HyperRAB® S/D Prescribing Information
Please refer to the HyperRAB S/D Prescribing Information (PDF) for full prescribing details. To print a copy of the PDF, click here.
HyperRAB S/D (Rabies Immune Globulin [Human]) should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.
The attending physician who wishes to administer HyperRAB S/D to persons with isolated immunoglobulin A (IgA) deficiency must weigh the benefits of immunization against the potential risks of hypersensitivity reactions. Such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.
As with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders.
Soreness at the site of injection and mild temperature elevations may be observed at times. Sensitization to repeated injections has occurred occasionally in immunoglobulin-deficient patients. Angioneurotic edema, skin rash, nephrotic syndrome, and anaphylactic shock have rarely been reported after intramuscular injection so that a causal relationship between immunoglobulin and these reactions is not clear.
Administration of live virus vaccines (e.g., MMR) should be deferred for approximately 3 months after rabies immune globulin (human) administration.
HyperRAB S/D is made from human plasma. Product made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.
For full Prescribing Information, click here.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
United States
