Icatibant

FIRAZYR

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Icatibant ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Icatibant ballicule

What it isSelective bradykinin B2 receptor antagonist; acute attacks of hereditary angioedema.

Why this oneIt blocks the mediator directly, so it works in the bradykinin-mediated angioedema that antihistamines, steroids and epinephrine do not touch.

What limits it⚑ That distinction is the teaching point: ACE-inhibitor and hereditary angioedema are bradykinin-mediated, and the usual anaphylaxis drugs fail. Self-injected subcutaneously; injection-site reactions are near-universal.

Icatibant molecular structure (skeletal formula) — Molecular structure: Icatibant

FDA label

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FDA dosing	Population	Start	Target	Max
Acute attacks of hereditary angioedema (HAE)	Adults (≥18 yr)	30 mg SC (abdominal area) at attack onset	30 mg SC; may repeat if response inadequate or symptoms recur (≥6 h apart)	3 doses (90 mg) SC per 24 h

Renal No adjustment needed

Hepatic No adjustment needed

Repeat doses at intervals of at least 6 h; no more than 3 doses in any 24-h period

Instructions

SC injection into abdominal area over at least 30 seconds; use only the provided 25-gauge needle
Inspect visually: solution should be clear and colorless; do not use if particulates or discolored
Patients may self-administer upon recognizing an HAE attack after training by a healthcare professional
After treating a laryngeal attack, seek immediate medical attention (airway obstruction risk)

Available strengths

inj 10 mg/mL

Cautions

Laryngeal attacks: treat, then seek immediate medical attention in an appropriate healthcare facility (airway obstruction risk)

Adverse reactions

Injection site reactions (97%: bruising, erythema, pain, swelling, pruritus, etc.)
Pyrexia
Transaminase increase
Dizziness
Rash
Urticaria (postmarketing)

Pregnancy Human data have not identified drug-associated risk of birth defects or miscarriage; animal studies showed premature birth/abortion (rabbits) and delayed parturition/fetal death (rats) at low multiples of MRHD

Lactation No human data; present in rat milk, but systemic absorption in infant via breast milk not expected — weigh benefits against risk

Cost

Icatibant (FIRAZYR)

Strength		#/mo	generic $/unit	CostPlus
10 mg/mL	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Icatibant is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

NO BOXED WARNINGS

Principal riskInjection-site reactions; it does not treat histaminergic angioedema

Classes and tags

Clinical profile

Therapeutic safety burden1 / 4

Overdose danger1 / 4

Weight-gain liability0 / 4

Sedation liability1 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk1 / 4

Legacy pregnancy categoryC

Defining liabilityFrequent injection-site reactions; prompt airway assessment remains essential

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