BIVIGAM 5 g/50mL
Immune Globulin Intravenous (Human) 10% · INJECTION, SOLUTION · ADMA Biologics, Inc.
Bivigam is an intravenous injection containing human immunoglobulins used to treat immune deficiency disorders and certain autoimmune conditions by helping the body fight infections and regulate immune function. It works by providing antibodies that the patient's immune system cannot produce adequately on its own.
Key Facts
- Brand Name
- BIVIGAM
- Generic Name
- Immune Globulin Intravenous (Human) 10%
- NDC Code (Product)
69800-6502- Manufacturer
- ADMA Biologics, Inc.
- Strength
- 5 g/50mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA125389
- Drug Class
- Human Immunoglobulin G [EPC]
- Marketing Start
- 01/21/2013
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, indicated for the treatment of adults and pediatric patients 2 years of age and older with primary humoral immunodeficiency (PI). [1] 1.1 Primary Humoral Immunodeficiency BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, indicated for the treatment of adults and pediatric patients 2 years of age and older with primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For Intravenous Use Only Intravenous Use Only Indication Dose Initial Infusion Rate Maintenance Infusion Rate (if tolerated) PI 300-800 mg/kg every 3-4 weeks 0.5 mg/kg/min for first 10 minutes Increase every 20 minutes (if tolerated) by 0.8 mg/kg/min up to 6 mg/kg/min. Ensure that patients with pre-existing renal insufficiency are not volume depleted; discontinue BIVIGAM if renal function deteriorates. [5.3] For patients at risk of renal dysfunction or thrombotic events, administer BIVIGAM at the minimum infusion rate practicable. [5.1 , 5.3] 2.1 Preparation and Handling BIVIGAM is a clear or slightly opalescent, colorless to pale yellow solution. Inspect BIVIGAM visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or turbid, or contains particulate matter. Allow refrigerated product to come to room temperature before use. Do not freeze or heat. Do not use any solution that has been frozen or heated. DO NOT SHAKE. Do not mix BIVIGAM with other IGIV products or other intravenous medications. If large doses of BIVIGAM are to be administered, several vials may be pooled using aseptic technique into …
Contraindications
4 CONTRAINDICATIONS BIVIGAM is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. BIVIGAM is contraindicated in IgA deficiency patients with antibodies to IgA and a history of hypersensitivity. History of anaphylactic or severe systemic reactions to human immunoglobulin. [4] IgA deficient patients with antibodies to IgA and a history of hypersensitivity. [4 , 5.2]
Drug Interactions
7 DRUG INTERACTIONS Passive transfer of antibodies may transiently interfere with the immune response to live virus vaccines, such as measles, mumps, rubella, and varicella. [7] Passive transfer of antibodies may confound the results of serological testing. [5.10] 7.1 Live Virus Vaccines Immunoglobulin administration may transiently impair the efficacy of live attenuated virus vaccines such as measles, mumps, rubella, and varicella because the continued presence of high levels of passively acquired antibody may interfere with an active antibody response. 15,16 The immunizing physician should be informed of recent therapy with BIVIGAM so that appropriate measures may be taken (see Patient Counseling Information [17.7] ).
Adverse Reactions
6 ADVERSE REACTIONS Serious adverse reactions observed in clinical trial subjects receiving BIVIGAM were vomiting and dehydration in one subject. The most common adverse reactions to BIVIGAM (reported in ≥5% of clinical study subjects) were headache, fatigue, infusion site reaction, nausea, sinusitis, blood pressure increased, diarrhea, dizziness, and lethargy. The most common adverse reactions to BIVIGAM (reported in ≥5% of clinical study subjects) were headache, fatigue, infusion site reaction, nausea, sinusitis, blood pressure increased, diarrhea, dizziness, and lethargy. [6] To report SUSPECTED ADVERSE REACTIONS, contact ADMA Biologics at (800) 458-4244 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials cannot be directly compared to rates in the clinical trials of another product and may not reflect the rates observed in clinical practice. In a multicenter, open-label, non-randomized clinical trial, 63 subjects with PI, on regular IGIV replacement therapy, received doses of BIVIGAM ranging from 254 to 1029 mg/kg (median dose 46…
Frequently Asked Questions
What is BIVIGAM used for?
Bivigam is an intravenous injection containing human immunoglobulins used to treat immune deficiency disorders and certain autoimmune conditions by helping the body fight infections and regulate immune function. It works by providing antibodies that the patient's immune system cannot produce adequately on its own.
Is BIVIGAM a controlled substance?
BIVIGAM is not classified as a controlled substance by the DEA.
What is the generic name for BIVIGAM?
The generic name for BIVIGAM is Immune Globulin Intravenous (Human) 10%. There are no other listed brand versions of Immune Globulin Intravenous (Human) 10%.
What is the NDC code for BIVIGAM 5 g/50mL?
The NDC (National Drug Code) for BIVIGAM 5 g/50mL is 69800-6502, listed by ADMA Biologics, Inc..
Other BIVIGAM Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)