Immune globulin infusion (human)

What is Immune globulin infusion (human)?

• Immune globulin infusion (human) (GAMMAGARD LIQUID) used as replacement therapy for primary humoral immunodeficiency (PI) and as a maintenance therapy to improve muscle strength.

What are the uses of this medicine?

• GAMMAGARD LIQUID is a ready-to-use, liquid medicine that contains immunoglobulin G (IgG) antibodies, which protect the body against infection.
• GAMMAGARD LIQUID is used to treat patients with primary immunodeficiency diseases (PI) and patients with multifocal motor neuropathy (MMN).

• There are many forms of PI. The most common types of PI result in an inability to make a very important type of protein called antibodies, which help the body fight off infections from bacteria or viruses. GAMMAGARD LIQUID is made from human plasma that is donated by healthy people. GAMMAGARD LIQUID contains antibodies collected from these healthy people that replace the missing antibodies in PI patients.
• MMN is a rare disease that causes muscle weakness that worsens over time. It affects the strength of the lower parts of arms and hands more than the legs, usually without affecting the touch sensation.

How does this medicine work?

• GAMMAGARD LIQUID supplies a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents.
• GAMMAGARD LIQUID also contains a spectrum of antibodies capable of interacting with and altering the activity of cells of the immune system as well as antibodies capable of reacting with cells such as erythrocytes.
• The role of these antibodies and the mechanism of action of IgG in GAMMAGARD LIQUID have not been fully elucidated.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have a known history of a severe allergic reaction to immune globulin or other blood products.

What drug interactions can this medicine cause?

• Passive transfer of antibodies may transiently interfere with immune responses to live virus vaccines, such as measles, mumps, rubella, and varicella. Inform the immunizing physician of recent therapy with GAMMAGARD LIQUID so that appropriate precautions can be taken.

Is this medicine FDA approved?

• Initial U.S. Approval: 2005

How should this medicine be used?

Recommended dosage: Intravenous Administration for PI:

• 300 to 600 mg/kg every 3 to 4 weeks based on clinical response at the infusion rate of 0.5 mL/kg/hr (0.8 mg/kg/min) for 30 minutes.
• The infusion rate can be Increase every 30 minutes at the rate of (if tolerated) up to 5 mL/kg/hr (8 mg/kg/min).

Intravenous Administration for MMN:

• Dose range 0.5 to 2.4 grams/kg/month based on clinical response at the infusion rate of 0.5mL/kg/hr (0.8 mg/kg/min).
• The infusion rate may be advanced if tolerated to 5.4 mL/kg/hr (9 mg/kg/min).

Subcutaneous Administration for PI:

• Initial Dose 40 kg BW and greater: 30 mL/site at 20 mL/hr/site.
• Initial Dose 40 kg BW and greater:30 mL/site at 20 to 30 mL/hr/site.

• Maintenance dose Under 40 kg BW:20 mL/site at 15 mL/hr/site

Administration:

• GAMMAGARD LIQUID is given into a vein (intravenously) or under the skin (subcutaneously).
• For patients with PI, infusions into the vein are usually given every 3 or 4 weeks whereas infusions under the skin are given every week.
• For patients with MMN, infusions are given into a vein every 2 to 4 weeks as ordered by your physician.
• You and your healthcare provider will decide which way is best for you. Most of the time infusions under the skin are given at home by patients or caregivers.
• Although it is possible to give yourself infusions into the vein at home they are more often given in a hospital or infusion center by a nurse.
• Instructions for giving GAMMAGARD LIQUID under the skin (subcutaneously) are provided in the Instructions for Use brochure.
• Only use GAMMAGARD LIQUID by yourself after you have been instructed by your healthcare provider.

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

This medicine is available in fallowing doasage form:

• As Aqueous solution containing 10% IgG (100 milligram/mL)

This medicine is available in fallowing brand namesː

• GAMMAGARD LIQUID

What side effects can this medication cause?

The most common side effects of this medicine include:

• Headache
• Chills/Shaking chills
• Migraine
• Dizziness
• Fever
• Nausea/Vomiting
• Fatigue
• Faster Heart Rate
• Itching
• Upper Abdominal Pain
• Rash/Hives
• Increased Blood Pressure
• Cough
• Muscle cramps
• Chest pain/tightness
• Sore throat

The following one or more possible reactions may occur at the site of infusion:

• Mild or moderate pain
• Redness
• Swelling
• Bruising
• Itching
• Warmth

What special precautions should I follow?

IgA deficient patients with antibodies to IgA are at greater risk of developing severe hypersensitivity and anaphylactic reaction. Monitor renal function, including blood urea nitrogen, serum creatinine, and urine output in patients at risk of acute renal failure. Hyperproteinemia, increased serum viscosity and hyponatremia may occur. Thrombosis may occur. Monitor for signs and symptoms of thrombosis and assess blood viscosity for those at risk for hyperviscosity. Aseptic Meningitis Syndrome (AMS) may occur. Conduct a thorough neurological examination on patients exhibiting such symptoms and signs, including CSF studies, to rule out other causes of meningitis. Hemolytic anemia can develop. Monitor for clinical signs and symptoms of hemolysis and hemolytic anemia. GAMMAGARD LIQUID is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease agent.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• With intravenous administration, overdose of GAMMAGARD LIQUID may lead to fluid overload and hyperviscosity.

Can this medicine be used in pregnancy?

• It is not known whether GAMMAGARD LIQUID can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Can this medicine be used in children?

PI

• Safety and efficacy of GAMMAGARD LIQUID in pediatric patients below the age of 2 have not been established.

MMN

• Safety and effectiveness in pediatric patients with MMN have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• HUMAN IMMUNOGLOBULIN G

Inactive ingredients:

• GLYCINE

Who manufactures and distributes this medicine?

• GAMMAGARD LIQUID® is a registered trademark of Baxalta Incorporated, a Takeda company.
• Baxalta US Inc.
• Lexington, MA USA

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

• Store vials in their original boxes to protect from light.
• Do not freeze GAMMAGARD LIQUID.
• You can store GAMMAGARD LIQUID in the refrigerator or at room temperature.
• The maximum storage time for GAMMAGARD LIQUID depends on the storage temperature you choose.
• In the Refrigerator: at 2° to 8°C (36° to 46°F) for up to 36 months.
• Room Temperature: up to 25°C (77°F) for up to 24 months.

• Dailymed label info on Immune globulin infusion (human)
• FDA Immune globulin infusion (human)

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