpox vaccination in addition to cases of non-ischemic dilated cardiomyopathy
- Individuals diagnosed with 3 or more risk factors for ischemic coronary disease (high blood pressure; elevated blood cholesterol; diabetes mellitus, first degree relative who had a heart condition before the age of 50; or cigarette smoking) are at increased risk
- Accidental eye infection (ocular vaccinia) may result in ocular complications including keratitis, corneal scarring and blindness. Patients using corticosteroid eye drops may be at an increased risk of developing such complication [US Black Box Warning]
- Persons with weakened immune systems, including patients with leukemia, lymphoma, organ transplantation, generalized malignancy, HIV/AIDS, cellular or humoral immune deficiency, radiation therapy, or treatment with antimetabolites, alkylating agents, or high-dose corticosteroids (>10 mg prednisone/day or equivalent for
2 weeks) may suffer from severe localized or systemic infection with vaccinia (progressive vaccinia) - Persons with eczema of any description (e.g., atopic dermatitis, neurodermatitis, and other eczematous conditions) regardless of the severity or with a history of these conditions are at higher risk of developing eczema vaccinatum. Vaccinees with close contacts who have such conditions may be at an increased risk. Vaccinees with other active acute, chronic or exfoliative skin disorders such as burns, impetigo, varicella zoster, acne vulgaris with open lesions, Darier’s disease, psoriasis, seborrheic dermatitis, erythroderma, pustular dermatitis, etc., or vaccinees with household contacts having such skin conditions may also be at a higher risk for eczema vaccinatum [US Black Box Warning]
- Avoid blood or organ donation within 1 month post-vaccination
- Tuberculin skin testing (PPD) should be delayed for 1 month following smallpox vaccination
- Live vaccinia smallpox vaccine may not protect all individuals exposed to smallpox
Cautions: Use cautiously in
- History of MI
- Angina in patients or close contacts
- Patients with congestive heart failure
- Patients with chest pain or shortness of breath with activity
- History of stroke or transient ischemic attack
- Hypersensitivity to albumin, neomycin, or polymyxin B
- Hypersensitivity to latex
- Lactation
Supplemental Patient Information
- Advise patients to avoid contact with persons at high risk of serious adverse effects of vaccinia virus including those with past or present eczema, immunodeficiency states, pregnancy, or infants <1 yr
- Inform patients that the vaccinia virus may be transmitted by direct physical contact; advise them that the virus is shed from the skin lesion at the inoculation site from day 3 until scabbing occurs, typically between days 14-21 after primary vaccination
Pregnancy Category:D
Breastfeeding: The CDC recommends that nursing mothers should not receive smallpox vaccine, even if they are pumping their milk and feeding it to their infant by bottle feeding. Women who have received smallpox vaccine during pregnancy or breastfeeding should avoid breastfeeding and handling any baby for at least 3 to 4 weeks until the vaccination scab has separated from the vaccination site. It is recommended that if nursing mothers have been in close contact with individuals who have received smallpox vaccine, they should wash their hands with soap and warm water after direct contact with the vaccination site or anything that has touched the vaccination site (e.g., bandages, clothing, towels, bedding, etc.). This will prevent the spread of vaccinia virus to young babies. If a breastfeeding mother who has had a close contact with a person recently vaccinated against smallpox develops a rash, she should check with the healthcare provider to determine the cause of rash and if it is vaccine-related; breastfeeding should be discontinued until all scabs from the rash have fallen off. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 24 Jun 2011). As per manufacturer's data, it is not known whether vaccine virus or its antibodies are secreted in human milk, but live vaccinia virus can be inadvertently transmitted from a lactating mother to her infant. Thus, infants are at high risk of developing serious complications from live vaccinia smallpox vaccination.
