- CYCLOSET (bromocriptine mesylate) Tablets are a dopamine receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
- 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.
- Do not use CYCLOSET (bromocriptine mesylate) Tablets 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.
- 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.
- CYCLOSET may exacerbate psychotic disorders or reduce the effectiveness of drugs that treat psychosis. Use in patients with severe psychotic disorders is not recommended.
- CYCLOSET may cause somnolence, particularly when initiating therapy. Advise patients not to drive or operate heavy machinery if symptoms of somnolence occur.
- CYCLOSET is a dopamine receptor agonist. 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 other dopamine receptor agonists for other indications and concomitant use is not recommended.
- 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.
- CYCLOSET may increase the unbound fraction of highly protein-bound therapies, altering their effectiveness and safety profiles. CYCLOSET may increase ergot-related side effects or reduce ergot effectiveness for migraines if co-administered within 6 hours of ergot-related drugs.
- CYCLOSET is 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.
- The safety and effectiveness of CYCLOSET in pediatric patients have not been established.
- 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.
CLICK HERE FOR FULL PRESCRIBING INFORMATION FOR CYCLOSET.
References: 1. CYCLOSET [package insert]. Tiverton, RI: VeroScience, LLC; 2016. 2. Vinik AI, Cincotta
AH, Scranton RE, Bohannon N, Ezrokhi M, Gaziano JM. Effect of bromocriptine-QR on glycemic
control in subjects with uncontrolled hyperglycemia on one or two oral anti-diabetes agents.
Endocr Pract. 2012;18(6):931-943.