United States14 May 2022

PNS Congress

Peripheral Nerve Society 2022 Annual Meeting

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Octapharma is proud to support the Peripheral Nerve Society (PNS) 2022 Annual Meeting!

Through this page, you will access detailed information about Octapharma's most recent Phase III clinical studies with IVIG in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Dermatomyositis (DM), as well as some additional insights on Dermatomyositis and our IVIG products, panzyga® and octagam®, now approved for the treatment of CIDP and DM respectively.

Visit us at EXHIBIT TABLE #19

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ProCID Trial

Efficacy and Safety of IVIG in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Chronic inflammatory demyelinating polyneuropathy (CIDP) is an immune mediated neuropathy characterised by progressive weakness and impaired sensory function in the limbs.

The ProCID study was a prospective, double-blind, randomised, multi-centre phase III study that assessed the efficacy and safety of Panzyga® in patients with CIDP and compared two different maintenance dosages of Panzyga® (a higher one of 2.0 g/kg and a lower one of 0.5 g/kg) with the standard dosing scheme of 1.0 g/kg every 3 weeks. The results of the study confirmed the efficacy of Panzyga® in adults with CIDP at the standard dose of 1.0 g/kg every 3 weeks. Almost 80% (55/69) of patients responded to treatment with a decrease of at least 1 point in the adjusted inflammatory neuropathy cause and treatment (INCAT) disability score by the end of the 24-week treatment period. Results also suggested a dose response with a greater proportion of patients responding with increasing doses of Panzyga®.

Learn more about the ProCID trial

Watch Dr. Kadar, investigator in the ProCID trial, providing insights on the study

ProDERM Trial

Efficacy, Tolerability and Safety of IVIg (octagam® 10%) in Adult Patients with Active Dermatomyositis

Dermatomyositis is a rare, idiopathic autoimmune disorder, with patients commonly suffering from skin rashes, chronic muscle inflammation and progressive muscle weakness.

The ProDERM study was a double-blind, placebo-controlled randomised trial that investigated the efficacy and safety of octagam® 10% in adults with dermatomyositis. A significantly higher proportion of the patients randomised to octagam® 10% showed a response to treatment compared with the placebo group in the initial 16-week period (79% vs 44%, p=0.0008).

Based on the results from the phase ProDERM study, the U.S. Food and Drug Administration (FDA) has granted approval to Octapharma USA for Octagam® 10% [Immune Globulin Intravenous (Human)], the first and only intravenous immunoglobulin (IVIg) to be indicated for the treatment of adult dermatomyositis.

Octagam® 10% has also been approved for the treatment of dermatomyositis in the EU and is indicated for use in adults with active dermatomyositis treated with immunosuppressive drugs, including corticosteroids, or with intolerance or contraindications to those drugs. 

Learn more about the ProDERM trial

Watch Prof. Rohit Aggarwal, Medical Director of the Arthritis and Autoimmunity Center at the University of Pittsburgh School of Medicine and a member of the ProDERM study Steering Committee, providing insights on the study

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR OCTAGAM® IMMUNE GLOBULIN INTRAVENOUS (HUMAN) 10% LIQUID PREPARATION

WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE

Please click on full Prescribing Information for additional important safety information.

  • 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 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%. 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 product containing sucrose. Octagam 10% does not contain sucrose.

  • For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer Octagam 10% 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.

Indications and Use
Octagam 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of dermatomyositis (DM) in adults.

Octagam 10% is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) to rapidly raise platelet counts to control or prevent bleeding in adults.

Important Safety Information

Contraindications
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 IgA (average 106 μg/mL in a 10% solution). It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.

Warnings and Precautions
IgA-deficient patients with antibodies against IgA 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 Octagam 10% treatments. 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.

Adverse Reactions
Dermatomyositis: The most common adverse reactions reported in greater than 5% of subjects during a clinical trial were headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, and infusions site reactions.

The following serious adverse reactions were observed in the DM study: muscle spasms and dyspnea in one subject, loss of consciousness in one subject, and thromboembolic events (TEEs) in five subjects, including deep vein thrombosis and pulmonary embolism in one subject, cerebrovascular accident in one subject, cerebral infarction in one subject, hypoesthesia in one subject and pulmonary embolism in one subject.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR PANZYGA® IMMUNE GLOBULIN INTRAVENOUS (HUMAN) – IFAS 10% LIQUID PREPARATION

WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE

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

  • Thrombosis may occur with immune globulin intravenous (IVIg) products, including Panzyga. 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 IVIg products, including Panzyga. 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 IVIg products containing sucrose. Panzyga does not contain sucrose.

  • For patients at risk of thrombosis, renal dysfunction, or acute renal failure, administer Panzyga 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. [see Full Prescribing Information, Warnings and Precautions (5.2, 5.4)]

Indications and Usage

Panzyga (Immune Globulin Intravenous [Human] - ifas) is indicated for the treatment of primary humoral immunodeficiency (PI) in patients 2 years of age and older; this includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies; chronic immune thrombocytopenia (cITP) in adults to raise platelet counts to control or prevent bleeding; and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults to improve neuromuscular disability and impairment.

Contraindications

Panzyga 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 Precautions

Monitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at risk of developing acute renal failure.

Hyperproteinemia, increased serum osmolarity, and hyponatremia may occur in patients receiving Panzyga.

Aseptic meningitis syndrome may occur in patients receiving Panzyga, especially with high doses or rapid infusion.

Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to Panzyga treatments. Risk factors for hemolysis include high doses and non-O-blood group. Closely monitor patients for hemolysis and hemolytic anemia.

Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).

Monitor blood pressure prior to, during, and following Panzyga infusion.

Carefully consider the relative risks and benefits before prescribing the high dose regimen (for cITP) in patients at increased risk of volume overload.

Panzyga is made from human plasma and may contain infectious agents, e.g. viruses and theoretically, the Creutzfeldt-Jakob disease agent.

Adverse Reactions

PI – The most common adverse reactions (≥5% study subjects) were headache, nausea, fever, fatigue, and abdominal pain.

cITP in adults – The most common adverse reactions (≥5% study subjects) were headache, fever, nausea, vomiting, dizziness, and anemia.

CIDP in adults – The most common adverse reactions reported in greater than 5% of subjects were: headache, fever, dermatitis, and blood pressure increase.

The risk information provided here is not comprehensive; see full Prescribing Information and Boxed Warning for Panzyga.

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