KALBITOR

Generic Name/API: ecallantide

Manufacturer: Takeda Pharmaceuticals U.S.A.

Dosage Forms & Strength & Pack Size:
Single use glass vial containing 10 mg/mL of ecallantide as a solution for
injection. NDC (47783-101-01): 3 single-use vials in 1 carton

Storage:
KALBITOR should be kept refrigerated (2ºC to 8ºC/36ºF to 46ºF). Vials removed from
refrigeration should be stored below 86ºF/30ºC and used within 14 days or returned to
refrigeration until use.
Protect vials from light until use.
Do not use beyond the expiration date.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS
KALBITOR® 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.

Important Safety Information

What is the most important information I should know about KALBITOR?
Serious allergic reactions may happen in some people who receive KALBITOR. These allergic reactions can be life-threatening and usually happen within 1 hour after receiving KALBITOR.

KALBITOR should be given to you by a doctor or nurse in a healthcare setting where serious allergic reactions and hereditary angioedema (HAE) can be treated.
Symptoms of a serious allergic reaction to KALBITOR can be similar to the symptoms of HAE, the condition that you are being treated for. Your doctor or nurse should watch you for any signs of a serious allergic reaction after treatment with KALBITOR.
Tell your doctor or nurse right away if you have any of these symptoms of a serious allergic reaction during or after treatment with KALBITOR:
wheezing, shortness of breath, cough, chest tightness, or trouble breathing
dizziness, fainting, fast or weak heartbeat, or feeling nervous
reddening of the face, itching, hives, or feeling warm
swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing
runny nose, nasal congestion, or sneezing
Who should not receive KALBITOR?
Do not receive KALBITOR if you are allergic to KALBITOR. Before receiving KALBITOR, tell your doctor if you have ever had an allergic reaction to KALBITOR.

What else should I tell my doctor before I receive KALBITOR?
Tell your doctor if you are pregnant, plan to become pregnant, breast-feeding, or plan to breast-feed. It is not known if KALBITOR will harm your unborn baby or pass into your breast milk.

Tell your doctor about all the medicines you take, including prescriptions and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects?
Common side effects of KALBITOR include headache, nausea, diarrhea, fever, injection site reactions, such as redness, rash, swelling, itching, or bruising, and stuffy nose. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Talk to your doctor for more information about your medical condition or treatment.

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