"FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit. There are no"...
- Patient Information:
Details with Side Effects
Hypersensitivity Reactions, Including Anaphylaxis
Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with KALBITOR (ecallantide injection) . In 255 HAE patients treated with intravenous or subcutaneous KALBITOR (ecallantide injection) in clinical studies, 10 patients (3.9%) experienced anaphylaxis. For the subgroup of 187 patients treated with subcutaneous KALBITOR (ecallantide injection) , 5 patients (2.7%) experienced anaphylaxis. Symptoms associated with these reactions have included chest discomfort, flushing, pharyngeal edema, pruritus, rhinorrhea, sneezing, nasal congestion, throat irritation, urticaria, wheezing, and hypotension. These reactions occurred within the first hour after dosing.
Other adverse reactions indicative of hypersensitivity reactions included the following: pruritus (5.1 %), rash (3.1 %), and urticaria (2.0%).
Patients should be observed for an appropriate period of time after administration of KALBITOR (ecallantide injection) , taking into account the time to onset of anaphylaxis seen in clinical trials. Given the similarity in hypersensitivity symptoms and acute HAE symptoms, patients should be monitored closely in the event of a hypersensitivity reaction.
KALBITOR (ecallantide injection) should not be administered to any patients with known clinical hypersensitivity to KALBITOR [see CONTRAINDICATIONS].
Patient Counseling Information
- Patients should be advised that KALBITOR (ecallantide injection) may cause anaphylaxis and other hypersensitivity reactions. Patients should be advised that KALBITOR (ecallantide injection) should be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Patients who have known clinical hypersensitivity to KALBITOR (ecallantide injection) should be instructed not to receive additional doses of KALBITOR. [see BOXED WARNING, CONTRAINDICATIONS, and WARNINGS AND PRECAUTIONS]
- Patients should be advised to consult the Medication Guide for additional information regarding the risk of anaphylaxis and other hypersensitivity reactions.
Carcinogenesis, Mutagenesis, Impairment of Fertility
There are no animal or human studies to assess the carcinogenic or mutagenic potential of KALBITOR (ecallantide).
KALBITOR (ecallantide injection) had no effects on fertility and reproductive performance in rats at subcutaneous doses up to 25 mg/kg/day (approximately 21 times the MRHD on a mg/kg basis).
Use In Specific Populations
Pregnancy Category C
There are no adequate and well-controlled trials of KALBITOR (ecallantide injection) in pregnant women. KALBITOR (ecallantide injection) has been shown to cause developmental toxicity in rats, but not rabbits. Because animal reproductive studies are not always predictive of human response, KALBITOR (ecallantide injection) should be used during pregnancy only if clearly needed.
In rats, intravenous KALBITOR (ecallantide injection) at an intravenous dose approximately 13 times the maximum recommended human dose (MRHD) on a mg/kg basis caused increased numbers of early resorptions and percentages of resorbed conceptuses per litter in the presence of mild maternal toxicity. No development toxicity was observed in rats that received an intravenous dose approximately 8 times the MRHD on a mg/kg basis. There were no adverse effects of KALBITOR (ecallantide injection) on embryofetal development in rats that received subcutaneous doses up to approximately 2.4 times the MRHD on an AUC basis, and in rabbits that received intravenous doses up to approximately 6 times the MRHD on an AUC basis.
Labor and Delivery
No information is available on the effects of KALBITOR (ecallantide injection) during labor and delivery.
It is not known whether ecallantide is excreted in human milk. Caution should be exercised when ecallantide is administered to a nursing woman.
Safety and effectiveness of KALBITOR (ecallantide injection) in patients below 16 years of age have not been established.
Clinical trials of KALBITOR (ecallantide injection) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Last reviewed on RxList: 12/14/2009
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.
Find out what women really need.