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Frequently Asked Questions

Below are frequently asked questions about INVOKAMET® XR and INVOKAMET® (canagliflozin/metformin HCl), which provide the clinical attributes of INVOKANA®—the most-prescribed SGLT2 inhibitor—in a fixed-dose combination with metformin XR or metformin.1-3

Efficacy

What studies have been conducted with INVOKAMET® XR and INVOKAMET®?

While there have been no clinical efficacy studies conducted with INVOKAMET® XR or INVOKAMET®, bioequivalence of INVOKAMET® XR to canagliflozin and metformin XR and of INVOKAMET® to canagliflozin and metformin coadministered as individual tablets has been demonstrated in healthy subjects.1,2

Canagliflozin + metformin XR was studied in a 26-week, double-blind, active-controlled study to evaluate the efficacy and safety of its use as initial therapy.1

INVOKANA® has been studied in more than 20,000 patients with type 2 diabetes across 15 completed and ongoing and ongoing double-blind clinical trials.3

Multiple trials included patients who received INVOKANA® in combination with metformin, with or without other antihyperglycemic agents (AHAs).2-4

Placebo-controlled trials included2,4,5:

  • Metformin
  • A sulfonylurea
  • Metformin + a sulfonylurea
  • Metformin + pioglitazone
  • Insulin (with or without other AHAs, including metformin)

Active-controlled trials included2,4,5:

  • 2 trials vs Januvia® (sitagliptin) (1 in combination with metformin* and 1 in combination with metformin + a sulfonylurea)
  • 1 trial vs glimepiride (in combination with metformin)

*Patients were randomized to INVOKANA® 100 mg, INVOKANA® 300 mg, Januvia® 100 mg, or placebo, administered once daily.

References: 1. INVOKAMET® XR [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 2. INVOKAMET® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 3. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ. 4. INVOKANA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 5. Lavalle-González FJ, Januszewicz A, Davidson J, et al. Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. Diabetologia. 2013;56:2582-2592. Supplemental tables available at: http://link.springer.com/article/10.1007%2Fs00125-013-3039-1 . Accessed September 1, 2016.

 

Can you explain why the A1C reductions demonstrated by INVOKAMET® XR when studied vs metformin XR appear to not be affected by dose (ie, canagliflozin 100 mg vs canagliflozin 300 mg)?

Of the 11 phase 3 trials with INVOKANA® completed to date, 10 have demonstrated clear dose-dependent A1C reductions for the 100-mg and 300-mg doses.1 The study of INVOKAMET® XR vs metformin XR is the only one in which the difference in A1C reductions between the 100-mg and 300-mg doses of canagliflozin was not apparent.2

However, a dose-dependent response was observed for those patients achieving A1C <7.0% in the INVOKAMET® XR and INVOKANA® monotherapy arms, which may be clinically relevant for patients and clinicians.2

References: 1. INVOKANA® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 2. Rosenstock J, Chuck L, González-Ortiz M, et al. Initial combination therapy with canagliflozin plus metformin versus each component as monotherapy for drug-naïve type 2 diabetes. Diabetes Care. 2016;39(3):353-362.

 

Dosage and administration

When should I prescribe INVOKAMET® XR versus INVOKAMET®?

The choice of prescribing INVOKAMET® XR versus INVOKAMET® is up to you and the individual patient’s needs. Prescribe INVOKAMET® XR if you prefer once-daily dosing for a particular patient. Prescribe INVOKAMET® when you believe twice-daily dosing is appropriate.

 

What is the appropriate baseline A1C level to initiate treatment with INVOKAMET® XR or INVOKAMET®?

The AACE Guidelines recommend use of dual therapy for patients with a baseline A1C ≥7.5%.1

Reference: 1. Garber AJ, Abrahamson MJ, Barzilay JI, et al; American Association of Clinical Endocrinologists, American College of Endocrinology. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm—2016 executive summary. Endocr Pract. 2016;22(1):84-113.

 

What dose of INVOKAMET® XR and INVOKAMET® should be administered to patients who are currently taking metformin 850 mg twice a day and INVOKANA® 100 mg or INVOKANA® 300 mg once a day?

For INVOKAMET® XR, individualize the starting dose based on the patient’s current regimen.1 Patients should take 2 INVOKAMET® XR tablets once daily with the morning meal. Adjust dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of metformin 2000 mg and canagliflozin 300 mg.1

For INVOKAMET®, individualize the starting dose based on the patient’s current regimen.2 Patients should take 1 INVOKAMET® tablet twice daily with meals. Adjust dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of metformin 2000 mg and canagliflozin 300 mg.2

References: 1. INVOKAMET® XR [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 2. INVOKAMET® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.

 

Why should INVOKAMET® XR and INVOKAMET® be taken with meals?

It is recommended that INVOKAMET® XR and INVOKAMET® be taken with meals to reduce the gastrointestinal side effects associated with metformin.1,2

References: 1. INVOKAMET® XR [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 2. INVOKAMET® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.

 

Safety

What is the incidence of nocturia with INVOKAMET® XR and INVOKAMET®?

All SGLT2 inhibitors are associated with increased urination. INVOKAMET® XR and INVOKAMET® are equivalent to INVOKANA® in terms of SGLT2 effects. Two placebo-controlled phase 2 studies examined the safety and efficacy of canagliflozin; one study evaluated QD (once-daily) and BID (twice-daily) dosing and the other study evaluated BID dosing, as used with INVOKAMET® (50 mg BID and 150 mg BID). No reports of nocturia occurred with canagliflozin (QD or BID) or placebo in either study.1,2

SGLT2=sodium-glucose co-transporter 2.

References: 1. INVOKAMET® XR [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 2. INVOKAMET® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.

 

Why do INVOKAMET® XR and INVOKAMET® have a boxed warning?

Metformin and all metformin containing products require a boxed warning due to the risk for lactic acidosis caused by metformin accumulation.1,2

Please refer to the Important Safety Information and full Prescribing Information, including boxed warning, for more information.

References: 1. INVOKAMET® XR [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 2. INVOKAMET® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.

 

Affordability

Now that INVOKAMET® XR and INVOKAMET® are approved for first-line use, will prescription insurance plans eliminate the requirement that treatment-naïve patients with type 2 diabetes receive therapy with metformin before they will cover the cost of additional therapies?

Some plans may still have a step-through for metformin, but most plans have not challenged the initial use indication to date.1

Reference: 1. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ.

 

Learn about SPEAKER EVENTS

References: 1. INVOKAMET® XR [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 2. INVOKAMET® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. 3. Data on file. Janssen Pharmaceuticals, Inc., Titusville, NJ.