Gepotidacin: uses, dosing, side effects & brands

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…

BLUJEPA is contraindicated in patients with a history of severe hypersensitivity to BLUJEPA [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] . A history of severe hypersensitivity to BLUJEPA. ( 4 )

CYP3A4 Inhibitors: Increase gepotidacin exposure. ( 7.1 ) • Strong CYP3A4 inhibitors: Avoid concomitant use of BLUJEPA with strong CYP3A4 inhibitors. ( 5.1 , 7.1 ) • Moderate CYP3A4 inhibitors: Avoid concomitant use of BLUJEPA with moderate CYP3A4 inhibitors in patients with uncomplicated urogenital gonorrhea. ( 5.1 , 7.1 ) • CYP3A4 Inducers: Decrease gepotidacin exposure. ( 7.1 ) • For uUTI: Avoid concomitant use of BLUJEPA with strong CYP3A4 inducers. ( 7.1 ) • For uncomplicated urogenital gonorrhea: Avoid concomitant use of BLUJEPA with strong and moderate CYP3A4 inducers. ( 7.1 ) • CYP3A4 Substrates: Avoid concomitant use of BLUJEPA with drugs that are extensively metabolized by CYP3A4 where minimal concentration changes may lead to serious adverse reactions. ( 7.2 ) • Digoxin: Due to an increase in digoxin exposures, consider monitoring digoxin serum concentration, as appropriate, with concomitant administration of BLUJEPA. ( 7.2 ) 7.1 Effect of Other Drugs on BLUJEPA CYP3A4 Inhibitors Table 3. Recommendations for Concomitant Administration of CYP3A4 Inhibitors with BLUJEPA Indication Moderate CYP3A4 Inhibitors Strong CYP3A4 Inhibitors Uncomplicated UTI No dosage adjustment Avoid concomitant administration of BLUJEPA with strong inhibitors of CYP3A4 due to an increase in gepotidacin exposure [see Warnings and Precautions ( 5.1 ), Clinical Pharmacology ( 12.3 )]. Uncomplicated Urogenital Gonorrhea Avoid concomitant administration of BLUJEPA with moderate CYP3A4 inhibitors due to an increase in gepotidacin exposure [see Warnings and Precautions ( 5.1 ), Clinical Pharmacology ( 12.3 )]. Avoid concomitant administration of BLUJEPA with strong inhibitors of CYP3A4 due to an increase in gepotidacin exposure [see Warnings and Precautions ( 5.1 ), Clinical Pharmacology ( 12.3 )]. CYP3A4 Inducers Due to decreased gepotidacin exposures, avoid coadministration of BLUJEPA with CYP3A4 inducers as follows: • Uncomplicated urinary tract infections: Avoid concomitant use of BLUJEPA with strong CYP3A4 inducers [see Clinical Pharmacology ( 12.3 )] . • Uncomplicated urogenital gonorrhea: Avoid concomitant use of BLUJEPA with strong and moderate CYP3A4 inducers [see Clinical Pharmacology ( 12.3 )] . 7.2 Effect of BLUJEPA on Other Drugs CYP3A4 Substrates Avoid concomitant administration of BLUJEPA with drugs that are extensively metabolized by CYP3A4 where minimal concentration changes may lead to serious adverse reactions [see Clinical Pharmacology ( 12.3 )] . Digoxin Due to an increase in digoxin exposures, consider monitoring digoxin serum concentrations, as appropriate, with concomitant administration of BLUJEPA [see Clinical Pharmacology ( 12.3 )] . 7.3 Cholinergic/Anticholinergic Drugs As gepotidacin is an acetylcholinesterase inhibitor, there is potential for an exaggerated effect of concomitantly administered succinylcholine‑type neuromuscular blocking agents resulting in a delay in recovery of neuromuscular function. BLUJEPA may augment the effect of other acetylcholinesterase inhibitors. Monitor for exaggerated neuromuscular blockade or excessive cholinergic effects [see Warnings and Precautions ( 5.2 )] . There is potential for an antagonistic effect with systemic anticholinergic medications or non‑depolarizing neuromuscular blocking agents. Consider the potential for this interaction if BLUJEPA is administered concomitantly with anticholinergic medications [see Warnings and Precautions ( 5.2 )] . 7.4 Drugs that Prolong the QTc Interval Due to the increased risk of QTc prolongation, avoid concomitant administration of BLUJEPA with other medications that have the potential to prolong the QTc interval [see Warnings and Precautions ( 5.1 )] .