Firazyr
Pronunciation: FIR-a-zeer
Generic name: icatibant
Dosage form: single-dose, prefilled syringe for subcutaneous use (30 mg/3 mL)
Drug class: Hereditary angioedema agents
What is Firazyr?
Firazyr is used to treat acute attacks of hereditary angioedema (HAE) in adults. It can be self-administered by subcutaneous (under the skin) injection up to 3 times in 24 hours during an acute attack.
Firazyr (icatibant) gained FDA approval on August 25, 2011. A generic is available.
How does Firazyr work?
Firazyr's mechanism of action involves competing with bradykinin for the bradykinin B2 receptor. Bradykinin is a vasodilator thought to be responsible for characteristic HAE symptoms such as localized swelling, inflammation, and pain. By binding with the B2 receptor and preventing bradykinin from binding to it, Firazyr treats the symptoms of an acute episodic attack of HAE. It does not cure HAE.
Firazyr belongs to the drug class called hereditary angioedema agents.
How quickly does it work?
Clinical trials report that Firazyr takes an average of 2 to 2.5 hours to relieve symptoms of HAE.
- 92.4% of attacks were treated with a single dose of Firazyr.
Firazyr side effects
The most common side effects of Firazyr are:
- redness, bruising, swelling, warmth, burning, itching, irritation, hives, numbness, pressure, or pain at the injection site
- fever
- too much of an enzyme called transaminase in your blood
- dizziness
- nausea
- headache
- a rash.
Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of this medicine. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Serious side effects and warnings
If you have a laryngeal attack, inject Firazyr and then go to the nearest hospital emergency room right away. Laryngeal attacks can become life-threatening.
Firazyr may cause an allergic reaction with symptoms similar to the signs of hereditary angioedema, such as hives, trouble breathing, or swelling of your face, lips, tongue, or throat.
Do not use more than three Firazyr injections within a 24-hour period. Call your doctor if your symptoms do not improve, or if they get worse after using this medication.
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Before taking this medicine
Do not use this medicine if you are allergic to icatibant, Firazyr, or any inactive ingredients in the injection.
Before using Firazyr tell your doctor about all your medical conditions including:
- any allergies
- all medicines you take, including heart or blood pressure medications
- if you are pregnant or intending to become pregnant
- if you are breastfeeding or intending to breastfeed.
Older adults may be more sensitive to the effects of this medicine.
Firazyr is not approved for use by anyone younger than 18 years old.
Pregnancy
It is not known if Firazyr can harm an unborn baby.
Breastfeeding
It is not known if Firazyr passes into breast milk.
How should I use Firazyr?
Read the Instructions for Use at the end of the Firazyr Package Insert for detailed instructions about the
right way to use this medicine.
Use Firazyr exactly as your healthcare provider tells you to.
- Your healthcare provider will prescribe the right dose for you and tell you when to use it.
- You or a caregiver should know how to self-administer this medicine upon recognition of an HAE attack.
- Firazyr is injected under the skin. A healthcare provider will also teach you or a caregiver about how to give the injection.
- If you still have symptoms of angioedema after the first injection, or they come back, you may use another injection after at least 6 hours have passed.
- Do not use more than 3 Firazyr injections within 24 hours.
If you have a laryngeal attack, inject Firazyr and then go to the nearest hospital emergency room right away.
Call your doctor if your symptoms do not improve, or if they get worse after using this medicine.
How to inject a Firazyr injection
Wash your hands with soap and water before preparing your injection.
Prepare an injection only when you are ready to give it. Do not use the medicine if it has changed colors, looks cloudy, or has particles in it. Call your pharmacist for new medicine.
- Remove the prefilled syringe and needle from the carton.
- Twist the needle cap to break the seal. The needle should remain inside the protective needle cap. Screw the needle on the prefilled syringe.
- Choose your injection site. This should be a fold of skin on your stomach, about 2 to 4 inches (5 to 10 cm) below your belly button on either side.
- Do not inject Firazyr into an area that is painful, swollen, scarred, or bruised.
- Clean the site with an alcohol swab and allow it to dry.
- Remove the needle from the needle cap.
- Hold the syringe in your hand between your fingers and thumb.
- Use your other hand to gently pinch up the fold of skin.
- Hold the syringe at a 45 to 90-degree angle to your skin and quickly insert the needle into the skin fold.
- Push the plunger at the top of the syringe for at least 30 seconds until no Firazyr is in the syringe.
- Release the skin fold and gently pull the needle out.
- Dispose of your used prefilled syringe in an FDA-cleared sharps disposal container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
See How do you administer/inject Firazyr for more information.
Each prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.
Dosing information
Usual Adult Dose of Firazyr for Hereditary Angioedema:
- 30 mg subcutaneously once, in the abdominal area.
- Additional injections of 30 mg may be administered at intervals of at least 6 hours.
- Do not administer more than 3 injections in 24 hours.
- Maximum dose: 90 mg/day
What happens if I miss a dose?
Since Firazyr is used when needed, it does not have a daily dosing schedule. Call your doctor if your symptoms do not improve after using this medicine.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include redness, itching, or feeling like you might pass out.
What should I avoid after using Firazyr?
Tiredness, drowsiness, and dizziness can happen in people who take Firazyr. If this happens, do not drive a car, use machinery, or do anything that needs you to be alert.
Storage
Store the prefilled syringe in its original container in a refrigerator or at room temperature. Do not freeze.
What other drugs will affect Firazyr?
Tell your doctor about all your other medicines, especially heart or blood pressure medication.
Other drugs may interact with icatibant, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Firazyr ingredients
Active ingredient: icatibant acetate
Inactive ingredients: sodium chloride (isotonicity reagent), glacial acetic acid (pH adjuster), sodium hydroxide (pH adjuster), and water.
Available as a 10 mg/mL injection.
Who makes Firazyr?
Jerini AG originally developed Firazyre, but Shire Pharmaceuticals later acquired it. Shire was subsequently acquired by Takeda Pharmaceutical Company in 2019.
Takeda's global headquarters are located in Tokyo, Japan, though they have major operational hubs in several countries. Some other notable drugs manufactured by Takeda include:
- Vyvanse (lisdexamfetamine) for ADHD
- Entyvio (vedolizumab) for ulcerative colitis and Crohn's disease
- Advate for hemophilia A
- Ninlaro (ixazomib) for multiple myeloma
- Alunbrig (brigatinib) for non-small cell lung cancer.
Frequently asked questions
References
More about Firazyr (icatibant)
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- Drug class: hereditary angioedema agents
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.