Firazyr

(Icatibant Acetate)

The active ingredient in Firazyr is icatibant acetate, which is a bradykinin B2 receptor antagonist. It is used to treat acute attacks of HAE. People who have HAE have an absence or deficiency of C1-esterase inhibitors in their system, which leads to the increased production of bradykinin.

Firazyr works by blocking the action of bradykinin, a substance that causes swelling, pain, and fluid leakage into tissues. By stopping this pathway, Firazyr rapidly reduces swelling and relieves symptoms during an angioedema attack.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Firazyr. However, the following is a synopsis of the general guidelines for the use of Firazyr:

• Firazyr is given as a subcutaneous injection, meaning it is injected just under the skin.
• It is supplied as a pre-filled syringe designed for single use.
• Firazyr injections are used to treat an acute HAE attack as soon as symptoms begin.
• Common injection areas include the abdominal area, away from the navel.
• Patients or caregivers may be trained by a healthcare professional to inject Firazyr safely at home.
• Firazyr should not be injected into areas of skin that are bruised, infected, or scarred.
• After the injection, the needle cap and syringe should be disposed of properly according to local guidelines.
• Your healthcare provider will decide whether Firazyr is appropriate for home use and will provide instructions on when to seek medical attention, especially for laryngeal attacks involving the throat.

Some mild or most common side effects of Firazyr seen in clinical trials include:

• Injection site reactions such as pain, redness, swelling, warmth, or itching.
• Nausea.
• Dizziness.
• Headache.
• Fatigue.
• Abnormal liver tests.

Some individuals may experience serious side effects while using Firazyr. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of a severe allergic reaction, including hives, swelling of the face or throat, or trouble breathing.
• Worsening symptoms of a laryngeal attack, such as difficulty swallowing or breathing.
• Chest pain or severe abdominal pain that does not improve after treatment.

These are not all of the possible side effects of Firazyr. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Firazyr, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• A history of allergic reaction to icatibant or any ingredient in Firazyr.
• Heart disease or conditions affecting blood vessels.
• Liver problems or elevated liver enzymes.
• Any condition that may increase the risk of complications during an acute HAE attack.
• Patients experiencing laryngeal attacks should seek immediate medical attention, even if Firazyr is administered, due to the risk of airway obstruction.

Firazyr is contraindicated in patients with known hypersensitivity to icatibant acetate or any component of the formulation.

Firazyr begins working soon after injection. Many patients experience symptom relief within 2 hours of treatment, though response time can vary depending on the severity and location of the HAE attack. Some attacks may require additional doses within a 24-hour period.

When Firazyr is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Angiotensin-converting enzyme inhibitors (ACE inhibitors), which may worsen hereditary angioedema symptoms.

Firazyr is supplied as a pre-filled syringe containing 30 mg of icatibant in 3 mL solution for subcutaneous use.

• The recommended dose for adults is one 30 mg subcutaneous injection at the onset of an acute HAE attack.
• If symptoms persist or recur, additional doses may be given at intervals of at least 6 hours.
• No more than three doses should be administered within a 24-hour period.

It should be stored at room temperature, away from the reach of children or pets.

Firazyr is manufactured by Takeda Pharmaceuticals.

At this time, Firazyr is available as a brand-name medication.

Firazyr is used only during an acute HAE attack and is not taken on a daily schedule. Do not use Firazyr more often or in higher amounts than prescribed. If you feel your attacks are becoming more frequent or severe, speak with your healthcare provider about long-term management options.

Limited data is available on the use of Firazyr during pregnancy, and your healthcare provider will weigh the potential benefits against possible risks. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant.

It is not known whether icatibant passes into breast milk during lactation. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed.