Firazyr

Generic Name: icatibant (Subcutaneous route)

eye-KA-ti-bant

Commonly used brand name(s)

In the U.S.

• Firazyr

Available Dosage Forms:

• Solution

Uses For Firazyr

Icatibant injection is used to treat sudden attacks of hereditary angioedema (HAE). Icatibant works by blocking a chemical in the body that causes swelling, inflammation, and pain for patients with HAE. This medicine is not a cure for HAE.

This medicine is available only with your doctor's prescription.

Before Using Firazyr

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of icatibant injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of icatibant injection in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Captopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Firazyr

A nurse or other trained health professional will give you this medicine in a hospital or emergency clinic. This medicine is given as a shot under your skin, usually in the abdomen or stomach.

This medicine may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

To use:

• Wash your hands with soap and water before and after using this medicine.


• Remove the prefilled syringe and needle from the carton.


• Check the liquid in the prefilled syringe. It should be clear and colorless. If the liquid is cloudy, discolored, or contains particles, do not use it. Select another syringe.


• Remove the seal from the needle cap. Use the needle only when you are ready to use it.


• Firmly screw the provided needle on the syringe. Do not use a different needle.


• Choose an injection site on your body (e.g., abdomen or stomach area). Do not choose an area that is bruised, painful, or swollen. Clean the injection site with a fresh alcohol wipe, and let it dry.


• Remove the needle cap by pulling the syringe. Be careful not to pull up on the plunger.


• With two fingers, pinch together the skin at the injection site. Use your other hand to quickly insert the needle.


• Push the plunger for at least 30 seconds until no medicine is left in the syringe.


• Release your fingers at the injection site and gently pull the needle out.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  • For attacks of hereditary angioedema:
    
    • Adults—30 milligrams (mg) or 3 milliliters (mL) injected under your skin. Your doctor may give you or tell you to use an additional dose after 6 hours if your symptoms continue or come back. Do not use more than 3 doses in 24 hours.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

You may store this medicine in the refrigerator or at room temperature. Store the medicine in the original carton until you are ready to use it. Do not freeze.

Throw away used prefilled syringe with the needle attached in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using Firazyr

It is very important that your doctor check your progress closely to make sure that this medicine is working properly and to decide if you should continue to receive it.

During a laryngeal (throat) HAE attack, you may have shortness of breath or troubled breathing. If you have a laryngeal HAE attack, inject this medicine and go to the nearest hospital or emergency clinic right away.

This medicine may cause severe tenderness and pain at the site of injection. Contact your doctor right away if you notice any of these side effects at the injection site: bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth.

This medicine may make you dizzy, drowsy, or tired. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Firazyr Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Fever

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Less common

• Dizziness

Incidence not known

• Headache


• nausea


• rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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