Atoltivimab/maftivimab/odesivimab

What Is Atoltivimab/maftivimab/odesivimab?

• Atoltivimab, maftivimab, and odesivimab-ebgn (Inmazeb) is a combination of Zaire ebolavirus glycoprotein-directed human monoclonal antibodies (atoltivimab, maftivimab, and odesivimab).

What are the uses of this medicine?

• This medicine is indicated for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection.

How does this medicine work?

• Inmazeb is an antiviral drug combination of three recombinant human IgG1κ monoclonal antibodies (atoltivimab, maftivimab, and odesivimab) that inhibit Zaire ebolavirus.
• Maftivimab is a neutralizing antibody that blocks entry of the virus into susceptible cells.
• Odesivimab is a non-neutralizing antibody that induces antibody-dependent effector function through FcyRIIIa signaling when bound to its target.
• Odesivimab also binds to the soluble form of Zaire ebolavirus glycoprotein (sGP).
• Atoltivimab combines both neutralization and FcyRIIIa signaling activities.

Who Should Not Use this medicine ?

• The efficacy of Inmazeb has not been established for other species of the Ebola virus and Marburgvirus genera.
• Zaire ebolavirus can change over time, and factors such as emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs.
• Consider available information on drug susceptibility patterns for circulating Zaire ebolavirus strains when deciding whether to use Inmazeb.

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

• The recommended dosage of Inmazeb is 50 mg of atoltivimab, 50 mg of maftivimab, and 50 mg of odesivimab per kg diluted and administered as a single intravenous infusion.

Administration

• Inmazeb must be administered by a healthcare provider.
• Allow the diluted infusion solution to come to room temperature prior to administration.
• Administer the diluted infusion solution intravenously through an intravenous line containing a sterile, in-line or add-on 0.2-micron filter.
• The infusion rate is based on the patient's body weight and prepared infusion volume.
• Select an appropriate infusion rate for the diluted infusion solution .
• The rate of infusion of Inmazeb may be slowed or interrupted if the patient develops any signs of infusion-associated events or other adverse events.
• Do not mix other medications with Inmazeb.
• Compatibility studies of Inmazeb have not been performed when co-administering other drugs simultaneously through the same infusion line.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Injection: 241.7 mg of atoltivimab, 241.7 mg of maftivimab, and 241.7 mg of odesivimab per 14.5 mL (16.67 mg/16.67 mg/16.67 mg per mL) in a single-dose vial.

This medicine is available in fallowing brand namesː

• Inmazeb

What side effects can this medication cause?

Common possible side effects of this medicine include:

• Pyrexia (Elevation in fever)
• Chills
• Tachycardia
• Tachypnea
• Vomiting
• Hypotension
• Diarrhea
• Hypoxia

What special precautions should I follow?

• Monitor patients and in the case of severe or life-threatening hypersensitivity reactions, discontinue the administration of Inmazeb immediately and administer appropriate emergency care.
• Hypersensitivity reactions including infusion-associated events have been reported during and post-infusion with Inmazeb.
• These may include acute, life-threatening reactions during and after the infusion.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Zaire ebolavirus infection is life-threatening for both the mother and fetus and treatment should not be withheld due to pregnancy.

Can this medicine be used in children?

• The safety and effectiveness of Inmazeb for the treatment of infection caused by Zaire ebolavirus have been established in pediatric patients from birth to less than 18 years of age.

What should I know about storage and disposal of this medication?

• Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) injection is a clear to slightly opalescent and colorless to pale yellow solution.

It is supplied in a carton containing one single dose vial of: 241.7 mg of atoltivimab, 241.7 mg of maftivimab, and 241.7 mg of odesivimab per 14.5 mL (16.67 mg/16.67 mg/16.67 mg per mL) (NDC 61755-018-01)

Prior to dilution

• Store Inmazeb 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.

After dilution

• Inmazeb does not contain preservatives.
• It is always recommended to administer intravenous medication immediately after preparation when possible.

• Store the diluted Inmazeb solution as fallowsː

0.9% Sodium Chloride Injection, USP Store at room temperature up to 25°C (77°F) for no more than 8 hours or refrigerated at 2°C to 8°C (36°F to 46°F) for no more than 24 hours. 5% Dextrose Injection, USP or Lactated Ringer's Injection, USP Store at room temperature up to 25°C (77°F) for no more than 4 hours or refrigerated or at 2°C to 8°C (36°F to 46°F) for no more than 4 hours.

• Do not freeze the diluted solution.

• Dailymed label info on Atoltivimab/maftivimab/odesivimab
• FDA Atoltivimab/maftivimab/odesivimab

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