Sajazir (Icatibant)

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

•   30 mg injected subcutaneously in the abdominal area. (
  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.
  )
•   If response is inadequate or symptoms recur, additional injections of 30 mg may be administered at intervals of at least 6 hours. (
  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.
  )
•   Do not administer more than 3 injections in 24 hours. (
  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.
  )
•   Patients may self-administer upon recognition of an HAE attack. (
  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 ]

  .
  )

SAJAZIR is supplied in a prefilled syringe delivering 30 mg icatibant. Each syringe delivers 3 mL solution with a concentration of 10 mg per mL.

•   Elderly patients demonstrate increased systemic exposure to icatibant. Differences in efficacy and safety between elderly and younger patients have not been identified. (
  8.5 Geriatric Use

  Clinical studies of icatibant injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients are likely to have increased systemic exposure to icatibant injection compared to younger (18-45 years) patients

  [see Clinical Pharmacology ]

  . Since other reported clinical experience has not identified differences in efficacy and safety between elderly and younger patients, no dose adjustment is recommended.
  )

• Laryngeal attacks: Following treatment of laryngeal attacks with SAJAZIR, advise patients to seek immediate medical attention. (
  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.
  )