EFFICACY & SAFETY

 

BLUJEPA was studied in a range of patients1*

Patient population: EAGLE-2 and EAGLE-3 combined1,2

Age groups

Patients BLUJEPA
(n=628)		 NTF
(n=573)		 Total
(n=1201)
Age, years (mean) 50.7 52.2 51.5
Age group      
<18 years 1 (<1%) 4 (<1%) 5 (<1%)
18-50 years 292 (46%) 251 (44%) 543 (45%)
>50 years 335 (53%) 318 (55%) 653 (54%)

History of recurrent uUTI†

Patients BLUJEPA
(n=628)		 NTF
(n=573)		 Total
(n=1201)
History of recurrent uUTI 262 (42%) 224 (39%) 486 (40%)
No history of recurrent uUTI 366 (58%) 349 (61%) 715 (60%)

Common (≥2%) qualifying uropathogens‡

Patients BLUJEPA
(n=628)		 NTF
(n=573)		 Total
(n=1201)
Escherichia coli 566 (90%) 520 (91%) 1086 (90%)
Klebsiella pneumoniae 14 (2%) 16 (3%) 30 (2%)
Citrobacter freundii
complex		 12 (2%) 5 (<1%) 17 (1%)
Staphylococcus
saprophyticus		 15 (2%) 14 (2%) 29 (2%)
Enterococcus faecalis 14 (2%) 7 (1%) 21 (2%)

Renal function (based on CrCl)

Patients BLUJEPA
(n=628)		 NTF
(n=573)		 Total
(n=1201)
Normal (≥90 mL/min) 464 (74%) 403 (70%) 867 (72%)
Mild impairment
(60-89 mL/min)		 116 (18%) 116 (20%) 232(19%)
Moderate impairment
(30-59 mL/min)§		 30 (5%) 38 (7%) 68 (6%)
Severe impairment
(<30 mL/min)§		 3 (<1%) 2 (<1%) 5 (<1%)
Missing 15 14 29

Diabetes

Patients BLUJEPA
(n=628)		 NTF
(n=573)		 Total
(n=1201)
History of diabetes 92 (15%) 92 (16%) 184 (15%)
No history of diabetes 536 (85%) 481 (84%) 1017 (85%)

Race

Patients BLUJEPA
(n=628)		 NTF
(n=573)		 Total
(n=1201)
White 530 (84%) 480 (84%) 1010 (84%)
American Indian or
Alaska Native		 27 (4%) 31 (5%) 58 (5%)
Black or African
American		 38 (6%) 29 (5%) 67 (6%)
Asian 25 (4%) 29 (5%) 54 (4%)
Mixed race 6 (1%) 4 (<1%) 10 (1%)
Native Hawaiian or
other Pacific Islander		 1 (<1%) 0 1 (<1%)
Missing 1 (<1%) 0 1 (<1%)

Ethnicity

Patients BLUJEPA
(n=628)		 NTF
(n=573)		 Total
(n=1201)
Hispanic or Latino 193 (31%) 156 (27%) 349 (29%)
Not Hispanic or Latino 435 (69%) 417 (73%) 852 (71%)
  • *

    The tables show the microbiological intent-to-treat (ITT) nitrofurantoin-susceptible (NTF-S) population.1

  • †

    Recurrent uUTI was defined as a confirmed infection with at least 1 episode within 3 months before trial entry, at least 2 episodes within 6 months before trial entry, or at least 3 episodes within 12 months before trial entry.1

  • ‡

    Patients with more than 1 uropathogen of the same species or group were counted once.1

  • §

    Patients were excluded from the trial if they had a known creatinine clearance of <60 mL/min or elevated serum creatinine as determined by the investigator. However, a small percentage of patients with moderate or severe renal impairment were enrolled prior to baseline central laboratory results being available.1

CrCl=creatinine clearance; NTF=nitrofurantoin; uUTI=uncomplicated urinary tract infection.

Subgroup analyses1

Learn about the data for BLUJEPA among patients who were >50 years old, had a history of recurrent uUTIs, or were infected with antibiotic-resistant uropathogens.

SEE THE DATA

Indication & Important Safety Info

Indication

Important Safety Information

Indication

BLUJEPA is indicated for the treatment of female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg) with uncomplicated urinary tract infections (uUTI) caused by susceptible microorganisms.

Usage to Reduce Development of Drug-Resistant Bacteria

To reduce the development of drug-resistant bacteria and maintain the effectiveness of BLUJEPA and other antibacterial drugs, BLUJEPA should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

Important Safety Information

CONTRAINDICATIONS

BLUJEPA is contraindicated in patients with a history of severe hypersensitivity to BLUJEPA.

WARNINGS AND PRECAUTIONS

QTc Prolongation

  • A dose and concentration-dependent prolongation of the QTc interval has been observed with BLUJEPA. Avoid use of BLUJEPA in patients with a history of QTc prolongation or with relevant pre-existing cardiac disease, patients taking antiarrhythmic agents, or in patients receiving drugs that prolong the QTc interval.
  • 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:
    • Concomitant use of strong CYP3A4 inhibitors
    • Severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min)
    • Severe hepatic impairment (Child-Pugh Class C)

Acetylcholinesterase Inhibition

  • Dysarthria and other adverse reactions potentially attributed to acetylcholinesterase inhibition have been reported with BLUJEPA, a reversible acetylcholinesterase inhibitor. Increased cholinergic effects can be associated with severe adverse reactions, including atrioventricular block, bradycardia, bronchospasm, and seizures/convulsions. Monitor patients with medical conditions that may be exacerbated by acetylcholinesterase inhibition and patients receiving succinylcholine-type or non-depolarizing neuromuscular blocking agents, or systemic anticholinergic medications.

Hypersensitivity Reactions

  • Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving BLUJEPA. If an allergic reaction to BLUJEPA occurs, discontinue the drug and institute appropriate supportive measures.

Clostridioides difficile Infection

  • Clostridioides difficile infection (CDI) has been reported with nearly all systemic antibacterial agents, including BLUJEPA. Evaluate patients who develop diarrhea.
ADVERSE REACTIONS
  • The most common adverse reactions occurring in ≥1% of patients are diarrhea, nausea, abdominal pain, flatulence, headache, soft feces, dizziness, vomiting, and vulvovaginal candidiasis.
DRUG INTERACTIONS
  • CYP3A4 Inhibitors: Avoid coadministration of BLUJEPA with strong CYP3A4 inhibitors due to increased gepotidacin exposure.
  • CYP3A4 Inducers: Avoid coadministration of BLUJEPA with strong CYP3A4 inducers due to decreased gepotidacin exposure.
  • CYP3A4 Substrates: Avoid coadministration of BLUJEPA with drugs that are extensively metabolized by CYP3A4 where minimal concentration changes may lead to serious adverse reactions.
  • Digoxin: Due to an increase in digoxin exposures, consider monitoring digoxin serum concentration, as appropriate, with concomitant administration of BLUJEPA.
USE IN SPECIFIC POPULATIONS
  • Renal Impairment: Avoid use of BLUJEPA in patients with severe renal impairment with eGFR <30 mL/min, including those receiving dialysis.
  • Hepatic Impairment: Avoid use of BLUJEPA in patients with severe hepatic impairment (Child-Pugh Class C).

Please see full Prescribing Information, including Medication Guide, for BLUJEPA. 

To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or 1-888-825-5249 or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References

  1. Wagenlehner F, Perry CR, Hooton TM, et al. Oral gepotidacin versus nitrofurantoin in patients with uncomplicated urinary tract infection (EAGLE-2 and EAGLE-3): two randomised, controlled, double-blind, double-dummy, phase 3, non-inferiority trials. Lancet. 2024;403(10428)741-755. doi:10.1016/S0140-6736(23)02196-7

  2. Wagenlehner F, Perry CR, Hooton TM, et al. Oral gepotidacin versus nitrofurantoin in patients with uncomplicated urinary tract infection (EAGLE-2 and EAGLE-3): two randomised, controlled, double-blind, double-dummy, phase 3, non-inferiority trials. Supplementary appendix. Lancet. 2024;403(10428)1-33. doi:10.1016/S0140-6736(23)02196-7