Brand Name
Inpefa
Generic Name
Sotagliflozin
View Brand Information FDA approval date: May 21, 2018
Classification: Sodium-Glucose Cotransporter 2 Inhibitor
Form: Tablet
What is Inpefa (Sotagliflozin)?
INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors INPEFA is a sodium-glucose cotransporter 2 inhibitor indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors
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Brand Information
INPEFA (sotagliflozin)
1INDICATIONS AND USAGE
INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with:
- heart failure or
- type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors
2DOSAGE FORMS AND STRENGTHS
INPEFA 200 mg printed tablet is an oval, blue, film-coated tablet imprinted in black ink with “LX200” on one side.
INPEFA 200 mg debossed tablet is an oval, blue, film-coated tablet debossed with “LEX” on one side and “200” on the other side.
INPEFA 400 mg debossed tablet is an oval, yellow, film-coated tablet debossed with “LEX” on one side and “400” on the other side.
3CONTRAINDICATIONS
INPEFA is contraindicated in patients with a history of serious hypersensitivity reaction to INPEFA.
4ADVERSE REACTIONS
The following important adverse reactions are described elsewhere in the labeling:
- Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis
- Volume Depletion
- Urosepsis and Pyelonephritis
- Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues
- Necrotizing Fasciitis of the Perineum (Fournier's Gangrene)
- Genital Mycotic Infections
4.1Clinical 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 to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In the phase 3 (SOLOIST
In the SOLOIST study, 336 patients (56%) reached the 400 mg dose. In the SCORED study, 3,934 patients (74%) reached the 400 mg dose.
In the SOLOIST study, 5.6% of patients in the INPEFA group and 5.4% of patients in the placebo group discontinued therapy due to adverse events (AEs). In the SCORED study, 5.0% of patients in the INPEFA group and 4.5% of patients in the placebo group discontinued therapy due to AEs.
5OVERDOSAGE
There were no confirmed reports of symptomatic overdose with sotagliflozin during the clinical development program of INPEFA.
In the event of an overdose with INPEFA, contact the Poison Control Center. Employ the usual supportive measures as dictated by the patient's clinical status.
The removal of sotagliflozin by hemodialysis has not been studied.
6DESCRIPTION
INPEFA tablets for oral administration contain sotagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor.
The chemical name of sotagliflozin is (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol.
Its molecular formula is C
Sotagliflozin is a white to off-white solid. It is practically insoluble in water.
Each film-coated tablet of INPEFA contains 200 mg or 400 mg of sotagliflozin and the following inactive ingredients. The core of the tablet contains colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and talc. The film coating for the 200 mg tablet contains: indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol (partly hydrolyzed), talc, and titanium dioxide. The film coating for the 400 mg tablet contains: hypromellose, lactose monohydrate, titanium dioxide, triacetin, and yellow iron oxide. The 200 mg printed tablet also includes black ink which contains: ammonium hydroxide, black iron oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol, and shellac.
7HOW SUPPLIED/STORAGE AND HANDLING
INPEFA tablets are oval and film-coated.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (