Firazyr

Firazyr is a prescription medication used to treat attacks of hereditary angioedema (HAE), an immune system disorder, in adults 18 years and older. Firazyr belongs to a group drugs called bradykinin B2 receptor antagonists. It works by blocking bradykinin, a substance which is believed to be responsible for the HAE symptoms of inflammation, swelling, and pain.

Firazyr is a prescription medication used to treat attacks of hereditary angioedema (HAE), an immune system disorder, in adults 18 years and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Shire Orphan Therapies, Inc.

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.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take an ACE inhibitor. The following is a list of available ACE inhibitors:

• benazepril (Lotensin)
• captopril (Capoten)
• enalapril (Vasotec)
• fosinopril (Monopril)
• lisinopril (Prinivil, Zestril)
• moexipril (Univasc)
• perindopril (Aceon)
• quinapril (Accupril)
• ramipril (Altace)
• trandolapril (Mavik)

This is not a complete list of Firazyr drug interactions. Ask your doctor or pharmacist for more information.

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.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Firazyr there are no specific foods that you must exclude from your diet when receiving this medication.

Before you use Firazyr, tell your healthcare provider if you:

• have any other medical conditions.
• are breastfeeding or plan to breastfeed. 
• are pregnant or plan to become pregnant. 

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Firazyr falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

It is not known if Firazyr crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using 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.
• 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.

Step-by-Step Instructions for your Firazyr injection

Step 1. Preparing your dose of Firazyr 

• Wash your hands with soap and water.
• You will need the following supplies:
  • Your Firazyr carton that includes 1 single-use Firazyr prefilled syringe and 1 needle.
  • An alcohol wipe
  • The medicine inside your Firazyr prefilled syringe should be clear and colorless. Do not use your Firazyr prefilled syringe if the solution contains particles, is cloudy, or an unusual color.

Step 2. Remove the prefilled syringe and needle from the carton.

Step 3. Remove the seal from the needle cap (the needle should remain inside the protective needle cap until ready to use).

Step 4. Hold the syringe firmly. Carefully attach the needle to the prefilled syringe containing the colorless Firazyr solution. 

Step 5. Firmly screw the needle on the prefilled syringe. Be careful not to remove the needle from the needle cap.

Step 6. Choose the injection site. The injection site 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. 

The area you choose for injection should be at least 2 inches (5 cm) away from any scars. Do not choose an area that is bruised, swollen, or painful.

Step 7. Clean your Firazyr injection site with an alcohol wipe and allow it to dry.

Injecting your Firazyr 

Step 8. Remove the needle from the needle cap by holding the needle cap and carefully pulling the syringe. Do not pull up on the plunger. 

Step 9. Hold the Firazyr prefilled syringe in 1 hand, between your fingers and thumb.

Step 10. Use your other hand to gently pinch the fold of skin you cleaned with the alcohol wipe between your thumb and fingers for your injection. 

Step 11. Hold the syringe between a 45 to 90 degree angle to your skin with the needle facing the fold of skin you are holding.

Step 12. Hold the fold of skin. Bring the syringe to the skin and quickly insert the needle into the skin fold.

Step 13. Push the plunger, at the top of the syringe, over at least 30 seconds until no Firazyr is in the syringe.

Step 14. Release the skin fold and gently pull the needle out.

Disposal of your used Firazyr prefilled syringe

Step 15. Place the used Firazyr syringe with the needle attached, in a sharps container (such as a red biohazard container), a hard, plastic container, (such as a detergent bottle), or a metal container (such as an empty coffee can). Seal the container and throw it away the right way. There may be state and local laws about the right way to throw away used syringes and needles. Ask your healthcare provider or pharmacist how to throw away used syringes and needles.

The recommended dose of Firazyr is 30 mg administered by subcutaneous injection (under the skin) in the abdominal area. Additional doses may be administered at intervals of at least 6 hours if response is inadequate or if symptoms recur. No more than 3 doses may be administered in any 24 hour period.

If you take too much Firazyr, call your local Poison Control Center or seek emergency medical attention right away.

• 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.