Zoliflodacin

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. 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.

NUZOLVENCE is an antibacterial drug.

Pregnancy Testing: Obtain a pregnancy test in females of reproductive potential prior to initiating NUZOLVENCE. NUZOLVENCE must be mixed with water before administering. Do not mix NUZOLVENCE with other liquids or sprinkle on food. 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. 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. Patients weighing 35 kg to less than 50 kg: Administer NUZOLVENCE on an empty stomach, 1 hour before or 2 hours after food. Patients weighing greater than or equal to 50 kg: Administer NUZOLVENCE with food. See full prescribing information for complete details on preparation and administration of NUZOLVENCE.

NUZOLVENCE is contraindicated in: patients with a known history of hypersensitivity to NUZOLVENCE. patients who use concomitant moderate or strong CYP3A4 inducers because concomitant use is predicted to result in decreased plasma concentrations of zoliflodacin and may reduce the efficacy of NUZOLVENCE. Known history of hypersensitivity to NUZOLVENCE. Concomitant use with moderate or strong CYP3A4 inducers because this is predicted to result in decreased plasma concentrations of zoliflodacin and may reduce NUZOLVENCE efficacy.

Embryo-Fetal Toxicity: Potential Risk for Pregnant Females: May cause fetal harm when administered during pregnancy based on data from animal studies. Advise pregnant females about the potential risk to the fetus with maternal exposure to NUZOLVENCE. Avoid use of NUZOLVENCE during pregnancy. Embryo-Fetal Toxicity: Potential Risk Related to Males with Female Partners of Reproductive Potential: Advise males with female partners of reproductive potential to use effective contraception for at least 3 months after administration of NUZOLVENCE. Testicular Toxicity and Risks to Male Fertility: May cause testicular toxicity and impair male fertility based on data from animal studies. An assessment of spermatogenesis has not been conducted in humans. Advise males of the potential risk.

The following clinically significant adverse reactions are discussed in the Warnings and Precautions section of the labeling: Hypersensitivity Reactions The most common adverse reactions including laboratory abnormalities (incidence ≥2%) with NUZOLVENCE are neutropenia, headache, leukopenia, dizziness, nausea, and diarrhea.

Effect of Other Drugs on NUZOLVENCE Moderate and Strong CYP3A4 Inducers Concomitant use of moderate or strong inducers of CYP3A4 with NUZOLVENCE is contraindicated. Zoliflodacin is a CYP3A4 substrate. Moderate and strong CYP3A4 inducers are predicted to result in decreased plasma concentrations of zoliflodacin and may reduce NUZOLVENCE efficacy.

NUZOLVENCE should be stored in the original packaging at room temperature 20 °C to 25 °C (68 °F to 77 °F), excursions permitted to 15 °C to 30 °C (59 °F to 86 °F). Do not freeze.