Firazyr · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-154336 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile In clinical studies used for registration, a total of 999 HAE attacks have been treated with 30 mg Firazyr administered subcutaneously by a healthcare professional. Firazyr 30 mg SC has been administered by a healthcare professional to 129 healthy subjects and 236 patients with HAE. Almost all subjects who were treated with subcutaneous icatibant in clinical trials developed reactions at the site of injection (characterised by skin irritation, swelling, pain, itchiness, erythema, burning 5 sensation). These reactions were generally mild to moderate in severity, transient, and resolved without further intervention. Tabulated list of adverse reactions The frequency of adverse reactions listed in Table 2 is defined using the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000). All adverse reactions from post-marketing experience are italicised. Table 2: Adverse reactions reported with icatibant System Organ Class Preferred Term (incidence category) Nervous system disorders (Common, ≥ 1/100 to < 1/10) Dizziness Headache Gastrointestinal disorders (Common, ≥ 1/100 to < 1/10) Nausea Skin and subcutaneous tissue disorders (Common, ≥ 1/100 to < 1/10) Rash Erythema Pruritus (Unknown) Urticaria General disorders and administration site conditions (Very Common, ≥ 1/10) Injection site reactions* (Common, ≥ 1/100 to < 1/10) Pyrexia Investigations (Common, ≥ 1/100 to < 1/10) Transaminases increased * Injection site bruising, Injection site hematoma, Injection site burning, I

Auszug; vollständigen Abschnitt im Original lesen.

HOS-154332 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-154331 · has-indication-information · PDF-Seite 2

Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older, with C1-esterase-inhibitor deficiency.

HOS-154334 · has-interaction-information · PDF-Seite 4

Pharmacokinetic drug interactions involving CYP450 are not expected (see section 5.2). 4 Co-administration of Firazyr with angiotensin-converting-enzyme (ACE) inhibitors has not been studied. ACE inhibitors are contraindicated in HAE patients due to possible enhancement of bradykinin levels. Paediatric population Interaction studies have only been performed in adults.

HOS-154335 · has-pregnancy-information · PDF-Seite 5

Pregnancy There is no or limited data from the use of icatibant in pregnant women. Animal studies showed effects on uterine implantation and parturition (see section 5.3), but the potential risk for humans is unknown. Firazyr should be used during pregnancy only if the potential benefit justifies the potential risk for the foetus (e.g for treatment of potentially life threatening laryngeal attacks). Breast-feeding Icatibant is excreted in the milk of lactating rats at concentrations similar to those in maternal blood. No effects were detected in the post-natal development of rat pups. It is unknown whether icatibant is excreted in human breast milk but it is recommended that breastfeeding women, who wish to take Firazyr, should not breastfeed for 12 hours after treatment. Fertility In both rats and dogs, repeated use of icatibant resulted in effects on reproductive organs. Icatibant had no effect on the fertility of male mice and rats (see section 5.3). In a study of 39 healthy adult men and women treated with 30 mg every 6 hours for 3 doses every 3 days for a total of 9 doses, there were no clinically significant changes from baseline in basal and GnRH-stimulated concentration of reproductive hormones in either females or males. There were no significant effects of icatibant on the concentration of luteal phase progesterone and luteal function, or on menstrual cycle length in females and there were no significant effects of icatibant on sperm count, motility and morphology in males. The dosing regimen used for this study is unlikely to be sustained in the clinical setting.

HOS-154333 · has-warning-information · PDF-Seite 4

Laryngeal attacks Patients with laryngeal attacks should be managed in an appropriate medical institution after injection until the physician considers discharge to be safe. Ischemic heart disease Under ischemic conditions, a deterioration of cardiac function and a decrease in coronary blood flow could theoretically arise from antagonism of bradykinin receptor type 2. Caution should therefore be observed in the administration of Firazyr to patients with acute ischemic heart disease or unstable angina pectoris (see section 5.3). Stroke Although there is evidence to support a beneficial effect of B2 receptor blockade immediately following a stroke, there is a theoretical possibility that icatibant may attenuate the positive late phase neuroprotective effects of bradykinin. Accordingly, caution should be observed in the administration of icatibant to patients in the weeks following a stroke. Caregiver/self-administration For patients who have never received Firazyr previously, the first treatment should be given in a medical institution or under the guidance of a physician. In case of insufficient relief or recurrence of symptoms after self-treatment or administration by a caregiver, it is recommended that the patient or caregiver should seek medical advice. For adults, subsequent doses that may be required for the same attack should be administered within a medical institution (see section 4.2). There are no data on administering subsequent doses for the same attack in adolescents or children. Patients experiencing a laryngeal attack should always seek medical advice and be observed in a medical institution also after having taken the injection at home. Sodium content This medicinal product contains less than 1 mmol (23 milligrams) of sodium per syringe, so it is essentially ‘sodium-free.’ Paediatric population There is limited experience with treatment of more than one HAE attack with Firazyr in the paediatric population.