Recommended Topic Related To:

Kalbitor

"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...

Kalbitor

Indications
Dosage
How Supplied

INDICATIONS

KALBITOR® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

Dosage Forms And Strengths

KALBITOR is a clear, colorless liquid free of preservatives. Each vial of KALBITOR contains ecallantide at a concentration of 10 mg/mL.

Storage And Handling

KALBITOR (ecallantide) is supplied as three 10 mg/mL single-use vials packaged in a carton. Each vial contains 10 mg of ecallantide. Each vial contains a slight overfill.

NDC (47783-101-01): 3 single-use vials in 1 carton

KALBITOR should be kept refrigerated (2°C to 8°C/36°F to 46°F). Vials removed from refrigeration should be stored below 86°F/30°C and used within 14 days or returned to refrigeration until use.

Protect vials from light until use.

Do not use beyond the expiration date.

Manufactured for: Dyax Corp. 55 Network Drive, Burlington, MA 01803. Revised: 09/2014

Last reviewed on RxList: 9/18/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.