HELP YOUR PATIENTS MAKE THE MOST OF THE INSULIN IN THEIR BODIES1

    A PATIENT WHO MAY BENEFIT MOST FROM CYCLOSET1-3

    LOOK FOR ADULT PATIENTS WITH T2DM WHO HAVE ADEQUATE PRANDIAL INSULIN AND ONE OR BOTH OF THESE CHARACTERISTICS1,2:

    • 1ELEVATED PRANDIAL GLUCOSE (PPG)
      • Postprandial glucose > 140 mg/dL3
    • 2MARKERS OF ELEVATED SYMPATHETIC NERVOUS SYSTEM (SNS) ACTIVITY4
      • Elevated resting heart rate ≥80 bpm5,6
      • -OR-
      • History of hypertension (high blood pressure) and elevated plasma triglycerides ≥150 mg/dL7,8

    FOR YOUR NEXT T2DM PATIENT WITH SNS OVERACTIVITY AND ADEQUATE PRANDIAL INSULIN, THINK CYCLOSET

    Robert, 52-year-old musician*

    Patient 1

    *Not an actual patient

    Medical history

    HbA1c: 7.9%

    BMI: 27.1 kg/m2

    PPG: 145 mg/dL

    MILD DYSLIPIDEMIA

    DISPLAYING SIGNS OF OVERACTIVE SNS9,10

    Elevated resting heart rate (>80 bpm)

    Hypertension (>140/90 mm Hg) and

    Elevated plasma triglycerides (>150 mg/dL)

    ADEQUATE PRANDIAL INSULIN WITH DPP4i

    ADEQUATE PRANDIAL INSULIN WITH DPP4i

    Sara, 48-year-old high school teacher*

    Patient 2

    *Not an actual patient

    Medical history

    HbA1c: 8.4%

    BMI: 31.5 kg/m2

    PPG: 148 mg/dL

    HYPERTENSION AND DYSLIPIDEMIA

    FAMILY HISTORY OF T2DM AND CARDIOVASCULAR DISEASE

    Adequate prandial insulin with GLP-1 agonist

    ADEQUATE PRANDIAL INSULIN WITH GLP-1 AGONIST

    ADEQUATE PRANDIAL INSULIN WITH GLP-1 AGONIST

    FOR IMPROVED GLUCOSE CONTROL, MAXIMIZE THE BENEFITS OF INSULIN SENSITIVITY IN PATIENTS WITH ADEQUATE INSULIN LEVELS1,11

    INDICATION

    CYCLOSET® (bromocriptine mesylate) 0.8 mg tablets is a dopamine receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

    IMPORTANT LIMITATIONS OF USE

    CYCLOSET should not be used to treat type 1 diabetes or diabetic ketoacidosis.

    There are limited efficacy data in combination with thiazolidinediones.

    Efficacy has not been confirmed in combination with insulin.

    IMPORTANT SAFETY INFORMATION

    Contraindications

    Do not use CYCLOSET in patients with hypersensitivity to ergot-related drugs, bromocriptine or to any of the excipients in CYCLOSET.

    Do not use CYCLOSET in patients with syncopal migraines. May precipitate hypotension.

    Do not use CYCLOSET in nursing women. May inhibit lactation. There have been postmarketing reports of stroke with bromocriptine in this patient population, although causality has not been proven. Based on CYCLOSET clinical trials, there is no evidence of increased risk for stroke when CYCLOSET is used to treat type 2 diabetes.

    Orthostatic Hypotension/Syncope

    CYCLOSET can cause orthostatic hypotension and syncope, particularly upon initiation or dose escalation. Use caution in patients taking anti-hypertensive medications. Orthostatic vital signs should be assessed prior to initiation of CYCLOSET and periodically thereafter.

    Advise patients during early treatment to avoid situations that could lead to injury if syncope were to occur, and to make slow postural changes.

    Exacerbation of Mental Illness

    Pathological gambling and exacerbation of psychotic disorders have been reported with bromocriptine generally given in higher doses than what is approved for diabetes treatment. There have been no reported cases of psychoses or pathological gambling among CYCLOSET-treated patients in clinical trials. The use of CYCLOSET in patients with severe psychotic disorders is not recommended.

    Somnolence

    CYCLOSET may cause somnolence, particularly when initiating therapy. Advise patients not to drive or operate heavy machinery if symptoms of somnolence occur.

    Concomitant Use of Dopamine Antagonists or Agonists

    Concomitant use with dopamine antagonists, such as neuroleptic agents, may diminish the effectiveness of both drugs and is not recommended.

    Effectiveness and safety are unknown in patients already taking dopamine receptor agonists for other indications and concomitant use is not recommended.

    Macrovascular Effects

    There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with CYCLOSET. CYCLOSET has not been associated with increased risk of macrovascular events.

    Safety and Effectiveness in Pediatrics

    The safety and effectiveness of CYCLOSET in pediatric patients have not been established.

    Adverse Reactions

    In clinical trials, the most common adverse reactions reported in ≥5% of patients treated with CYCLOSET, and reported more commonly than in patients treated with placebo, included nausea, fatigue, dizziness, vomiting, and headache. Postmarketing reports with higher doses of bromocriptine used for other indications include psychotic disorders, hallucinations, and fibrotic complications.

    To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Please click here for full Prescribing Information for CYCLOSET.

    References: 1. CYCLOSET [prescribing information]. Tiverton, RI: VeroScience, LLC. 2. DeFronzo RA. Bromocriptine: a sympatholytic, D2-dopamine agonist for the treatment of type 2 diabetes. Diabetes Care. 2011;34(4):789-794. 3. American Diabetes Association. Postprandial Blood Glucose. Diabetes Care. 2001:24(4):775-778. 4. Sclaich M, Strazinsky N, Lambert E, et al. Metabolic syndrome: a sympathetic disease? Lancet Diabetes Endocrinol. 2015:3(2):148-157. 5. Rogowski O, Steinvil A, Berliner S, et al. Elevated resting heart rate is associated with the metabolic syndrome. Cardiovasc Diabetol. 2009;8:55. doi: 10.1186/1475-2840-8-55. 6. Chamarthi B, Vinik AI, Ezrokhi M, et al. Dopamine agonist therapy reduces elevated heart rate and dysglycemia in type 2 diabetes subjects. Diabetes. 2016;65(Suppl1):A317. 7. Geerling JJ, Boon MR, Kooijman S, et al. Sympathetic nervous system control of triglyceride metabolism: novel concepts derived from recent studies. J Lipid Res. 2014;55(2):180-189. 8. Cincotta AH, Ezrokhi M. The anti-diabetes efficacy of Bromocriptine-QR in type 2 diabetes mellitus (T2DM) subjects is enhanced among those with elevated blood pressure and plasma triglyceride levels. Diabetes. 2013; 62(suppl 1):A305. 9. Tentolouris N, Argyrakopoulou G, Katsilambros N. Perturbed autonomic nervous system function in metabolic syndrome. Neuromolecular Med. 2008;10(3):169-178. 10. Thorp AA, Sclaich MP. Relevance of sympathetic nervous system activation in obesity and metabolic syndrome. J. Diabetes Res. 2015;2015:341583. 11. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35(6):1364-1379.

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    INDICATION

    CYCLOSET® (bromocriptine mesylate) 0.8 mg tablets is a dopamine receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

    IMPORTANT LIMITATIONS OF USE

    CYCLOSET should not be used to treat type 1 diabetes or diabetic ketoacidosis.

    There are limited efficacy data in combination with thiazolidinediones.

    Efficacy has not been confirmed in combination with insulin.

    IMPORTANT SAFETY INFORMATION

    Contraindications

    Do not use CYCLOSET in patients with hypersensitivity to ergot-related drugs, bromocriptine or to any of the excipients in CYCLOSET.

    Do not use CYCLOSET in patients with syncopal migraines. May precipitate hypotension.

    Do not use CYCLOSET in nursing women. May inhibit lactation. There have been postmarketing reports of stroke with bromocriptine in this patient population, although causality has not been proven. Based on CYCLOSET clinical trials, there is no evidence of increased risk for stroke when CYCLOSET is used to treat type 2 diabetes.

    Orthostatic Hypotension/Syncope

    CYCLOSET can cause orthostatic hypotension and syncope, particularly upon initiation or dose escalation. Use caution in patients taking anti-hypertensive medications. Orthostatic vital signs should be assessed prior to initiation of CYCLOSET and periodically thereafter.

    Advise patients during early treatment to avoid situations that could lead to injury if syncope were to occur, and to make slow postural changes.

    Exacerbation of Mental Illness

    Pathological gambling and exacerbation of psychotic disorders have been reported with bromocriptine generally given in higher doses than what is approved for diabetes treatment. There have been no reported cases of psychoses or pathological gambling among CYCLOSET-treated patients in clinical trials. The use of CYCLOSET in patients with severe psychotic disorders is not recommended.

    Somnolence

    CYCLOSET may cause somnolence, particularly when initiating therapy. Advise patients not to drive or operate heavy machinery if symptoms of somnolence occur.

    Concomitant Use of Dopamine Antagonists or Agonists

    Concomitant use with dopamine antagonists, such as neuroleptic agents, may diminish the effectiveness of both drugs and is not recommended.

    Effectiveness and safety are unknown in patients already taking dopamine receptor agonists for other indications and concomitant use is not recommended.

    Macrovascular Effects

    There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with CYCLOSET. CYCLOSET has not been associated with increased risk of macrovascular events.

    Safety and Effectiveness in Pediatrics

    The safety and effectiveness of CYCLOSET in pediatric patients have not been established.

    Adverse Reactions

    In clinical trials, the most common adverse reactions reported in ≥5% of patients treated with CYCLOSET, and reported more commonly than in patients treated with placebo, included nausea, fatigue, dizziness, vomiting, and headache. Postmarketing reports with higher doses of bromocriptine used for other indications include psychotic disorders, hallucinations, and fibrotic complications.

    To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Please click here for full Prescribing Information for CYCLOSET.