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 > 180 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, THINK CYCLOSET
Robert, 52-year-old musician*
*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 and
Elevated plasma triglycerides (>150 mg/dL)
ADEQUATE PRANDIAL INSULIN WITH DPP4i
ADEQUATE PRANDIAL INSULIN WITH DPP4i
Sara, 48-year-old high school teacher*
*Not an actual patient
Medical history
HbA1c: 8.4%
BMI: 31.5 kg/m2
PPG: 195 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.
LIMITATIONS OF USE
CYCLOSET should not be used to treat type 1 diabetes or diabetic ketoacidosis.
Limited efficacy data in combination with thiazolidinediones.
Efficacy has not been confirmed in combination with insulin.
IMPORTANT SAFETY INFORMATION
Contraindications
CYCLOSET is contraindicated in:
Patients with hypersensitivity to ergot-related drugs, bromocriptine or to any of the excipients in CYCLOSET.
Patients with syncopal migraines. May precipitate hypotension.
Postpartum patients. Serious and life-threatening adverse reactions have been reported.
Lactating patients. CYCLOSET contains bromocriptine which inhibits lactation.
Orthostatic Hypotension/Syncope
CYCLOSET can cause orthostatic hypotension and syncope, particularly upon initiation or dose escalation. Use caution in patients taking antihypertensive 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.
Psychotic Disorders
The use of CYCLOSET in patients with severe psychotic disorders is not recommended.
Impulse Control/Compulsive Behaviors
Consider dose reduction or discontinuation of CYCLOSET if a patient develops intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably and/or other intense urges.
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.
Risks in Postpartum Patients
CYCLOSET is contraindicated in postpartum patients. Serious and life-threatening adverse reactions have been reported in postpartum women who were administered bromocriptine for inhibition of lactation. These risks may be higher in postpartum patients with cardiovascular disease. The indication for use of bromocriptine for inhibition of postpartum lactation was withdrawn from bromocriptine-containing products and is not approved for CYCLOSET.
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.
Drug Interactions
May increase the unbound fraction of highly protein-bound therapies, altering their effectiveness and safety profiles.
May increase ergot-related side effects or reduce ergot effectiveness for migraines if co-administered within 6 hours of ergot-related drugs.
Extensively metabolized by CYP3A4. Limit CYCLOSET dose to 1.6 mg/day during concomitant use of moderate CYP3A4 inhibitors. Avoid concomitant use of CYCLOSET with strong CYP3A4 inhibitors.
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.
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.
LIMITATIONS OF USE
CYCLOSET should not be used to treat type 1 diabetes or diabetic ketoacidosis.
Limited efficacy data in combination with thiazolidinediones.
Efficacy has not been confirmed in combination with insulin.
IMPORTANT SAFETY INFORMATION
Contraindications
CYCLOSET is contraindicated in:
Patients with hypersensitivity to ergot-related drugs, bromocriptine or to any of the excipients in CYCLOSET.
Patients with syncopal migraines. May precipitate hypotension.
Postpartum patients. Serious and life-threatening adverse reactions have been reported.
Lactating patients. CYCLOSET contains bromocriptine which inhibits lactation.
Orthostatic Hypotension/Syncope
CYCLOSET can cause orthostatic hypotension and syncope, particularly upon initiation or dose escalation. Use caution in patients taking antihypertensive 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.
Psychotic Disorders
The use of CYCLOSET in patients with severe psychotic disorders is not recommended.
Impulse Control/Compulsive Behaviors
Consider dose reduction or discontinuation of CYCLOSET if a patient develops intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably and/or other intense urges.
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.
Risks in Postpartum Patients
CYCLOSET is contraindicated in postpartum patients. Serious and life-threatening adverse reactions have been reported in postpartum women who were administered bromocriptine for inhibition of lactation. These risks may be higher in postpartum patients with cardiovascular disease. The indication for use of bromocriptine for inhibition of postpartum lactation was withdrawn from bromocriptine-containing products and is not approved for CYCLOSET.
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.
Drug Interactions
May increase the unbound fraction of highly protein-bound therapies, altering their effectiveness and safety profiles.
May increase ergot-related side effects or reduce ergot effectiveness for migraines if co-administered within 6 hours of ergot-related drugs.
Extensively metabolized by CYP3A4. Limit CYCLOSET dose to 1.6 mg/day during concomitant use of moderate CYP3A4 inhibitors. Avoid concomitant use of CYCLOSET with strong CYP3A4 inhibitors.
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.