An FDA-APPROVED,
single-dose oral treatment for uncomplicated urogenital gonorrhea1
INDICATION
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.
SELECTED IMPORTANT SAFETY INFORMATION
Contraindications
- 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 the NUZOLVENCE efficacy.
Warnings and Precautions
- Embryo-Fetal Toxicity: Potential Risk for Pregnant Females:
- Based on data from animal studies, NUZOLVENCE may cause fetal harm when administered to a pregnant female at clinically relevant doses. Avoid use during pregnancy. Advise pregnant females about the potential risk to the fetus with maternal exposure to NUZOLVENCE. Obtain a pregnancy test prior to initiation in persons of reproductive potential.
- Embryo-Fetal Toxicity: Potential Risk Related to Males with Female Partners of Reproductive Potential:
- Based on data from an animal toxicity study, the risk of early pregnancy loss may be increased in female partners of males treated with NUZOLVENCE. Advise males with female partners of reproductive potential to use effective contraception for at least 3 months after NUZOLVENCE administration.
- Testicular Toxicity and Risks to Male Fertility:
- Based on findings from animal studies, NUZOLVENCE may cause testicular toxicity and impair male fertility. An assessment of spermatogenesis has not been conducted in humans. Advise males that NUZOLVENCE may cause testicular toxicity and impair male fertility.
Please see additional Important Safety Information below.
Medical
questions
If you have a question about NUZOLVENCE or another Innoviva Specialty Therapeutics product and would like to speak with a medical information specialist, please reach out to:
(Monday to Friday, 9 am to 5 pm ET,
excluding holidays)
or
Obtain a pregnancy test in females of reproductive potential prior to initiating NUZOLVENCE
Advise patients that:
- NUZOLVENCE must be mixed with 60 mL of water to make an oral suspension before administering
- The oral suspension must be consumed within 15 minutes
—Do not mix NUZOLVENCE with other liquids or sprinkle on food
For complete Dosage and Administration information, see the Full Prescribing Information prior to use.
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SELECTED IMPORTANT SAFETY INFORMATION (continued)
Warnings and Precautions (continued)
- Hypersensitivity Reactions:
- Hypersensitivity reactions, including rash and pruritus, have been reported in patients receiving NUZOLVENCE. Before therapy with NUZOLVENCE is instituted, carefully inquire about previous hypersensitivity reactions to NUZOLVENCE. If an allergic reaction to NUZOLVENCE occurs, discontinue NUZOLVENCE and institute appropriate supportive measures.
- Clostridioides difficile Infection (CDI):
- CDI has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
- Development of Drug-Resistant Bacteria:
- Prescribing NUZOLVENCE in the absence of a proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Adverse Reactions
The most common adverse reactions (≥2%) are headache, dizziness, nausea, and diarrhea. Laboratory abnormalities (neutropenia, leukopenia) were also observed.
Drug Interactions
Concomitant use with moderate or strong CYP3A4 inducers is contraindicated.
Use in Specific Populations
- Pregnancy: Based on findings from animal studies, NUZOLVENCE may cause fetal malformations or increased embryo-fetal loss when administered to a pregnant female. A postmarketing descriptive pregnancy safety study is available for NUZOLVENCE. If exposure occurs during pregnancy, pregnant females or their healthcare providers should report the pregnancy to Entasis Therapeutics at 1-800-651-3861.
- Lactation: There are no data on the presence of zoliflodacin in either human or animal milk, effects on the breastfed infant, or effects on milk production. If NUZOLVENCE is present in breast milk, intestinal flora alteration in the breastfed infant could occur.
- Females and Males of Reproductive Potential: Based on animal studies, NUZOLVENCE may cause fetal malformations when administered to a pregnant female at clinically relevant doses. Additionally, based on data from an animal study, the risk of early pregnancy loss may be increased in partners of males treated with NUZOLVENCE.
- Pregnancy Testing: Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with NUZOLVENCE.
- Contraception: Advise males with female partners of reproductive potential to use effective contraception for at least 3 months after their single-dose treatment of NUZOLVENCE.
- Infertility: Based on data from repeat-dose animal toxicity and fertility studies, NUZOLVENCE may cause testicular toxicity and impair male fertility.
- Pediatric Use: The safety and effectiveness of NUZOLVENCE in pediatric patients younger than 12 years of age or weighing less than 35 kg have not been established.
- Geriatric Use: Clinical studies of NUZOLVENCE did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients.
Reporting Adverse Events
You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact:
Innoviva Specialty Therapeutics™
1-800-651-3861
medinfo@istx.com
U.S. Food and Drug Administration
1-800-FDA-1088
www.fda.gov/medwatch
Before administering, please see the Full Prescribing Information for NUZOLVENCE.