Summary

• INVOKANA is available as 100 mg and 300 mg film-coated tablets for oral administration.¹
• A phase 1 study evaluated the clinical safety, tolerability, and pharmacokinetics (PK) of INVOKANA when administered as a single 300 mg oral dose in combination with a single intravenous (IV) 10 mcg infusion of ¹⁴C-canagliflozin.²
• Clinical studies evaluating the safety and efficacy of INVOKANA administered intramuscularly (IM) or subcutaneously (SC) have not been conducted.

CLINICAL STUDIES

Intravenous

• An open-label, single-center, single-dose, phase 1 study was conducted to determine the absolute oral bioavailability of a single 300 mg dose of INVOKANA. Secondary objectives included evaluation of the PK of INVOKANA after administration of a single oral dose of 300 mg together with a single IV dose of 10 mcg of ¹⁴C-canagliflozin, and the determination of the extent of biliary excretion of a single 10 mcg IV dose of ¹⁴C-canagliflozin.²
  • Nine healthy male subjects received a single 300 mg oral dose of INVOKANA followed by a 15-minute IV infusion of 10 mcg of INVOKANA that was combined with a radioactive carbon isotope referred to as ¹⁴C-canagliflozin.
  • The mean absolute oral bioavailability of canagliflozin was reported to be 65%.^1,2

Intramuscular and Subcutaneous

Clinical studies evaluating the safety and efficacy of INVOKANA administered IM or SC have not been conducted.

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 14 October 2024.