BLUJEPA

Pharmacokinetic Parameters The pharmacokinetic properties of gepotidacin are summarized in Table 4 as mean (standard deviation [SD]) unless otherwise specified. Table 4. Pharmacokinetic Parameters of Gepotidacin a Pharmacokinetic parameters are presented at steady state in patients with uUTI and eGFR greater than or equal to 90 mL/min after oral administration of BLUJEPA 1,500 mg every 12 hours over 5 days, and in simulated results in adults with eGFR greater than or equal to 90 mL/min after ora...

14.1 Uncomplicated Urinary Tract Infections A total of 3,136 female patients with uncomplicated urinary tract infections (uUTI) were randomized in 2 multicenter, parallel‑group, double‑blind, double‑dummy, non‑inferiority (NI) trials (Trial 1 [NCT04020341] and Trial 2 [NCT04187144]). Both trials compared BLUJEPA 1,500 mg (administered orally twice daily with food for 5 days) to nitrofurantoin 100 mg (administered orally twice daily for 5 days). Patients entered the trials with at least 2 symptoms consistent with uUTI (dysuria, frequency, urgency, or lower abdominal pain) and with evidence of u...

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• QTc Prolongation [see Warnings and Precautions ( 5.1 )] .
• Acetylcholinesterase Inhibition [see Warnings and Precautions ( 5.2 )] .
• Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] .
• Clostridioides difficile Infection [see Warnings and Precautions ( 5.4 )] .
• uUTI: The most common adverse reactions occurring in ≥1% of patients are diarrhea, nausea, abdominal pain, flatulenc...

BLUJEPA is contraindicated in patients with a history of severe hypersensitivity to BLUJEPA [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] . A history of severe hypersensitivity to BLUJEPA. ( 4 )

• 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. ( 5.1 )
• 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: ( 5.1 , 7.1 , 8.6 , 8.7 )
• Concomitant use of strong CYP3A4 inhibitors
• Severe renal impairment (estimated glomerular filtrat...

7 DRUG INTERACTIONS

• CYP3A4 Inhibitors: Increase gepotidacin exposure. ( 7.1 )
• Strong CYP3A4 inhibitors: Avoid concomitant use of BLUJEPA with strong CYP3A4 inhibitors. ( 5.1 , 7.1 )
• Moderate CYP3A4 inhibitors: Avoid concomitant use of BLUJEPA with moderate CYP3A4 inhibitors in patients with uncomplicated urogenital gonorrhea. ( 5.1 , 7.1 )
• CYP3A4 Inducers: Decrease gepotidacin exposure. ( ...