What is Cutaquig used for?

Replacement therapy in adults, children, and adolescents (0–18 years) in: primary immunodeficiency syndromes (PID) with impaired antibody production (see section 4.4). secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment, and either proven specific antibody failure (PSAF)* or a serum IgG level < 4 g/L. *PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide a

What is the active ingredient in Cutaquig?

Immunoglobulinum humanum normale (Immunoglobulinum humanum normale)

What pharmaceutical form is Cutaquig available in?

Cutaquig: Roztwór do wstrzykiwań 165 mg/ml (podskórna)

Is Cutaquig OTC or prescription only?

Cutaquig requires a doctor's prescription.

What are the side effects of Cutaquig?

Summary of the safety profile Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure, and moderate low back pain may occur occasionally. Rarely, normal human immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration. Local reactions at the infusion sites may occur frequently: swelling, soreness, redn

Who should NOT take Cutaquig?

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4). Cutaquig must not be administered intravascularly. It must also not be administered intramuscularly in cases of severe thrombocytopenia or other disorders of haemostasis.

Can Cutaquig be used during pregnancy?

Pregnancy The safety of this medicinal product during pregnancy has not been established in controlled clinical trials, and it should therefore be administered to pregnant women and breastfeeding mothers only with caution. Immunoglobulin products have been shown to cross the placenta, increasingly during the third trimester. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy or on the health of the foetus or newborn are to be expected. Breastfeed

What ATC class does Cutaquig belong to?

Cutaquig: ATC J06BA01. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Cutaquig

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Cutaquig — Description, Dosage, Side Effects | PillsCard

Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for extravascular administration, ATC code: J06BA01. Normal human immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. Normal human immunoglobulin contains the IgG antibodies present in the general population. It is generally prepared from pooled human plasma from no fewer than 1,000 donors. It has a distribution of immunoglobulin G subclasses proportional to that found in native human plasma. Adequate doses of this medicinal product can restore abnormally low immunoglobulin G levels to the normal range. In a clinical study, a total of 75 subjects (37 adults, 12 young children [≥ 2 and < 6], 14 older children [≥ 6 and < 12], 12 adolescents [≥ 12 and < 17]) with primary immunodeficiency syndromes were treated with Cutaquig for up to 64 weeks. The mean weekly dose administered per patient was 0.187 g/kg in adults, 0.150 g/kg in young children, 0.164 g/kg in older children, and 0.170 g/kg in adolescents. Subjects received a total of 4,462 weekly Cutaquig infusions. No serious bacterial infections were reported in subjects receiving Cutaquig in the clinical study, either during the wash-in/wash-out period or during the efficacy period. Cutaquig was evaluated in 38 paediatric subjects (26 children [aged between 2 and < 12 years] and 12 adolescents [aged between 12 and < 16 years]) with primary immunodeficiency. No paediatric-specific dose adjustments were required to achieve the desired serum IgG level. The extension study was a prospective, open-label, single-arm, multicentre phase III safety study that enrolled 27 subjects (17 adults, 2 young children [≥ 2 and < 6], 4 older children [≥ 6 and < 12], 4 adolescents [≥ 12 and < 17]) with primary immunodeficiency. Twenty-one subjects had previously been treated in the pivotal study and 6 subjects were newly enrolled. Subjects were followed for up to 4.5 years for those previously enrolled in the pivotal study and for 12 months for new subjects. Subjects received Cutaquig on a weekly schedule (25 subjects) or on an "every other week" schedule (2 subjects). The mean actual infusion dose of Cutaquig per patient was 0.127 g/kg in young children, 0.210 g/kg in older children, 0.160 g/kg in adolescents, and 0.166 g/kg in adults. Subjects received a total of 2,777 infusions (2,740 weekly and 37 every other week). One SBI (serious bacterial infection) of the bacteraemia/sepsis type was reported. To monitor the safety, tolerability, and efficacy of Cutaquig, 64 subjects with PID (59 adults, 1 young child [≥ 2 and < 6], 2 older children [≥ 6 and < 12], 2 adolescents [≥ 12 and < 17]) aged 5 to 74 years were enrolled in a prospective, open-label, three-arm, multicentre phase III study. After completing a 4-week stabilisation period, subjects entered a treatment period with follow-up for 24 weeks and were assigned to one of 3 cohorts: Cohort 1 evaluated an increased volume per infusion site, up to a maximum of 100 mL/site. Cohort 2 evaluated an increased infusion flow rate per infusion site, up to a maximum of 100 mL/h/site or the maximum flow rate achievable by the pump. Cohort 3 evaluated Cutaquig on an every-other-week schedule at a dose corresponding to twice the body-weight-dependent weekly dose (mg/kg). The secondary primary endpoint was a comparison of total trough IgG levels between weekly and every-other-week infusions, and an assessment of the safety and tolerability of increased infusion volumes and increased infusion rates at each infusion site and of every-other-week dosing. A total of 1,338 infusions were administered to subjects (386 in cohort 1, 396 in cohort 2, 556 in cohort 3). In cohort 1 (n = 15 adults), the mean maximum volume achieved per infusion site was 69.4 mL/site, with a maximum volume of 108 mL/site. One third of subjects (5/15; 33.3%) achieved ≥ 90% of the permitted maximum volume of 100 mL/site, another third achieved between 50% and < 90% of the permitted maximum, and one third achieved < 50% of the permitted maximum. The median maximum flow rate achieved per subject was 56.9 mL/h, ranging from 34.0 mL/h to 94.7 mL/h. In cohort 2 (n = 15; 13 adults, 1 older child [≥ 6 and < 12], 1 adolescent [≥ 12 and < 17]), the mean maximum flow rate achieved per infusion site was 42.1 mL/h/site, with a maximum flow rate of 67.5 mL/h/site. In 73.3%, the maximum flow rate per infusion site reached < 50% of the permitted maximum of 100 mL/h/site, and in the remaining 26.7% it reached 50% to 75% of the permitted maximum. The median maximum flow rate achieved per subject was 135.0 mL/h, ranging from 51.4 mL/h to 192.0 mL/h. In cohort 3 (n = 34; 31 adults, 1 young child [≥ 2 and < 6], 1 older child [≥ 6 and < 12], 1 adolescent [≥ 12 and < 17]), every-other-week dosing was associated with a reduction in mean (SD) total IgG trough levels (9.927 [2.0146] g/L) compared with once-weekly dosing (10.364 [1.9632] g/L) (p = 0.0017; 1-sided 97.5% lower confidence limit [LCL] = -0.799). The median maximum flow rate achieved per subject was 93.5 mL/h, ranging from 24.3 mL/h to 145.9 mL/h. The mean actual weight-based dose of Cutaquig administered was 0.143 g/kg in cohort 1, 0.157 g/kg in cohort 2, and 0.256 g/kg in cohort 3, respectively. No SBIs were reported during the study, and the overall SBI rate was 0.00 per person-year (98% CI upper bound [alternative method] = 0.135 [0.614 in cohort 1, 0.602 in cohort 2, and 0.244 in cohort 3]). Paediatric population No differences in pharmacodynamic properties were observed between adult and paediatric patients.

⚠️ Warnings

Each time Cutaquig is administered to a patient, it is strongly recommended that the name and batch number of the product be recorded in order to maintain a link between the patient and the product batch. This medicinal product contains up to 90 mg of maltose per mL as an excipient. Interference of maltose with blood glucose measurement may result in falsely elevated glucose readings and, as a consequence, in inappropriate administration of insulin, leading to life-threatening hypoglycaemia and death. Likewise, true hypoglycaemia may go untreated if the hypoglycaemic state is masked by a falsely elevated glucose reading (see section 4.5). For information on acute renal failure, see below. Cutaquig is intended for subcutaneous administration only. If Cutaquig is inadvertently administered into a blood vessel, patients may develop shock. The recommended infusion rate stated in section 4.2 must be carefully observed. Patients must be closely monitored throughout the infusion period and any symptoms carefully observed. Certain adverse reactions may occur more frequently in patients receiving normal human immunoglobulin for the first time or, in rare cases, when switching from one normal human immunoglobulin product to another, or when there has been a long interval since the last infusion. Potential complications can often be avoided by: initially injecting the product slowly (see section 4.2). ensuring that patients are carefully monitored for any symptoms throughout the infusion. During the first infusion and for the first hour after the first infusion, any adverse signs should be monitored particularly closely in patients receiving normal human immunoglobulin for the first time, in patients who have switched from an alternative immunoglobulin product, or when there has been a long interval since the previous infusion. All other patients should be observed for at least 20 minutes after the end of the infusion. In the event of an adverse reaction, either the rate of administration must be reduced or the infusion must be stopped. If an allergic or anaphylactic-type reaction is suspected, administration must be discontinued immediately. The treatment required depends on the nature and severity of the adverse reaction. In case of shock, standard medical management for shock should be implemented. Hypersensitivity True allergic reactions are rare. They may occur particularly in patients with anti-IgA antibodies, who must be treated with special caution. Patients with anti-IgA antibodies for whom treatment with subcutaneous IgG products remains the only option may be treated with Cutaquig only under close medical supervision. Rarely, normal human immunoglobulin may induce a fall in blood pressure with anaphylactic reaction, even in patients who have tolerated previous treatment with normal human immunoglobulin. Thromboembolism Arterial and venous thromboembolic events, including myocardial infarction, stroke, deep vein thrombosis, and pulmonary embolism, have been associated with the use of immunoglobulins. Patients must be adequately hydrated before immunoglobulin administration. Caution should be exercised in patients with pre-existing risk factors for thrombotic events (e.g., advanced age, hypertension, diabetes mellitus and vascular disease or a history of thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged immobilisation, patients with severe hypovolaemia, and patients with diseases that increase blood viscosity). Patients should be informed of the early signs of thromboembolic events, which include shortness of breath, pain and swelling of a limb, focal neurological deficits, and chest pain, and should be advised to contact their physician immediately at the onset of symptoms. Aseptic meningitis syndrome (AMS) Aseptic meningitis syndrome has been reported in association with subcutaneous immunoglobulin therapy; symptoms typically begin within several hours to two days after treatment. Discontinuation of immunoglobulin therapy may lead to remission of AMS within several days without sequelae. Patients should be informed of the early symptoms, which include severe headache, neck stiffness, drowsiness, fever, photophobia, nausea, and vomiting. Renal impairment/renal failure Serious renal adverse reactions have been reported in patients receiving immunoglobulin therapy, particularly with products containing sucrose (Cutaquig does not contain sucrose). These include acute renal failure, acute tubular necrosis, proximal tubular nephropathy, and osmotic nephrosis. Factors that increase the risk of renal complications include, but are not limited to, pre-existing renal insufficiency, diabetes mellitus, hypovolaemia, concomitant nephrotoxic medicinal products, age over 65 years, sepsis, hyperviscosity, and paraproteinaemia. Haemolysis IgG products may contain blood group antibodies that can act as haemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, which can be detected as a positive direct antiglobulin test (Coombs test) and rarely cause haemolysis. Recipients of immunoglobulin products should be monitored for clinical signs and symptoms of haemolysis. Sodium content This medicinal product contains 33.1 mg of sodium per 48 mL vial and 13.8 mg of sodium per 20 mL vial, equivalent to 1.7% and 0.7%, respectively, of the WHO recommended maximum daily dietary sodium intake of 2 g for an adult. Interference with serological testing After injection of immunoglobulin, the transient rise in various passively transferred antibodies in the patient's blood may cause false-positive results in serological testing. Passive transmission of antibodies to erythrocyte antigens, such as A, B, and D, may interfere with some serological tests for red cell antibodies, for example the direct antiglobulin test (DAT, direct Coombs test). Transmissible agents Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection, and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, the possibility of transmitting infectious agents cannot be totally excluded when medicinal products prepared from human blood or plasma are administered. This also applies to unknown or emerging viruses and other pathogens. The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). The measures taken may be of limited value against non-enveloped viruses such as hepatitis A virus (HAV) and parvovirus B19. There is reassuring clinical experience that no transmission of hepatitis A or parvovirus B19 occurs with immunoglobulins, and it is also assumed that the antibody content makes an important contribution to antiviral safety. Paediatric population The warnings and precautions listed apply to both adults and children.

Cutaquig

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