1. HCP
  2. About Sajazir
  3. Dosing and administration

SAJAZIR (icatibant): a portable, subcutaneous treatment,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 (Icatibant) injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.1

SAJAZIR is a prefilled, self-administered, subcutaneous injection to treat acute HAE attacks, that can be used as soon as your patients recognize the symptoms of an attack.1

Storing SAJAZIR1

  • SAJAZIR may be stored at room temperature. Store between 36°F and 77°F (2°C and 25°C)​

Administering SAJAZIR​1

  • Requires no reconstitution/mixing, no dose calculation, no special handling, no dose titration, and no refrigeration​
  • Do not administer if the product contains particulates or is discolored
  • SAJAZIR is administered over at least 30 seconds into the abdominal area​
  • Patients may subcutaneously self-administer SAJAZIR upon recognition of symptoms of an HAE attack, after training by a healthcare provider​

Access Full Instructions for Use (IFU) here.

Dosing​1

  • SAJAZIR is available as a 3 mL, prefilled, single-use syringe (30 mg)​
  • If response is inadequate or symptoms recur, additional doses of SAJAZIR may be administered at intervals of 6 hours or longer​
    • No more than 3 doses may be used in a 24-hour period​
  • SAJAZIR is available in a convenient pack containing 3 cartons​
    • Single cartons are also available​

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Mechanism of action

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Safety profile

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.