Gamunex-C

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What is Gamunex-C?[edit | edit source]


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What are the uses of this medicine?[edit | edit source]

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


  • 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?[edit | edit source]

  • 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 ?[edit | edit source]

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?[edit | edit source]

  • 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?[edit | edit source]

  • Initial U.S. Approval: 2003


How should this medicine be used?[edit | edit source]

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?[edit | edit source]

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?[edit | edit source]

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:


What special precautions should I follow?[edit | edit source]

  • 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?[edit | edit source]

Symptoms of overdosage may include:


Can this medicine be used in pregnancy?[edit | edit source]

  • 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?[edit | edit source]

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?[edit | edit source]

Active Ingredients:

  • Human Immunoglobulin G

Inactive ingredients:

  • Glycine
  • Water


Who manufactures and distributes this medicine?[edit | edit source]

Manufactured by:

  • Grifols Therapeutics LLC
  • Research Triangle Park, NC USA


What should I know about storage and disposal of this medication?[edit | edit source]

  • 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.
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