About hereditary angioedema (HAE)​

HAE is characterized by the overproduction of bradykinin, leading to acute HAE attacks1​–5

HAE is a rare and life-long, genetic condition that affects somewhere between 1 in 10,000–50,000 people in the general population.1–5​

HAE is usually caused by a shortage or malfunctioning of a protein called C1 esterase inhibitor (C1-INH).1–5 This leads to the overproduction of another protein called bradykinin, which can cause an HAE attack.1–5

Diagnosis of HAE remains an ongoing challenge1,5

Exactly where in the body, how often and how severe is different for everyone and can change over time.1 Because HAE is so rare, it can be difficult to diagnose in the beginning and symptoms are often confused with other conditions, such as allergies.5

Treatment is critical for patients suffering acute HAE attacks1​

During an HAE attack, fluid in the blood vessels leaks into the surrounding area, causing painful and sometimes disfiguring swelling—most commonly in the face, feet, hands, stomach, genitals, and even the throat.1–6 While attacks on the throat are less frequent, they are potentially life-threatening, as the swelling can interfere with breathing.2–4

References

  1. Maurer M, et al. Allergy. 2018;73(8):1575–1596.
  2. Zuraw BL, et al. J Allergy Clin Immunol Pract. 2013;1(5):458–467.
  3. El-Shanawany T. Hereditary Angioedema. British Society for Immunology. https://www.immunology.org/public-information/bitesized-immunology/immune-dysfunction/hereditary-angioedema (accessed October 2021).
  4. Ghazi A, Grant JA. Biologics. 2013;7:103–113.
  5. Lumry W, et al. Journal of Infusion Nursing. 2020;43(3):134–145.
  6. SAJAZIR™ (icatibant) Injection. Prescribing Information. Cycle Pharmaceuticals Limited. ​
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Indication and Important Safety Information

SAJAZIR™ (Icatibant) injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

Warnings and precautions: 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: The most commonly reported adverse reactions were injection-site reactions, which occurred in almost all patients (97%) in clinical trials. These injection-site reactions included bruising, hematoma, burning, erythema, hypoesthesia, irritation, numbness, edema, pain, pressure sensation, pruritus, swelling, urticaria, and warmth.

Other common adverse reactions included pyrexia (4%), transaminase increase (4%), and dizziness (3%), as well as rash, nausea, and headache.

Drug interactions: Icatibant is a bradykinin B2 receptor antagonist and thereby has the potential to have a pharmacodynamic interaction with ACE inhibitors where SAJAZIR may attenuate the antihypertensive effect of ACE inhibitors. Clinical trials to date have excluded subjects taking ACE inhibitors.

Use in specific populations: Clinical studies of Icatibant included a limited number of subjects aged 65 and over. Elderly patients are likely to have increased systemic exposure. Reported clinical experience has not identified differences in efficacy and safety between elderly and younger patients.

Safety and effectiveness in patients below 18 years of age have not been established.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

For more detailed information, please refer to the Full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS contact Cycle Pharmaceuticals at 1-800-836-4380, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

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Indication

SAJAZIRTM (icatibant) injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

Important Safety Information
Warnings and Precautions

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

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 (4%), transaminase increase (4%), dizziness (3%), and rash.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of icatibant: urticaria.

Drug Interactions:

ACE Inhibitors. Icatibant is a bradykinin B2 receptor antagonist and thereby has the potential to have a pharmacodynamic interaction with ACE inhibitors where icatibant may attenuate the antihypertensive effect of ACE inhibitors. Clinical trials to date have excluded subjects taking ACE inhibitors.

Use in Specific Populations

Pregnancy: 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.

Lactation: 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 icatibant or from the underlying maternal condition.

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 18 years have not been established.

Geriatric Use: Elderly patients are likely to have increased systemic exposure to icatibant injection compared to younger (18-45 years) patients. No dose adjustment is recommended.

For more detailed information, please refer to the full Prescribing Information

To report SUSPECTED ADVERSE REACTIONS contact Cycle Pharmaceuticals at 1-800-836-4380, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.