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Icatibant: Drug information

Icatibant: Drug information
2024© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Icatibant: Patient drug information" and "Icatibant: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Firazyr;
  • Sajazir
Brand Names: Canada
  • Firazyr
Pharmacologic Category
  • Selective Bradykinin B2 Receptor Antagonist
Dosing: Adult
Hereditary angioedema attacks, treatment

Hereditary angioedema attacks, treatment:

Note: To minimize morbidity and mortality, should be self-administered (or administered by a caregiver) at the onset of an attack whenever possible (Ref).

SUBQ: 30 mg once; may repeat every 6 hours if response is inadequate or symptoms recur; maximum dose: 90 mg per 24 hours.

Dosing: Kidney Impairment: Adult

No dosage adjustment is recommended (has not been studied); icatibant is cleared by nonrenal mechanisms and is not expected to accumulate in patients with renal impairment.

Dosing: Hepatic Impairment: Adult

No dosage adjustment necessary.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Icatibant: Pediatric drug information")

Hereditary angioedema

Hereditary angioedema (HAE): Limited data available: Children ≥2 years and Adolescents: SubQ: 0.4 mg/kg once; maximum dose: 30 mg/dose. Dosing based on an open-label study of 32 patients (mean age: 12.3 ± 3.5 years) with HAE (Ref).

Dosing: Kidney Impairment: Pediatric

There are no pediatric-specific dosage adjustments provided in the manufacturer's labeling; however, icatibant is cleared by nonrenal mechanisms and is not expected to accumulate in patients with renal impairment.

Dosing: Hepatic Impairment: Pediatric

There are no pediatric-specific dosage adjustments provided in the manufacturer's labeling; however, based on adult experience, no change in systemic exposure was observed in patients with mild to moderate hepatic impairment.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Local: Injection site reaction (97%)

1% to 10%:

Hepatic: Increased serum transaminase (4%)

Immunologic: Antibody development (4%; anti-icatibant, no association with efficacy observed)

Nervous system: Dizziness (3%)

Miscellaneous: Fever (4%)

Frequency not defined:

Dermatologic: Skin rash

Gastrointestinal: Nausea

Nervous system: Headache

Postmarketing: Dermatologic: Urticaria

Contraindications

There are no contraindications listed in the manufacturer’s labeling.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to icatibant acetate or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Airway obstruction: Airway obstruction may occur during acute laryngeal attacks of HAE. Patients with laryngeal attacks should be instructed to seek medical attention immediately in addition to treatment with icatibant.

• CNS effects: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving).

Warnings: Additional Pediatric Considerations

Airway obstruction may occur during acute laryngeal attacks of HAE; due to smaller airway passages, this may occur more rapidly in pediatric patients. Patients with laryngeal attacks should seek medical attention immediately following icatibant administration.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Prefilled Syringe, Subcutaneous, as acetate [preservative free]:

Firazyr: 30 mg/3 mL (3 mL)

Sajazir: 30 mg/3 mL (3 mL)

Generic: 30 mg/3 mL (3 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution Prefilled Syringe (Firazyr Subcutaneous)

30 mg/3 mL (per mL): $4,459.00

Solution Prefilled Syringe (Icatibant Acetate Subcutaneous)

30 mg/3 mL (per mL): $520.00 - $4,236.05

Solution Prefilled Syringe (Sajazir Subcutaneous)

30 mg/3 mL (per mL): $4,459.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Prefilled Syringe, Subcutaneous, as acetate:

Firazyr: 30 mg/3 mL (3 mL)

Administration: Adult

SubQ: For SubQ injection only. Patients may self-administer upon recognition of an HAE attack. Inject into the abdomen over ≥30 seconds, using the 25 gauge needle provided. Inject 2 to 4 inches below belly button and away from any scars; do not inject into an area that is bruised, swollen, or painful.

Administration: Pediatric

SubQ: For SubQ administration only. For doses <30 mg, transfer the appropriate volume needed for dose from the prefilled syringe into a graduated syringe. Inject into the abdomen over ≥30 seconds. Inject 2 to 4 inches below belly button and at least 2 inches away from any scars; do not inject into an area that is bruised, swollen, or painful.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 3]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).

Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

Use: Labeled Indications

Hereditary angioedema attacks, treatment: Treatment of acute attacks of hereditary angioedema.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Angiotensin-Converting Enzyme Inhibitors: Icatibant may diminish the antihypertensive effect of Angiotensin-Converting Enzyme Inhibitors. Risk C: Monitor therapy

Pregnancy Considerations

Outcome data following maternal administration of icatibant for the treatment of hereditary angioedema (HAE) attacks during pregnancy are limited (Boufleur 2014; Farkas 2016; Hakl 2018; Kaminsky 2017; Tran 2013; Zanichelli 2015).

When treatment for acute attacks of hereditary angioedema in pregnancy is needed, agents other than icatibant are recommended. Patients with HAE should be monitored closely during pregnancy and for at least 72 hours after delivery (Betschel 2019; WAO/EAACI [Maurer 2022]).

Breastfeeding Considerations

It is not known if icatibant is present in breast milk.

Systemic absorption in infants is not expected following exposure via breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Lactation may increase the frequency of hereditary angioedema (HAE) attacks; patients with HAE should be monitored closely. When treatment for acute attacks of hereditary angioedema in lactating patients is needed, agents other than icatibant are recommended (Betschel 2019; WAO/EEACI [Maurer 2022]).

Monitoring Parameters

Symptom relief; laryngeal symptoms or airway obstruction (immediate medical attention required in addition to icatibant therapy)

Mechanism of Action

Icatibant is a selective competitive antagonist for the bradykinin B2 receptor. Patients with HAE have an absence or dysfunction of C1-esterase-inhibitor which leads to the production of bradykinin. The presence of bradykinin may cause symptoms of localized swelling, inflammation, and pain. Icatibant inhibits bradykinin from binding at the B2 receptor, thereby treating the symptoms associated with acute attack.

Pharmacokinetics (Adult Data Unless Noted)

Onset: Median time to 50% decrease of symptoms: ~2 hours

Duration: Inhibits symptoms caused by bradykinin for ~6 hours

Distribution: Vdss:

Children ≥2 years: 0.39 ± 0.11 L/kg (Farkas 2017)

Adolescents: 0.44 ± 0.18 L/kg (Farkas 2017)

Adults: 29 ± 8.7 L

Metabolism: Metabolized by proteolytic enzymes to metabolites (inactive)

Bioavailability: ~97%

Half-life elimination:

Children ≥2 years: 0.8 ± 0.04 hours (Farkas 2017)

Adolescents: 1.34 ± 0.96 hours (Farkas 2017)

Adults: 1.4 ± 0.4 hours

Time to peak:

Children ≥2 years: 0.42 ± 0.13 hours (Farkas 2017)

Adolescents: 0.55 ± 0.19 hours (Farkas 2017)

Adults: ~0.75 hours

Excretion: Urine (<10% unchanged)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Firazyr;
  • (AR) Argentina: Firazyr;
  • (AT) Austria: Firazyr | Icatibant accord | Icatibant ratiopharm;
  • (AU) Australia: Cipla icatibant | Firazyr | Fyzant | Icatibant lupin;
  • (BE) Belgium: Firazyr | Icatibant | Icatibant fresenius;
  • (BG) Bulgaria: Firazyr;
  • (BR) Brazil: Firazyr;
  • (CH) Switzerland: Firazyr | Icatibant xiromed;
  • (CO) Colombia: Firazyr;
  • (CZ) Czech Republic: Firazyr | Icatibant accord | Icatibant fresenius | Icatibant teva | Icatibant zentiva;
  • (DE) Germany: Firazyr | Icatibant accord | Icatibant axiromed | Icatibant cipla | Icatibant glenmark | Icatibant stada | Icatibant zentiva;
  • (EE) Estonia: Firazyr | Icatibant accord | Icatibant teva;
  • (ES) Spain: Firazyr | Icatibant accord | Icatibanto cipla | Icatibanto glenmark | Icatibanto gp-pharm | Icatibanto stada;
  • (FI) Finland: Firazyr | Icatiban accord | Icatibant accord | Icatibant avansor | Icatibant glenmark | Icatibant ratiopharm | Icatibant sandoz | Icatibant stada | Icatibant zentiva;
  • (FR) France: Firazyr | Icatibant accord | Icatibant fresenius | Icatibant viatris | Icatibant zentiva;
  • (GB) United Kingdom: Icatibant | Icatibant accord | Icatibant sandoz;
  • (GR) Greece: Firazyr;
  • (HK) Hong Kong: Firazyr;
  • (HR) Croatia: Firazyr;
  • (HU) Hungary: Firazyr | Icatibant accord | Icatibant fresenius | Icatibant stada | Icatibant teva;
  • (IE) Ireland: Firazyr | Icatibant accord;
  • (IT) Italy: Firazyr | Icatibant accord | Icatibant eg | Icatibant fresenius | Icatibant piramal | Icatibant teva | Icatibant zentiva;
  • (JP) Japan: Firazyr;
  • (KR) Korea, Republic of: Firazyr;
  • (KW) Kuwait: Firazyr;
  • (LT) Lithuania: Icatibant teva;
  • (LV) Latvia: Firazyr;
  • (MX) Mexico: Firazyr;
  • (NL) Netherlands: Firazyr | Icatibant accord | Icatibant fresenius | Icatibant teva | Icatibant viatris | Icatibant xiromed;
  • (NO) Norway: Firazyr | Icatibant | Icatibant glenmark | Icatibant newbury;
  • (NZ) New Zealand: Firazyr;
  • (PL) Poland: Firazyr | Icatibant accord | Ikatybant ranbaxy;
  • (PR) Puerto Rico: Firazyr | Icatibant;
  • (PT) Portugal: Firazyr | Icatibant accord | Icatibant fresenius;
  • (QA) Qatar: Firazyr;
  • (RO) Romania: Firazyr | Icatibant stada | Icatibant terapia | Icatibant zentiva;
  • (RU) Russian Federation: Firazir | Icatibant psk;
  • (SA) Saudi Arabia: Firazyr;
  • (SE) Sweden: Firazyr | Icatibant accord | Icatibant avansor | Icatibant glenmark | Icatibant medical valley | Icatibant newbury | Icatibant sandoz | Icatibant stada | Icatibant teva | Icatibant viatris | Icatibant zentiva;
  • (SI) Slovenia: Firazyr;
  • (SK) Slovakia: Firazyr | Icatibant glenmark | Icatibant zentiva;
  • (TH) Thailand: Firazyr;
  • (TR) Turkey: Bradikant | Estereban | Heact | Icatin | Iktu;
  • (TW) Taiwan: Firazyr;
  • (ZA) South Africa: Firazyr
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