HepaGam B Side Effects
Generic Name: hepatitis b immune globulin
Please note - some side effects for HepaGam B may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
HepaGam B Side Effects - for the Professional
HepaGam B
Overall Adverse Reaction Profile
The most common expected adverse drug reactions for intravenous immune globulins like HepaGam B are chills, fever, headaches, vomiting, allergic reactions, nausea, arthralgia and moderate low back pain7,8. In a clinical trial in liver transplant patients, 2 adverse drug reactions of tremor and hypotension were reported in 2 of 14 patients who received intravenous infusions of HepaGam B8. In studies with healthy volunteers, only 1 adverse drug reaction of nausea was reported in the 70 adult subjects who received an intramuscular administration of HepaGam B8.
Although no anaphylactic reactions have been reported following HepaGam B administration, anaphylactic reactions have been reported following the administration of other immune globulin products on rare occasions [see Warnings and Precautions (5.2)].
Adverse Reactions in Clinical Trials
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.
Hepatitis B-Related Liver Transplantation
In an ongoing clinical trial, only 2 adverse drug reactions occurred following the 313 (<1%) HepaGam B infusions in 14 liver transplant patients. A listing of all adverse events (including those assessed as unrelated to study drug) occurring in >10% of patients are summarized in Table 4 below. These adverse events were reported in an interim analysis from a one-year Phase 3 clinical trial examining HepaGam B for the prevention of hepatitis B recurrence following liver transplantation. This study utilized the recommended dosing regimen outlined in Table 1 [see Dosage and Administration (2.1)]. The 2 attributed adverse drug reactions of tremor and hypotension were reported in 2 patients. All reactions were associated with a single HepaGam B infusion during the first week post-transplant. All reactions resolved on the same day and did not recur with subsequent HepaGam B infusions.
| Adverse Event by system organ class | Number of AEs (in number of patients) N=14 |
| Blood and lymphatic systems disorder - Splenomegaly |
8 (6) |
| Eye disorders - Presbyopia |
2 (2) |
| Gastrointestinal disorders - Aphthous stomatitis - Diarrhoea - Dyspepsia - Gingival Hyperplasia |
3 (3) 10 (8) 5 (5) 3 (3) |
| General disorders - Fatigue - Oedema peripheral - Pyrexia |
6 (6) 3 (2) 3 (3) |
| Hepatobiliary disorders - Hepatobiliary disease |
3 (3) |
| Immune system disorders - Liver transplant rejection |
7 (5) |
| Infections and infestations - Diarrhoea Infectious - Pneumonia - Sepsis |
2 (2) 2 (2) 3 (2) |
| Metabolism and nutrition disorders - Hyperglycaemia |
4 (4) |
| Musculoskeletal - Back pain |
2 (2) |
| Nervous system disorders - Amnesia - Essential Tremor - Headache |
2 (2) 6 (2) 15 (9) |
| Psychiatric disorders - Agitation |
2 (2) |
| Renal and urinary disorders - Nocturia |
2 (2) |
| Respiratory, thoracic and mediastinal - Pleural effusion |
3 (3) |
| Skin and subcutaneous tissue disorders - Pruritus - Rash |
3 (3) 2 (2) |
| Vascular disorders - Hypertension - Hypotension |
8 (7) 2 (2) |
Healthy Volunteer Studies
Seventy healthy male and female volunteers received a single dose of HepaGam B intramuscularly in clinical trials8. Seventeen (17) subjects reported 30 adverse events following administration of HepaGam B. The most frequently reported adverse events included 4 subjects (6%) who experienced headache, 7 subjects (10%) who had cold symptoms or flu and 2 subjects (3%) who experienced lightheadedness/fainted. The majority of events were reported as mild and were not related to study drug. One adverse event, an episode of nausea, was considered to be drug related. There were no serious adverse events reported. A similar number of subjects in the comparator groups reported adverse events.
Postmarketing Experience
As of April 2007, there have been no postmarketing adverse events reported for HepaGam B administered IM
TopSide Effects by Body System - for Healthcare Professionals
General
Most side effects have been classified as mild.
Local
Local side effects have included erythema, pain, ecchymosis, and tenderness at the injection site.
Hypersensitivity
Hypersensitivity side effects including allergic reactions have been commonly reported. Urticaria, angioedema, and anaphylactic reactions have been reported rarely.
Gastrointestinal
Gastrointestinal side effects including nausea and vomiting have been commonly reported. Aphthous stomatitis, diarrhea, dyspepsia, and gingival hyperplasia have been reported in greater than 10% of patients.
Other
Other side effects have included fatigue (greater than 10%), peripheral edema (greater than 10%), pyrexia (greater than 10%), cold or flu symptoms (10%), lightheadedness (3%), fainting (3%), malaise, chills, and fever.
Musculoskeletal
Musculoskeletal side effects have been commonly reported. These have included back pain (greater than 10%), moderate low back pain, and arthralgia. Myalgia and joint stiffness have been reported.
Hematologic
Hematologic side effects have included splenomegaly (greater than 10%) and decreased white blood cells.
Hepatic
Hepatic side effects have included hepatobiliary disease (greater than 10%), increased AST, and alkaline phosphatase.
Renal
Renal side effects have included nocturia (greater than 10%) and increased creatinine.
Respiratory
Respiratory side effects including pleural effusion have been reported in greater than 10% of patients.
Dermatologic
Dermatologic side effects including pruritus and rash have been reported in greater than 10% of patients.
Psychiatric
Psychiatric side effects including agitation have been reported in greater than 10% of patients.
Immunologic
Immunologic side effects including liver transplant rejection, diarrhea infections, pneumonia, and sepsis have been reported in greater than 10% of patients.
Cardiovascular
Cardiovascular side effects including hypertension and hypotension have been reported in greater than 10% of patients.
Metabolic
Metabolic side effects have included hyperglycemia.
Nervous system
Nervous system side effects have included amnesia (greater than 10%), essential tremor (greater than 10%), and headache (6% to greater than 10%). At least two cases of tremor have been reported.
Ocular
Ocular side effects including presbyopia have been reported in greater than 10% of patients.
TopMore HepaGam B resources
- HepaGam B Prescribing Information (FDA)
- HepaGam B Consumer Overview
- HepaGam B Advanced Consumer (Micromedex) - Includes Dosage Information
- BayHep B MedFacts Consumer Leaflet (Wolters Kluwer)
- Hepatitis B Immune Globulin Monograph (AHFS DI)
- Nabi-HB Prescribing Information (FDA)
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