"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"...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
ECALLANTIDE - INJECTION
COMMON BRAND NAME(S): Kalbitor
WARNING: Ecallantide may infrequently cause serious (rarely fatal) allergic reactions. Patients who experience a severe allergic reaction with this drug must never use it again. Because the symptoms can be the same for an allergic reaction and the condition which this medication treats, you will be monitored closely by your healthcare providers as you receive this medication in a clinic or hospital. Immediate medical attention should be provided if you develop any signs of an allergic reaction such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, or chest pain.
USES: This medication is used to treat an acute attack of a certain immune disease passed down through families (hereditary angioedema-HAE). Ecallantide blocks a natural substance produced by the body (kallikrein) which acts to increase amounts of another natural substance (bradykinin) thought to cause the symptoms seen during an acute attack of HAE. This medication does not cure HAE. Ecallantide may lessen the symptoms during an acute attack of HAE such as rapid swelling and pain of the hands, feet, limbs, face, tongue, or throat. When attacks involve the intestines, symptoms may include abdominal pain/cramps, diarrhea or vomiting. Attacks of swelling may occur without reason. However, anxiety, stress, sickness, and surgery may trigger attacks in some people.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using ecallantide and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Your healthcare provider will inject this medication under your skin either in the abdomen, thigh, or upper arms as directed by your doctor. You will receive three separate shots which should be separated by at least 2 inches (5 centimeters). An additional three shots may be given in a 24-hour period if the HAE attack continues.
Do not receive an injection into skin that is tender, red, or hard.
Dosage is based on your medical condition and response to treatment.
Tell your doctor if your condition does not improve or if it worsens.
Additional Kalbitor Information
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