"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Anaphylaxis, encephalitis including death, meningitis, neuroparalytic events such as encephalitis, transient paralysis, Guillain-Barre Syndrome, myelitis, and retrobulbar neuritis; and multiple sclerosis have been reported to be temporally associated with the use of RabAvert. See PRECAUTIONS and ADVERSE EVENTS sections. A patient's risk of developing rabies must be carefully considered, however, before deciding to discontinue immunization.
RABAVERT MUST NOT BE USED SUBCUTANEOUSLY OR INTRADERMALLY.
RabAvert must be injected intramuscularly. For adults, the deltoid area is the preferred site of immunization; for small children and infants, administration into the anterolateral zone of the thigh is preferred. The use of the gluteal region should be avoided, since administration in this area may result in lower neutralizing antibody titers1.
DO NOT INJECT INTRAVASCULARLY.
Unintentional intravascular injection may result in systemic reactions, including shock. Immediate measures include catecholamines, volume replacement, high doses of corticosteroids, and oxygen.
This product contains albumin, a derivative of human blood. It is present in RabAvert at concentrations of less than 0.3 mg/dose. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeld-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
Care is to be taken by the health care provider for the safe and effective use of the product. The health care provider should also question the patient, parent or guardian about 1) the current health status of the vaccinee; and 2) reactions to a previous dose of RabAvert, or a similar product. Preexposure vaccination should be postponed in the case of sick and convalescent persons, and those considered to be in the incubation stage of an infectious disease. A separate, sterile syringe and needle should be used for each patient. Needles must not be recapped and should be properly disposed of. As with any rabies vaccine, vaccination with RabAvert may not protect 100% of susceptible individuals.
At present there is no evidence that persons are at increased risk if they have egg hypersensitivities that are not anaphylactic or anaphylactoid in nature. Although there is no safety data regarding the use of RabAvert in patients with egg allergies, experience with other vaccines derived from primary cultures of chick embryo fibroblasts demonstrates that documented egg hypersensitivity does not necessarily predict an increased likelihood of adverse reactions. There is no evidence to indicate that persons with allergies to chickens or feathers are at increased risk of reaction to vaccines produced in primary cultures of chick embryo fibroblasts.
Since reconstituted RabAvert contains processed bovine gelatin and trace amounts of chicken protein, neomycin, chlortetracycline and amphotericin B, the possibility of allergic reactions in individuals hypersensitive to these substances should be considered when administering the vaccine.
Epinephrine injection (1:1000) must be immediately available should anaphylactic or other allergic reactions occur.
When a person with a history of hypersensitivity must be given RabAvert, antihistamines may be given; epinephrine (1:1000), volume replacement, corticosteroids and oxygen should be readily available to counteract anaphylactic reactions.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term studies with RabAvert have not been conducted to assess the potential for carcinogenesis, mutagenesis, or impairment of fertility.
Use In Pregnancy
Pregnancy Category C
Animal reproductive studies have not been conducted with RabAvert. It is also not known whether RabAvert can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RabAvert should be given to a pregnant woman only if clearly needed. The ACIP has issued recommendations for use of rabies vaccine in pregnant women1.
Use In Nursing Mothers
It is not known whether RabAvert is excreted in animal or human milk, but many drugs are excreted in human milk. Although there are no data, because of the potential consequences of inadequately treated rabies exposure, nursing is not considered a contraindication to postexposure prophylaxis. If the risk of exposure to rabies is substantial, preexposure vaccination might also be indicated during nursing.
Children and infants receive the same dose of 1 mL, given IM, as do adults.
Only limited data on the safety and efficacy of RabAvert in the pediatric age group are available. However, in three studies some preexposure and postexposure experience has been gained (12, 19, 26; see also Clinical Studies in CLINICAL PHARMACOLOGY section).
Clinical studies of RabAvert did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
1. CDC. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Human Rabies Prevention - United States, 1999. Morbidity and Mortality Weekly Report Recommendations and Report, January 8, 1999, Vol.48, RR-1, pg 1.1-21.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/22/2014
Additional Rabavert Information
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