NUZOLVENCE 3 g/1
zoliflodacin · FOR SUSPENSION · La Jolla Pharmaceutical Company
NUZOLVENCE is a for suspension containing zoliflodacin at 3 g/1, taken oral. Manufactured by La Jolla Pharmaceutical Company.
Key Facts
- Brand Name
- NUZOLVENCE
- Generic Name
- zoliflodacin
- NDC Code (Product)
68547-915- Manufacturer
- La Jolla Pharmaceutical Company
- Strength
- 3 g/1
- Dosage Form
- FOR SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- NDA219491
- Marketing Start
- 04/01/2026
Recall History
No Recall HistoryFull Prescribing Information
Indications & 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. Wh…
Dosage & 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.…
Contraindications
4 CONTRAINDICATIONS NUZOLVENCE is contraindicated in: patients with a known history of hypersensitivity to NUZOLVENCE [see Warnings and Precautions (5.4) ] . 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 [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ]. Known history of hypersensitivity to NUZOLVENCE. ( 4 ) 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. ( 4 , 7.1 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Effect of Other Drugs on NUZOLVENCE Moderate and Strong CYP3A4 Inducers Concomitant use of moderate or strong inducers of CYP3A4 with NUZOLVENCE is contraindicated [see Contraindications (4) ] . 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 [see Clinical Pharmacology (12.3) ] .
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in the Warnings and Precautions section of the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] The most common adverse reactions including laboratory abnormalities (incidence ≥2%) with NUZOLVENCE are neutropenia, headache, leukopenia, dizziness, nausea, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Entasis Therapeutics, Inc. at 1-800-651-3861 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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. A total of 782 patients received a 3 g dose of zoliflodacin across all phases of clinical trials. The safety of NUZOLVENCE was evaluated in a phase 3, randomized, open-label, active-controlled, multicenter, multinational trial (NCT03959527) (Trial 1). In total, 927 patients with suspected uncomplicated gonorrhea due to N. gonorrhoeae were randomized (2:1) and treated w…
Frequently Asked Questions
What is NUZOLVENCE used for?
NUZOLVENCE contains zoliflodacin. It is a for suspension taken oral. Consult your doctor for specific uses.
Is NUZOLVENCE a controlled substance?
NUZOLVENCE is not classified as a controlled substance by the DEA.
What is the generic name for NUZOLVENCE?
The generic name for NUZOLVENCE is zoliflodacin. There are no other listed brand versions of zoliflodacin.
What is the NDC code for NUZOLVENCE 3 g/1?
The NDC (National Drug Code) for NUZOLVENCE 3 g/1 is 68547-915, listed by La Jolla Pharmaceutical Company.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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