pharmacopeia
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Mechanism of action

Sourced from openFDA

Icatibant is a competitive antagonist selective for the bradykinin B2 receptor, with an affinity similar to bradykinin. Hereditary angioedema is caused by an absence or dysfunction of C1-esterase-inhibitor, a key regulator of the Factor XII/kallikrein proteolytic cascade that leads to bradykinin production.

Bradykinin B2 Receptor

Indications

Sourced from openFDA
  • SAJAZIR (icatibant) injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. SAJAZIR (icatibant) injection is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

Contraindications

Sourced from openFDA
  • None. None.contraindicated

Dosage & administration

Sourced from openFDA

30 mg injected subcutaneously in the abdominal area. ( 2.1 ) If response is inadequate or symptoms recur, additional injections of 30 mg may be administered at intervals of at least 6 hours. ( 2.1 ) Do not administer more than 3 injections in 24 hours. ( 2.1 ) Patients may self-administer upon recognition of an HAE attack. ( 2.2 ) 2.1 Recommended Dosing The recommended dose of SAJAZIR is 30 mg administered by subcutaneous (SC) injection in the abdominal area. Additional doses may be administered at intervals of at least 6 hours if response is inadequate or if symptoms recur. No more than 3 doses may be administered in any 24 hour period. 2.2 Administration Instructions SAJAZIR should be inspected visually for particulate matter and discoloration prior to administration. The drug solution should be clear and colorless. Do not administer if the product contains particulates or is discolored. Attach the provided 25 gauge needle to the syringe hub and screw on securely. Do not use a different needle. Disinfect the injection site and administer SAJAZIR by subcutaneous injection over at least 30 seconds. Patients may self-administer SAJAZIR upon recognition of symptoms of an HAE attack after training under the guidance of a healthcare professional [see Patient Counseling Information ( 17 )] .

Warnings & precautions

Sourced from openFDA

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.

Adverse reactions

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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 1. 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.

Use in specific populations

Sourced from openFDA

Elderly patients demonstrate increased systemic exposure to icatibant. Differences in efficacy and safety between elderly and younger patients have not been identified. ( 8.5 ) 8.1 Pregnancy Risk Summary Available data from published literature and the pharmacovigilance database with icatibant use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, icatibant, administered by the subcutaneous route during the period of organogenesis, did not cause structural abnormalities in rats or rabbits; however, premature birth and abortion were observed in rabbits at doses approximately 0.025 times the maximum recommended human dose (MRHD) and higher. Decreased embryofetal survival was observed in rabbits at a subcutaneous dose that was 13 times the MRHD. In a pre-and post-natal development study in rats, delayed parturition was observed at subcutaneous doses 0.5 times the MRHD and higher, which resulted in deaths of dams at doses 2 times the MRHD and higher. Fetal death and early pup deaths were observed with doses 2 times the MRHD ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Pharmacokinetics

Sourced from openFDA
Metabolism
The pharmacokinetics of icatibant injection has been characterized in studies using both intravenous and subcutaneous administration to healthy subjects and patients. The pharmacokinetic profile of icatibant injection in patients with HAE is similar to that in healthy subjects.

Overdosage

Sourced from openFDA

In a clinical study evaluating a 90 mg dose (30 mg in each of 3 subcutaneous sites), the adverse event profile was similar to that seen with 30 mg administered in a single subcutaneous site. In another clinical study, a dose of 3.2 mg/kg administered intravenously (approximately 8 times the therapeutic dose for HAE) caused erythema, itching and hypotension in healthy subjects. No therapeutic intervention was necessary.

Approval history

Sourced from openFDA
  • Aug 25, 2011NDANDA022150Takeda Pharms Usa
  • Jul 15, 2019ANDAANDA210118Teva Pharms Usa
  • Mar 9, 2020ANDAANDA211021Jiangsu Hansoh Pharm
  • Jun 18, 2020ANDAANDA208317Fresenius Kabi Usa
  • Jul 13, 2020ANDAANDA212446Cipla
  • Aug 14, 2023ANDAANDA213521Eugia Pharma
  • Jun 14, 2024ANDAANDA213773Alembic

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Icatibant Acetate, Injection, 10 mg/1 mL (NDC 63323-574-86)To be discontinued
    Sponsor: Fresenius Kabi USA, LLC
    Updated
  • Icatibant Acetate, Injection, 10 mg/1 mL (NDC 63323-574-93)To be discontinued
    Sponsor: Fresenius Kabi USA, LLC
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
8,494 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Hereditary Angioedema3,44040%
  2. 2Drug Ineffective7789.2%
  3. 3Product Dose Omission Issue6577.7%
  4. 4Weight Decreased6267.4%
  5. 5Weight Increased6067.1%
  6. 6Product Use Issue4875.7%
  7. 7Injection Site Pain4765.6%
  8. 8Off Label Use4285.0%
  9. 9Headache4235.0%
  10. 10Inappropriate Schedule Of Product Administration4134.9%
  11. 11Malaise3774.4%
  12. 12Stress3604.2%
  13. 13Covid-193534.2%
  14. 14Nausea3113.7%
  15. 15Pain3063.6%

Clinical trials

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The 10 most recently updated of 33 ClinicalTrials.gov registrations naming Icatibant as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Icatibant work?
Icatibant is a competitive antagonist selective for the bradykinin B2 receptor, with an affinity similar to bradykinin. Hereditary angioedema is caused by an absence or dysfunction of C1-esterase-inhibitor, a key regulator of the Factor XII/kallikrein proteolytic cascade that leads to bradykinin production.
What is Icatibant used for?
According to FDA labeling, Icatibant carries indications including: SAJAZIR (icatibant) injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. SAJAZIR (icatibant) injection is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Icatibant?
Icatibant is classified as Drugs used in hereditary angioedema, Bradykinin B2 Receptor Antagonist, Bradykinin B2 Receptor Antagonists, Vascular Tone Alteration.
What are the brand names for Icatibant?
Icatibant is marketed under brand names including Firazyr, Sajazir.
What are the contraindications for Icatibant?
Icatibant labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.
Note. Data for icatibant is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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