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How to Enroll

If you are interested in enrolling in the Cycle Vita hub for SAJAZIR (Icatibant), simply click the download form button below. Print the enrolment form, share it with your doctor and discuss completing the SAJAZIR enrollment form.

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If you have any questions during the enrollment process, the Cycle Vita team are only a phone call away.

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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.

Important Safety Information

Laryngeal attacks can become life threatening. If you have an HAE attack of the throat (laryngeal attack), inject SAJAZIR and then go to the nearest hospital emergency room right away.

The most common side effects of SAJAZIR include:

redness, bruising, swelling, warmth, burning, itching, irritation, hives, numbness, pressure, or pain at the injection site

fever

too much of an enzyme called transaminase in your blood

dizziness

nausea

headache

rash

These are not all of the possible side effects of SAJAZIR. Tell your healthcare provider if you have any side effects.

Also tell your healthcare provider if you have any other medical conditions, are breastfeeding or plan to breastfeed, or if you are pregnant or planning to become pregnant. SAJAZIR has not been evaluated in pregnant or nursing women. You and your healthcare provider will decide if SAJAZIR is right for you.

If your symptoms continue or come back, you may repeat your SAJAZIR injection at least 6 hours apart. Do not use more than 3 doses of SAJAZIR in a 24-hour period.

Tiredness, drowsiness, and dizziness have been reported following the use of SAJAZIR. If this occurs, do not drive a car, use machinery, or do anything that needs you to be alert.

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.