Vivaglobin Side Effects
Generic Name: immune globulin subcutaneous
Please note - some side effects for Vivaglobin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Vivaglobin Side Effects - for the Professional
Vivaglobin
In clinical studies, administration of Vivaglobin®, Immune Globulin Subcutaneous (Human) has been shown to be safe and well tolerated in both adult and pediatric subjects. Reactions similar to those reported with administration of other immune globulin products may also occur with Vivaglobin®. Rarely, immediate anaphylactoid and hypersensitivity reactions may occur. In exceptional cases, sensitization to IgA may result in an anaphylactic reaction.
Should evidence of an acute hypersensitivity reaction be observed, the infusion should be stopped promptly, and appropriate treatment and supportive therapy should be administered.
In the US and Canada clinical study, the safety of Vivaglobin® was evaluated for 15 months (3-month wash-in/wash-out period followed by 12-month efficacy period) in 65 subjects with PID. The most frequent adverse reaction was local reaction at the injection site. Table 5 summarizes the most frequent adverse events by subject reported in the clinical study, and Table 6 summarizes the most frequent adverse events by infusion.
| Adverse Events (≥ 10% of subjects) |
No. of Subjects (% of total) |
|---|---|
| Adverse Events at the Injection Site | 60 (92%) |
| Non-Injection Site Reactions | |
| Headache | 31 (48%) |
| Gastrointestinal disorder | 24 (37%) |
| Fever | 16 (25%) |
| Nausea | 12 (18%) |
| Sore throat | 11 (17%) |
| Rash | 11 (17%) |
| Allergic reaction | 7 (11%) |
| Pain | 6.7 (10%)† |
| Diarrhea | 6.7 (10%)† |
| Cough increased | 6.7 (10%)† |
| Adverse Events (≥ 1% of infusions) (Number of Infusions: 3656) |
No. of Adverse Events (Rate†) |
|---|---|
| Adverse Events at the Injection Site | 1789 (49%) |
| Mild | 1112 (30%) |
| Moderate | 601 (16%) |
| Severe | 65 (2%) |
| Unknown Severity | 11 (< 1%) |
| Non-Injection Site Reactions | |
| Headache | 159 (4%) |
| Gastrointestinal disorder | 40.3 (1%)‡ |
Table 7 summarizes the most frequent related adverse events by subject reported in the clinical study, and Table 8 summarizes the most frequent related adverse events by infusion.
| Related Adverse Event (≥ 2 subjects) |
No. of Subjects (% of total) |
|---|---|
|
|
| Adverse Events at the Injection Site | 60 (92%) |
| Non-Injection Site Reactions | |
| Headache | 21 (32%) |
| Nausea | 7 (11%) |
| Rash | 4 (6%) |
| Asthenia | 3 (5%) |
| Gastrointestinal disorder | 3 (5%) |
| Fever | 2 (3%) |
| Skin disorder | 2 (3%) |
| Tachycardia | 2 (3%) |
| Urine abnormality | 2 (3%) |
| Related Adverse Event (≥ 2 AEs) (Number of Infusions: 3656) |
No. of AEs (Rate†) |
|---|---|
| Adverse Events at the Injection Site | 1787 (49%) |
| Non-Injection Site Reactions | |
| Headache | 59 (1.6%) |
| Rash | 9 (0.2%) |
| Nausea | 9 (0.2%) |
| Nervousness | 4 (0.1%) |
| Asthenia | 3 (0.1%) |
| Gastrointestinal disorder | 3 (0.1%) |
| Skin disorder | 3 (0.1%) |
| Urine abnormality | 3 (0.1%) |
| Fever | 2 (0.1%) |
| Dyspnea | 2 (0.1%) |
| Gastrointestinal pain | 2 (0.1%) |
| Tachycardia | 2 (0.1%) |
In the non-IND Europe and Brazil clinical study, the safety of Vivaglobin® was evaluated for 10 months in 60 subjects with PID. The adverse events and their rates reported in this study were similar to those reported in the US and Canada study, with two notable exceptions for the related adverse events. These events were 59 episodes of headache (1.6%) and 2 episodes of fever (0.1%) in the US and Canada study and no episodes of headache and 18 episodes of fever (0.8%) in the Europe and Brazil study.
Local (Injection Site) Reactions
Local injection site reactions consisting of mostly mild or moderate swelling, redness and itching, have been observed with the use of Vivaglobin®. No serious local site reactions were observed. The majority of injection site reactions resolved within four days. Additionally, the number of subjects reporting local injection site reactions decreased substantially after repeated use. Only three subjects in the US and Canada study and one subject in the Europe and Brazil study discontinued due to local site reactions.
Figure 1: Subjects Reporting Local Site Reactions By Infusion
Note: Analysis is confined to 70 infusions.
TopSide Effects by Body System
Local
Local side effects have been reported the most frequently. Up to 92% of patients reported adverse events at the injection site.
Gastrointestinal
Gastrointestinal side effects have been reported often (37%), including nausea (18%) and diarrhea (10%).
Dermatologic
Dermatologic side effects have included rash (17%).
Hypersensitivity
Hypersensitivity side effects have rarely included immediate anaphylactoid and hypersensitivity reactions. Allergic reactions (11%) have also been reported.
General
General side effects have included headache (48%), fever (25%), sore throat (17%), and pain (10%).
Respiratory
Respiratory side effects have included an increase in cough (10%).
Top
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