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FIRAZYR- icatibant acetate injection, solution


  1. What Is Icatibant Injection?
  2. Before You Use Icatibant Injection, Tell Your Healthcare Provider If You:
  3. How Should I Use Icatibant Injection?
  4. What Should I Avoid While Using Icatibant Injection?
  5. The Most Common Side Effects Of Icatibant Injection Include:
  6. How Should I Store Icatibant Injection?
  7. Active Ingredient:
  8. Inactive Ingredients:
  9. What Is Firazyr?
  10. Before You Use Firazyr, Tell Your Healthcare Provider If You:
  11. How Should I Use Firazyr?
  12. What Should I Avoid While Using Firazyr?
  13. The Most Common Side Effects Of Firazyr Include:
  14. How Should I Store Firazyr?
  15. Patient Information

What Is Icatibant Injection? 

Icatibant injection is a medicine used to treat acute attacks of hereditary angioedema (HAE) in adults 18 years and older. It is not known if icatibant injection is safe or effective for children under 18 years of age.

Before You Use Icatibant Injection, Tell Your Healthcare Provider If You: 

  • have any other medical conditions.
  • are breastfeeding or plan to breastfeed. It is not known if icatibant passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use icatibant injection.
  • are pregnant or plan to become pregnant. It is not known if icatibant will harm your unborn baby. You and your healthcare provider will decide if icatibant injection is right for you.

Tell your healthcare provider about all the medicines you take,including prescription and non-prescription medicines, vitamins, and herbal supplements.

How Should I Use Icatibant Injection? 

  • Use icatibant injection exactly as your healthcare provider tells you to use it.
  • Your healthcare provider will prescribe the right dose of icatibant injection for you and tell you when to use it.
  • Your healthcare provider will teach you or a caregiver how to give icatibant injections
  • Read the Instructions for Use at the end of the Patient Information for information about the right way to use icatibant injection.
  • If your symptoms continue or come back, you may repeat your icatibant injection at least six hours apart.
  • Do not use more than 3 doses in 24 hours.
  • If you have a laryngeal attack,inject icatibant and then go to the nearest hospital emergency room right away.

What Should I Avoid While Using Icatibant Injection? 

Tiredness, drowsiness, and dizziness can occur in people who take icatibant injection. If this occurs, do not drive a car, use machinery, or do anything that needs you to be alert.

The Most Common Side Effects Of Icatibant Injection Include: 

  • 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
  • rash

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of icatibant injection. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store Icatibant Injection? 

  • Store icatibant between 36 F to 77 F (2 C to 25 C).
  • Do not freeze.
  • Store icatibant in the original carton until you are ready to use it.

Keep icatibant injection and all medicines out of the reach of children.

General information about the safe and effective use of icatibant injection

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use icatibant injection for a condition for which it was not prescribed. Do not give icatibant injection to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about icatibant injection. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about icatibant injection that is written for health professionals.

For more information, call 1-800-828-2088.

Active Ingredient: 

icatibant acetate

Inactive Ingredients: 

sodium chloride, glacial acetic acid, sodium hydroxide, and water

What Is Firazyr? 

FIRAZYR is a medicine used to treat acute attacks of hereditary angioedema (HAE) in adults 18 years and older. It is not known if FIRAZYR is safe or effective for children under 18 years of age.

Before You Use Firazyr, Tell Your Healthcare Provider If You: 

  • have any other medical conditions.
  • are breastfeeding or plan to breastfeed. It is not known if FIRAZYR passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use FIRAZYR.
  • are pregnant or plan to become pregnant. It is not known if FIRAZYR will harm your unborn baby. You and your healthcare provider will decide if FIRAZYR is right for you.

Tell your healthcare provider about all the medicines you take,including prescription and non-prescription medicines, vitamins, and herbal supplements.

How Should I Use Firazyr? 

  • Use FIRAZYR exactly as your healthcare provider tells you to use it.
  • Your healthcare provider will prescribe the right dose of FIRAZYR for you and tell you when to use it.
  • Your healthcare provider will teach you or a caregiver how to give FIRAZYR injections
  • Read the Instructions for Use at the end of the Patient Information for information about the right way to use FIRAZYR.
  • If your symptoms continue or come back, you may repeat your FIRAZYR injection at least six hours apart.
  • Do not use more than 3 doses in 24 hours.
  • If you have a laryngeal attack,inject FIRAZYR and then go to the nearest hospital emergency room right away.

What Should I Avoid While Using Firazyr? 

Tiredness, drowsiness, and dizziness can occur in people who take FIRAZYR. If this occurs, do not drive a car, use machinery, or do anything that needs you to be alert.

The Most Common Side Effects Of Firazyr Include: 

  • 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
  • rash

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of FIRAZYR. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store Firazyr? 

  • Store FIRAZYR between 36 F to 77 F (2 C to 25 C).
  • Do not freeze.
  • Store FIRAZYR in the original carton until you are ready to use it.

Keep FIRAZYR and all medicines out of the reach of children.

General information about the safe and effective use of FIRAZYR

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use FIRAZYR for a condition for which it was not prescribed. Do not give FIRAZYR to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about FIRAZYR. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about FIRAZYR that is written for health professionals.

For more information, go to www.FIRAZYR.com or call 1-800-828-2088.

Patient Information 

See FDA-approved patient labeling (Patient InformationandInstructions for Use).

17.1 Information for Patients

Patients may self-administer icatibant injection upon recognition of an HAE attack after training under the guidance of a healthcare professional.

Patients with laryngeal symptoms should seek medical attention immediately in an appropriate healthcare facility after administration of icatibant injection [seeWarnings and Precautions (5.1)].

Injection site reactions are reported in most patients after administration of icatibant injection. Other adverse reactions reported after administration of icatibant injection include pyrexia, increase in transaminases, dizziness, and rash [seeAdverse Reactions (6.1)].

Tiredness, drowsiness, and dizziness have been reported following the use of icatibant injection. Patients should be advised not to drive or use machinery if they feel tired or dizzy.

Manufactured for:
Shire Orphan Therapies LLC, a Takeda company
300 Shire Way
Lexington, MA 02421

SHIRE and the Shire Logo are trademarks or registered trademarks of members of the Shire group of companies, now part of Takeda.

2019 Takeda Pharmaceutical Company Limited. All rights reserved.



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