Ecallantide

Ecallantide Injection is a prescription medication used for the treatment of acute attacks of hereditary angioedema (HAE). 

• Ecallantide is available under the following different brand names: Kalbitor.

Common side effects of Ecallantide include:

• Headache,
• Nausea,
• Diarrhea,
• Fever,
• Stuffy nose,
• Sore throat, and
• Skin reactions where the medicine was injected (redness, rash, itching, bruising, swelling)

Serious side effects of Ecallantide include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Chest pain or tightness,
• Fast or weak heartbeat,
• Wheezing,
• Cough,
• Throat irritation,
• Hoarse voice,
• Tight feeling in the throat,
• Swelling or redness in the face,
• Itching,
• Rash,
• Flushing (warmth, redness, or tingly feeling),
• Sneezing,
• Runny or stuffy nose,
• Dizziness, and
• Lightheadedness

Rare side effects of Ecallantide 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, coordination loss, 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 and pediatric dosage

Injectable solution

• 10 mg/mL (3 mL, single-dose vial)

Hereditary Angioedema

Adult dosage

• 30 mg (3 mL) subcutaneously administered in 3 separate 10 mg (1 mL) injections.
• If the attack persists, may administer an additional dose of 30 mg within 24 hours.

Pediatric dosage

• Children aged below 12 years: Safety and efficacy not established.
• Children aged 12 years and above: As adults; 30 mg (3 mL) subcutaneous was administered in 3 separate 10 mg (1 mL) injections.
• If the attack persists, may administer an additional 30 mg dose within 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.

• Ecallantide has severe interactions with no other drugs.
• Ecallantide has serious interactions with the following drugs:
  • axicabtagene ciloleucel
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • idecabtagene vicleucel
  • lisocabtagene maraleucel
  • tisagenlecleucel
• Ecallantide has moderate interactions with the following drugs:
  • isavuconazonium sulfate
  • ublituximab
• Ecallantide 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 the products you use. 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

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Risk of potentially serious hypersensitivity reactions, including anaphylaxis; observe patients for an appropriate period after administration; do not administer to patients with known hypersensitivity to Ecallantide (see Contraindications and Black Box Warnings)

Pregnancy and Lactation

• Available data have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Lactation
  • No data available on the presence of human milk, its effects on breastfed infants, effects on milk production