Blujepa

Blujepa (gepotidacin) is an antibiotic tablet used to treat uncomplicated gonorrhea in patients 12 years and older, and uncomplicated urinary tract infections (uUTI) in women and girls 12 years and older.

Blujepa is a new class of antibiotics called a triazaacenaphthylene antibiotic. Because it works differently from other antibiotics, it has a lower potential for antibiotic resistance.

Blujepa works by blocking bacterial DNA replication. Blujepa does this by targeting and blocking two essential bacterial enzymes, DNA gyrase (topoisomerase II) and topoisomerase IV, which are needed for bacterial DNA replication.

Blujepa is bactericidal, which means it kills the bacteria rather than just inhibiting bacterial growth.

Blujepa tablets are taken twice daily (every 12 hours), after a meal, to decrease the risk of stomach upset. Each tablet contains 750mg of gepotidacin.

Blujepa FDA approval was granted for uncomplicated urinary tract infections in certain patients after positive results from phase III EAGLE-2 and EAGLE-3 clinical trials. FDA approval was granted for uncomplicated urogential gonorrhoea on December 11, 2025.

Blujepa FDA-approved indications are for:

Uncomplicated urinary tract infections (uUTI), in

• Female adult and pediatric patients 12 years of age and older weighing at least 88 lbs (40 kg)
• Caused by the bacteria Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, or Enterococcus faecalis.

Uncomplicated Urogenital Gonorrhea, in

• Adult and pediatric patients 12 years of age and older weighing at least 99 lbs (45 kg)
• Those who have limited or no alternative treatment options
• Caused by susceptible strains of Neisseria gonorrhoea
• Approval of this indication is based on limited clinical safety data for this indication

This medicine should be used only to treat infections that are proven or strongly suspected to be caused by bacteria, to reduce the development of drug-resistant bacteria.

Blujepa's mechanism of action is by blocking two bacterial type II topoisomerase enzymes called bacterial topoisomerase II (DNA gyrase) and topoisomerase IV, which are needed for the bacteria to replicate. By blocking these two enzymes Blujepa inhibits bacterial DNA replication and kills the bacteria.

Blujepa is a triazaacenaphthylene bacterial type II topoisomerase inhibitor.

How well does Blujep work for uUTI?

Blujepa was superior to nitrofurantoin for treating uUTI in females 12 years and older:

• 58·5% of Blujepa patients had therapeutic success* compared to 43.6% of patients taking nitrofurantoin (adjusted difference 14·6%) in the EAGLE3 (NCT04187144) clinical trial.
• Therapeutic success is defined as combined clinical success (complete symptom resolution) and microbiological success (reduction of qualifying uropathogens to <103 CFU/mL) without other systemic antimicrobial use.
• The EAGLE-3 compared the treatment of Blujepa 1500 mg twice daily for 5 days to oral nitrofurantoin 100 mg twice daily for 5 days in female patients 12 years and older who weigh 40 kg or more with a confirmed uUTI.

How well does Blujeap work for uncomplicated urogenital gonorrhea?

Blujepa was non-inferior to the standard of care combination treatment for gonorrhoea (intramuscular ceftriaxone plus oral azithromycin) in the EAGLE-1 phase III trial (NCT04010539).

The EAGLE-1 phase III trial compared Blujepa (oral, two doses of 3,000mg) to intramuscular ceftriaxone (500mg) plus oral azithromycin (1,000mg) in adults and adolescents with uncomplicated urogenital gonorrhoea

Do not take this medicine if:

• You have had a severe allergic reaction to Blujepa's active ingredient, gepotidacin, or any of the inactive ingredients contained in this tablet
• If you have severe kidney (renal) impairment (eGFR <30 mL/min), including if you receive dialysis.
• If you have severe liver (hepatic) impairment (Child-Pugh Class C).
• If you are being treated for gonorrhea and take moderate CYP3A4 inhibitors, or have two or more of the following: body weight between 99 lbs and 132 lbs (45 to 60 kg), moderate kidney impairment, or moderate liver impairment.

Before taking this medicine, tell your healthcare provider about your medical conditions, including if you have:

• Heart rhythm problems
• Slow heartbeat (bradycardia).
• Have had a heart attack recently.
• Low potassium in your blood (hypokalemia).
• Are planning a procedure with a general anesthetic that will use a type of medicine given through your veins (I.V.) that relaxes your muscles.
• Liver problems.
• Kidney problems, kidney failure, or are on dialysis.

Pregnancy

Tell your healthcare professionals if you are pregnant or plan to become pregnant as it is not known if Blujepa will harm your unborn baby. If you become pregnant or think you are pregnant during your treatment with this medicine tell your healthcare provider immediately.

There is a pregnancy exposure registry for women who are exposed to this medicine during pregnancy. The purpose of this registry is to check the health of you and your baby. If you are pregnant or become pregnant during your treatment with Blujepa, talk to your healthcare provider about registering with GlaxoSmithKline. You can register by calling GlaxoSmithKline at 1-888-825-5249.

Breastfeeding

Tell your healthcare professional if you are breastfeeding or plan to breastfeed, as it is not known if this medicine passes into breast milk. Talk to your healthcare provider about the best way to feed your baby during your treatment with this medicine

Common Blujepa side effects

Common Blujepa side effects include:

• Diarrhea 16%
• Nausea 9%
• Abdominal pain 4%
• Flatulence 3%
• Headache 2%
• Soft bowel movements 2%
• Dizziness 2%
• Vomiting 2%
• Vaginal yeast infections 1%

These common side effects occurred in 1% or more of Blujepa patients taking 1500mg twice daily for 5 days, in Clinical Trials 1 and 2.

The most common side effects of Blujepa in people treated for gonorrhea include diarrhea, dizziness, nausea, soft stools, stomach pain, headache, vomiting, feeling tired, gas, and excessive sweating.

Serious side effects and warnings

QTc prolongation. This medication can affect the heart and can cause QTc prolongation (also called prolonged QTc interval) that can lead to serious heart rhythm problems, including Torsade de Pointes. There may be changes in your heartbeat (a fast or irregular heartbeat). Tell your healthcare provider before you start this medication if:

• You or a family member has ever had a heart rhythm problem, problems with heart rate or heartbeat, or QTc prolongation
• If you take any medicines to treat heart rhythm problems. Using heart rhythm medicines with Blujepa may cause serious side effects. If you are not sure, ask your healthcare provider.

Tell your healthcare provider right away if you have any of the following heart symptoms:

• Fast, pounding, or uneven heartbeat
• Feeling lightheaded
• Dizziness
• Losing consciousness (pass out)
• Feeling faint

Cholinergic effects. Blujepa can cause an increase in a chemical in your nervous system called acetylcholine. When acetylcholine is increased in your nervous system it may cause cholinergic side effects including:

• Diarrhea
• Vomiting
• Feeling faint
• Trouble saying words clearly
• Muscle spasms
• Nausea
• Increased saliva
• Increased sweating
• Stomach pain.

Call your healthcare professional right away if you have trouble saying words clearly, have shortness of breath, or if you faint. These symptoms may be cholinergic effects of this medicine. Increased acetylcholine can also be connected to other symptoms. Call your healthcare provider right away if you have any of these additional symptoms.

• Irregular heartbeat (heart block)
• Fainting
• Slow heartbeat (bradycardia)
• Chest tightness causing difficulty breathing
• Seizures

Hypersensitivity Reactions Allergic reactions can happen in people who take Blujepa including a severe allergic reaction called anaphylaxis. Stop taking these tablets and get medical help right away if you have any symptoms of a severe allergic reaction, including:

• Hives
• Feeling faint or dizzy
• Rash
• Swelling of your lips, tongue, or throat

Diarrhea. Diarrhea is a common side effect caused by antibiotics including this medicine. The diarrhea may happen at the beginning of your treatment with Blujepa and usually stops after the antibiotic is stopped. In most cases the diarrhea will go away without treatment. In some cases, diarrhea may be caused by Clostridioides difficile infection (CDI). CDI is a severe infection of the intestines (bowels) that can happen up to 2 months after finishing treatment with antibiotic medicines, including these tablets. CDI can be life-threatening and can lead to death. Do not take medicines to treat diarrhea without checking first with your healthcare provider. Call your healthcare provider right away if you have the following symptoms:

• Stomach cramps
• Diarrhea that does not go away
• Fever
• Watery diarrhea
• Bloody bowel motions.

• For urinary tract infections (uUTI): Take two tablets twice daily (about 12 hours apart), for 5 days. For gonorrhea: Take 4 tablets, followed by a second dose of 4 tablets about 12 hours later.
• Take tablets after a meal to decrease the chance of stomach upset.
• If you miss a dose, take it as soon as possible, then continue your treatment as before. Do not take 2 doses at the same time to make up for a missed dose.

Blujepa is available as 750mg tablets.

Other drugs may interact with Blujepa, including prescription and over-the-counter medicines, vitamins, and herbal products.

Tell your healthcare professional about all medications that you take. Medications that interact with Blujepa include:

• CYP3A4 Inhibitors Avoid coadministration of Blujepa with strong CYP3A4 inhibitors. If you are being treated for gonorrhea, also avoid moderate CYP3A4 inhibitors.
• CYP3A4 Inducers Avoid coadministration of this medicine with strong CYP3A4 inducers.
• CYP3A4 Substrates Avoid coadministration of Blujepa with drugs that are extensively metabolized by CYP3A4 and have a narrow therapeutic window.
• Digoxin due to an increase in digoxin exposures, consider monitoring digoxin levels.

Not all possible drug interactions are listed here. Ask your healthcare professional to check for drug interactions with this medicine.

HCPs and patients often use the Blujepa Package Insert (PI) for more detailed information about this medicine. The Blujepa Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Blujepa Prescribing Information (PI) or FDA label.

Store tablets at room temperature between 68°F to 77°F (20°C to 25°C).

Active ingredient: gepotidacin mesylate

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.

Blujepa manufacturer GSK GlaxoSmithKline