"The U.S. Food and Drug Administration today approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, k"...
Immune Globulin Subcutaneous
- Patient Information:
Details with Side Effects
Vivaglobin® Immune Globulin Subcutaneous (Human), is a pasteurized, polyvalent human normal immunoglobulin for subcutaneous infusion. Vivaglobin® is manufactured from large pools of human plasma by cold alcohol fractionation and is not chemically altered or enzymatically degraded.
Vivaglobin® (immune globulin subcutaneous human) is supplied as a sterile liquid to be administered by the subcutaneous route. Vivaglobin® (immune globulin subcutaneous human) is a 16% (160 mg/mL) protein solution, with a content of at least 96% immunoglobulin G (IgG). The distribution of IgG subclasses is similar to that present in normal human plasma. Vivaglobin® (immune globulin subcutaneous human) contains 2.25% glycine, 0.3% sodium chloride, and water for injection, U.S.P. The pH of Vivaglobin® (immune globulin subcutaneous human) is 6.4 to 7.2. Vivaglobin® (immune globulin subcutaneous human) contains no preservative.
All plasma used in the manufacture of Vivaglobin® (immune globulin subcutaneous human) is tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 (HIV-1/2) as well as FDA-licensed Nucleic Acid Testing (NAT) for HCV and HIV-1 and found to be nonreactive (negative). For hepatitis B virus (HBV), an investigational NAT procedure is used and the plasma found to be negative. However, the significance of a negative result has not been established. In addition, the plasma has been tested by NAT for hepatitis A virus (HAV) and parvovirus B19 (B19). Only plasma that passed virus-screening is used for production and the limit for B19 in the fractionation pool is set not to exceed 104 IU of B19 DNA per mL.
The manufacturing procedure for Vivaglobin® (immune globulin subcutaneous human) includes multiple processing steps that reduce the risk of virus transmission. The virus reduction capacity of two steps was evaluated in a series of in vitro spiking experiments; the steps were ethanol - fatty alcohol / pH precipitation and pasteurization in aqueous solution at 60°C for 10 hours. Total mean cumulative virus reductions ranged from 9.0 to ≥ 14.1 log10 as shown in Table 1.
Table 1: Mean Virus Reduction Factors CSL Behring
|Virus Studied:||Ethanol - Fatty
Alcohol / pH
|HIV-1||≥ 6.2||≥ 6.5||≥ 12.7|
|BVDV||≥ 5.3||≥ 8.7||≥ 14.0|
|WNV||≥ 4.4||≥ 9.3||≥ 13.7|
|PRV||≥ 6.2||≥ 7.9||≥ 14.1|
|PEV||≥ 6.7||3.7||≥ 10.4|
|HIV-1: Human immunodeficiency virus type
1, model for HIV types 1 and 2
BVDV: Bovine viral diarrhea virus, model for HCV and WNV
WNV: West Nile virus
PRV: Pseudorabies virus, model for large enveloped DNA viruses (e.g., herpes virus)
PEV: Porcine enterovirus, model for HAV (in an immunoglobulin product)
CPV: Canine parvovirus, model for parvovirus B19
* Reduction of parvovirus B19 (evaluated using porcine IgG) by pasteurization was ≥ 3.5 log10.
What are the possible side effects of immune globulin (Hizentra, Vivaglobin)?
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...
What are the precautions when taking immune globulin subcutaneous (human) (Vivaglobin)?
See Side Effects section.
Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other immune globulin products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: a certain type of immune system deficiency (selective IgA deficiency with known antibody against IgA).
Before using this medication, tell your doctor or pharmacist your medical history.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and...
Last reviewed on RxList: 3/3/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Vivaglobin Information
Vivaglobin - User Reviews
Vivaglobin User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
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.
Find out what women really need.