Drug Information

Kalbitor

What is KALBITOR?

(KALBITOR) 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 should I use KALBITOR?

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.

What should I tell my health care provider before I take 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 unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

What may interact with KALBITOR?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

What should I watch for while using KALBITOR?

Ecallantide may rarely 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.

What if I miss a dose of KALBITOR?

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

What side effects may I notice from receiving KALBITOR?

See also Warning section. Bruising, itching, redness, swelling of the skin at the injection site may occur. Nausea, fever, or stuffy nose may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Where should I keep KALBITOR?

Not applicable. This medication is given in a clinic and will not be stored at home.

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