What Makes cutaquig® Different?

Intended for US audiences only.

Subcutaneous Immunoglobulin Therapy (SCIg)

For over 60 years, immunoglobulin replacement therapy has been the standard of care in primary immunodeficiency (PI) diseases. With the introduction of subcutaneous immunoglobulin (SCIg) products — infused under the skin rather than into a vein — treatment options have expanded for patients who require immunoglobulin (Ig) therapy.¹ Intravenous immunoglobulins (IVIg) are typically infused every 3 – 4 weeks in a clinical setting and administration must be conducted by qualified healthcare providers. In comparison, the infusion of immunoglobulins by SCIg provides more flexibility for the patient. SCIg medication can be self-administered (after training) by the patient or administered by a caregiver more quickly and more frequently — often weekly — and at a schedule and location convenient for the patient, providing more autonomy and accommodation of individual preference.¹ In addition, SCIg administration is often associated with fewer systemic adverse reactions than IVIg and can provide a more constant level of protective antibodies due to its more frequent infusion schedule.^1,2 All this has made SCIg a popular choice for PI patients worldwide.¹

Each SCIg Medication Differs from Others

Today, there are several SCIg products available and depending on the concentration of antibodies they contain, they can be classified as either 10% (low concentration), 16.5% (medium concentration), or 20% (high concentration) formulations.³ These differences in concentration affect how each product can be infused and how well they may be tolerated by individual patients.

For example, low-concentration SCIg products will require more frequent infusions and more injection sites when an infusion is given. High-concentration products offer the possibility of less frequent infusions and fewer injection sites with each infusion.⁴ However, because they are more concentrated, high-concentration products may be more viscous (thicker) and this increased viscosity often makes infusion more difficult and uncomfortable for the patient. Generally speaking, safety and tolerability profiles may differ by individual SCIg product and also by patient.^2,7 These factors are often weighed by prescribers when making treatment choices.

Additional factors that are usually taken into consideration when choosing an Ig product for a PI patient are the specifics of its formulation, including what other composition factors are included. Immunoglobulin G (abbreviated IgG) is the primary and active ingredient of SCIg. However, the content levels of other composition factors, such as the sodium content, pH, and stabilizers, also vary widely by SCIg medication. Stabilizers are included in IgRT formulations to prevent the IgG from clumping together to form aggregates–which could contribute to the risk of serious adverse reactions.⁵ Stabilizers used for SCIg products today include glycine, maltose, and L-proline.⁵ These differences in serum composition may also contribute to how a patient might react to or tolerate a particular product.⁵

The Unique Attributes of cutaquig

As a medium-concentration product with a 16.5% formulation, cutaquig may offer advantages over both high- and low-concentration products⁶
When compared to low-concentration products (10%), with cutaquig there is less volume needed, meaning less frequent infusions and/or fewer injection sites required⁴
When compared to high-concentration products (20%), cutaquig has a lower viscosity, which may result in a more comfortable infusion experience.^2,4

What Makes cutaquig Different?

Cutaquig is a 16.5% immunoglobulin solution for subcutaneous infusion indicated for the treatment of PI in adult patients.

The most significant difference between cutaquig and other SCIg products is its 16.5% concentration. Cutaquig is the only product with this 16.5% concentration, falling between the 10% and 20% solutions of all other SCIg products currently available. As previously mentioned, lower concentration solutions (10%) require higher volumes, and thus more frequent infusions and/or needle sticks.⁴ The opposite is the case for higher concentration solutions (20%), but some patients may experience difficulties infusing a more viscous solution. Higher concentrations also affect the thickness (or viscosity) of a solution. Cutaquig’s lower viscosity may improve the ease of preparing and administering the solution because it requires less force and is easier to handle. Preparation and self-administration of an SCIg product that is less viscous may be of particular benefit for elderly patients as well as patients suffering from hand dexterity problems.^2,8

In cases where patients experience issues at either end of the concentration scale, the mid-range concentration level of 16.5% offers another option.⁷ The availability of such a medium-concentration 16.5% solution means that appropriate doses can be administered in smaller volumes, requiring fewer injections sites per infusion and/or less frequent infusions, while still being easily administered and well tolerated by most patients.^4,8

Comparison of SCIg Product Concentrations³

Product	Ig Concentration
IVIg or SCIg Products
Gammagard Liquid	10%
Gammaked	10%
Gamunex-C	10%
SCIg Products
Cutaquig	16.5%
Cuvitru	20%
Hizentra	20%
HyQvia	10%

Table includes SCIg products currently available in the U.S. Comparisons of efficacy or safety cannot be made based on this data. Presentation of concentration data is not intended to imply equivalence, superiority, or inferiority of any products.

Talk to Your Healthcare Provider

It should now be very clear that prescribing an immunoglobulin product requires an in-depth analysis of the specific formulation in question, in combination with the individual patient situation. That’s why it is so important to consult with your healthcare provider.

With its medium-concentration of 16.5%, dosing and administration profile, and demonstrated tolerability profile, many PI patients today are finding that cutaquig is a good choice for their needs.^6,8 Talk to your healthcare provider to see if cutaquig is right for you.

Please see Indications and Important Safety Information below.

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The page contains general medical information that cannot safely be applied to any individual case. Medical knowledge and practice can change rapidly. Therefore, this page should not be used as a substitute for professional medical advice.

References:

1. Kobrynski L. Subcutaneous immunoglobulin therapy: a new option for patients with primary immunodeficiency diseases. Biologics. 2012;6:277-287.

2. Gelbmann, N, Zöchling, A, Pichotta, A, et al. Octanorm [cutaquig®], a new immunoglobulin (human) subcutaneous 16.5% solution for injection (165 mg/mL) – Biochemical characterization, pathogen safety, and stability. Biologicals. 2019;(60):60-67.

3. U.S. Food and Drug Administration. Approved Blood Products – Immune Globulins. FDA.gov. https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/immune-globulins. Accessed November 19, 2020.

4. Jolles S, Orange JS, Gardulf A, et al. Current treatment options with immunoglobulin G for the individualization of care in patients with primary immunodeficiency disease. Clin Experiment Immunol. 2015;179:146–160.

5. Skoda-Smith, Torgerson, Ochs. Subcutaneous immunoglobulin replacement therapy in the treatment of patients with primary immunodeficiency disease. Ther Clin Risk Manag. 2010;6:1-10.

6. Cutaquig Full Prescribing Information. Paramus, NJ: Octapharma; rev October 2021.

7. Ness S. Differentiating characteristics and evaluating intravenous and subcutaneous immunoglobulin. Am J Care. 2019;25:S98-S104.

8. Kobayashi RH, Gupta S, Melamed I, et al. Clinical efficacy, safety, and tolerability of a new subcutaneous immunoglobulin 16.5% (octanorm [cutaquig®]) in the treatment of patients with primary immunodeficiencies. Front. Immunol. 2019;10(40):1-12.

Indications and Important Safety Information for cutaquig^® (Immune Globulin Subcutaneous [Human]– hipp, 16.5% solution)

WARNING: THROMBOSIS

See the cutaquig full prescribing information for complete boxed warning

Thrombosis may occur with immune globulin products, including cutaquig.

Indications and Important Safety Information for cutaquig^® (Immune Globulin Subcutaneous [Human]– hipp, 16.5% solution)

WARNING: THROMBOSIS

See the cutaquig full prescribing information for complete boxed warning

Thrombosis may occur with immune globulin products, including cutaquig.

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 cutaquig 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 of hyperviscosity.

Indications and Usage

Cutaquig^® (Immune Globulin Subcutaneous (Human)-hipp) is a 16.5% immune globulin solution for subcutaneous infusion (IGSC), indicated as replacement therapy for primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

IMPORTANT SAFETY INFORMATION

Contraindications

Cutaquig is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the subcutaneous administration of human immune globulin or to any of the components of cutaquig such as Polysorbate 80, and in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity.

Warnings and Precautions

Severe hypersensitivity reactions may occur with cutaquig, even in patients who tolerated previous treatment with human immune globulin. If a hypersensitivity reaction occurs, discontinue the cutaquig infusion immediately and initiate appropriate treatment. IgA-deficient patients with anti-IgA antibodies are at greater risk of severe reactions.

Thrombosis may occur following treatment with immune globulin products, including cutaquig. For patients at risk of thrombosis, administer cutaquig 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.

Falsely elevated blood glucose readings may occur during and after the infusion of cutaquig with some glucometer and test strip systems. When administering cutaquig, measure blood glucose with a glucose-specific method.

Aseptic meningitis syndrome (AMS) can occur with cutaquig. AMS has been reported after the use of human immune globulin administered intravenously and subcutaneously and may occur within 2 days following treatment. Discontinuation of immunoglobulin treatment has resulted in remission within several days without sequelae.

Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis and death may occur with use of human immune globulin, especially those containing sucrose. cutaquig does not contain sucrose. Monitor patients for signs and symptoms of renal dysfunction. Monitor blood urea nitrogen, serum creatinine, and urine output in patients at risk of acute renal failure.

Monitor cutaquig recipients for clinical signs and symptoms of hemolysis, particularly patients with pre-existing anemia and/or cardiovascular or pulmonary compromise. Consider appropriate confirmatory laboratory testing if signs and symptoms of hemolysis are present after cutaquig infusion.

Non-cardiogenic pulmonary edema may occur in patients administered human immune globulin products. Monitor for pulmonary adverse reactions (transfusion-related acute lung injury, TRALI). If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies in both the product and patient’s serum. Patients with TRALI may be managed using oxygen therapy with adequate ventilatory support.

Cutaquig 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 disease (CJD) agent.

Drug Interactions

After infusion of cutaquig, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield false positive serological test results, with the potential for misleading interpretation.

Adverse Reactions

The most common adverse reactions (≥ 5% of study subjects) were local infusion site reactions (such as redness, swelling, itching), headache, fever, dermatitis, asthma, diarrhea, and cough.

Please see the cutaquig full prescribing information

CUTA-0360