Icatibant

Icatibant is a prescription medication used for the treatment of acute attacks of hereditary angioedema. 

• icatibant is available under the following different brand names: Firazyr, Sajazir

Common side effects of Icatibant include:

• Fever,
• Headache,
• Dizziness,
• Abnormal liver function tests,
• Nausea,
• Rash, and
• Pain, numbness, bruising, redness, swelling, warmth, burning, irritation, hives, itching, or feeling of pressure where the injection was given.

Serious side effects of Icatibant include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat, and
• Severe dizziness

Rare side effects of Icatibant include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Subcutaneous injection, prefilled syringe

• 30 mg (10 mg/mL)

Hereditary Angioedema

Adult dosage

• 3 mL (30 mg) SC in abdominal area
• If the response is inadequate or symptoms recur, additional 30-mg injections may be administered at intervals of at least 6 hours.
• Not to exceed 3 injections/24 hours.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Icatibant has severe interactions with no other drugs.
• Icatibant has serious interactions with the following drugs.
  • axicabtagene ciloleucel
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • idecabtagene vicleucel
  • lisocabtagene maraleucel
  • tisagenlecleucel
• Icatibant has moderate interactions with the following drugs.
  • benazepril
  • captopril
  • enalapril
  • fosinopril
  • isavuconazonium sulfate
  • moexipril
  • ofatumumab SC
  • ozanimod
  • perindopril
  • quinapril
  • ramipril
  • siponimod
  • trandolapril
  • ublituximab
• Iicatibant has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice or health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Icatibant?”

Long-Term Effects

• See “What Are Side Effects Associated with Icatibant?”

Cautions

• Given the potential for airway obstruction during acute laryngeal HAE attacks, advise patients to seek medical attention in an appropriate healthcare facility immediately in addition to treatment with icatibant.
• Advise patients not to drive or use machinery if they feel tired or dizzy.
• Drug interaction overview
• ACE inhibitors
  • Monitor closely.
• Icatibant, a bradykinin B2 receptor antagonist, may attenuate the antihypertensive effect of ACE inhibitors.

Pregnancy and Lactation

• Available data from published literature and pharmacovigilance database use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• Lactation
  • There are no data on the presence of icatibant in human milk, its effects on the breastfed infant, or milk production.
  • The drug and its M2 metabolite were found in rat milk following subcutaneous administration; when a drug is present in animal milk, it is likely drug will be present in human milk; however, systemic absorption in infants is not expected after oral exposure through breast milk.
  • Developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for the drug and any potential adverse effects on the breastfed child from the drug or underlying maternal condition.