Acting As a Sympatholytic Insulin Sensitizer,
CYCLOSET May be Appropriate for your patients1
A PATIENT WHO MAY BENEFIT FROM CYCLOSET
ADULT PATIENTS WITH T2DM WHO HAVE ADEQUATE INSULIN PRODUCTION AND POTENTIAL SIGNS OF ELEVATED SNS ACTIVITY MAY BENEFIT FROM CYCLOSET AS AN ADJUNCT TO DIET AND EXERCISE1-4:
- ASSOCIATED SIGNS OF ELEVATED SNS ACTIVITY5
-
Elevated resting heart rate (≥80 bpm)3- History of hypertension (130/80 mmHg) along with elevated plasma triglycerides (>150 mg/dL)4,6,a
aThe AACE recommends that BP control be individualized, but that a target of <130/80 mmHg is appropriate for most patients.6
-
CONSIDER CYCLOSET FOR YOUR APPROPRIATE PATIENTS
Robert, 52-year-old musician*
*Not an actual patient
Medical history
HbA1c: 7.9%
2-hour PPG: 245 mg/dL
MILD DYSLIPIDEMIA
DISPLAYING SIGNS OF OVERACTIVE SNS
Elevated resting heart rate
Hypertension and elevated plasma triglycerides
Robert is a 52-year-old musician with a 4-year history of T2DM. In addition to his T2DM, he has mild dyslipidemia, and has trouble keeping up with his daughter. His prandial insulin is adequately addressed with a DPP-4 inhibitor in addition to diet and regular physical activity. He is currently on anti-hypertensive medication to manage his elevated blood pressure readings that have been recorded during his routine visits. He is also monitoring his blood pressure at home.
Because Robert has T2DM and is exhibiting potential signs of elevated SNS activity, he may be a candidate for CYCLOSET therapy.1
GOAL: To improve glucose control throughout the meals of the day without further raising plasma insulin levels.1
TREATMENT PLAN FOR ROBERT: Prescribe CYCLOSET, in addition to diet and exercise.
Robert is a 52-year-old musician with a 4-year history of T2DM. In addition to his T2DM, he has mild dyslipidemia, and has trouble keeping up with his daughter. His prandial insulin is adequately addressed with a DPP-4 inhibitor in addition to diet and regular physical activity. He is currently on anti-hypertensive medication to manage his elevated blood pressure readings that have been recorded during his routine visits. He is also monitoring his blood pressure at home.
Kathy, 49-year-old chef*
*Not an actual patient
Medical history
HbA1c: 8.1%
2-hour PPG: 240 mg/dL
HYPERTENSION AND DYSLIPIDEMIA
DISPLAYING SIGNS OF OVERACTIVE SNS
Elevated resting heart rate
Hypertension and elevated plasma triglycerides
Kathy is a 49-year-old chef with a history of T2DM. She works long shifts at the restaurant, and her schedule interferes with her ability to eat regularly scheduled meals. Her fasting plasma glucose levels are near normal, but her HbA1c is not optimal, which suggests that postprandial dysglycemia may be contributing to poor overall glucose control. Her prandial insulin is adequately addressed with a GLP-1 agonist. When discussing treatment options with her endocrinologist, she expressed concern about her cardiovascular risk factors, including her cholesterol levels and blood pressure, since she has a family history of heart disease. Her endocrinologist suggested a management plan that includes an anti-hypertensive for her elevated blood pressure, along with diet and physical activity.
Because Kathy has T2DM, elevated PPG, and therapy to support adequate insulin production, she may be a candidate for CYCLOSET therapy.1
GOAL: To improve glucose control by decreasing postprandial glucose levels throughout the day, without further raising plasma insulin levels.1
TREATMENT PLAN FOR KATHY: Prescribe CYCLOSET, in addition to diet and exercise.
Kathy is a 49-year-old chef with a history of T2DM. She works long shifts at the restaurant, and her schedule interferes with her ability to eat regularly scheduled meals. Her fasting plasma glucose levels are near normal, but her HbA1c is not optimal, which suggests that postprandial dysglycemia may be contributing to poor overall glucose control. Her prandial insulin is adequately addressed with a GLP-1 agonist. When discussing treatment options with her endocrinologist, she expressed concern about her cardiovascular risk factors, including her cholesterol levels and blood pressure, since she has a family history of heart disease. Her endocrinologist suggested a management plan that includes an anti-hypertensive for her elevated blood pressure, along with diet and physical activity.
FOR YOUR NEXT T2DM PATIENT WITH ADEQUATE INSULIN PRODUCTION, CONSIDER CYCLOSET.
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; 2020. 2. Licht CM, Vreeburg SA, van Reedt Dortland AK, et al. Increased sympathetic and decreased parasympathetic activity rather than changes in hypothalamic-pituitary-adrenal axis activity is associated with metabolic abnormalities. J Clin Endocrinol Metab. 2010;95(5):2458-2466. 3. Chamarthi B, Vinik A, Ezrokhi M, Cincotta AH. Circadian-timed quick-release bromocriptine lowers elevated resting heart rate in patients with type 2 diabetes mellitus. Endocrinol Diabetes Metab. 2020;3(1):e00101. doi:10.1002/edm2.101. 4. Garber AJ, Handelsman Y, Grunberger G, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm – 2020 executive summary. Endocr Pract. 2020;26(1):107-139. 5. Tentolouris N, Argyrakopoulou G, Katsilambros N. Perturbed autonomic nervous system function in metabolic syndrome. Neuromolecular Med. 2008;10(3):169-178. 6. American Diabetes Association. Standards of Medical Care in Diabetes – 2021 abridged for primary care providers. Clin Diabetes. 2021;39(1):14-43.
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.