HepaGam B
HepaGam B Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
HepaGam B in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
- left-sided stomach pain; or
- nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
- upset stomach, diarrhea;
- tremors or shaking;
- joint or back pain;
- fever, chills;
- headache; or
- tired feeling.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for HepaGam B (Hepatitis B Immune Globulin (Human)) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
HepaGam B Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist promptly.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for HepaGam B (Hepatitis B Immune Globulin (Human))»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
HepaGam B FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Overall Adverse Reaction Profile
The most common expected adverse drug reactions for intravenous immune globulins like HepaGam B (hepatitis b immune globulin (human)) are chills, fever, headaches, vomiting, allergic reactions, nausea, arthralgia and moderate low back pain.7-8 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 B.8 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 B (hepatitis b immune globulin (human)) .8
Although no anaphylactic reactions have been reported following HepaGam B (hepatitis b immune globulin (human)) administration, anaphylactic reactions have been reported following the administration of other immune globulin products on rare occasions [see WARNINGS AND PRECAUTIONS].
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 (hepatitis b immune globulin (human)) 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 (hepatitis b immune globulin (human)) 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]. The 2 attributed adverse drug reactions of tremor and hypotension were reported in 2 patients. All reactions were associated with a single HepaGam B (hepatitis b immune globulin (human)) infusion during the first week post-transplant. All reactions resolved on the same day and did not recur with subsequent HepaGam B (hepatitis b immune globulin (human)) infusions.
Table 4 - Adverse Events (AEs) Occurring in >10% of Liver
Transplant Patients
| 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 | 3(3) |
| - Diarrhoea | 10(8) |
| - Dyspepsia | 5(5) |
| - Gingival Hyperplasia | 3(3) |
| General disorders | |
| - Fatigue | 6(6) |
| - Oedema peripheral | 3(2) |
| - Pyrexia | 3(3) |
| Hepatobiliary disorders | |
| - Hepatobiliary disease | 3(3) |
| Immune system disorders | |
| - Liver transplant rejection | 7(5) |
| Infections and infestations | |
| - Diarrhea Infectious | 2(2) |
| - Pneumonia | 2(2) |
| - Sepsis | 3(2) |
| Metabolism and nutrition disorders | |
| - Hyperglycaemia | 4(4) |
| Musculoskeletal | |
| - Back pain | 2(2) |
| Nervous system disorders | |
| - Amnesia | 2(2) |
| - Essential Tremor | 6(2) |
| - Headache | 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 | 3(3) |
| - Rash | 2(2) |
| Vascular disorders | |
| - Hypertension | 8(7) |
| - Hypotension | 2(2) |
Healthy Volunteer Studies
Seventy healthy male and female volunteers received a single dose of HepaGam B™ (Hepatitis B Immune Globulin Intravenous [Human]) intramuscularly in clinical trials.8 Seventeen (17) subjects reported 30 adverse events following administration of HepaGam B (hepatitis b immune globulin (human)) . 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 lightheadeness/ 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 (hepatitis b immune globulin (human)) administered i.m.
Read the entire FDA prescribing information for HepaGam B (Hepatitis B Immune Globulin (Human)) »
Additional HepaGam B Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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