What is Cuvitru 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 achieve at least a two-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypepti

What is the active ingredient in Cuvitru?

Immunoglobulinum humanum normale (Immunoglobulina ludzka normalna)

What pharmaceutical form is Cuvitru available in?

Cuvitru: Roztwór do wstrzykiwań 200 mg/ml (podskórna)

Is Cuvitru OTC or prescription only?

Cuvitru requires a doctor's prescription.

What are the side effects of Cuvitru?

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 on previous administration. Local infusion-site reactions may occur commonly: swelling, soreness, redness, indur

Who should NOT take Cuvitru?

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 not be administered intramuscularly in cases of severe thrombocytopenia or other disorders of haemostasis.

Can Cuvitru 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 given with great caution to pregnant women and breastfeeding mothers. 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. Breastfeeding Im

Who manufactures Cuvitru?

Takeda Pharma Sp. z o.o. (Belgia)

What ATC class does Cuvitru belong to?

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

Cuvitru

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

Cuvitru — 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 usually prepared from pooled human plasma from no fewer than 1,000 donors. It has a distribution of immunoglobulin G subclasses closely 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 adult patients, 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 infusions of Cutaquig. 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 dosage adjustments were required to achieve the desired serum IgG levels. 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 were originally 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 12 months for the new subjects. Subjects received Cutaquig either weekly (25 subjects) or every other week (2 subjects). The mean actual infused 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 adult patients. 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. A prospective, open-label, three-arm, multicentre phase III study was conducted to evaluate the safety, tolerability, and efficacy of Cutaquig and enrolled 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. After completing a 4-week stabilisation period, subjects entered a 24-week treatment-and-follow-up period and were assigned to one of 3 cohorts: Cohort 1 evaluated an increased volume per infusion site, with a maximum volume of 100 mL/site. Cohort 2 evaluated an increased infusion rate per site up to a maximum of 100 mL/h/site or the maximum rate achievable by the pump. Cohort 3 evaluated Cutaquig administered every other week at a dose equivalent to twice the patient's body-weight-based weekly dose (mg/kg). A secondary primary endpoint was the comparison of total trough IgG levels between weekly and every-other-week infusions, and the assessment of the safety and tolerability of increased infusion volumes and infusion rates per site, as well as every-other-week dosing. Subjects received a total of 1,338 infusions (386 in Cohort 1, 396 in Cohort 2, 556 in Cohort 3). In Cohort 1 (n = 15 adults), the mean maximum volume actually 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%) reached ≥ 90% of the permitted maximum volume of 100 mL/site, another third reached between 50% and < 90% of the permitted maximum, and one third reached < 50% of the permitted maximum. The median maximum infusion 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 infusion rate actually achieved per site was 42.1 mL/h/site, with a maximum rate of 67.5 mL/h/site. In 73.3% of subjects, the maximum rate per site was < 50% of the permitted maximum of 100 mL/h/site, and in the remaining 26.7% it was between 50% and 75% of the permitted maximum. The median maximum infusion 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 produced lower mean (SD) trough total IgG levels (9.927 [2.0146] g/L) compared with weekly dosing (10.364 [1.9632] g/L) (p = 0.0017; 1-sided 97.5% lower confidence limit [LCL] = -0.799). The median maximum infusion rate achieved per subject was 93.5 mL/h, ranging from 24.3 mL/h to 145.9 mL/h. The mean actual body-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. 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 so that a link between the patient and the batch of the product is maintained. This medicinal product contains up to 90 mg of maltose per mL as an excipient. Interference of maltose in blood glucose measurements can lead to falsely elevated glucose readings and, consequently, to inappropriate administration of insulin, resulting in life-threatening hypoglycaemia and death. True hypoglycaemia may also 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 given 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 previous 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 period. In particular, patients receiving normal human immunoglobulin for the first time, patients switched from an alternative immunoglobulin product, or those in whom there has been a long interval since the previous infusion should be monitored during the first infusion and for the first hour after the first infusion in order to detect any potential adverse signs. All other patients should be observed for at least 20 minutes after administration is complete. In the event of an adverse reaction, either the rate of administration must be reduced or the infusion must be stopped. If allergic or anaphylactic-type reactions are suspected, administration must be discontinued immediately. The treatment required depends on the nature and severity of the adverse reaction. In the 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 in whom treatment with subcutaneous IgG products remains the only option may be treated with Cutaquig only under careful medical supervision. 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 should be adequately hydrated before administration of immunoglobulins. Caution should be exercised in patients with pre-existing risk factors for thrombotic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilisation, patients with severe hypovolaemia, and patients with conditions that increase blood viscosity). Patients should be informed of the first signs of thromboembolic events, including shortness of breath, pain and swelling of a limb, focal neurological deficits, and chest pain, and should be advised to contact their doctor immediately at the onset of symptoms. Aseptic meningitis syndrome (AMS) Aseptic meningitis syndrome has been reported in association with subcutaneous immunoglobulin treatment; symptoms usually begin within several hours to two days after treatment. Discontinuation of immunoglobulin treatment may result in remission of AMS within several days without sequelae. Patients should be informed of the first signs, 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 undergoing immunoglobulin treatment, 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, 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 (Coombs) test and, rarely, can 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 intake of 2 g of sodium for an adult. Interference with serological testing After injection of immunoglobulin, a transient rise in passively transferred antibodies in the patient's blood may result in falsely positive serological test results. Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, and D, may interfere with some serological tests for red blood cell antibodies, such as 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 transmission of infectious agents cannot be totally excluded when administering medicinal products prepared from human blood or plasma. This also applies to unknown or emerging viruses and other pathogens. The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). The effectiveness of the measures taken may be limited 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 contributes substantially to the antiviral safety. Paediatric population The warnings and precautions listed apply to both adults and children.

Cuvitru

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