Ecallantide
Generic Name: ecallantide
Brand Names:
Kalbitor
11 DESCRIPTION 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.
Overview
11 DESCRIPTION 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.
Uses
1 INDICATIONS AND USAGE KALBITOR ® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older. KALBITOR is a plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION 30 mg (3 mL), administered subcutaneously in three 10 mg (1 mL) injections. If an attack persists, an additional dose of 30 mg may be administered within a 24 hour period. ( 2.1 ) KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. ( 2.2 ). 2.1 Recommended Dosing The recommended dose of KALBITOR is 30 mg (3 mL), administered subcutaneously in three 10 mg (1 mL) injections. If the attack persists, an additional dose of 30 mg may be administered within a 24 hour period. 2.2 Administration Instructions KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema.
Side Effects
6 ADVERSE REACTIONS Hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with KALBITOR [ see Contraindications (4) and Warnings and Precautions (5.1) ]. The most common adverse reactions occurring in ≥3% of KALBITOR-treated patients and greater than placebo are headache, nausea, diarrhea, pyrexia, injection site reactions, and nasopharyngitis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A., Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS No formal drug interactions studies were performed. No in vitro metabolism studies were performed.
Warnings
WARNING: ANAPHYLAXIS 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. 5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Including Anaphylaxis: Anaphylaxis has occurred in 4% of treated patients. Administer KALBITOR in a setting equipped to manage anaphylaxis and hereditary angioedema. Given the similarity in hypersensitivity symptoms and acute HAE symptoms, monitor patients closely for hypersensitivity reactions ( 5 ). 5.1 Hypersensitivity Reactions, Including Anaphylaxis Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with KALBITOR. In 255 HAE patients treated with intravenous or subcutaneous KALBITOR in clinical studies, 10 patients (4%) experienced anaphylaxis. For the subgroup of 187 patients treated with subcutaneous KALBITOR, 5 patients (3%) experienced anaphylaxis. 4 CONTRAINDICATIONS Do not administer KALBITOR to a patient who has known clinical hypersensitivity to KALBITOR. [ see Warnings and Precautions (5.1) ]. Do not administer KALBITOR to a patient who has known clinical hypersensitivity to KALBITOR. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary The available data from the pharmacovigilance database for KALBITOR have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In an animal reproduction study, increased early fetal deaths resulting in decreased live fetuses were observed in rats following treatment during the period of organogenesis at an intravenous dose approximately 1.6 times the maximum recommended human dose (MRHD) in the presence of maternal toxicity.
Storage
KALBITOR should be kept refrigerated (2°C to 8°C/36°F to 46°F). Vials removed from refrigeration should be stored below 86°F/30°C and used within 14 days or returned to refrigeration until use. Protect vials from light until use. Do not use beyond the expiration date.
Frequently Asked Questions
What is Ecallantide used for?▼
1 INDICATIONS AND USAGE KALBITOR ® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older. KALBITOR is a plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older. ( 1 )
What are the side effects of Ecallantide?▼
6 ADVERSE REACTIONS Hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with KALBITOR [ see Contraindications (4) and Warnings and Precautions (5.1) ]. The most common adverse reactions occurring in ≥3% of KALBITOR-treated patients and greater than placebo are headache, nausea, diarrhea, pyrexia, injection site reactions, and nasopharyngitis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A., Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Ecallantide during pregnancy?▼
8.1 Pregnancy Risk Summary The available data from the pharmacovigilance database for KALBITOR have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In an animal reproduction study, increased early fetal deaths resulting in decreased live fetuses were observed in rats following treatment during the period of organogenesis at an intravenous dose approximately 1.6 times the maximum recommended human dose (MRHD) in the presence of maternal toxicity.
What are the important warnings for Ecallantide?▼
WARNING: ANAPHYLAXIS 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. 5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Including Anaphylaxis: Anaphylaxis has occurred in 4% of treated patients. Administer KALBITOR in a setting equipped to manage anaphylaxis and hereditary angioedema. Given the similarity in hypersensitivity symptoms and acute HAE symptoms, monitor patients closely for hypersensitivity reactions ( 5 ). 5.1 Hypersensitivity Reactions, Including Anaphylaxis Potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with KALBITOR. In 255 HAE patients treated with intravenous or subcutaneous KALBITOR in clinical studies, 10 patients (4%) experienced anaphylaxis. For the subgroup of 187 patients treated with subcutaneous KALBITOR, 5 patients (3%) experienced anaphylaxis. 4 CONTRAINDICATIONS Do not administer KALBITOR to a patient who has known clinical hypersensitivity to KALBITOR. [ see Warnings and Precautions (5.1) ]. Do not administer KALBITOR to a patient who has known clinical hypersensitivity to KALBITOR. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.