BLUJEPA
Generic Name/API: gepotidacin
Manufacturer: GlaxoSmithKline
Packaging & Strength & Form:
Tablets: 750 mg of gepotidacin
Storage: 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 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].
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 (kg) with uncomplicated urinary tract infections (uUTI) caused by the following susceptible microorganisms:
Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.
WARNINGS AND PRECAUTIONS
• QTc Prolongation: Avoid use of BLUJEPA in patients with a history of
QTc prolongation, or with relevant pre-existing cardiac disease, and in patients receiving drugs that prolong the QTc interval. Due to an increase in BLUJEPA exposure, avoid concomitant administration of BLUJEPA with strong CYP3A4 inhibitors and in patients with severe hepatic impairment (Child-Pugh Class C) and in patients with severe renal
impairment (estimated glomerular filtration rate [eGFR] <30 mL/min). (5.1)
• Acetylcholinesterase inhibition: Dysarthria and other adverse reactions have been reported in patients receiving BLUJEPA. Monitor patients with
underlying medical conditions that may be exacerbated by acetylcholinesterase inhibition and patients receiving succinylcholine-type neuromuscular blocking agents, systemic anticholinergic medications, or non-depolarizing neuromuscular blocking agents. (5.2)
• 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. (5.3)
• Clostridioides difficile Infection (CDI): CDI has been reported with nearly all systemic antibacterial agents, including BLUJEPA. Evaluate patients who develop diarrhea. (5.4)
*The contents of this site are for reference only. We do not offer drug procurement service. All information must not be used for any commercial purpose.
