INVOKANA™ FILM-COATED TABLETS 100 MG [SIN14506P]

Product Info

INVOKANA™ FILM-COATED TABLETS 100 MG

[SIN14506P]

Indications
Monotherapy and Combination Therapy

INVOKANA™ is indicated as an adjunct to diet and exercise and standard care therapy:

• to improve glycemic control in adults with type 2 diabetes mellitus.

• to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD) who have inadequate glycemic control.

• to reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adult patients with type 2 diabetes mellitus and diabetic nephropathy with albuminuria >300mg/day.

Dosage and Administration
Dosage – Adults 18 years of age and older
The recommended dose of INVOKANA™ is 100 mg or 300 mg once daily. See Table 1 for dosage recommendations based on estimated glomerular filtration rate (eGFR). The 300 mg dose may be considered for patients with an eGFR ≥ 60 mL/min/1.73 m² [CrCl ≥ 60 mL/min], who need tighter glycemic control and who have a low risk of adverse reactions associated with reduced intravascular volume with INVOKANA™ treatment (see below and Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

A starting dose of 100 mg once daily should be used in patients on loop diuretics and patients ≥ 75 years of age. In patients with evidence of reduced intravascular volume, correcting this condition prior to initiation of INVOKANA™ is recommended. For those patients who are tolerating INVOKANA™ 100 mg and who need tighter glycemic control, the dose can be increased to INVOKANA™ 300 mg (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

When INVOKANA™ is used as add-on therapy with insulin or an insulin secretagogue (e.g., sulfonylurea), a lower dose of insulin or the insulin secretagogue may be considered to reduce the risk of hypoglycemia (see Warnings and Precautions and Adverse Reactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Administration
INVOKANA™ should be taken orally once a day, preferably before the first meal of the day (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Tablets are to be swallowed whole.

Missed dose
If a dose is missed, it should be taken as soon as the patient remembers; however, a double dose should not be taken on the same day.

Special populations
Pediatrics (< 18 years of age)
The safety and efficacy of INVOKANA™ have not been established in pediatric patients.

Elderly
In patients ≥ 75 years of age, the starting dose of INVOKANA™ is 100 mg once daily. Renal function and risk of volume depletion should be taken into account (see Warnings and Precautions and Adverse Reactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications
History of a serious hypersensitivity reaction to INVOKANA™.

Patients on dialysis.

Hypersensitivity to the active substance or to any of the excipients (see Adverse Reactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).