Gepotidacin

BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: • Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). • Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety data for this indication. Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of BLUJEPA and other antibacterial drugs, BLUJEPA should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

BLUJEPA is an antibacterial drug.

• uUTI: The recommended dosage of BLUJEPA is 1,500 mg (two 750 mg tablets) taken orally, twice daily (approximately 12 hours apart), for 5 days. • Uncomplicated Urogenital Gonorrhea: The recommended dosage of BLUJEPA is 3,000 mg (four 750 mg tablets) taken orally, followed by a second dose of 3,000 mg (four 750 mg tablets) approximately 12 hours later. • Administer BLUJEPA tablets after a meal to reduce the possibility of gastrointestinal intolerance.

BLUJEPA is contraindicated in patients with a history of severe hypersensitivity to BLUJEPA. A history of severe hypersensitivity to BLUJEPA.

• QTc Prolongation: • Avoid use of BLUJEPA in patients with a history of QTc prolongation, or with relevant pre‑existing cardiac disease, or in patients receiving drugs that prolong the QTc interval. • Due to an increase in gepotidacin exposure and the risk of QTc interval prolongation, avoid use of BLUJEPA in patients who have any of the following risk factors: • Concomitant use of strong CYP3A4 inhibitors • Severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min) • Severe hepatic impairment (Child-Pugh Class C) • Additionally, avoid BLUJEPA in uncomplicated urogenital gonorrhea patients, who have any of the following risk factors for increased gepotidacin exposure: • Concomitant use of moderate CYP3A4 inhibitors • Two or more of the following risk factors: Body weight between 45 kilograms and 60 kilograms, Moderate renal impairment (eGFR 30 to 59 mL/min), Moderate hepatic impairment (Child-Pugh Class B) • Acetylcholinesterase Inhibition: Dysarthria and other…

The following adverse reactions are discussed in greater detail in other sections of the labeling: • QTc Prolongation. • Acetylcholinesterase Inhibition. • Hypersensitivity Reactions. • Clostridioides difficile Infection. • uUTI: The most common adverse reactions occurring in ≥1% of patients are diarrhea, nausea, abdominal pain, flatulence, headache, soft feces, dizziness, vomiting, and vulvovaginal candidiasis. • Uncomplicated Urogenital Gonorrhea: The most common adverse reactions occurring in ≥2% of patients are diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, soft feces, headache, fatigue, and hyperhidrosis.

• CYP3A4 Inhibitors: Increase gepotidacin exposure. • Strong CYP3A4 inhibitors: Avoid concomitant use of BLUJEPA with strong CYP3A4 inhibitors. • Moderate CYP3A4 inhibitors: Avoid concomitant use of BLUJEPA with moderate CYP3A4 inhibitors in patients with uncomplicated urogenital gonorrhea. • CYP3A4 Inducers: Decrease gepotidacin exposure. • For uUTI: Avoid concomitant use of BLUJEPA with strong CYP3A4 inducers. • For uncomplicated urogenital gonorrhea: Avoid concomitant use of BLUJEPA with strong and moderate CYP3A4 inducers. • CYP3A4 Substrates: Avoid concomitant use of BLUJEPA with drugs that are extensively metabolized by CYP3A4 where minimal concentration changes may lead to serious adverse reactions. • Digoxin: Due to an increase in digoxin exposures, consider monitoring digoxin serum concentration, as appropriate, with concomitant administration of BLUJEPA.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).