1. HCP
  2. About Sajazir
  3. Efficacy

SAJAZIR (icatibant): reduced hereditary angioedema (HAE) attack symptoms,1 within easy reach*

*SAJAZIR injection is a prefilled syringe for subcutaneous use.1 Patients should not inject SAJAZIR until they have been trained by a Cycle Vita product support nurse or their healthcare provider.

SAJAZIR is for the treatment of cutaneous, abdominal, and laryngeal acute HAE attacks.1

SAJAZIR: effective symptom reduction for cutaneous and abdominal attacks1

In clinical trials, icatibant has been shown to:

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​Reduce symptoms by 50% in a median time of 2.0 hours vs. 19.8 hours with placebo (P<0.001)

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Achieve almost complete symptom relief in a median time of 8.0 hours vs. 36.0 hours with placebo​

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Treat 9 of 10 attacks with a single dose​

In all 3 controlled trials, patients were eligible for treatment of subsequent attacks in an open-label extension. Patients were treated with icatibant injection 30 mg and could receive up to 3 doses of icatibant injection 30 mg administered at least 6 hours apart for each attack. A total of 225 patients were treated with 1,076 doses of 30 mg icatibant injection for 987 attacks of acute HAE. 

Trial 1 was a randomized, placebo-controlled, double-blind, parallel-group study of 98 adult patients with a median age of 36 years. Patients who had developed moderate to severe cutaneous or abdominal or mild to moderate laryngeal attacks of HAE were randomized to receive either icatibant injection 30 mg or placebo by subcutaneous injection. Patients with severe laryngeal attacks of HAE received open-label icatibant injection 30 mg. The primary endpoint was assessed using a 100 mm 3-item composite visual analog score (VAS), comprising averaged assessments of skin swelling, skin pain, and abdominal pain. Response was defined as at least a 50% reduction from the pre-treatment composite 3-item VAS score. 

Trial 2 was a placebo-controlled trial and trial 3 was an active-controlled trial, a total of 26 and 35 patients, respectively, received icatibant injection 30 mg for the treatment of an acute HAE attack. 

Across the three trials, icatibant injection had a median time to 50% reduction from baseline symptoms ranging from 2.0 to 2.3 hours. 

SAJAZIR: consistent efficacy for multiple attacks1

In an assessment of the first 5 attacks treated with icatibant injection,† patients experienced a similar median time to 50% reduction in symptoms based on pretreatment composite 3-item VAS score.​

Trial 1 was a randomized, placebo-controlled, double-blind, parallel-group study of 98 adult patients with a median age of 36 years. Patients who had developed moderate to severe cutaneous or abdominal or mild to moderate laryngeal attacks of HAE were randomized to receive either icatibant injection 30 mg or placebo by subcutaneous injection. Patients with severe laryngeal attacks of HAE received open-label icatibant injection 30 mg. The primary endpoint was assessed using a 100 mm 3-item composite visual analog score (VAS), comprising averaged assessments of skin swelling, skin pain, and abdominal pain. Response was defined as at least a 50% reduction from the pre-treatment composite 3-item VAS score.​

In a second placebo-controlled trial and an active-controlled trial, a total of 26 and 35 patients, respectively, received icatibant injection 30 mg for the treatment of an acute HAE attack.

Across the three trials, icatibant injection had a median time to 50% reduction from baseline symptoms ranging from 2.0 to 2.3 hours.​

SAJAZIR: consistent efficacy for laryngeal attacks1

In 60 patients treated for laryngeal attacks in the controlled trials, icatibant injection demonstrated similar efficacy outcomes to those observed for nonlaryngeal (cutaneous and abdominal) attacks.

In the case of acute laryngeal HAE attacks, patients should be advised to inject SAJAZIR and then go to the nearest hospital emergency room right away.​

In all 3 controlled trials, patients were eligible for treatment of subsequent attacks in an open-label extension. Patients were treated with icatibant injection 30 mg and could receive up to 3 doses of icatibant injection 30 mg administered at least 6 hours apart for each attack. A total of 225 patients were treated with 1,076 doses of 30 mg icatibant injection for 987 attacks of acute HAE.​

Trial 1 was a randomized, placebo-controlled, double-blind, parallel-group study of 98 adult patients with a median age of 36 years. Patients who had developed moderate to severe cutaneous or abdominal or mild to moderate laryngeal attacks of HAE were randomized to receive either icatibant injection 30 mg or placebo by subcutaneous injection. Patients with severe laryngeal attacks of HAE received open-label icatibant injection 30 mg. The primary endpoint was assessed using a 100 mm 3-item composite visual analog score (VAS), comprising averaged assessments of skin swelling, skin pain, and abdominal pain. Response was defined as at least a 50% reduction from the pre-treatment composite 3-item VAS score.​

Trial 2 was a placebo-controlled trial and trial 3 was an active-controlled trial, a total of 26 and 35 patients, respectively, received icatibant injection 30 mg for the treatment of an acute HAE attack.

Across the three trials, icatibant injection had a median time to 50% reduction from baseline symptoms ranging from 2.0 to 2.3 hours. ​

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Footnote

†621 doses for a total of 582 attacks.1

Reference

  1. 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.