Bivigam

What is Bivigam?

• Bivigam is an Immune Globulin Intravenous (Human) used for the treatment of primary humoral immunodeficiency (PI).

What are the uses of this medicine?

• BIVIGAM is an Immune Globulin Intravenous (Human), 10% Liquid, used for the treatment of patients with primary humoral immunodeficiency (PI).

How does this medicine work?

• BIVIGAM is a replacement therapy in patients with primary humoral immunodeficiency (PI) (e.g. agammaglobulinaemia, hypogammaglobulinaemia, CVID, SCID).
• The broad spectrum of neutralizing IgG antibodies against bacterial and viral pathogens and their toxins helps to avoid recurrent serious opportunistic infections.
• IgG antibodies are opsonins that increase phagocytosis and elimination of pathogens from the circulation.
• The mechanism of action has not been fully elucidated in PI.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.
• IgA deficiency patients with antibodies to IgA and a history of hypersensitivity.

What drug interactions can this medicine cause?

• 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.

Is this medicine FDA approved?

• Initial U.S. Approval : 2012

How should this medicine be used?

Recommended dosage:

• The recommended dose of BIVIGAM for replacement therapy in primary humoral immunodeficiency (PI) is 300 to 800 mg/kg body weight administered every 3 to 4 weeks.

Administration:

• 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 sterile infusion bags and infused.
• Do not dilute BIVIGAM.
• BIVIGAM contains no preservatives. BIVIGAM vial is for single use only. Any vial of BIVIGAM that has been entered should be used promptly and any unused portion should be discarded immediately. Do not reuse or save for future use.
• Maintain BIVIGAM at room temperature during administration.
• Do not use after expiration date.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As BIVIGAM is a liquid solution containing 10% IgG (100mg/mL) for
• intravenous infusion; (5g in 50mL solution, 10g in 100mL solution).

This medicine is available in fallowing brand namesː BIVIGAM

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• fatigue
• infusion site reaction
• nausea
• sinusitis
• blood pressure increased
• diarrhea
• dizziness
• lethargy

What special precautions should I follow?

• Thrombotic events have occurred in patients receiving IGIV therapy. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for those at risk of hyperviscosity.
• IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have medications such as epinephrine available immediately to treat any acute severe hypersensitivity reactions.
• Monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output in patients at risk of developing acute renal failure.
• Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV therapy.
• Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments, especially with high doses or rapid infusion.
• Hemolytic anemia can develop subsequent to treatment with IGIV products. Monitor patients for hemolysis and hemolytic anemia.
• Monitor patients for pulmonary adverse reactions (Transfusion-related acute lung injury [TRALI]). If transfusion-related acute lung injury is suspected, test the product and patient for antineutrophil antibodies.
• Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Use in pregnant women has not been evaluated. Use BIVIGAM in pregnant women only if clearly needed.

Can this medicine be used in children?

• BIVIGAM was evaluated in 9 pediatric patients (4 children ages 6 – 11 years and 5 adolescents ages 12 – 16 years) with PI.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• HUMAN IMMUNOGLOBULIN G

Inactive ingredients:

• None

Who manufactures and distributes this medicine?

• Packager: ADMA Biologics, Inc.

What should I know about storage and disposal of this medication?

• Refrigerate between 2 to 8°C (36 to 46°F).
• Do not freeze or heat. Do not use any solutions that have been frozen or heated.
• Allow refrigerated product to come to room temperature before use.
• Do not use after expiration date.
• BIVIGAM may be stored until expiration date on vial packaging at 2 to 8°C (36 to 46°F).

• Dailymed label info on Bivigam
• FDA Bivigam

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