About cutaquig®
Indication and clinical use
Cutaquig® is indicated for the treatment of patients with primary immune deficiency (PID) and secondary immune deficiency (SID) who require immune globulin replacement therapy.
Contraindications
Cutaquig® is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the
formulation or component of the container. Cutaquig® is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human IgG or to components of cutaquig® such as maltose or polysorbate 80.
Most serious warnings and precautions
Anaphylactic Reaction: Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin. Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment should be administered.
Thromboembolic Events: There is clinical evidence of an association between the administration of immunoglobulins and thromboembolic events such as myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis. Therefore, caution should be exercised when prescribing and administering immunoglobulins. Risk factors for thromboembolic events include: advanced age, use of estrogens, in-dwelling central vascular catheters, history of vascular disease or thrombotic episodes, acquired or inherited hypercoagulable states, prolonged periods of immobilization, severe hypovolemia, diseases which increase blood viscosity and cardiovascular risk factors (including obesity, hypertension, diabetes mellitus, history ofatherosclerosis and/or impaired cardiac output).
Thrombosis: Thrombosis may occur even in the absence of known risk factors. The physician should discuss the risks and benefits of this product the patient, before prescribing or administering to the patient.
Other relevant warnings and precautions
Products made from human plasma may contain infectious agents, such as viruses and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, 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.
Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin. In case of hypersensitivity, discontinue the cutaquig® infusion immediately and institute appropriate treatment.
Pregnant women
The safety of cutaquig® for use in human pregnancy has not been established in controlled clinical trials. Cutaquig® should be given to pregnant women only if clearly needed.
Nursing women
cutaquig® has not been evaluated in nursing mothers. After administration of IVIG products, IgGs are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate.
Pediatrics
(< 18 years of age): In the Pivotal Phase III study there were no apparent differences in the safety and efficacy profiles of pediatric subjects as compared with adult subjects being treated with cutaquig®. No pediatric- specific dose requirements were necessary to achieve the desired serum IgG levels. Cutaquig® was not studied in neonates or infants.
Geriatrics
(> 65 years of age): In the Pivotal Phase III study, 3 patients over 65 years of age were evaluated. The pivotal clinical study did not include sufficient number of subjects over the age of 65 years to determine whether they respond differently from younger patients. No overall differences in safety profile or efficacy are to be expected between these subjects and younger subjects.
Adversed drug reactions overview
No related serious adverse drug reactions were observed in subjects treated with cutaquig® during the clinical studies evaluating its safety profile. The most common related adverse drug reactions reported in patients treated with cutaquig® were local reactions at the site of injection (71.2%) and pyrexia (3.4%).
Adverse events should be reported to adr.canada@octapharma.com
