Vivaglobin
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Vivaglobin
Vivaglobin 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.
Vivaglobin in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; dizziness, feeling like you might pass out; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- swelling, rapid weight gain, feeling short of breath, urinating less than usual or not at all;
- pain, swelling, redness, warmth, or a lump in your arms or legs;
- pale or yellowed skin, dark colored urine, fast heart rate;
- fever, severe headache, sore throat, neck stiffness, chills, increased sensitivity to light, confusion, and general ill feeling;
- chest pain or tightness, trouble breathing; or
- signs of new infection such as high fever, chills, body aches, flu symptoms, or sores in your mouth and throat.
Less serious side effects may include:
- pain, redness, warmth, itching, and swelling of skin where the injection was given;
- nausea, vomiting, diarrhea, stomach pain;
- headache;
- mild skin rash;
- back pain;
- joint or muscle pain; or
- tired feeling;
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.
Read the entire detailed patient monograph for Vivaglobin (Immune Globulin Subcutaneous (Human)) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Vivaglobin 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.
This medication may rarely cause blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you are severely dehydrated, or have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as very long plane flights or bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, if you have any of these conditions report them to your doctor or pharmacist. Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, slurred speech, weakness on one side of the body, sudden vision changes, confusion.
Though very unlikely to occur, this product may contain substances such as viruses that could cause infections because it is made from human blood (plasma). Careful screening of blood donors, special manufacturing methods, and tests are all used to reduce this risk. Discuss the benefits and risks of treatment with your doctor. Tell your doctor immediately if you develop any signs of an infection such as: persistent fever, persistent sore throat, unusual tiredness, yellowing eyes/skin, dark urine.
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.
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 Vivaglobin (Immune Globulin Subcutaneous (Human))»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Vivaglobin FDA Prescribing Information: Side Effects
(Adverse Reactions)
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
 |
Read the entire FDA prescribing information for Vivaglobin (Immune Globulin Subcutaneous (Human)) »
Additional Vivaglobin Information
Vivaglobin - User Reviews
Vivaglobin User Reviews
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Here is a collection of user reviews for the medication Vivaglobin sorted by most helpful.
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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