FIRST AND ONLY*

FOR PATIENTS WITH TYPE 2 DIABETES NOT AT GOAL, (HbA1c ≥7.5%), ALONG WITH DIET AND EXERCISE

HELP YOUR TYPE 2 DIABETES PATIENTS

UNLOCK

THEIR INSULIN

POTENTIAL

Key

*First and only dopamine receptor agonist for type 2 diabetes.

For patients not at goal (HbA1c ≥7.5%),
along with diet and exercise

INDICATION FOR CYCLOSET

CYCLOSET 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 or in patients with syncopal migraines, as it may precipitate hypotension.

Do not use CYCLOSET in nursing women, as it may inhibit lactation. There have been postmarketing reports of stroke in this patient population.

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

CYCLOSET may exacerbate psychotic disorders or reduce the effectiveness of drugs that treat psychosis. Use 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 Other 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 other 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 or any other antidiabetic drug. CYCLOSET does not increase the 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.

References: 1. CYCLOSET [prescribing information]. Tiverton, RI: VeroScience, LLC.

INDICATION FOR CYCLOSET

CYCLOSET 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 or in patients with syncopal migraines, as it may precipitate hypotension.

Do not use CYCLOSET in nursing women, as it may inhibit lactation. There have been postmarketing reports of stroke in this patient population.

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

CYCLOSET may exacerbate psychotic disorders or reduce the effectiveness of drugs that treat psychosis. Use 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 Other 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 other 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 or any other antidiabetic drug. CYCLOSET does not increase the 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.