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INMAZEB 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.
Limitations of Use: The efficacy of INMAZEB has not been established for other species of the Ebolavirus 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 to use INMAZEB.
Important Safety Information
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions Including Infusion-Associated Events: 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. Monitor all patients for signs and symptoms including, but not limited to, hypotension, chills and elevation of fever, during and following INMAZEB infusion. In the case of severe or life-threatening hypersensitivity reactions, discontinue the administration of INMAZEB immediately and administer appropriate emergency care.
Infusion could not be completed in 1% of subjects who received INMAZEB due to infusion-associated adverse events. 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.
- The most common adverse events reported in at least 10% of subjects who received INMAZEB were pyrexia (or elevation in fever), chills, tachycardia, tachypnea, vomiting, hypotension, diarrhea and hypoxia. The evaluation of adverse events in subjects who received INMAZEB may have been confounded by the signs and symptoms of the underlying Zaire ebolavirus infection.
- Selected grade 3 and 4 laboratory abnormalities for INMAZEB included high sodium (≥ 154 mmol/L), low sodium (<125 mmol/L), high potassium (≥ 6.5 mmol/L), low potassium (< 2.5 mmol/L), creatinine ((mg/dL) ≥ 1.8 x ULN), high alanine aminotransferase ((U/L) ≥ 5 x ULN) and high aspartate aminotransferase ((U/L) ≥ 5 x ULN).
DRUG INTERACTIONS: INMAZEB may reduce the efficacy of live vaccine therefore, avoid the concurrent administration of a live vaccine during treatment with INMAZEB. The interval between live vaccination following initiation of INMAZEB therapy should be in accordance with current vaccination guidelines. The efficacy of INMAZEB among subjects who reported receipt of a recombinant live vaccine prior to their enrollment in the PALM clinical trial was similar to subjects who did not receive a vaccine.
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