XERAVA (eravacycline dihydrochloride)

Following single-dose intravenous administration, eravacycline AUC and Cmax increase approximately dose-proportionally over doses from 1 mg/kg to 3 mg/kg (3 times the approved dose). The mean exposure of eravacycline after single and multiple intravenous infusions (approximately 60 minutes) of 1 mg/kg administered to healthy adults every 12 hours is presented in Table 2. There is approximately 45% accumulation following intravenous dosing of 1 mg/kg every 12 hours.

Table 2Mean (%CV) Plasma Exp...

14.1 Complicated Intra-abdominal Infections in Adults A total of 1,041 adults hospitalized with cIAI were enrolled in two Phase 3, randomized, double-blind, active-controlled, multinational, multicenter trials (

Trial 1NCT01844856, and

Trial 2NCT02784704). These studies compared XERAVA (1 mg/kg intravenous every 12 hours) with either ertapenem (1 g every 24 hours) or meropenem (1 g every 8 hours) as the active comparator for 4 to 14 days of therapy. Complicated intra-abdominal infections included appendicitis, cholecystitis, diverticulitis, gastric/duodenal perforation, intra-abdominal absc...

The following clinically significant adverse reactions are described in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [Warning and Precautions ( 5.1 )] Tooth Discoloration [ Warning and Precautions ( 5.2 )] Inhibition of Bone Growth [Warning and Precautions ( 5.3 )] Clostridioides difficile -Associated Diarrhea [Warning and Precautions ( 5.4 )] Tetracycline Class Adverse Reactions [Warning and Precautions ( 5.5 )] Most common adverse reactions (incidence ≥ 3%...

XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or to any of the excipients [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )]. Known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or any of the excipients in XERAVA. ( 4 , 5 , 6 )

Hypersensitivity Reactions : Life-threatening hypersensitivity (anaphylactic) reactions have been reported with tetracycline antibacterial drugs, including XERAVA. Avoid use in patients with known hypersensitivity to tetracyclines. ( 5.1 ) Tooth Discoloration and Enamel Hypoplasia : The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia. ( 5.2 , 8.1 ,...

7 DRUG INTERACTIONS Strong CYP 3A Inducers: Co-administration decreases the exposure of eravacycline; increase XERAVA dose with concomitant use. ( 2.3 , 7.1 , 12.3 ) Anticoagulant Drugs: Downward adjustment of anticoagulant dosage may be required. ( 7.2 ) 7.1 Effect of Other Drugs on XERAVA Strong CYP3A Inducers Concomitant use of strong CYP3A inducers decreases the exposure of eravacycline, which...