Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most commonly reported adverse reactions were injection site reactions, which occurred in almost all patients (97%) in clinical trials.
Other common adverse reactions occurring in greater than 1% of patients included pyrexia, transaminase increase, dizziness, and rash.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at 1-800-836-4380 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience The safety of icatibant was evaluated in three controlled trials that included 223 patients who received icatibant injection 30 mg (n=113), placebo (n=75), or comparator (n=38).
The mean age at study entry was 38 years (range 18 to 83 years), 64% were female, and 95% were white.
The data described below represent adverse reactions observed from the two placebo-controlled trials, consisting of 77 patients who received icatibant injection at a dose of 30 mg SC, and 75 who received placebo.
The most frequently reported adverse reactions (occurring in greater than 1% of patients and at a higher rate with icatibant injection versus placebo) are shown in Table
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Table 1 Adverse reactions observed in >1% of patients with acute attacks of HAE and at a higher rate with Icatibant injection versus placebo in the placebo-controlled trials a a Events occurring within 14 days of study drug administration b Injection site bruising, Injection site hematoma, Injection site burning, Injection site erythema, Injection site hypoesthesia, Injection site irritation, Injection site numbness, Injection site edema, Injection site pain, Injection site pressure sensation, Injection site pruritus, Injection site swelling, Injection site urticaria, and Injection site warmth I catibant injection (N =77) Placebo (N = 75) System Organ Class Preferred Term Subjects (%) Subjects (%) General disorders and administration site conditions Injection site reaction b 75 (97) 25 (33) Pyrexia 3 (4) 0 Investigations Transaminase increased 3 (4) 0 Nervous system disorders Dizziness 2 (3) 1 (1) The third trial was active-controlled and was comprised of 35 patients who received icatibant injection 30 mg and 38 patients who received the comparator.
Adverse reactions for icatibant injection were similar in nature and frequency to those reported in Table
In all three controlled trials, patients were eligible for treatment of subsequent attacks in an open-label extension.
5 WARNINGS AND PRECAUTIONS Laryngeal attacks: Following treatment of laryngeal attacks with SAJAZIR, advise patients to seek immediate medical attention.
( 5.1 ) 5.1 Laryngeal Attacks Given the potential for airway obstruction during acute laryngeal HAE attacks, patients should be advised to seek medical attention in an appropriate healthcare facility immediately in addition to treatment with SAJAZIR.
Like all medications, Sajazir can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: