Kalbitor Injection

Kalbitor (ecallantide) is a prescription medicine used to treat sudden attacks of hereditary angioedema (HAE) in people 12 years of age and older. Kalbitor is not a cure for HAE. It is not known if Kalbitor is safe and effective in children under 12 years of age.

WARNING

ANAPHYLAXIS

Anaphylaxis (serious allergic reaction) has been reported after administration of Kalbitor. Because of the risk of anaphylaxis, Kalbitor should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema.

Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. Do not administer Kalbitor to patients with known clinical hypersensitivity to Kalbitor.

Common side effects of Kalbitor include:

• headache
• nausea
• diarrhea
• fever
• injection site reactions, such as redness, rash, swelling, itching, or bruising
• stuffy nose

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

Recommended Dosing

• The recommended dose of Kalbitor is 30 mg (3 mL), administered subcutaneously in three 10 mg (1 mL) injections.
• If the attack persists, an additional dose of 30 mg may be administered within a 24 hour period.

Administration Instructions

• Kalbitor should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema.
• Kalbitor should be refrigerated and protected from the light. Kalbitor is a clear, colorless liquid; visually inspect each vial for particulate matter and discoloration prior to administration. If there is particulate matter or discoloration, the vial should not be used.
• Using aseptic technique, withdraw 1 mL (10 mg) of Kalbitor from the vial using a large bore needle.
  • Change the needle on the syringe to a needle suitable for subcutaneous injection.
  • The recommended needle size is 27 gauge. Inject Kalbitor into the skin of the abdomen, thigh, or upper arm.
  • Repeat the procedure for each of the 3 vials comprising the Kalbitor dose.
  • The injection site for each of the injections may be in the same or in different anatomic locations (abdomen, thigh, upper arm).
  • There is no need for site rotation. Injection sites should be separated by at least 2 inches (5 cm) and away from the anatomical site of attack.
• The same instructions apply to an additional dose administered within 24 hours.
• Different injection sites or the same anatomical location (as used for the first administration) may be used.

• The available data from the pharmacovigilance database for Kalbitor have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
• There are no data on the presence of ecallantide in human milk, the effects on the breastfed infant, or the effects on milk production.
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Kalbitor and any potential adverse effects on the breastfed child from Kalbitor or from the underlying maternal condition.