Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 25 April 2017
• IgA deficient patients with antibodies against IgA and a history of hypersensitivity (4.2)
WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE
See full prescribing information for complete boxed warning.
• Thrombosis may occur with immune globulin products, including GAMUNEX-C. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
• For patients at risk of thrombosis, administer GAMUNEX-C at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
• Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients.
• Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMUNEX-C does not contain sucrose.
• For patients at risk of renal dysfunction or failure, administer GAMUNEX-C at the minimum concentration available and the minimum infusion rate practicable. (5.2)
• 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. (5.1)
• Hyperproteinemia, with resultant changes in serum viscosity and electrolyte imbalances may occur in patients receiving IGIV therapy. (5.3)
• Aseptic Meningitis Syndrome (AMS) has been reported with GAMUNEX-C and other IGIV treatments, especially with high doses or rapid infusion. (5.5)
• 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. Monitor patients for hemolysis and hemolytic anemia. (5.6)
• Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]). (5.7)
• Volume overload. (5.8)
• 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 (CJD) disease agent. (5.9)
• 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. (5.10)
• Passive transfer of antibodies may confound serologic testing. (5.12)
PI: Intravenous: Headache, cough, injection site reaction, nausea, pharyngitis and urticaria.
Subcutaneous: Infusion site reactions, headache, influenza, fatigue, arthralgia and pyrexia.
ITP: Headache, vomiting, fever, nausea, back pain and rash.
CIDP: Headache, fever, chills, hypertension, rash, nausea and asthenia.
|Indication||Dose||Initial Infusion Rate||Maintenance Infusion Rate
|ITP (2.3)||2 g/kg||1 mg/kg/min||8 mg/kg/min|
|CIDP (2.4)||loading dose 2 g/kg
maintenance dose 1 g/kg
|2 mg/kg/min||8 mg/kg/min
Every 3 weeks
• For patients at risk of renal dysfunction or thrombosis, administer GAMUNEX-C at the minimum infusion rate practicable. (5.2, 5.4)
Intravenous or Subcutaneous Administration: PI (2.2)
DO NOT ADMINISTER SUBCUTANEOUSLY FOR ITP PATIENTS (5.10)
|Dose*||Initial Infusion Rate||Maintenance Infusion Rate
|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
(< 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)
* See section 2.2.
† Adults: use up to 8 infusion sites simultaneously; pediatric: use up to 6 infusion sites simultaneously; for all ages, ensure infusion sites are at least 2 inches (5 cm) apart. (2.5)
|Date First Approved||13-10-2010|
|Marketing authorisation holder||Grifols Therapeutics Inc.|