An icatibant injection has been released in the United States as an alternative treatment for acute attacks of hereditary angioedema in adults over the age of 18 years.
An icatibant injection has been released in the United States as an alternative treatment for acute attacks of hereditary angioedema (HAE) in adults over the age of 18 years. Icatibant injection is a bradykinin B2 receptor antagonist that has been approved by the FDA with immediate availability.
HAE is a rare and life-threatening genetic condition that affects approximately 6000 people across the country. In order to treat an acute attack of HAE, icatibant injection can be self-administered subcutaneously into the abdomen.
Icatibant injection is currently available in 3 mL prefilled, single-use syringes that can be self-administered in and outside of the home, following training from a health care professional.
“For people with HAE, an acute attack can occur anywhere, at any time and can be life-threatening,” said John Ducker, president and CEO of Fresenius Kabi USA, in a press release. “Fresenius Kabi wants to be a valuable resource for patients and their care teams, which is why we are offering a patient support program for the first time.”
The support program available is KabiCare, which can help patients not only access icatibant injection, but also remain compliant with their therapy. Therapy compliance resources include access to live case managers, co-pay assistance, and self-injection training. Also, in the event there is a delay in patient coverage, pharmaceutical samples are available to allow for unabridged access to therapy.
For patients with HAE, the adverse events (AEs) that can occur upon the administration of icatibant injection are injection site reactions, which were reported in 97% of patients during clinical trials. Other common AEs that occurred in more than 1% of patients during trials were pyrexia, transaminase increases, dizziness, and rash.
Since icatibant injection is a bradykinin B2 receptor antagonist, it has the potential to develop a pharmacodynamic interaction with angiotensin-converting enzyme (ACE) inhibitors. This interaction can occur due to the ability of icatibant injection to attenuate the antihypertensive effect of ACE inhibitors.
During clinical trials, researchers observed that elderly patients had an increased systemic exposure to icatibant. However, the differences in efficacy and safety between elderly and younger patients is unknown. Additionally, the efficacy and safety of icatibant injection for pediatric patients under the age of 18 years has not yet been assessed.
Fresenius Kabi Launches Icatibant Injection to Treat Acute Attacks of Hereditary Angioedema in Adults. Lake Zurich, Il: Fresenius Kabi; December 1, 2020. fresenius-kabi.com/us/news/fresenius-kabi-launches-icatibant-injection-to-treat-acute. Accessed December 9, 2020.