SAJAZIR (icatibant acetate)

There are 0 contraindications.

There are 0 severe contraindications.

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
No disease contraindications

There are 6 severe adverse reactions.

More Frequent	Less Frequent
None.	Abnormal hepatic function tests Hypersensitivity drug reaction

Rare/Very Rare
Cardiac arrhythmia Increased alanine transaminase Increased aspartate transaminase Laryngeal edema

There are 18 less severe adverse reactions.

More Frequent	Less Frequent
Injection site erythema Injection site sequelae	Abdominal distension Diarrhea Dizziness Fatigue Fever Headache disorder Nasal congestion Nausea Pharyngitis Pruritus of skin Sinusitis Skin rash Urinary tract infection Xerostomia

Rare/Very Rare
Non-cardiac chest pain Urticaria

Available data on icatibant use during pregnancy have not established an association between the drug and major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneous administration of icatibant during the period of organogenesis did not cause structural abnormalities in rats or rabbits. Premature birth and abortion were observed in rabbits at doses approximately 0.025

times the maximum recommended human dose (MRHD) and higher, and decreased embryofetal survival was observed in rabbits at a subcutaneous dose that was 13 times the MRHD. In a pre andpost-natal development study in rats, delayed parturition was observed at subcutaneous doses 0.5 times the MRHD and higher, whichresulted in deaths of dams at doses 2 times the MRHD and higher. Fetal death and early pup deaths were observed with doses 2 times theMRHD.

There are no data on the presence of icatibant in human milk, the effects on the breastfed infant, or the effects on milk production. Icatibant and its M2 metabolite are distributed into milk in rats; when a drug is present in animal milk, it is likely to also be present in human milk. However, systemic absorption of icatibant in infants is not expected after oralexposure through breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for icatibant and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Clinical studies of icatibant did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients. Other clinical experience has not revealed age-related differences in response and safety. Systemic exposure (area under the concentration-time curve (AUC)) and peak plasma concentration following a single 30-mg dose of icatibant were increased by approximately 100 and 12-14%, respectively, in geriatric patients compared with younger patients.