Icatibant

Dosage Forms & Strengths

SC injection, prefilled syringe

• 30mg (10 mg/mL)

Hereditary Angioedema

Bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE)

3 mL (30 mg) SC in abdominal area

If response inadequate or symptoms recur, additional injection of 30 mg may be administered at intervals of at least 6 hr

Do not exceed a total of 3 injections/24 hr

Dosage Modifications

Hepatic or renal impairment: No dosage adjustment required

<18 years: Safety and efficacy not established

Limited information is available for patients >65 years old

Increased Cmax and AUC in elderly patients (particularly women) have been observed

Differences in efficacy and safety between elderly and younger patients have not been identified, no dose adjustment recommended

Hereditary Angioedema

Bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE)

3 mL (30 mg) SC in abdominal area

If response inadequate or symptoms recur, additional injection of 30 mg may be administered at intervals of at least 6 hr

Do not exceed a total of 3 injections/24 hr

Contraindications

Hypersensitivity

Cautions

Given the potential for airway obstruction during acute laryngeal HAE attacks, patients should be advised to seek medical attention in an appropriate healthcare facility immediately in addition to treatment

Patients should be advised not to drive or use machinery if they feel tired or dizzy

Report suspected adverse reactions to Shire Human Genetic Therapies at OnePath phone # 1-866-888-0660 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Icatibant 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.

Icatibant is part of the drug class:

• Drugs used in hereditary angioedema

• Use icatibant exactly as your healthcare provider tells you to use it.
• Your healthcare provider will prescribe the right dose of icatibant for you and tell you when to use it.
• Your healthcare provider will teach you or a caregiver how to give icatibant injections.
• 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.

Step-by-Step Instructions for your icatibant injection

Step 1. Preparing your dose of icatibant

• Wash your hands with soap and water.
• You will need the following supplies:
  • Your icatibant carton that includes 1 single-use icatibant prefilled syringe and 1 needle.
  • An alcohol wipe
  • The medicine inside your icatibant prefilled syringe should be clear and colorless. Do not use your icatibant 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 icatibant 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 icatibant injection site with an alcohol wipe and allow it to dry.

Injecting your icatibant

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 icatibant 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 icatibant is in the syringe.

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

Disposal of your used icatibant prefilled syringe

Step 15. Place the used icatibant 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.

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

Icatibant is used to treat attacks of hereditary angioedema (an immune system disorder). This medication is used in people who are at least 18 years old.

Icatibant is not a cure for hereditary angioedema.

Icatibant may also be used for purposes not listed in this medication guide.

• It is used to treat swelling attacks in people with hereditary angioedema (HAE).

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take icatibant or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to icatibant. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

(eye KAT i bant)

Icatibant is a selective competitive antagonist for the bradykinin B2 receptor. Patients with HAE have an absence or dysfunction of C1-esterase-inhibitor which leads to the production of bradykinin. The presence of bradykinin may cause symptoms of localized swelling, inflammation, and pain. Icatibant inhibits bradykinin from binding at the B2 receptor, thereby treating the symptoms associated with acute attack.

Distribution

Vdss: 20.3 to 37.7 L

Metabolism

Metabolized by proteolytic enzymes to metabolites (inactive)

Excretion

Urine (<10% unchanged)

Inhibits symptoms caused by bradykinin for ~6 hours

Half-Life Elimination

1 to 1.8 hours

Data not available

Administration advice:
-Initial treatment should be given under the guidance of a physician in a medical institution. Patients may self-administer this drug after initial training.
-Attach the provided 25 gauge needle to the syringe hub and screw on securely. Do not use a different needle.
-Disinfect the injection site and administer by subcutaneous injection over at least 30 seconds.

Storage requirements:
-Store between 2 and 25C (36 to 77F). Do not freeze.
-Store in carton until time of administration.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

Patient advice:
-Advise patients to seek medical attention immediately if laryngeal symptoms occur.
-In case of insufficient relief or recurrence after self-treatment, patients should seek medical attention.
-Injection site reactions are reported in most patients after administration of this drug.
-Advise patients not to drive or use machinery if they feel tired or dizzy.