NUZOLVENCE

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE NUZOLVENCE is a spiropyrimidinetrione bacterial type II topoisomerase inhibitor indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg. ( 1.1 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZOLVENCE and other antibacterial drugs, NUZOLVENCE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.2 ) 1.1 Uncomplicated Urogenital Gonorrhea NUZOLVENCE is indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg [see Clinical Studies (14) ]. 1.2 Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZOLVENCE and other antibacterial drugs, NUZOLVENCE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Dosage and administration 2 DOSAGE AND ADMINISTRATION Pregnancy Testing: Obtain a pregnancy test in females of reproductive potential prior to initiating NUZOLVENCE. ( 2.1 ) NUZOLVENCE must be mixed with water before administering. ( 2.2 ) Do not mix NUZOLVENCE with other liquids or sprinkle on food. ( 2.2 ) Administer the entire dose within 15 minutes of mixing. If the dose is not administered within 15 minutes of mixing, a new dose of NUZOLVENCE must be prepared. ( 2.2 , 2.4 ) Adults and pediatric patients 12 years of age and older, weighing at least 35 kg: Recommended dose is 3 g (one packet) administered as a single dose orally. ( 2.3 ) Patients weighing 35 kg to less than 50 kg: Administer NUZOLVENCE on an empty stomach, 1 hour before or 2 hours after food. ( 2.3 ) Patients weighing greater than or equal to 50 kg: Administer NUZOLVENCE with food. ( 2.3 ) See full prescribing information for complete details on preparation and administration of NUZOLVENCE. ( 2.4 ) 2.1 Pregnancy Testing in Females of Reproductive Potential Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with NUZOLVENCE [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ]. 2.2 Important Administration Instructions NUZOLVENCE must be mixed with water before administering. Do not mix NUZOLVENCE with other liquids or sprinkle on food. Do not take NUZOLVENCE in the dry form. Administer the entire dose within 15 minutes of mixing. If the dose is not administered within 15 minutes of mixing, a new dose of NUZOLVENCE must be prepared [see Dosage and Administration (2.4) ] . 2.3 Recommended Dosage in Adults and Pediatric Patients 12 Years of Age and Older Weighing at Least 35 Kg The recommended dose of NUZOLVENCE in adults and pediatric patients 12 years of age and older weighing at least 35 kg is 3 grams (g) (one packet) administered as a single dose orally. See Table 1 for instructions on whether to administer NUZOLVENCE with or without food based on body weight [see Clinical Pharmacology (12.3) ] . Table 1: Administration of NUZOLVENCE With or Without Food Based on Weight Dose of NUZOLVENCE Body Weight (kg) Administration of NUZOLVENCE Relative to the Ingestion of Food 3 g administered as a single, oral dose 35 kg to less than 50 kg Take on an empty stomach, 1 hour before or 2 hours after food Greater than or equal to 50 kg Take with food 2.4 Preparation and Administration Instructions for NUZOLVENCE for Oral Suspension NUZOLVENCE must be mixed with water before administering. Do not mix NUZOLVENCE with other liquids or sprinkle on food. Accurately measure 60 mL of water into the provided mixing container. Add the entire contents of one unit-dose packet of NUZOLVENCE to the mixing container and immediately secure the provided lid onto the mixing container. Shake vigorously for at least 60 seconds. Continue to shake until all granules are suspended and there is a uniform suspension. Once NUZOLVENCE is mixed to achieve a uniform suspension, administer the entire contents of the mixing container immediately. To ensure the full dose of NUZOLVENCE is consumed, add an additional 60 mL of water to the same mixing container, shake, and administer the entire additional 60 mL of water. Administer the entire dose within 15 minutes of mixing. If the dose is not administered within 15 minutes of mixing, a new dose of NUZOLVENCE must be prepared. See the Instructions for Use for additional details on the preparation and administrati