FOR cIAI IN ADULTS CAUSED BY DESIGNATED SUSCEPTIBLE GRAM-NEGATIVE MICROORGANISMS
ADVERSE REACTIONS
EMBLAVEOTM was evaluated in 3 clinical trials1-3
- REJUVENATEPHASE 2cIAI (N=34)
- REVISITPHASE 3cIAI (n=203/275) and HABP/VABP (n=72/275)*
- ASSEMBLEPHASE 3BSI (n=4/12), cIAI (n=2/12), cUTI (n=3/12), HABP/VABP (n=3/12)*
In total, 321 patients were treated with EMBLAVEO.
*HABP/VABP, BSI, and cUTI are not approved indications for EMBLAVEO.
BSI, bloodstream infection; cIAI, complicated intra-abdominal infection; cUTI, complicated urinary tract infection; HABP, hospital-acquired bacterial pneumonia; VABP, ventilator-associated bacterial pneumonia.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.4
Adverse reactions occurring in >5%
of patients in the phase 3 REVISIT trial4
In the phase 3 REVISIT trial, EMBLAVEO was evaluated in a total of 275 patients: 203 patients with cIAI and 72 with HABP/VABP (not an approved indication for EMBLAVEO). As part of the comparative trial, a total of 137 patients were treated with meropenem ± colistin.1†
| ADVERSE REACTION |
EMBLAVEO (N=275) % (n) |
MEROPENEM ± COLISTIN (N=137) % (n) |
|---|---|---|
| Hepatic adverse reactions* | 14.5% (40) | 11.7% (16) |
| Anemia† | 8.0% (22) | 5.1% (7) |
| Diarrhea | 5.8% (16) | 3.6% (5) |
| Hypokalemia | 5.8% (16) | 2.9% (4) |
| Pyrexia‡ | 5.8% (16) | 5.1% (7) |
During the REVISIT trial, death occurred in 6.9% of patients (19/275) who received EMBLAVEO and in 8.0% of patients (11/137) who received comparator. In patients with cIAI, death occurred in 3.0% of patients (6/203) treated with EMBLAVEO and 2.9% of patients (3/103) treated with comparator.1
Overall, 3.6% of the patients (10/275) who received EMBLAVEO and 3.6% treated with meropenem + colistin (5/137) discontinued treatment due to an adverse reaction in the REVISIT trial.1
†This is the safety analysis set (ie, patients in the ITT analysis set who received the study drug).
‡Includes the following adverse reaction terms: alanine aminotransferase increased, aspartate aminotransferase increased, hepatic function abnormal, hypertransaminasemia, transaminases increased, hepatic enzyme increased, liver injury.
§Includes anemia, hemoglobin decreased.
¶Includes pyrexia, hyperpyrexia, hyperthermia, body temperature increased.
References: 1. EMBLAVEO. Prescribing Information. AbbVie, Inc; 2025. 2. Carmeli Y, Cisneros JM, Paul M, et al. Lancet Infect Dis. Published online October 7, 2024. doi:10.1016/S1473-3099(24)00499-7 3. Daikos GL, Cisneros JM, Carmeli Y, et al. Poster presented at: 34th European Congress of Clinical Microbiology and Infectious Diseases; April 27-30, 2024; Barcelona, Spain. 4. Cornely OA, Cisneros JM, Torre-Cisneros J, et al. J Antimicrob Chemother. 2020;75(3):618-627. doi:10.1093/jac/dkz497
