Octanorm [cutaquig®], a new immunoglobulin (human) subcutaneous 16.5% solution for injection (165 mg/mL) – Biochemical characterization, pathogen safety, and stability

Gelbmann, Nicola; Zöchling, Alfred; Pichotta, Alexander; Schmidt, Torben Dall; Murányi, Andrej; Ernegger, Thomas; Pock, Katharina; Römisch, Jürgen

doi:10.1016/j.biologicals.2019.05.002

Cited by 9 publications

(6 citation statements)

References 24 publications

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“…SCIg are commercially available as 20% and 16.5% products. The latter have a lower viscosity and can be injected with less injection force allowing a more comfortable infusion experience which might be particularly relevant for elderly patients or those suffering from hand dexterity symptoms [22]. Due to its low viscosity, Gammanorm®, a wellestablished 16.5% SCIg with proven tolerability and efficacy, enables self-administration not only by pumps, but also by using standard equipment (i.e.…”

Section: Discussionmentioning

confidence: 99%

Subcutaneous Gammanorm® by pump or rapid push infusion: Impact of the device on quality of life in adult patients with primary immunodeficiencies

Warnatz

Jolles

Agostini

et al. 2022

Clinical Immunology

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Section: Discussionmentioning

confidence: 99%

Subcutaneous Gammanorm® by pump or rapid push infusion: Impact of the device on quality of life in adult patients with primary immunodeficiencies

Warnatz

Jolles

Agostini

et al. 2022

Clinical Immunology

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“…Depending on the needs of the patient, cSCIG may be administered as frequently as every day or weekly [ 41 ], to biweekly [ 58 ]; cSCIG products include 10% [ 50 , 59 ], 16.5% [ 60 ], and 20% [ 39 , 61 ] IgG formulations (Table 3 ). Monthly SCIG dosing is possible with fSCIG as it allows higher infusion and absorption volume with the addition of hyaluronidase [ 62 ].…”

Section: Initiating Scig/fscig Treatment For Patients With Piddmentioning

confidence: 99%

A clinician’s guide for administration of high-concentration and facilitated subcutaneous immunoglobulin replacement therapy in patients with primary immunodeficiency diseases

Epland

Suez

2022

Allergy Asthma Clin Immunol

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Immunoglobulin replacement therapy is the standard-of-care treatment for patients with primary immunodeficiency diseases who have impaired antibody production and function. Clinicians and patients may consider intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin (SCIG) options, and each route may offer different benefits for the individual. IVIG requires fewer infusion sites and less frequent infusions than some formulations of SCIG. However, SCIG does not require venous access, is associated with fewer systemic adverse infusion reactions than IVIG, and can independently be self-administered at home. Importantly, tailoring treatment experiences to the needs of the individual may improve treatment adherence and quality of life for patients with primary immunodeficiency diseases who often rely on long-term or lifelong treatment. This review aims to educate United States (US) healthcare providers on the administration process of SCIG, with a focus on more concentrated formulations of SCIG and facilitated SCIG. It provides practical guidance on initiating, optimizing, and monitoring SCIG therapy. The advantages and disadvantages of the different treatment options are also presented for discussion between the patient and clinician.

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“…Octanorm (marketed as cutaquig R in the USA, Canada and Europe; Octapharma AG, Switzerland) is a 16.5% human Ig solution for subcutaneous administration [8,9]. The manufacturing process for octanorm is based on the well-established process of Octapharma's IVIG product octagam R and makes use of the same virus elimination procedures [10]. In a prospective, open-label, single-arm, Phase III study that included 61 pediatric and adult patients with PID, octanorm effectively prevented infections, with no serious bacterial infections (SBIs) reported, and was well tolerated [11].…”

Section: Figure 1 Study Designmentioning

confidence: 99%

Efficacy and Safety of Octanorm (cutaquig ^® ) in Adults with Primary Immunodeficiencies with Predominant Antibody Deficiency: A Prospective, Open-Label Study

Latysheva¹,

Rodina

Sizyakina

et al. 2020

Immunotherapy

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Aim: To evaluate efficacy and safety of octanorm (16.5% subcutaneous immunoglobulin) in adult patients with primary immunodeficiencies. Patients & methods: Primary immunodeficiencies patients (18–70 years) previously treated with intravenous immunoglobulin were included in this Phase III study. Octanorm was administered subcutaneously once weekly over 8 months. End points included infections, adverse events and quality of life. Results: 25 patients (mean age 35.2 years, female 60.0%) were recruited, 24 completed the study. Mean dose of octanorm was 0.11 g/kg/week. No serious bacterial infections occurred. Three patients (12.0%) had an adverse event (mild) assessed as related to octanorm. Both the mental and physical summary 36-item Short Form Health Survey scores were improved. Conclusion: Octanorm is effective, safe and improves quality of life. Clinical Trial registration number: NCT03988426.

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Octanorm [cutaquig®], a new immunoglobulin (human) subcutaneous 16.5% solution for injection (165 mg/mL) – Biochemical characterization, pathogen safety, and stability

Cited by 9 publications

References 24 publications

Subcutaneous Gammanorm® by pump or rapid push infusion: Impact of the device on quality of life in adult patients with primary immunodeficiencies

Subcutaneous Gammanorm® by pump or rapid push infusion: Impact of the device on quality of life in adult patients with primary immunodeficiencies

A clinician’s guide for administration of high-concentration and facilitated subcutaneous immunoglobulin replacement therapy in patients with primary immunodeficiency diseases

Efficacy and Safety of Octanorm (cutaquig ^® ) in Adults with Primary Immunodeficiencies with Predominant Antibody Deficiency: A Prospective, Open-Label Study

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Octanorm [cutaquig®], a new immunoglobulin (human) subcutaneous 16.5% solution for injection (165 mg/mL) – Biochemical characterization, pathogen safety, and stability

Cited by 9 publications

References 24 publications

Subcutaneous Gammanorm® by pump or rapid push infusion: Impact of the device on quality of life in adult patients with primary immunodeficiencies

Subcutaneous Gammanorm® by pump or rapid push infusion: Impact of the device on quality of life in adult patients with primary immunodeficiencies

A clinician’s guide for administration of high-concentration and facilitated subcutaneous immunoglobulin replacement therapy in patients with primary immunodeficiency diseases

Efficacy and Safety of Octanorm (cutaquig ® ) in Adults with Primary Immunodeficiencies with Predominant Antibody Deficiency: A Prospective, Open-Label Study

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Product

Resources

About

Octanorm [cutaquig®], a new immunoglobulin (human) subcutaneous 16.5% solution for injection (165 mg/mL) – Biochemical characterization, pathogen safety, and stability

Efficacy and Safety of Octanorm (cutaquig ^® ) in Adults with Primary Immunodeficiencies with Predominant Antibody Deficiency: A Prospective, Open-Label Study