Bivigam (immune globulin,gamm(IgG)/glycine/IgA greater than 50 mcg/mL)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Immune globulin IM (IGIM), immune globulin IV (IGIV), and immune globulin subcutaneous are sterile, nonpyrogenic preparations of globulins containing many antibodies normally present in adult human blood.
USES: This medication is used to strengthen the body's natural defense system (immune system) to lower the risk of infection in persons with a weakened immune system. This medication is made from healthy human blood that has a high level of certain defensive substances (antibodies), which help fight infections. It is also used to increase the blood count (platelets) in persons with a certain blood disorder (idiopathic thrombocytopenia purpura-ITP).
Platelets are needed to stop bleeding and form blood clots. Some immune globulin products may also be used to treat certain types of muscle weakness problem (multifocal motor neuropathy, dermatomyositis) or a certain nerve disorder (chronic inflammatory demyelinating polyneuropathy-CIDP). Some products may also be used to prevent certain blood vessel disorders in people with Kawasaki syndrome.
Generic name: immune globulin,gamm(IgG)/glycine/IgA greater than 50 mcg/mL
Pronunciation: (ih-MYOON GLOB-you-lin)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Bivigam
Indications
The following indications are listed for Bivigam:
- Agammaglobulinemia
- Common Variable Agammaglobulinemia
- Primary Immune Deficiency Disorder
- Severe Combined Immunodeficiency Disease
- Wiskott-Aldrich Syndrome
- X-Linked Agammaglobulinemia
Also known as: Abnormal Decrease Of Gamma Globulin Level, Bruton's Agammaglobulinemia, Bruton's Hypogammaglobulinemia, Combined T-Cell And B-Cell Immunodeficiency, Common Variable Immunodeficiency, Immunodeficiency With Thrombocytopenia And Eczema, Primary Antibody Deficiency Disorders, Primary Immune Deficiency Diseases, Wiskott-Aldrich-Huntley Syndrome.
Dosing
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Drug interactions
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There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
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There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
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There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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Animal reproduction studies have not been performed with IGIM, IGIV, or immune globulin subcutaneous and it is not known whether immune globulins can cause fetal harm when administered to pregnant women. Some manufacturers state that immune globulin should be used during pregnancy only when clearly needed.
ACIP states that there are no known risks associated with use of immune globulins for passive immunization in pregnant women.
Intact immune globulins, such as those contained in IGIV, cross the placenta in increasing amounts after 30 weeks of gestation. Results of studies in pregnant women with ITP who received IGIV prior to delivery indicate that the platelet response and clinical effects of IGIV were similar in the mother and neonate.
Animal reproduction studies have been performed with the recombinant human hyaluronidase component of immune globulin subcutaneous 10% with recombinant human hyaluronidase (Hyqvia(R)). In mice and rabbits, antibodies to recombinant human hyaluronidase (anti-rHuPH20 antibodies) that developed in the mother were not associated with adverse effects on pregnancy; these antibodies crossed the placenta and were transferred to offspring in utero. It is not known whether anti-recombinant human hyaluronidase antibodies that develop in women cause fetal harm. The manufacturer states that Hyqvia(R) should be used during pregnancy only if clearly needed,
IGIV and immune globulin subcutaneous have not been evaluated in nursing women.
It is not known whether immune globulin is distributed into milk following IM, IV, or subcutaneous administration, affects milk production, or affects the breast-fed infant.
Immune globulin should be used with caution in nursing women. The benefits of breast-feeding and the importance of immune globulin to the woman should be considered along with the potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.
The manufacturer of immune globulin subcutaneous 10% with recombinant human hyaluronidase (Hyqvia(R)) states that data are not available regarding use in nursing women. In lactating animals, maternal antibodies bound to recombinant human hyaluronidase (anti-rHuPH20 antibodies) were transferred to nursing offspring; no adverse effects on pregnancy or offspring development were associated with these antibodies. The possible effects of these antibodies to recombinant human hyaluronidase that may be transferred to infants are unknown.
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ICD codes
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Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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