Cabolin ®

Hyperprolactinemic disorders:

Initial: 0.25 to 0.5 mg/week administered in 1 or 2 divided weekly doses

May increase dose by 0.25 to 0.5 mg/week no sooner than every 4 weeks if needed based on serum prolactin levels

Contraindications:

Known hypersensitivity to cabergoline, ergot derivatives, or any component of the formulation; uncontrolled hypertension; history of cardiac valvular disorders (indicated by valvulopathy of any valve, thickening of valve leaflet, valve restriction, or mixed valve restriction stenosis)

Serotonergic Agents (High Risk): Ergot Derivatives may enhance the serotonergic effect of Serotonergic Agents (High Risk). This could result in serotonin syndrome. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability, mental status changes) when these agents are combined. Risk C: Monitor therapy

Metoclopramide: Cabergoline may diminish the therapeutic effect of Metoclopramide. Metoclopramide may diminish the therapeutic effect of Cabergoline. Risk X: Avoid combination

Pregnancy and Lactation:

Information related to the use of cabergoline for the treatment of hyperprolactinemia in pregnancy is available but limited compared to the use of other agents. If treatment of hyperprolactinemia during pregnancy is required, cabergoline may be used, but other agents are preferred. Monitoring of prolactin levels should be suspended during pregnancy.

It is not known if cabergoline is present in breast milk. Cabergoline interferes with lactation. When used for the treatment of hyperprolactinemic disorders (idiopathic or caused by pituitary adenomas), cabergoline should not be given to patients postpartum who are breastfeeding or who are planning to breastfeed.

Warning and Precaution:

• Cardiac valvulopathy: Cardiac valvulopathy has been reported with use. Risk is increased with use of high doses (eg, >2 mg/day). Although some conflicting data exist, a majority of observational evidence suggests the risk of valvulopathy in patients receiving typical low dose regimens (eg, ≤2 mg/week) is minimal or absent
• Cardiovascular effects: Initial doses >1 mg may cause orthostatic hypotension; may be symptomatic. Use with caution in patients with cardiovascular disease; hypertension, stroke, and seizure have been reported with other dopamine agonists. Concurrent use with antihypertensives may increase risk.
• CNS depression: May cause somnolence, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving).
• Pleural/retroperitoneal fibrosis: Cases of pleural, pericardial, and retroperitoneal fibrosis have been reported. Do not use in patients with a history of cardiac or extracardiac fibrotic disorders. Following diagnosis of fibrosis, discontinuation of cabergoline may result in improvement of condition.
• Psychiatric disorders: Aggression, psychotic behavior, and impulse control disorders such as pathological gambling, increased libido, hypersexuality, compulsive spending or buying, and binge eating have been reported with use; generally reversible with dose reduction or discontinuation of treatment.

Adverse Reactions:

Gastrointestinal: Nausea (27% to 29%)

Nervous system: Headache (26%), dizziness (15% to 17%)

Storage:

Store below 30ºC and protect from light and moisture.