1 INDICATIONS AND USAGE Cabergoline tablets are an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults.

Limitations of Use Avoid use of cabergoline tablets for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions [see Warnings and Precautions (5.4)].

Cabergoline tablets are an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults.

( 1 ) Limitations of Use Avoid use of cabergoline tablets for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions.

( 5.4 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Cardiac Valvulopathy and Pericardial Fibrosis [see Warnings and Precautions ( 5.1 )] .

Pleural, Retroperitoneal, and Pulmonary Fibrosis [see Warnings and Precautions ( 5.2 )] .

Orthostatic Hypotension [see Warnings and Precautions ( 5.3 )] .

Impulse Control Disorders and Compulsive Behaviors [see Warnings and Precautions ( 5.5 )] .

The most common adverse reactions (incidence >10%) are nausea, headache, and dizziness.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of cabergoline tablets has been evaluated in more than 900 patients with hyperprolactinemic disorders.

In a 4-week, double-blind, placebo-controlled trial (cabergoline tablets vs.

placebo) [see Clinical Studies ( 14 )], the incidence of the most common adverse reactions during the placebo-controlled trial in patients with hyperprolactinemic disorders is presented in Table 1.

Table 1.

Adverse Reactions (n (%)* During the 4-Week, Double-Blind, Placebo-Controlled Trial in Hyperprolactinemic Females Cabergoline Tablets (n=168) Placebo (n=20) Nausea 45 (27%) 4 (20%) Headache 43 (26%) 5 (25%) Dizziness 25 (15%) 1 (5%) Constipation 16 (10%) 0% Fatigue 12 (7%) 0% Postural hypotension 6 (4%) 0% Dyspepsia 4 (2%) 0% Vomiting 4 (2%) 0% Nervousness 4 (2%) 0% Vertigo 2 (1%) 0% Paresthesia 2 (1%) 0% Breast pain 2 (1%) 0% Dysmenorrhea 2 (1%) 0% Abnormal vision 2 (1%) 0% * Adverse reactions that occurred ≥1% in the cabergoline tablets group and frequency more than that reported in the placebo group.

In the 8-week, double-blind period of the comparative trial with bromocriptine, 2% (4/221) of cabergoline tablets-treated patients (0.5 mg twice weekly) discontinued treatment because of an adverse event and 6% (14/231) of bromocriptine-treated patients (at a dose of 2.5 mg twice daily) discontinued treatment because of an adverse event.

The most common reasons for cabergoline tablets discontinuation were headache, nausea, and vomiting (3, 2, and 2 patients, respectively).

The incidence of the most common adverse events during the double-blind period of the comparative trial with bromocriptine is presented in Table 2.

Table 2.

Adverse Events* During the 8-Week, Double-Blind Period of the Comparative Trial in Hyperprolactinemic Females Cabergoline Tablets (n=221) Bromocriptine (n=231) Nausea 63 (29%) 100 (43%) Headache 58 (26%) 62 (27%) Dizziness 38 (17%) 42 (18%) Constipation 15 (7%) 21 (9%) Asthenia 13 (6%) 15 (6%) Abdominal pain 12 (5%) 19 (8%) Dyspepsia 11 (5%) 16 (7%) Fatigue 10 (5%) 18 (8%) Vertigo 9 (4%) 10 (4%) Vomiting 9 (4%) 16 (7%) Depression 7 (3%) 5 (2%) Hot flashes 6 (3%) 3 (1%) Breast pain 5 (2%) 8 (3%) Dry mouth 5 (2%) 2 (1%) Paresthesia 5 (2%) 6 (3%) Somnolence 5 (2%) 5 (2%) Diarrhea 4 (2%) 7 (3%) Flatulence 4 (2%) 3 (1%) Pain 4 (2%) 6 (3%) Acne 3 (1%) 0% Anorexia 3 (1%) 3 (1%) Anxiety 3 (1%) 3 (1%) Hypotension 3 (1%) 4 (2%) Insomnia 3 (1%) 2 (1%) Syncope 3 (1%) 3 (1%) Abnormal vision 2 (1%) 2 (1%) Arthralgia 2 (1%) 0% Dependent edema 2 (1%) 1 (<1%) Dysmenorrhea 2 (1%) 1 (<1%) Impaired concentration 2 (1%) 1 (<1%) Influenza-like symptoms 2 (1%) 0% Malaise 2 (1%) 0% Nervousness 2 (1%) 5 (2%) Palpitation 2 (1%) 5 (2%) Periorbital edema 2 (1%) 2 (1%) Peripheral edema 2 (1%) 1 (<1%) Pruritus 2 (1%) 1 (<1%) Rhinitis 2 (1%) 9 (4%) Throat irritation 2 (1%) 0% Toothache 2 (1%) 0% * Adverse events reported ≥1% in the cabergoline tablets group.

Abbreviation: n=number of patients.

Events that were reported at an incidence of <1% in the clinical studies follow: Body As a Whole: facial edema, influenza-like symptoms, malaise Cardiovascular System: hypotension, syncope, palpitations Digestive System: dry mouth, flatulence, diarrhea, anorexia Metabolic and Nutritional System: weight loss, weight gain Nervous System: somnolence, nervousness, paresthesia, insomnia, anxiety Respiratory System: nasal stuffiness, epistaxis Skin and Appendages: acne, pruritus Special Senses: abnormal vision Urogenital System: dysmenorrhea, increased libido 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of cabergoline tablets.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Psychiatric: impulse control disorders and compulsive behaviors including, hypersexuality, increased libido, pathological gambling; psychotic disorder, aggression Skin and subcutaneous: alopecia