Icatibant Subcutaneous

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. icatibant is not a cure for HAE.

icatibant is available only with your doctor's prescription.

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 icatibant, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to icatibant 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

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 icatibant, 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 icatibant 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.

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

icatibant may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using icatibant 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.

icatibant 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 icatibant.
• 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 icatibant 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 icatibant. 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 icatibant 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.

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:

• 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:

• 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

• Dizziness

• 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.

Icatibant is used to treat sudden attacks of a certain immune system condition passed down through families called hereditary angioedema (HAE). Although this medication is not a cure for HAE, icatibant may lessen the symptoms of an attack such as rapid swelling and pain of the hands, arms, feet, legs, face, tongue, and upper airway. When attacks involve the stomach/intestines, symptoms may include abdominal pain/cramps, diarrhea, constipation, or vomiting. Attacks may happen at any time. However, stress, injury, or illness may trigger attacks in some people.

Icatibant works by blocking the action of a natural substance in the body called bradykinin. Bradykinin is thought to cause the symptoms of an HAE attack.

How to use Icatibant Syringe

Read the Patient Information Leaflet before you start using icatibant and each time you get a refill. If you are giving this medication to yourself at home, learn all preparation and usage instructions in the product package and from your health care professional. Your health care professional will also teach you how to recognize the symptoms of a sudden attack of HAE. If any of the information is unclear, consult your health care professional.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.

Inject this medication under the skin in the stomach/abdominal area as directed by your doctor, usually over at least 30 seconds. If your symptoms continue or come back, you may give another dose after at least 6 hours. Do not use more than 3 doses in 24 hours.

If you have a sudden HAE attack of your throat area/voice box/upper airway (larynx), give yourself an injection of icatibant and then get medical help right away. This type of attack may lead to a blocked airway and serious breathing trouble.

Learn how to store and discard medical supplies safely.

Tell your doctor if your symptoms do not improve or if they worsen.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Missed Dose

Not applicable.

Storage

Store at room temperature in a cool place or in the refrigerator. Do not freeze. Store this drug in the manufacturer's carton until you are ready to use it. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.