Neutralizing monoclonal antibody cocktail REGN-EB3 for Ebola virus disease (EVD)

Neutralizing monoclonal antibody cocktail REGN-EB3 for Ebola virus disease (EVD) CLINICAL INDICATIONS REGN-EB3 is also known by the commercial name INMAZEB™ and molecular names atoltivimab, maftivimab, odesivimab. Neutralizing monoclonal antibody cocktail REGN-EB3 for Ebola virus disease (EVD) 2 August 2022 © World Health Organization 2022. Some rights reserved. This work is available under the CC BY-NC-SA 3.0 IGO licence. WHO reference number: WHO/EVD/therapeutics/REGN-EB3/Poster_A/2022.1 • All patients with RT-PCR confirmed EVD caused by Zaire ebolavirus, including children, pregnant women, breastfeeding women and older people. • Neonates < 7 days, without EVD RT-PCR confirmation, born to mothers with RT-PCR confirmed EVD. Patients should receive REGN-EB3 as soon as possible after confirmation of RT-PCR diagnosis of EVD. Both the REGN-EB3 and mAb114 are recommended for use in EVD. The two drugs should not be given together. The choice of which monoclonal antibody to use depends on availability, including emerging information about effectiveness. AVAILABLE FORMULATION A vial of REGN-EB3 (14.5 mL) contains: • 241.7 mg (16.67 mg per mL) of atoltivimab • 241.7 mg (16.67 mg per mL) of maftivimab • 241.7 mg (16.67 mg per mL) of odesivimab. Note: Each vial is used for only one patient, it must not be used for multiple patients. DOSAGE AND ROUTE The recommended dosage of REGN-EB3 is 150 mg/kg (equivalent to 3 mL/kg): • 50 mg of atoltivimab per kg • 50 mg of maftivimab per kg • 50 mg of odesivimab per kg diluted and administered as a single intravenous (IV) infusion. Volume of REGN-EB3 needed (mL) = body weight (kg) x 3 Number of vials of REGN-EB3 needed = volume of REGN-EB3 / 14.5 Guidance for health care workers STORAGE Prior to dilution Store REGN-EB3 vial refrigerated at 2 °C to 8 °C (36 °F to 46 °F) in the original carton to protect from light. Do not freeze or shake. Expiry The expiration date for the product is available via a product-specific website, which is frequently updated (www.regeneron.com). TABLE 1. Storage conditions depending on the different dilution solutions Dilution solution Storage conditions 0.9% sodium chloride Store at room temperature up to 25 °C for no more than 8 hours or refrigerated at 2 °C to 8 °C for no more than 24 hours. 5% dextrose solution or Ringer’s lactate solution Store at room temperature up to 25 °C for no more than 4 hours or refrigerated at 2 °C to 8 °C for no more than 4 hours. 2-8 °C COVID-19 C G M -0 °C 2-8 °C COVID-19 C G M -0 °C 2-8 °C COVID-19 C G M -0 °C After dilution The maximum duration between preparation of the diluted REGN-EB3 to completion of administration to the patient depends on the dilution solution used and the storage conditions within the times in table one. • If the infusion is stopped for any reason, it can be restarted as long as the time from dilution to completing the infusion remains within the time stated in table one. • If the timeframe has been exceeded the remaining dosage required for the patient should be calculated, new vials prepared, diluted then administered and the excess diluted drug should be safely disposed. Drugs should not be moved from high-risk to low-risk zones for temporary storage.