SAJAZIR™ (icatibant) Injection

What is SAJAZIR?

SAJAZIR is an FDA-approved injection indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults aged 18 years and older.1,2 SAJAZIR comes in the form of a convenient, prefilled injection that you will be trained to self-administer subcutaneously as soon as you notice the signs of an HAE attack coming on.1

At Cycle, we know that supporting people with rare diseases is about more than just the medicine. That’s why we created Cycle Vita, delivering individualized product support with SAJAZIR to support your experience throughout your journey. With SAJAZIR, HAE control is within easy reach.1

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*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 product support available to you

Start your SAJAZIR enrollment here

Download and print the enrollment form, share it with your doctor and discuss why you think SAJAZIR may be suited to your needs.

The first 24hrs

Your Cycle Vita team will quickly get to work with your insurance provider to help you understand your coverage.

We will coordinate seamlessly between different parties, such as insurance companies, doctors, and pharmacists to meet your prior authorization and documentation requirements.

We will route your SAJAZIR therapy to the appropriate specialty pharmacy and follow-up to ensure swift shipment of your medication.

Additional assistance, when required, throughout your journey

In some cases, an appeal may be needed. Where this is the case, our experienced team will work with your insurer and doctor to understand and overcome any SAJAZIR reimbursement gaps.

If you are 18 or older and have commercial insurance, you may be eligible for the Cycle Vita Co-Pay Assistance Program. This program will help cover the cost of insurance co-pays for SAJAZIR at 100%, up to the program maximum, for those who are eligible. Please contact our Access Specialists to find out more about this and other programs that may be available to you (such as Quick Start, Bridge Program, etc.).

Important notice

If you are 18 or older and have commercial insurance, you may be eligible for the Cycle Vita Quick Start Program. This program will provide you with a free supply of SAJAZIR to allow you to begin therapy immediately while Cycle Vita secures appropriate benefit verification and authorization. Quick Start may also be requested if you are an existing patient who is temporarily experiencing disruption in therapy due to insurance coverage. Please contact our Access Specialists to find out more about this and other programs that may be available to you (such as Co-pay Assistance, Bridge Program, etc.).

Important notice

Our proactive team will remind your doctor when your SAJAZIR prescription needs to be renewed, in a timely manner, to ensure an uninterrupted supply of your therapy.

We provide product support to help you manage every aspect of your SAJAZIR therapeutic routine, such as clinical education and 1-to-1 injection training either at home or in-clinic.

Translation services are available on request.

What is HAE?

HAE is a rare and life-long, genetic condition that affects somewhere between 1 in 10,000–50,000 people. HAE is usually caused by a shortage or malfunctioning of a protein called C1 esterase inhibitor (C1-INH). This leads to the overproduction of another protein called bradykinin, which can cause an HAE attack.3–7

During an HAE attack, fluid in the blood vessels leaks out into the surrounding area, causing painful and sometimes disfiguring swelling.3,4,7 It most commonly affects the face, feet, hands, stomach, genitals and sometimes the throat.1,3–7 Attacks on the throat happen less often but they can be life-threatening, as swelling here can interfere with your breathing.4–6 If you experience an HAE attack affecting your airways, inject SAJAZIR and then go to the nearest hospital emergency room right away.1

Exactly where in the body, how often and how severe is different for everyone and can change over time.3 Because HAE is so rare, it can be difficult to diagnose in the beginning and symptoms are often confused with other conditions, such as allergies.7 Living with HAE is a journey, but with Cycle Vita, you are never alone. The team is here to support you for life.

Resources

Footnote

*Some areas of support may not be accessible to all patients. Eligibility criteria may apply to ensure compliance with all applicable federal and state requirements, and benefits may be limited to commercially insured patients only. For more detailed information about eligibility, terms and conditions, please contact the Cycle Vita team at +1 (888) 360-8482.

Cycle Vita and SAJAZIR are trademarks of Cycle Pharmaceuticals Limited in the United States.

References

  1. SAJAZIR™ (icatibant) Injection. Prescribing Information. Cycle Pharmaceuticals Limited.
  2. FDA. FDA-approved Drugs. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022150 (Accessed August 2023).
  3. Maurer M, et al. Allergy. 2018;73(8):1575–1596.
  4. Zuraw BL, et al. J Allergy Clin Immunol Pract. 2013;1(5):458–467.
  5. El-Shanawany T. Hereditary Angioedema. British Society for Immunology. https://www.immunology.org/public-information/bitesized-immunology/immune-dysfunction/hereditary-angioedema (Accessed August 2023).
  6. Ghazi A, Grant JA. Biologics. 2013;7:103–113.
  7. Lumry W, et al. Journal of Infusion Nursing. 2020;43(3):134–145.
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Indication and Important Safety Information

INDICATION

SAJAZIR™ (Icatibant) injection is a medicine used to treat acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

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.