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Vivaglobin

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Vivaglobin

SIDE EFFECTS

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® (immune globulin subcutaneous (human)) . Rarely, immediate anaphylactoid and hypersensitivity reactions may occur. In exceptional cases, sensitization to IgA may result in an anaphylactic reaction (see CONTRAINDICATIONS).

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® (immune globulin subcutaneous (human)) 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.

Table 5: Most Frequent Adverse Events by Subject Irrespective of Causality* in the US and Canada Study

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%)†
*Excluding infections
† Due to missing subject diary information, values listed are estimates.

Table 6: Most Frequent Adverse Events by Infusion Irrespective of Causality* in the US and Canada Study

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%)†
*Excluding infections
**Rate = number of reactions/infusion
† Due to missing subject diary information, values listed are estimates.

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.

Table 7: Most Frequent Related Adverse Events by Subject* in the US and Canada Study

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%)
*Excluding infections

Table 8: Most Frequent Related Adverse Events by Infusion* in the US and Canada Study

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%)
*Excluding infections
**Rate = number of reactions/infusion

In the non-IND Europe and Brazil clinical study, the safety of Immune Globulin Subcutaneous (Human), Vivaglobin® (immune globulin subcutaneous (human)) 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® (immune globulin subcutaneous (human)) . 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 (see Figure 1). 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

Subjects Reporting Local Site Reactions By Infusion - Illustration

Read the Vivaglobin (immune globulin subcutaneous (human)) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Immunoglobulin administration can transiently impair the efficacy of live attenuated virus vaccines such as measles, mumps and rubella. The immunizing physician should be informed of recent therapy with Vivaglobin® Immune Globulin Subcutaneous (Human), so that appropriate precautions can be taken.

Vivaglobin (immune globulin subcutaneous (human)) ® should not be mixed with other medicinal products.

Read the Vivaglobin Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 3/3/2009
This monograph has been modified to include the generic and brand name in many instances.

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