Brand Name
Blujepa
Generic Name
Gepotidacin
View Brand Information FDA approval date: March 25, 2025
Form: Tablet
What is Blujepa (Gepotidacin)?
BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms with uncomplicated urinary tract infections caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.
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Brand Information
Blujepa (gepotidacin)
1DOSAGE FORMS AND STRENGTHS
Each film coated tablet of BLUJEPA contains 750 mg of gepotidacin. BLUJEPA tablets are yellow, capsule shaped, and debossed with “GS GU3” on one side and plain on the other side.
2CONTRAINDICATIONS
BLUJEPA is contraindicated in patients with a history of severe hypersensitivity to BLUJEPA
3ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- QTc Prolongation
- Acetylcholinesterase Inhibition
- Hypersensitivity Reactions
- Clostridioides difficile Infection
3.1Clinical 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).
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.
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
4OVERDOSAGE
There is a risk of QTc prolongation with overdosage. Intermittent hemodialysis is not likely to substantially remove BLUJEPA from the systemic circulation. Consider contacting the Poison Help line (1‑800‑222‑1222) or a medical toxicologist for additional overdose management recommendations.
5DESCRIPTION
BLUJEPA tablets contain gepotidacin mesylate, a triazaacenaphthylene antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV. The chemical name is (
*stereogenic center
Each BLUJEPA oral tablet contains gepotidacin 750 mg (equivalent to 910.7 mg of gepotidacin mesylate [anhydrous]). Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.
6HOW SUPPLIED/STORAGE AND HANDLING
BLUJEPA tablets are supplied as yellow, film-coated, capsule-shaped tablets debossed with “GS GU3” on one side and plain on the other side, containing 750 mg of gepotidacin.
Bottle of 8 tablets (NDC 0173-0922-38).
Bottle of 20 tablets (NDC 0173-0922-45).
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). [See USP Controlled Room Temperature].
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Important Administration Instructions
Counsel patients to take BLUJEPA after a meal to reduce the possibility of gastrointestinal intolerance
Prolongation of the QTc Interval
Counsel patients to inform their healthcare provider of any personal or family history of QTc prolongation or proarrhythmic conditions such as hypokalemia, bradycardia, or recent myocardial ischemia, or if they are taking any antiarrhythmic agents. Advise patients to notify their healthcare providers if they have any symptoms of prolongation of the QTc interval, including prolonged heart palpitations or a loss of consciousness
Acetylcholinesterase Inhibition
Counsel patients that BLUJEPA can cause dysarthria and other symptoms such as syncope, presyncope, muscle spasms, diarrhea, nausea, vomiting, abdominal pain, hypersalivation, and hyperhidrosis. Advise patients to inform their healthcare provider if they experience these symptoms or if they have an underlying medical condition that may be exacerbated by acetylcholinesterase inhibition or are planning to receive anesthesia where they may receive neuromuscular blocking agents, or if they are receiving other acetylcholinesterase inhibitors, or systemic anticholinergic medications
Hypersensitivity Reactions
Advise patients that hypersensitivity reactions, including anaphylaxis, could occur and require immediate treatment. Advise patients to inform their healthcare provider about any previous hypersensitivity reactions to BLUJEPA
Diarrhea
Counsel patients that diarrhea is a common problem caused by antibacterials, including BLUJEPA. Most reported cases of diarrhea with BLUJEPA were mild to moderate in severity. Diarrhea may occur early in treatment and usually ends when treatment with the antibacterial is discontinued. In most cases, the diarrhea resolved without treatment
Sometimes potentially serious diarrhea with frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, patients should contact their healthcare provider
Antibacterial Resistance
Patients should be counseled that antibacterial drugs, including BLUJEPA, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When BLUJEPA is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by BLUJEPA or other antibacterial drugs in the future
Drug Interactions
Advise patients of the potential interactions other medications may have with BLUJEPA or the effect BLUJEPA may have on other medications, as these may result in decreased effectiveness or increased toxicities of either BLUJEPA or the other medications. Patients should alert their healthcare provider if they are currently taking any medications, including herbal nutritional supplements, or are prescribed new medications during treatment with BLUJEPA
Pregnancy
Advise patients who are exposed to BLUJEPA during pregnancy to contact GlaxoSmithKline at 1‑888‑825‑5249
Manufactured for:
GlaxoSmithKline
Durham, NC 27701
Trademarks are owned by or licensed to the GSK group of companies.
©2025 GSK group of companies or its licensor.
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