Gepotidacin
Generic Name: gepotidacin
Brand Names:
Blujepa
11 DESCRIPTION BLUJEPA tablets contain gepotidacin mesylate, a triazaacenaphthylene antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV. The chemical name is ( R )-2-((4-(((3,4-dihydro-2 H -pyrano[2,3- c ]pyridin-6-yl)methyl)amino)piperidin-1-yl)methyl)-1,2-dihydro-3 H ,8 H -2a,5,8a-triazaacenaphthylene-3,8-dione methanesulfonate dihydrate. The molecular formula is C 24 H 28 N 6 O 3 ●CH 4 O 3 S●2H 2 O and its molecular mass is 580.66. The structural formula is shown below.
Overview
11 DESCRIPTION BLUJEPA tablets contain gepotidacin mesylate, a triazaacenaphthylene antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV. The chemical name is ( R )-2-((4-(((3,4-dihydro-2 H -pyrano[2,3- c ]pyridin-6-yl)methyl)amino)piperidin-1-yl)methyl)-1,2-dihydro-3 H ,8 H -2a,5,8a-triazaacenaphthylene-3,8-dione methanesulfonate dihydrate. The molecular formula is C 24 H 28 N 6 O 3 ●CH 4 O 3 S●2H 2 O and its molecular mass is 580.66. The structural formula is shown below.
Uses
1 INDICATIONS AND USAGE BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: • Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). ( 1.1 ) • Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety data for this indication.
Dosage
2 DOSAGE AND ADMINISTRATION • uUTI: The recommended dosage of BLUJEPA is 1,500 mg (two 750 mg tablets) taken orally, twice daily (approximately 12 hours apart), for 5 days. ( 2.1 ) • Uncomplicated Urogenital Gonorrhea: The recommended dosage of BLUJEPA is 3,000 mg (four 750 mg tablets) taken orally, followed by a second dose of 3,000 mg (four 750 mg tablets) approximately 12 hours later. ( 2.2 ) • Administer BLUJEPA tablets after a meal to reduce the possibility of gastrointestinal intolerance.
Side Effects
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.
Interactions
7 DRUG INTERACTIONS • 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.
Warnings
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... 4 CONTRAINDICATIONS 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 )
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry A pregnancy exposure registry will be established to monitor pregnancy outcomes in women exposed to BLUJEPA during pregnancy. Pregnant women exposed to BLUJEPA, and healthcare providers are encouraged to contact GlaxoSmithKline at 1‑888‑825‑5249. Risk Summary There are no available data on the use of BLUJEPA in pregnant women to evaluate for a drug‑associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 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 8 tablets (NDC 0173-0922-38). 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).
Frequently Asked Questions
What is Gepotidacin used for?▼
1 INDICATIONS AND USAGE BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: • Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). ( 1.1 ) • Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety data for this indication.
What are the side effects of Gepotidacin?▼
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.
Can I take Gepotidacin during pregnancy?▼
8.1 Pregnancy Pregnancy Exposure Registry A pregnancy exposure registry will be established to monitor pregnancy outcomes in women exposed to BLUJEPA during pregnancy. Pregnant women exposed to BLUJEPA, and healthcare providers are encouraged to contact GlaxoSmithKline at 1‑888‑825‑5249. Risk Summary There are no available data on the use of BLUJEPA in pregnant women to evaluate for a drug‑associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
What are the important warnings for Gepotidacin?▼
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... 4 CONTRAINDICATIONS 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 )
Related Medications
Metipranolol Hydrochloride
metipranolol hydrochloride
Manufactured by BAUSCH AND LOMB. Dosage form: SOLUTION/DROPS. Route: OPHTHALMIC. Active ingredients: METIPRANOLOL HYDROCHLORIDE (0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**). Application: NDA019907.
Spleen Stim Liquescence
spleen stim liquescence
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Chenopodium Album Pollen
chenopodium album pollen
Dosage form: INJECTION, SUSPENSION. Route: SUBCUTANEOUS. Active ingredients: CHENOPODIUM ALBUM POLLEN (10000 [PNU]/mL). Category: BLA.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.