The most common adverse reactions in >5% of subjects during clinical trials were injection site pain, headache, injection site nodule, abdominal pain, diarrhea, flatulence, nasal congestion, and oropharyngeal pain.
Clinical Trials Experience:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The new formulation for HYPERRAB is manufactured using caprylate/chromatography purification and has a rabies antibody concentration of 300 IU/mL. The previous formulation, HYPERRAB S/D, was manufactured using a solvent detergent process and had a rabies antibody concentration of 150 IU/mL. These products were evaluated in 2 clinical trials in a total of 20 healthy subjects using a 20 IU/kg single dose. The initial study evaluated the original 150 IU/mL HYPERRAB S/D in 8 subjects and the second study evaluated HYPERRAB in 12 subjects. The original study of HYPERRAB S/D reported headache (1/8; 13%).
In the study with HYPERRAB at 300 IU/mL, 5 subjects (5/12; 42%) experienced at least 1 adverse reaction. These were: injection site pain (4/12; 33%), injection site nodule (1/12; 8%), abdominal pain (1/12; 8%), diarrhea (1/12; 8%), flatulence (1/12; 8%), headache (1/12; 8%), nasal congestion (1/12; 8%), and oropharyngeal pain (1/12; 8%).
There are no data on the postmarketing use of HYPERRAB (300 IU/mL). The following adverse reactions have been identified during post approval use of the predecessor formulation, HYPERRAB S/D. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Among patients treated with HYPERRAB S/D, cases of allergic/hypersensitivity reactions including anaphylaxis have been reported. Soreness at the site of injection (injection site pain) may be observed following intramuscular injection of immune globulins.
Sensitization to repeated injections has occurred occasionally in immunoglobulin-deficient patients.
The following have been identified as the most frequently reported post-marketing adverse reactions: Immune system disorder:
Anaphylactic reaction*, hypersensitivity*.
Nervous system disorders:
Musculoskeletal and connective tissue disorders:
Arthralgia, myalgia, pain in extremity.
*These reactions have been manifested by dizziness, paresthesia, rash, flushing, dyspnea, tachypnea, oropharyngeal pain, hyperhidrosis, and erythema.