Fresenius Kabi’s FDA-approved, generic Icatibant Injection provides patients with a new option in treating acute attacks of Hereditary angioedema (HAE).
Icatibant Injection is less expensive, easy to use, fully substitutable, and chemically equivalent*.
Icatibant Injection is supplied as a 3 mL prefilled, single use syringe and is available in both single- and three-syringe packages.
Help your patients be prepared to treat HAE attacks by suggesting they carry Icatibant Injection with them at all times.
Icatibant Injection can be used to treat all acute HAE attacks, including cutaneous, abdominal, and laryngeal attacks. Instruct patients to take Icatibant Injection at the first sign of symptoms or as soon as possible after they start. Icatibant Injection can reduce the duration and time to resolution of the attack.
Icatibant Injection is appropriate for adults ≥18 years of age with HAE Type 1 or Type 2, including patients who are taking preventive therapy.
Fresenius Kabi’s generic Icatibant Injection is indicated for the treatment of acute attacks of Hereditary angioedema (HAE) in adults 18 years of age and older.
Fresenius Kabi’s Icatibant Injection is the generic self-administered, subcutaneous injection for the acute treatment of HAE attacks. The prefilled syringe requires:
Fresenius Kabi’s Icatibant Injection single-use syringe should be stored between 2°C – 25°C (36°F – 77°F). Do not freeze. Store in carton until time of administration.
Patients may self-administer Fresenius Kabi’s generic Icatibant Injection after proper administration training by a healthcare professional.
People who experience an HAE attack of the throat should seek immediate medical attention, even after taking an on-demand therapy
Icatibant injection is supplied in a prefilled syringe delivering 30 mg icatibant. Each syringe delivers 3 mL solution with a concentration of 10 mg per mL.
The recommended dose of Icatibant Injection is 30 mg administered by subcutaneous (SC) injection in the abdominal area at the first signs of attack symptoms. 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.
Icatibant is a competitive antagonist selective for the bradykinin B2 receptor, with an affinity similar to bradykinin. Hereditary angioedema is caused by an absence or dysfunction of C1-esterase-inhibitor, a key regulator of the Factor XII/kallikrein proteolytic cascade that leads to bradykinin production. Bradykinin is a vasodilator which is thought to be responsible for the characteristic HAE symptoms of localized swelling, inflammation, and pain. Icatibant inhibits bradykinin from binding the B2 receptor and thereby treats the clinical symptoms of an acute, episodic attack of HAE.
After Icatibant Injection is administered, the drug attaches to the B2R receptor, blocking bradykinin from attaching to it and thereby preventing further vasodilation.
The most commonly reported adverse reactions were injection site reactions, which occurred in almost all patients (97%) in clinical trials. Other common adverse reactions occurring in greater than 1% of patients included pyrexia, transaminase increase, dizziness, and rash.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.