Gepotidacinside effects

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. To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical

Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trial Experience in Patients with Uncomplicated UTI The safety of BLUJEPA was evaluated in 2 double‑blind, active‑controlled, randomized trials in female adult and pediatric patients 12 years of age and older with uUTI (Trial 1 and Trial 2). A total of 1,570 patients were treated with BLUJEPA and 1,558 patients were treated with nitrofurantoin (pooled safety populations for BLUJEPA and nitrofurantoin, respectively). Patients received treatment for a median duration of 5 days. In Trials 1 and 2 (pooled, intent-to-treat [ITT] population), the median age of patients treated with BLUJEPA was 49 (range 13 to 89) years; <1% were <18 years, 77% of patients were 18 to 64 years, 14% were 65 to 74 years, and 8% were ≥75 years. Patients were female (100%) and White (83%), Black or African American (7%), Asian (5%), or American Indian or Alaskan Native (4%); for ethnicity, 33% identified as Hispanic/Latino and 67% as non-Hispanic/Latino. The majority of patients were enrolled from the U.S. (55%). Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation: In the pooled trials (Trials 1 and 2), serious adverse reactions occurred in 1/1,570 (<1%) uUTI patients treated with BLUJEPA and 1/1,558 (<1%) uUTI patients treated with nitrofurantoin. The serious adverse reaction reported with BLUJEPA was dysarthria. No adverse reaction led to death in either treatment group. In the pooled trials, adverse reactions leading to discontinuation of treatment occurred in 79/1,570 (5%) uUTI patients treated with BLUJEPA and 30/1,558 (2%) uUTI patients treated with nitrofurantoin. Adverse reactions occurring in >1% of patients leading to treatment discontinuation in patients treated with BLUJEPA included diarrhea (3%) and nausea (1%).

Common Adverse Reactions: Table 1 lists the adverse reactions occurring in ≥1% of uUTI patients receiving BLUJEPA in the pooled trials (Trials 1 and 2). Table 1. Adverse Reactions Occurring in ≥1% of Uncomplicated Urinary Tract Infection Patients Treated with BLUJEPA (Trials 1 and 2 Pooled Data; Safety Population) a Abdominal pain includes abdominal pain, abdominal pain upper, abdominal pain lower, abdominal tenderness, abdominal discomfort, and gastrointestinal pain. Adverse Reaction BLUJEPA N = 1,570 n (%) Nitrofurantoin N = 1,558 n (%) Diarrhea 258 51 Nausea 146 64 Abdominal pain a 60 34 Flatulence 43 8 (<1) Headache 38 40 Soft feces 37 8 (<1) Dizziness 29 19 Vomiting 28 10 (<1) Vulvovaginal candidiasis 20 18 Diarrhea: In Trials 1 and 2, diarrhea was reported in 258/1,570 (16%) uUTI patients receiving BLUJEPA; 11% mild, 5% moderate, and <1% severe. The diarrhea started within the first 2 days of treatment for the majority of patients and the median duration of diarrhea was 4 days. Adverse Reactions Occurring in Less than 1% of uUTI Patients Receiving BLUJEPA in Trials 1 and 2 (Pooled): Gastrointestinal Disorders: Abdominal distension, dyspepsia (includes epigastric discomfort, eructation) Nervous System Disorders: Presyncope, dysarthria Infections and Infestations: Clostridioides difficile infection Musculoskeletal and Connective Tissue Disorders: Muscle spasms Vascular Disorders: Hot flush Cardiac Disorders: Tachycardia Eye Disorders: Blurred vision Ear and Labyrinth Disorders: Vertigo General Disorders and Administration Site Disorders: Fatigue Investigations: Alanine aminotransferase/aspartate aminotransferase increased Skin and Subcutaneous Tissue: Rash, hyperhidrosis Immune System Disorders: Hypersensitivity reactions Select Adverse Reactions Occurring in uUTI Patients Receiving BLUJEPA in Phase 1 and 2 Clinical Studies: Gastrointestinal Disorders: Hypersalivation (with oral daily doses ranging from 100 mg to 6,000 mg, which includes not approved doses) Clinical Trial Experience in Patients with Uncomplicated Urogenital Gonorrhea The safety of BLUJEPA was evaluated in a randomized, active‑controlled trial (Trial 3) comparing BLUJEPA to ceftriaxone and azithromycin in adult and pediatric patients 12 years of age and older with uncomplicated urogenital gonorrhea. A total of 309 patients received at least one dose of BLUJEPA (safety population). In Trial 3 (ITT population), the median age of patients randomized to receive BLUJEPA was 33 (range 16 to 64) years; >99% of patients were 18 to 65 years (no patients were >65 years). Overall, patients randomized to receive BLUJEPA treatment were predominately male (89%) and White (74%). Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation: No serious adverse reactions occurred in uncomplicated urogenital gonorrhea patients treated with BLUJEPA in Trial 3. Adverse reactions leading to discontinuation of treatment occurred in 3/309 (<1%) of uncomplicated urogenital gonorrhea patients treated with BLUJEPA.

Common Adverse Reactions: Table 2 lists the adverse reactions occurring in ≥2% of uncomplicated urogenital gonorrhea patients receiving BLUJEPA in Trial 3. Table 2. Adverse Reactions Occurring in ≥2% of Uncomplicated Urogenital Gonorrhea Patients Treated with BLUJEPA (Trial 3; Safety Population) a Abdominal pain includes abdominal pain, abdominal pain upper, and abdominal discomfort. b Fatigue includes fatigue and lethargy. Adverse Reaction BLUJEPA N = 309 n (%) Ceftriaxone and Azithromycin N = 313 n (%) Diarrhea 151 30 Nausea 73 9 Abdominal pain a 25 6 Vomiting 20 2 (<1) Flatulence 20 1 (<1) Dizziness 16 2 (<1) Soft feces 16 1 (<1) Headache 10 8 Fatigue b 10 0 Hyperhidrosis 7 0 Diarrhea: In Trial 3, diarrhea was reported in 151/309 (49%) uncomplicated urogenital gonorrhea patients receiving BLUJEPA (38% mild severity, 11% moderate severity). Most episodes of diarrhea started on the same day as dosing, with few diarrhea episodes after day 2. The median duration was 2 days. Discontinuation of BLUJEPA due to diarrhea was reported in 1/309 (<1%) uncomplicated urogenital gonorrhea patients. Adverse Reactions Occurring in Less than 2% of Uncomplicated Urogenital Gonorrhea Patients Receiving BLUJEPA in Trial 3: Skin and Subcutaneous Tissue: Rash Cardiac Disorders: Tachycardia Nervous System Disorders: Dysarthria, presyncope, syncope Musculoskeletal and Connective Tissue Disorders: Muscle spasms, myalgia, arthralgia Vascular Disorders: Hot flush Gastrointestinal Disorders: Hypersalivation, abdominal distension Eye Disorders: Vision blurred Ear and Labyrinth Disorders: Vertigo