SAJAZIR (icatibant) (Icatibant INJECTION) 30 mg/3mL

SAJAZIR (icatibant) is an FDA-approved orphan drug manufactured by Cycle Pharmaceuticals for the treatment of hereditary angioedema (HAE). It is administered via subcutaneous injection and belongs to the therapeutic category of allergy and immunology agents. This prescription medication represents an important treatment option for patients experiencing acute HAE attacks.

Strength

30 mg/3mL

Pack Size

1 SYRINGE, GLASS in 1 CARTON (70709-013-01) / 3 mL in 1 SYRINGE, GLASS

Manufacturer / TM Owner

Cycle Pharmaceuticals

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Indications & Clinical Uses

SAJAZIR is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adolescents and adults. HAE is a rare genetic disorder characterized by recurrent episodes of severe swelling affecting the skin, gastrointestinal tract, and potentially life-threatening airway involvement. SAJAZIR contains icatibant, a selective bradykinin B2 receptor antagonist that works by blocking the effects of bradykinin, a key mediator in the inflammatory cascade responsible for angioedema formation. The drug is specifically designed for patients with HAE types I, II, and III. By inhibiting bradykinin signaling, icatibant rapidly reduces swelling and provides symptomatic relief during acute attacks. SAJAZIR is administered as a subcutaneous injection, allowing for quick onset of action and improved patient outcomes during emergency situations.

Side Effects

Common side effects of SAJAZIR include injection site reactions such as erythema, pain, and swelling. Patients may also experience headache, diarrhea, and nausea. Serious adverse events are rare but may include hypersensitivity reactions and angioedema of the tongue or throat. Monitoring requirements include assessment of injection site reactions and observation for signs of allergic response. Patients should be monitored for symptom resolution following administration. Healthcare providers should evaluate renal and hepatic function periodically, particularly in patients with underlying organ dysfunction.

Precautions & Warnings

SAJAZIR is contraindicated in patients with known hypersensitivity to icatibant or any excipient. Use with caution in patients with severe renal or hepatic impairment. Pregnancy category information should be reviewed with healthcare providers, as limited data exist in pregnant women. Pediatric use is established in adolescents, though dosing adjustments may be necessary in younger children. Patients with a history of angioedema affecting the airway require careful monitoring. ACE inhibitors may increase angioedema risk and should be used cautiously. SAJAZIR should not be used as prophylactic therapy for HAE.

Avoid Interactions

SAJAZIR has minimal significant drug-drug interactions. However, concurrent use with ACE inhibitors may potentiate angioedema risk and should be avoided or used with extreme caution. No major food-drug interactions have been documented. Patients should inform healthcare providers of all medications, supplements, and herbal products. No dose adjustments are required based on concomitant medications in most cases.

Frequently Asked Questions

SAJAZIR is used to treat acute attacks of hereditary angioedema (HAE) in adolescents and adults. It works by blocking bradykinin, a substance that causes swelling during HAE attacks. The drug provides rapid relief of symptoms including skin swelling, abdominal pain, and airway involvement.

SAJAZIR is administered as a subcutaneous injection, typically given in the abdomen, thigh, or upper arm. Patients or caregivers can be trained to self-administer the injection during an acute attack. The medication should be administered as soon as symptoms of an HAE attack appear.

Common side effects include injection site reactions such as redness, pain, and swelling. Patients may also experience headache, diarrhea, and nausea. Most side effects are mild to moderate and resolve without intervention.

SAJAZIR is manufactured by Cycle Pharmaceuticals, a pharmaceutical company specializing in treatments for rare diseases and orphan indications.

Yes, SAJAZIR has been designated and approved as an orphan drug by the FDA. This designation recognizes its use in treating hereditary angioedema, a rare genetic disorder affecting a small patient population. Orphan drug status provides regulatory incentives and protections for manufacturers developing treatments for rare diseases.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated: 17 Jun 2026

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