Gonorrhea Treatments

For Oral Suspension: 3 g of zoliflodacin as white to off-white granules in each unit-dose packet of NUZOLVENCE.

NUZOLVENCE is contraindicated in:

The following clinically significant adverse reactions are discussed in the Warnings and Precautions section of the labeling:

NUZOLVENCE for oral suspension contains zoliflodacin, an oral spiropyrimidinetrione bacterial type II topoisomerase inhibitor. The chemical name of zoliflodacin is (2R,4S,4aS)-11-Fluoro-1,2,4,4a-tetrahydro-2,4-dimethyl-8-[(4S)-4-methyl-2-oxo-3-oxazolidinyl]spiro[isoxazolo[4,5-g][1,4]oxazino[4,3-a]quinoline-5(6H),5'(2'H)-pyrimidine]-2',4',6'(1'H,3'H)-trione. Its molecular formula is C

Each unit dose packet of NUZOLVENCE for oral suspension contains 3 g of zoliflodacin and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, talc, and xanthan gum.

A total of 930 patients with suspected uncomplicated gonorrhea due to

The primary analysis population was the microbiologic intent-to-treat (micro-ITT) urogenital population, which included patients who had

The demographic and baseline characteristics in the micro-ITT urogenital population were comparable between treatment groups. In total, 91% were male; 55% Black, 31% Asian, 13% White, and 4% Hispanic or Latino; the mean age was 30 years (range: 16 to 73) and the mean weight was 70 kg (range: 37 to 139 kg). The primary efficacy endpoint was microbiological cure as determined by confirmed bacterial eradication of

Table 6 shows the primary endpoint of microbiological cure rates at the urogenital site at TOC in the micro-ITT urogenital population. Trial 1 demonstrated non-inferiority of NUZOLVENCE to the combination of ceftriaxone and azithromycin.

Advise the patient to read the FDA-approved labeling (Medication Guide and Instructions for Use).

Advise males who receive NUZOLVENCE and have female partners of reproductive potential to use effective contraception for at least 3 months after receiving NUZOLVENCE

Advise males that NUZOLVENCE may cause testicular toxicity and impair male fertility

Advise patients that NUZOLVENCE are granules for oral suspension and must be mixed with water before administration. Instruct patients not to take the granules in the dry form

Advise the patient, their families, or caregivers that diarrhea is a common problem caused by antibacterial drugs, including NUZOLVENCE. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, tell them to contact their healthcare provider

Patients should be counseled that antibacterial drugs including NUZOLVENCE should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When NUZOLVENCE is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by NUZOLVENCE or other antibacterial drugs in the future

This Instructions for Use contains information on how to take NUZOLVENCE. Read this Instructions for Use before you take NUZOLVENCE.

This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk to your healthcare provider or pharmacist if you have any questions on how to prepare or take the prescribed dose of NUZOLVENCE.

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NUZOLVENCE

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NDC 68547-915-10

NUZOLVENCE

3g

UNIT-DOSE KIT

Each carton contains:

PHARMACIST: Dispense

ENTASIS