FAQ - Icatibant Injection from Fresenius Kabi

Q: What is the active ingredient in Fresenius Kabi’s Icatibant Injection?

The active ingredient is icatibant acetate—the same active ingredient in Firazyr^®*.^11,26

Q: What do I need to ask my patients before they start taking Icatibant Injection?

Confirm patients’ other medical conditions and prescription/OTC medicines and supplements. Ask female patients if they are pregnant or planning to become pregnant or if they are breastfeeding. Icatibant Injection has not been evaluated in pregnant or nursing women.¹¹

Q: Are there any contraindications for Icatibant Injection?

Q: Do my patients need training to give themselves the injection?

Yes, patients may only self-administer Icatibant Injection upon recognition of an HAE attack after formal training by a healthcare professional.¹¹

Q: Can someone else outside of my office give my patients the Icatibant Injection if they can’t do it themselves?

The patient can choose anyone to administer the Icatibant Injection, but they can only do so after formal training by a healthcare professional.¹¹

Q: Is it better if I or one of my staff members give the Icatibant Injection?

Patients will receive treatment faster after the first signs of symptoms if they can administer Icatibant Injection themselves. The next-best option, if they can’t do it themselves, is the closest available person who is formally trained to administer the injection.¹¹

Q: Can more than one dose of Icatibant Injection be administered during the same attack?

Icatibant Injection should be taken when patients first recognize the symptoms of an HAE attack. If symptoms do not resolve or if symptoms reoccur after the first dose, additional doses can be administered. Doses must be at least 6 hours apart and not exceed more than 3 doses in any 24-hour period.¹¹

Q: Does Icatibant Injection cause antibodies to develop?

Across repeated treatment in the controlled trials, four patients tested positive for anti-icatibant antibodies. Three of these patients had subsequent tests which were negative. No hypersensitivity or anaphylactic reactions were reported. No association between anti-icatibant antibodies and efficacy was observed.¹¹

Q: Will Icatibant Injection lose efficacy in my patients over time?

In an assessment of the first 5 icatibant injection-treated attacks (621 doses for 582 attacks), the median times to a 50% reduction from the pretreatment composite 3-item VAS score were similar across attacks (2, 2, 2.4, 2, 1.5 hours). The majority (93%) of these attacks of HAE were treated with a single dose of icatibant injection.¹¹

Q: What are the most common adverse side effects of Icatibant Injection?¹¹

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 .

Q: How do I switch my patients if they are already on another generic on-demand treatment?

You can indicate on the prescription to dispense Icatibant Injection manufactured by Fresenius Kabi.