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Vivaglobin

Side Effects & Drug Interactions
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SIDE EFFECTS

In clinical studies, administration of Immune Globulin Subcutaneous (Human), VivaglobinÃ? 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 VivaglobinÃ?. 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� was evaluated for 15 months (3­month 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 VivaglobinÃ? 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 VivaglobinÃ?. 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

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 Immune Globulin Subcutaneous (Human), VivaglobinÃ?, so that appropriate precautions can be taken.

VivaglobinÃ? should not be mixed with other medicinal products.

Brand Name: Vivaglobin
Generic Name: Immune Globulin Subcutaneous (Human)

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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