Zoliflodacin
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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 ] .
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 administration of NUZOLVENCE for oral suspension.
Drug interactions
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- Zoliflodacin
Label text (2 paragraphs)
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) ] .
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 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely cause of clinically apparent liver injury.
Zoliflodacin is a recently approved antibiotic used for oral treatment of uncomplicated urogenital gonorrhea. Zoliflodacin therapy is given as a single oral dose of 3 grams and has not been associated with serum aminotransferase elevations or with clinically apparent liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on findings from animal studies, NUZOLVENCE may cause fetal malformations or increased embryo-fetal loss when administered to a pregnant female. In pregnant mice, repeat oral administration of zoliflodacin during organogenesis was associated with fetal malformations (exencephaly) and increased embryo-fetal loss at AUC exposures 1.6-fold the MRHD and decreased fetal weights at 2.9-fold the MRHD. In pregnant rats, zoliflodacin administration resulting in AUC exposures 8.5-fold the MRHD increased embryo-fetal loss, and exposures 3.2-fold the MRHD decreased fetal weights.
There was no effect on embryo-fetal survival at exposures 5.5-fold the MRHD to zoliflodacin in pregnant rats. When zoliflodacin was administered to rats throughout pregnancy, parturition, and lactation, no effects on pup survival, birth weight, or growth were observed at maternal exposures up to 2.4-fold the MRHD (see Data ). There are no human data on NUZOLVENCE use in pregnancy to evaluate the drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Advise pregnant females about the potential risk to the fetus with maternal exposure to NUZOLVENCE [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] .
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. The background risk of major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defects, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data In pregnant mice, repeat oral administration of zoliflodacin at 250, 500, and 1000 mg/kg/day during organogenesis (gestation days [GD] 5-16) was associated with fetal exencephaly at and above doses of 500 mg/kg/day (AUC exposures equal to or greater than 1.6-fold the MRHD). Increased implant losses occurred at 500 mg/kg/day, and decreased fetal weights occurred at 1000 mg/kg/day (AUC exposures 2.9-fold the MRHD). No adverse embryo-fetal effects were observed at 250 mg/kg/day (AUC exposure 0.6-fold the MRHD).
In female rats, repeat oral administration of zoliflodacin at 200, 500, or 1000 mg/kg/day from at least 2 weeks prior to mating through organogenesis (GD 16), decreased pregnancy…
Breastfeeding (LactMed)
No information is available on the use of zoliflodacin during breastfeeding. Because zoliflodacin is 83% bound to plasma proteins, the amount in milk is likely to be low. If a mother requires zoliflodacin, it is not a reason to discontinue breastfeeding. Although unlikely after a single dose, monitor the infant for possible effects on the gastrointestinal flora, such as diarrhea and thrush.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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