EMBLAVEO

Following single or multiple dosing, the C max and AUC of both aztreonam and avibactam (components of EMBLAVEO) increase in an approximate dose-proportional manner over a dose range of 500 mg to 2000 mg aztreonam (0.25 to 1 times the approved maximum recommended loading dose) and of 50 mg to 2000 mg avibactam (0.07 to 3 times the approved maximum recommended loading dose). Aztreonam and avibactam (components of EMBLAVEO) pharmacokinetic properties are summarized in Table 6. There is minimal accu...

14.1 Complicated Intra-abdominal Infections The determination of efficacy of EMBLAVEO was supported in part by the previous findings of the efficacy and safety of aztreonam for the treatment of cIAI. The contribution of avibactam to EMBLAVEO was primarily established in vitro and in animal models of infection [see Clinical Pharmacology ( 12.4 )] . EMBLAVEO was studied in one randomized, active-controlled, multicenter trial (

Trial 1NCT03329092) in patients with cIAI or hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) (not an approved indication for E...

The following adverse reactions are discussed in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Serious Skin Disorders [see Warnings and Precautions ( 5.2 )] Hepatic Adverse Reactions [see Warnings and Precautions ( 5.3 )] Clostridioides Difficile -Associated Diarrhea [see Warnings and Precautions ( 5.4 )] The most common adverse reactions occurring at an incidence of greater than 5% were hepatic adverse reactions, anemia...

EMBLAVEO is contraindicated in patients with known hypersensitivity to the components of EMBLAVEO (aztreonam and avibactam) [see Warnings and Precautions ( 5.1 )] . Known hypersensitivity to the components of EMBLAVEO (aztreonam and avibactam). ( 4 )

Hypersensitivity Reactions : Hypersensitivity reactions were noted in patients treated with EMBLAVEO including rash, flushing, and bronchospasm. In case of hypersensitivity reactions, immediately discontinue EMBLAVEO and initiate appropriate medications and/or supportive care. ( 5.1 ) Serious Skin Disorders: Cases of toxic epidermal necrolysis have been reported in association with aztreonam (a component of EMBLAVEO) in patients undergoing bone marrow transplant with multiple risk factors. Disco...

7 DRUG INTERACTIONS 7.1 OAT 1 and 3 Transport Inhibitors Concomitant use of organic anion transporter (OAT) 1 and OAT 3 transporter inhibitors (e.g., probenecid) with EMBLAVEO is not recommended. There is insufficient information to characterize the effect of concomitant use of OAT 1/3 transport inhibitors with EMBLAVEO [see Clinical Pharmacology ( 12.3 )].