The First and Only FDA-Approved IVIg Therapy for Dermatomyositis in Adults
Newly Approved Indication!
The U.S. Food and Drug Administration (FDA) has approved octagam 10% [Immune Globulin Intravenous (Human)] for the treatment of dermatomyositis (DM) in adults1, a rare, immune-mediated inflammatory disease.
FDA approval for the new indication was based on the results of ProDERM, a pivotal randomized clinical trial and the first to evaluate the long-term efficacy and safety of IVIg therapy for adults with DM.
Thrombosis may occur with immune globulin intravenous (IgIV) products, including octagam 10%. 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.
Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of Immune Globulin Intravenous (Human) (IgIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IgIV products containing sucrose. Octagam 10% does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction or renal failure, administer octagam 10% at the minimum 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.
Indications and Use
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.
Important Safety Information
Dosage 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.
Octagam 10% is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin.
Octagam 10% contains trace amounts of lgA (average 106 μg/mL in a 10% solution). It is contraindicated in lgA--deficient patients with antibodies against lgA and history of hypersensitivity.
Warnings and Precautions
lgA-deficient patients with antibodies against lgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions to octagam 10%. Epinephrine should be available immediately to treat any severe acute hypersensitivity reactions.
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% with testing by some glucometers and test strip systems.
Hyperproteinemia, increased serum osmolarity and hyponatremia may occur in patients receiving octagam 10%.
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%, especially with high doses or rapid infusion. Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI)).
Octagam 10% is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent.
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.