INVOKAMET

CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Manufacturer: Janssen Pharmaceuticals, Inc.

Score: 144.0

Quick Summary

INVOKAMET is a combination of canagliflozin and metformin HCl used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is also indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease, as well as to reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria. The drug has several important safety considerations, including a boxed warning for lactic acidosis, and is contraindicated in patients with severe renal impairment, acute or chronic metabolic acidosis, and serious hypersensitivity reactions. Dosing recommendations vary based on the patient's current regimen and renal function, with gradual escalation to reduce gastrointestinal adverse reactions with metformin. Special population considerations include use during pregnancy, pediatric use, geriatric use, and nursing mothers.

Key Clinical Findings and Indications

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease
Reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria

Important Safety Information

Warning

Lactic acidosis, diabetic ketoacidosis, and serious hypersensitivity reactions

Contraindications

Severe renal impairment (eGFR less than 30 mL/min/1.73 m^2)
Acute or chronic metabolic acidosis, including diabetic ketoacidosis
Serious hypersensitivity reactions to canagliflozin or metformin HCl

Adverse Reactions

Lactic acidosis
Diabetic ketoacidosis
Hypotension
Postural dizziness
Orthostatic hypotension
Syncope
Dehydration
Necrotizing fasciitis of the perineum (Fournier's gangrene)
Genital mycotic infections
Hypersensitivity reactions

Dosing Recommendations

General Guidance

Gradually escalate metformin HCl dose to reduce gastrointestinal adverse reactions with metformin

Type 2 diabetes mellitus

Adult Dose

INVOKAMET: one tablet, twice daily with meals, recommended starting dose of canagliflozin is 50 mg twice daily and metformin HCl 500 mg twice daily

Pediatric Dose

Not recommended for use in pediatric patients under 18 years of age

Special Population Considerations

Pregnancy

Not recommended during the second and third trimesters of pregnancy due to potential adverse renal effects

Nursing Mothers

Caution should be exercised when administering INVOKAMET to nursing mothers

Pediatric Use

Not recommended for use in pediatric patients under 18 years of age

Geriatric Use

Monitor renal function more frequently after initiating INVOKAMET in the elderly and adjust dose based on renal function

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