Zoliflodacin

FDA label

Read the full label on DailyMed ↗

Renal Undefined

Hepatic Undefined

Instructions

• Obtain pregnancy test in females of reproductive potential before initiating
• Food by weight: 35 to <50 kg — take on empty stomach (1 h before or 2 h after food); >=50 kg — take with food
• Mix packet in 60 mL water, shake >=60 s to uniform suspension, drink entire contents immediately; add another 60 mL water to same container, shake, and drink to complete the dose
• Administer entire dose within 15 min of mixing — otherwise prepare a new dose
• Do not mix with other liquids, sprinkle on food, or take dry

Available strengths

• susp 3 g/packet

Contraindications

• Concomitant moderate or strong CYP3A4 inducers (predicted decreased zoliflodacin concentrations; may reduce efficacy)

Cautions

• Embryo-fetal toxicity (animal data: exencephaly, embryo-fetal loss near clinical exposures) — avoid in pregnancy; pregnancy test before use
• Male-mediated embryo-fetal risk — males with female partners of reproductive potential should use effective contraception for >=3 months after the dose
• Testicular toxicity and possible male fertility impairment (animal data; human spermatogenesis not assessed)
• Hypersensitivity reactions (rash, pruritus) — discontinue and treat
• Clostridioides difficile infection — evaluate if diarrhea occurs (may occur >2 months post-antibiotic)

Adverse reactions

• Laboratory: neutropenia 12%, leukopenia 9% (transient, no treatment required)
• Headache 10%, dizziness 3%, nausea 3%, diarrhea 2%

Pregnancy Animal data: fetal malformations (exencephaly) and embryo-fetal loss at exposures 1.6-8.5x MRHD — may cause fetal harm; avoid during pregnancy; obtain pregnancy test before treatment; postmarketing pregnancy safety study available

Lactation No human or animal milk data; intestinal-flora alteration possible in breastfed infant — weigh breastfeeding benefits vs maternal need