To ensure your patient receives SAJAZIR specifically, please complete an enrollment form and write the prescription for brand name SAJAZIR, including any special instructions required by your state (e.g. “dispense as written”). If you have questions about access for SAJAZIR or if you require a sample letter of medical necessity for an insurance claim, please contact an Access Specialist at Cycle Vita on 888 360-VITA (888 360-8482).
At Cycle Pharmaceuticals, we understand the importance of providing product support that complements treatment for patients living with a rare disease. That’s why we created Cycle Vita—delivering individualized product support for SAJAZIR—to help us fulfill our mission of improving the lives of people with rare diseases. Cycle Vita is here to give patients the product support they need at every step of their journey. To learn more visit www.cyclevita.life
Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering drug treatments and product support to the rare disease patient community. Cycle focuses on rare genetic metabolic disorders, immunological and neurological conditions. Cycle is headquartered in Cambridge, UK and has offices in Boston, Mass. (USA). For more information, please visit www.cyclepharma.com
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.