Source: FDA, National Drug Code (US) Revision Year: 2025
EKTERLY is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
The recommended dosage of EKTERLY is one dose of 600 mg (two tablets) orally at the earliest recognition of an acute HAE attack.
Refer to Table 1 for dosage modification of EKTERLY when used concomitantly with CYP3A4 inhibitors and inducers.
Table 1. Dosage Modification of EKTERLY for Concomitant use with CYP3A4 Inhibitors and Inducers:
| Dosage Modification for Concomitant use of EKTERLY with CYP3A4 Inhibitors | |
| Strong CYP3A4 Inhibitors | Avoid concomitant use with EKTERLY. |
| Moderate CYP3A4 Inhibitors | Reduce EKTERLY dosage to 300 mg (one tablet) orally at earliest recognition of an acute HAE attack. A second dose of 300 mg (one tablet) may be taken at least 3 hours after first dose if response is inadequate or if symptoms worsen or recur [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. |
| Weak CYP3A4 Inhibitors | No dosage modification of EKTERLY [see Dosage and Administration (2.1)]. |
| Dosage Modification for Concomitant use of EKTERLY with CYP3A4 Inducers | |
| Strong and Moderate CYP3A4 Inducers | Avoid concomitant use with EKTERLY. |
| Weak CYP3A4 Inducers | No dosage modification of EKTERLY [see Dosage and Administration (2.1)]. |
Refer to Table 2 for recommended dosage of EKTERLY in patients with hepatic impairment.
Table 2. Recommended Dosage of EKTERLY in Patients with Hepatic Impairment:
| Recommended Dosage of EKTERLY in Patients with Hepatic Impairment | |
| Severe Hepatic Impairment (Child- Pugh Class C) | Avoid use of EKTERLY [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. |
| Moderate Hepatic Impairment (Child- Pugh Class B) | Recommended dosage of EKTERLY is one dose of 300 mg (one tablet) orally at the earliest recognition of an acute HAE attack. A second dose of 300 mg (one tablet) may be taken at least 3 hours after the first dose if response is inadequate, or if symptoms worsen or recur [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. |
| Mild Hepatic Impairment (Child- Pugh Class A) | Recommended dosage is the same as the recommended dosage in patients with normal hepatic function [see Dosage and Administration (2.1)]. |
Consider contacting the poison control help line (1-800-222-1222) or medical toxicologist for overdose management recommendations.
Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.