"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(ecallantide) Injection, for Subcutaneous Use
Anaphylaxis 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. [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS]
KALBITOR (ecallantide) is a human plasma kallikrein inhibitor for injection for subcutaneous use. Ecallantide is a 60-amino-acid protein produced in Pichia pastoris yeast cells by recombinant DNA technology.
KALBITOR is a clear and colorless, sterile, and nonpyrogenic solution. Each vial contains 10 mg ecallantide as the active ingredient, and the following inactive ingredients: 0.76 mg disodium hydrogen orthophosphate (dihydrate), 0.2 mg monopotassium phosphate, 0.2 mg potassium chloride, and 8 mg sodium chloride in water for injection, USP. KALBITOR is preservative free, with a pH of approximately 7.0. A 30 mg dose is supplied as 3 vials each containing 1 mL of 10 mg/mL KALBITOR. Vials are intended for single use.
What are the possible side effects of ecallantide (Kalbitor)?
Tell your caregivers right away if you have any of these signs of an allergic reaction within 1 hour after receiving ecallantide:
- chest pain or discomfort, fast or weak heartbeat;
- flushing (warmth, redness, or tingly feeling);
- feeling like you might pass out;
- itching, rash, or hives;
- runny nose, sneezing, stuffy nose;
- wheezing, cough, throat irritation, trouble breathing; or
- swelling of your face, lips, tongue, or throat.
An allergic reaction to ecallantide can cause symptoms that are very similar to the signs of...
What are the precautions when taking ecallantide injection (Kalbitor)?
Before using ecallantide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk. Consult your doctor before...
Last reviewed on RxList: 9/18/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Kalbitor Information
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.
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