Gamunex-C

What is Gamunex-C?

• GAMUNEX-C is an immune globulin injection (human), 10% liquid used to treat primary immune deficiency (PI),Idiopathic Thrombocytopenic Purpura(ITP) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

What are the uses of this medicine?

GAMUNEX-C is an immune globulin injection (human), 10% liquid used for treatment of:

• Primary Humoral Immunodeficiency (PI) in patients 2 years of age and older
• Idiopathic Thrombocytopenic Purpura (ITP) in adults and children
• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in adults

• Immunoglobulin is another name for the purified antibodies from human plasma that defend the body against infections such as viruses and bacteria.
• People with PI lack the healthy antibodies needed to fight off these infections.
• GAMUNEX-C provides those healthy antibodies and will help lower the number and severity of infections you could get.

How does this medicine work?

• Primary Humoral Immunodeficiency(PI):

GAMUNEX-C supplies a broad spectrum of opsonic and neutralizing IgG antibodies against bacterial, viral, parasitic, and mycoplasmal agents, and their toxins. The mechanism of action in PI has not been fully elucidated.

• Idiopathic Thrombocytopenic Purpura(ITP):

The mechanism of action of high doses of immunoglobulins in the treatment of ITP has not been fully elucidated.

• Chronic Inflammatory Demyelinating Polyneuropathy(CIDP):

The precise mechanism of action in CIDP has not been fully elucidated.

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 deficient patients with antibodies against IgA and history of hypersensitivity.

What drug interactions can this medicine cause?

• The passive transfer of antibodies may transiently interfere with the response to live virus vaccines, such as measles, mumps and rubella.
• GAMUNEX-C with other drugs and intravenous solutions have not been evaluated. It is recommended that GAMUNEX-C be administered separately from other drugs or medications which the patient may be receiving.
• Avoid simultaneous administration of GAMUNEX-C and Heparin through a single lumen delivery device due to GAMUNEX-C, Heparin incompatibilities.

Is this medicine FDA approved?

• Initial U.S. Approval: 2003

How should this medicine be used?

Recommended dosage:

• Intravenous Administration Only: ITP and CIDP

Caption text

Indication	Dose	Initial Infusion Rate	Maintenance Infusion Rate (if tolerated)
ITP	2 g/kg	1 mg/kg/min	8 mg/kg/min
CIDP	loading dose 2 g/kg maintenance dose 1 g/kg	2 mg/kg/min	8 mg/kg/min Every 3 weeks

• Intravenous or Subcutaneous Administration: PI

Caption text

Route of Administration	Dose	Initial Infusion Rate	Maintenance Infusion Rate(if tolerated)
Intravenous (IV)	300 – 600 mg/kg	1 mg/kg/min	8 mg/kg/min Every 3 to 4 weeks
Subcutaneous (SC)	1.37 x current IV dose in grams/IV dose interval in weeks	Adult:†20 mL/hr/site;Pediatric:†10 mL/hr/site (< 25 kg) 15 mL/hr/site (≥ 25 kg) ||Adult:†20 mL/hr/site ;Pediatric†:10 mL/hr/site (< 25 kg) 20 mL/hr/site (≥ 25 kg) Weekly

• Do not administer GAMUNEX-C subcutaneously in patients with ITP

Administration:

• You will take GAMUNEX-C through infusions given just below the skin (in the subcutaneous tissue).
• As directed by your physician, one or more injection sites on your body will be selected.
• The number and location of the injection sites depends on the amount you need to receive.
• Typically, adults may use 1 to 4 needles in different locations at one time. You may use up to 8 needles as directed by your doctor.
• For children, use up to 6 infusion sites simultaneously. For patients of all ages ensure that the infusion sites are at least 2 inches (5 cm) apart.
• The needles are attached with a tube to the pump. You will need to have infusions once a week.

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

This medicine is available in fallowing doasage form:

• As a sterile solution for injection supplied in 1 g (10 mL), 2.5 g (25 mL), 5 g (50 mL), 10 g (100 mL), 20 g (200 mL), or 40 g (400 mL) single use vials.

This medicine is available in fallowing brand namesː

• GAMUNEX-C

What side effects can this medication cause?

The most common side effects of this medicine include:

• Redness, swelling, and itching at the injection site
• Fatigue
• Headache
• Pain (including pain in the joints, arms, legs)
• Diarrhea
• Nausea
• Migraine
• Fever

GAMUNEX-C may cause serious side effects include:

• renal failure
• thrombosis
• aseptic meningitis
• hemolytic anemia
• transfusion-related acute lung injury
• Fever over 100°F (37.8oC)

What special precautions should I follow?

• Severe hypersensitivity reactions may occur with IGIV products, including GAMUNEX-C. IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions.
• Hyperproteinemia, with resultant changes in serum viscosity and electrolyte imbalances may occur in patients receiving IGIV therapy.
• Aseptic Meningitis Syndrome (AMS) may occur, especially with high doses or rapid infusion.
• Hemolysis, either intravascular or due to enhanced RBC sequestration, can develop subsequent to GAMUNEX-C treatments. Risk factors include high doses and non-O blood group. Closely monitor patients for hemolysis and hemolytic anemia, especially in patients with pre-existing anemia and/or cardiovascular or pulmonary compromise.
• Noncardiogenic pulmonary edema may occur in patients following treatment with IGIV products, including GAMUNEX-C. Monitor patients for pulmonary adverse reactions. If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil and anti-HLA antibodies in both the product and patient serum. TRALI may be managed using oxygen therapy with adequate ventilatory support.
• GAMUNEX-C is made from human plasma and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
• GAMUNEX-C is not approved for subcutaneous use in ITP patients. Due to a potential risk of hematoma formation, do not administer GAMUNEX-C subcutaneously in patients with ITP.
• Passive transfer of antibodies may confound serologic testing.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• fluid overload
• hyperviscosity

Can this medicine be used in pregnancy?

• There are no data with GAMUNEX-C use in pregnant women to inform a drug-associated risk.
• It is not known whether GAMUNEX-C can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
• GAMUNEX-C should be given to a pregnant woman only if clearly needed.

Can this medicine be used in children?

PI:

• GAMUNEX-C was evaluated in 18 pediatric subjects (age range 0-16 years).
• Efficacy and safety in pediatric patients under 2 years of age using the Subcutaneous route of administration have not been established.

ITP:

• For treatment of ITP, GAMUNEX-C must be administered by the intravenous route.
• GAMUNEX-C was evaluated in 12 pediatric subjects with acute ITP.

CIDP:

• The safety and effectiveness of GAMUNEX-C have not been established in pediatric subjects with CIDP.

What are the active and inactive ingredients in this medicine?

Active Ingredients:

• Human Immunoglobulin G

Inactive ingredients:

• Glycine
• Water

Who manufactures and distributes this medicine?

Manufactured by:

• Grifols Therapeutics LLC
• Research Triangle Park, NC USA

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

• DO NOT FREEZE
• Keep the vial in the carton to protect from light.
• GAMUNEX-C may be stored for 36 months at 2-8°C (36-46°F) from the date of manufacture, AND product may be stored at temperatures not to exceed 25°C (77°F) for up to 6 months anytime during the 36 month shelf life, after which the product must be immediately used or discarded.
• Do not use after expiration date.

• Dailymed label info on Gamunex-C
• FDA Gamunex-C

Gamunex-C Resources
Latest articles Most recent articles Ongoing trials	Wikipedia

Gamunex-C Resources
Latest articles Most recent articles Ongoing trials	Wikipedia