Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • QTc Prolongation [see Warnings and Precautions ( 5.1 )] .
• Acetylcholinesterase Inhibition [see Warnings and Precautions ( 5.2 )] .
• Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] .
• Clostridioides difficile Infection [see Warnings and Precautions ( 5.4 )] .
• uUTI: The most common adverse reactions occurring in ≥1% of patients are diarrhea, nausea, abdominal pain, flatulence, headache, soft feces, dizziness, vomiting, and vulvovaginal candidiasis.
( 6.1 ) • Uncomplicated Urogenital Gonorrhea: The most common adverse reactions occurring in ≥2% of patients are diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, soft feces, headache, fatigue, and hyperhidrosis.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical 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).
5 WARNINGS AND PRECAUTIONS • QTc Prolongation: • Avoid use of BLUJEPA in patients with a history of QTc prolongation, or with relevant pre‑existing cardiac disease, or in patients receiving drugs that prolong the QTc interval.
( 5.1 ) • 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: ( 5.1 , 7.1 , 8.6 , 8.7 ) • Concomitant use of strong CYP3A4 inhibitors • Severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min) • Severe hepatic impairment (Child-Pugh Class C) • Additionally, avoid BLUJEPA in uncomplicated urogenital gonorrhea patients, who have any of the following risk factors for increased gepotidacin exposure: ( 5.1 , 7.1 , 8.6 , 8.7 ) • Concomitant use of moderate CYP3A4 inhibitors • Two or more of the following risk factors: Body weight between 45 kilograms and 60 kilograms, Moderate renal impairment (eGFR 30 to 59 mL/min), Moderate hepatic impairment (Child-Pugh Class B) • 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.
Like all medications, Blujepa can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: