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Prescribing Information, including BOXED WARNINGIndicationsOCTAGAM 5%
The FIRST and ONLY FDA-approved IVIg therapy for dermatomyositis (DM) in adults1OCTAGAM 10% [Immune Globulin Intravenous (Human)] liquid is FDA approved for 2 indications: DM in adults and cITP in adults1OCTAGAM 10% is the first and only IVIg therapy with a successful phase 3 study resulting in FDA approval for DM1

cITP=chronic immune thrombocytopenia; DM=dermatomyositis; FDA=US Food and Drug Administration; IVIg=intravenous immunoglobulin.

Learn more about OCTAGAM 10% for DM
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 OCTAGAM 10% for DM Efficacy Loading Safety & tolerability  Loading Dosing & infusion rates  Loading OCTAGAM 10% for cITP Efficacy Loading Safety & tolerability Loading Dosing & infusion rates  Loading Use this calculator to determine infusion ramp-up rates for the 2 indications Learn moreLoading Request a representative Request hereLoading Access resources, including a free patient app Access here LoadingReferenceOCTAGAM 10% [prescribing information]. Paramus, NJ: Octapharma USA Inc.; 2022.

To report an adverse event, please call 1-800-438-1985

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INDICATIONS AND USAGE

OCTAGAM® 10% [Immune Globulin Intravenous (Human)] liquid is indicated for the treatment of chronic immune thrombocytopenic purpura (cITP) to rapidly raise platelet counts to control or prevent bleeding in adults and for dermatomyositis (DM) in adults.

Please click here for Full Prescribing Information, including BOXED WARNING.

IMPORTANT SAFETY INFORMATIONWARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE
  • Thrombosis may occur with immune globulin intravenous (IgIV) products, including OCTAGAM 10% liquid. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
  • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients who receive IgIV products, including OCTAGAM 10% liquid. Patients predisposed to renal dysfunction include those with a degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IgIV products containing sucrose. OCTAGAM 10% liquid does not contain sucrose.
  • For patients at risk of thrombosis, renal dysfunction, or acute renal failure, administer OCTAGAM 10% liquid 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.
Dosing and Administration Patients with dermatomyositis are at increased risk for thromboembolic events; monitor carefully and do not exceed an infusion rate of 0.04 mL/kg/min. ContraindicationsOCTAGAM 10% liquid is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin and in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.Warnings and PrecautionsOCTAGAM 10% liquid may cause hypersensitivity in patients with a corn allergy. OCTAGAM 10% liquid contains maltose, which is derived from corn. Monitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at risk of developing acute renal failure. Falsely elevated blood glucose readings may occur during and after the infusion of OCTAGAM 10% liquid with testing by some glucometers and test strip systems. Hyperproteinemia, increased serum osmolarity, and hyponatremia may occur in patients receiving OCTAGAM 10% liquid. Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to treatment with OCTAGAM 10% liquid. Risk factors for hemolysis include high doses and non–O-blood group. Closely monitor patients for hemolysis and hemolytic anemia. Aseptic meningitis syndrome may occur in patients receiving OCTAGAM 10% liquid, especially with high doses or rapid infusion. Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]). OCTAGAM 10% liquid is made from human plasma and may contain infectious agents, eg, viruses and, theoretically, the Creutzfeldt-Jakob disease agent. Adverse Reactions cITP - The most common adverse reactions reported in >5% of study subjects were headache, fever, and increased heart rate. DM - The most common adverse reactions reported in >5% of study subjects were headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, and infusion site reactions.You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the US Food and Drug Administration (FDA) directly. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.OCTAGAM® is a registered trademark of Octapharma AG.Please click here for Full Prescribing Information, including BOXED WARNING.Helix ImageINDICATIONS AND USAGEOCTAGAM® 10% [Immune Globulin Intravenous (Human)] liquid is indicated for the treatment of chronic immune thrombocytopenic purpura (cITP) to rapidly raise platelet counts to control or prevent bleeding in adults and for dermatomyositis (DM) in adults.