HELP YOUR PATIENTS MAKE THE MOST OF
     THE INSULIN IN THEIR BODY1

    EARLY USE MAY HELP THEM GET TO GOAL1-3

    As an insulin sensitizer, CYCLOSET may work optimally in patients who produce insulin for the body to respond to.

    Early Stage

    help UNLOCK PATIENTS’ INSULIN POTENTIAL WITH CYCLOSET

    EARLY-STAGE PATIENT

    Carla, 48-year-old retail store manager

    Patient 1

    Not an actual patient

    Medical history

    Diagnosed with T2DM 1-2 years ago

    BMI: 27.1 kg/m2

    Mild dyslipidemia and perimenopausal

    Family history of T2DM and hypertension

    Current medications

    Metformin 1000 mg BID

    Statin for dyslipidemia

    WITH AN HbA1c of 7.7%, CARLA MAY BE AN APPROPRIATE EARLY-STAGE PATIENT FOR CYCLOSET

    WITH AN HbA1c of 7.7%, CARLA MAY BE AN APPROPRIATE EARLY-STAGE PATIENT FOR CYCLOSET

    MID-STAGE PATIENT

    Sara, 52-year-old high school teacher

    Patient 2

    Not an actual patient

    Medical history

    Diagnosed with T2DM 4 years ago

    BMI: 31.5 kg/m2

    Hypertension and dyslipidemia

    Family history of T2DM and cardiovascular disease

    Current medications

    Metformin 1000 mg BID

    GLP-1 receptor agonist (insulin secretagogue) 2 mg SC once weekly

    Lisinopril for hypertension and atorvastatin to reduce lipid levels

    WITH AN HbA1c of 8.1%, SARA MAY BE AN APPROPRIATE MID-STAGE PATIENT FOR CYCLOSET

    WITH AN HbA1c of 8.1%, SARA MAY BE AN APPROPRIATE MID-STAGE PATIENT FOR CYCLOSET

    FOR IMPROVED GLUCOSE CONTROL, MAXIMIZE THE BENEFITS OF INSULIN
    SENSITIVITY IN PATIENTS WITH ADEQUATE INSULIN LEVELS1,2

    INDICATION FOR CYCLOSET

    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 FOR CYCLOSET

    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 other 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 VeroScience, LLC 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. 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. 3. Buchanan TA, Xiang AH, Peters RK, et al. Preservation of pancreatic ß-cell function and prevention of type 2 diabetes by pharmacological treatment of insulin resistance in high-risk Hispanic women. Diabetes. 2002;51(9):2796-2803.

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    Salix Pharmaceuticals, 400 Somerset Corporate Blvd, Bridgewater, NJ 08807
    CYCLOSET is a registered trademark of VeroScience LLC, Tiverton, RI 02878 used under license.
    © All Rights Reserved. CYC.0048.USA.18

    INDICATION FOR CYCLOSET

    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 FOR CYCLOSET

    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 other 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 VeroScience, LLC 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.