Blujepa

Pronunciation: blu-JEP-ah
Generic name: gepotidacin
Dosage form: tablet (750mg)

Medically reviewed by Melisa Puckey, BPharm. Last updated on Apr 1, 2025.

What is Blujepa?

Blujepa (gepotidacin) is a new antibiotic tablet used to treat uncomplicated urinary tract infections (uUTI) in women and girls 12 years and older. An uncomplicated urinary tract infection (uUTI) is a bacterial infection that only affects the lower urinary tract, in women who are otherwise well and do not have other conditions such as diabetes, urinary complications, pregnancy, or are immunocompromised.

Blujepa is a new class of antibiotics called a triazaacenaphthylene antibiotic, which works differently than other antibiotics and has a lower potential for antibiotic resistance. Blujepa works 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 bacteria growth.

Blujepa is taken as two tablets twice daily (every 12 hours) for 5 days.  Tablets are best taken after a meal to decrease the possibility of stomach upset.

Blujepa FDA approval was granted on March 25, 2025, to GSK GlaxoSmithKline, after positive results from phase III EAGLE-2 and EAGLE-3 clinical trials. Blujepa launch date is expected to be the second half of 2025.

Who can use Blujepa?

Blujepa FDA-approved indication is 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.

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.

How does Blujepa work?

Blujepa's mechanism of action is 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 Blujepa work?

Blujepa had positive results in phase III EAGLE-2 (NCT04020341) and EAGLE-3 (NCT04187144) clinical trials.

The EAGLE3 clinical trial demonstrated that 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%,)

The EAGLE-2 clinical trials demonstrated that Blujepa was non-inferior to nitrofurantoin:

• 50.6% of Blujepa-treated patients had a therapeutic success compared to 47.0% of patients taking nitrofurantoin (adjusted difference 4·3%)

*  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-2 and 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. 

Blujepa side effects

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. 

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. Diarrhea usually stops after the antibiotic is stopped. 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.

Related/similar drugs

Who should not take this medicine?

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).

Before taking this medicine 

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

Blujepa dosing information

• Take two tablets twice daily (about 12 hours apart), for 5 days.
• 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.

What other drugs will affect this medicine 

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
• 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.

Blujepa Package Insert 

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.

Storage

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

Ingredients

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.

Manufacturer

Blujepa manufacturer GSK GlaxoSmithKline

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer