Cabergoline (Page 3 of 4)

NURSING MOTHERS

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from cabergoline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Use of cabergoline for the inhibition or suppression of physiologic lactation is not recommended (see PRECAUTIONS section).

The prolactin-lowering action of cabergoline suggests that it will interfere with lactation. Due to this interference with lactation, cabergoline should not be given to women postpartum who are breastfeeding or who are planning to breastfeed.

PEDIATRIC USE

Safety and effectiveness of cabergoline in pediatric patients have not been established.

GERIATRIC USE

Clinical studies of cabergoline did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

The safety of Cabergoline Tablets, USP has been evaluated in more than 900 patients with hyperprolactinemic disorders. Most adverse events were mild or moderate in severity.The safety of Cabergoline Tablets, USP has been evaluated in more than 900 patients with hyperprolactinemic disorders. Most adverse events were mild or moderate in severity.

In a 4-week, double-blind, placebo-controlled study, treatment consisted of placebo or cabergoline at fixed doses of 0.125, 0.5, 0.75, or 1 mg twice weekly. Doses were halved during the first week. Since a possible dose-related effect was observed for nausea only, the four cabergoline treatment groups have been combined. The incidence of the most common adverse events during the placebo-controlled study is presented in the following table.In a 4-week, double-blind, placebo-controlled study, treatment consisted of placebo or cabergoline at fixed doses of 0.125, 0.5, 0.75, or 1 mg twice weekly. Doses were halved during the first week. Since a possible dose-related effect was observed for nausea only, the four cabergoline treatment groups have been combined. The incidence of the most common adverse events during the placebo-controlled study is presented in the following table.

Incidence of Reported Adverse Events During the 4-week, Double-Blind, Placebo-Controlled Trial

Reported at ≥1% for cabergoline * Reported at ≥1% for cabergoline

Adverse Event * Cabergoline ( n = 168 ) 0 . 125 to 1 mg two times a week Placebo ( n = 20 )
Number ( percent )
Gastrointestinal
Nausea 45 (27) 4 (20)
Constipation 16 (10) 0
Abdominal pain 9 (5) 1 (5)
Dyspepsia 4 (2) 0
Vomiting 4 (2) 0
Central and Peripheral Nervous System
Headache 43 (26) 5 (25)
Dizziness 25 (15) 1 (5)
Paresthesia 2 (1) 0
Vertigo 2 (1) 0
Body As A Whole
Asthenia 15 (9) 2 (10)
Fatigue 12 (7) 0
Hot flashes 2 (1) 1 (5)
Psychiatric
Somnolence 9 (5) 1 (5)
Depression 5 (3) 1 (5)
Nervousness 4 (2) 0
Autonomic Nervous System
Postural hypotension 6 (4) 0
Reproductive Female
Breast pain 2 (1) 0
Dysmenorrhea 2 (1) 0
Vision
Abnormal vision 2 (1) 0

In the 8-week, double-blind period of the comparative trial with bromocriptine, cabergoline (at a dose of 0.5 mg twice weekly) was discontinued because of an adverse event in 4 of 221 patients (2%) while bromocriptine (at a dose of 2.5 mg two times a day) was discontinued in 14 of 231 patients (6%). The most common reasons for discontinuation from cabergoline were headache, nausea and vomiting (3, 2, and 2 patients, respectively); the most common reasons for discontinuation from bromocriptine were nausea, vomiting, headache, and dizziness or vertigo (10, 3, 3, and 3 patients, respectively). The incidence of the most common adverse events during the double-blind portion of the comparative trial with bromocriptine is presented in the following table.In the 8-week, double-blind period of the comparative trial with bromocriptine, cabergoline (at a dose of 0.5 mg twice weekly) was discontinued because of an adverse event in 4 of 221 patients (2%) while bromocriptine (at a dose of 2.5 mg two times a day) was discontinued in 14 of 231 patients (6%). The most common reasons for discontinuation from cabergoline were headache, nausea and vomiting (3, 2, and 2 patients, respectively); the most common reasons for discontinuation from bromocriptine were nausea, vomiting, headache, and dizziness or vertigo (10, 3, 3, and 3 patients, respectively). The incidence of the most common adverse events during the double-blind portion of the comparative trial with bromocriptine is presented in the following table.

Incidence of Reported Adverse Events During the 8-week, Double-Blind Period of the Comparative Trial with Bromocriptine

*Reported at ≥1% for cabergoline *Reported at ≥1% for cabergoline

Adverse Event * Cabergoline ( n = 221 ) Bromocriptine ( n = 231 )
Number ( percent )
Gastrointestinal
Nausea 63 (29) 100 (43)
Constipation 15 (7) 21 (9)
Abdominal pain 12 (5) 19 (8)
Dyspepsia 11 (5) 16 (7)
Vomiting 9 (4) 16 (7)
Dry mouth 5 (2) 2 (1)
Diarrhea 4 (2) 7 (3)
Flatulence 4 (2) 3 (1)
Throat irritation 2 (1) 0
Toothache 2 (1) 0
Central and Peripheral Nervous System
Headache 58 (26) 62 (27)
Dizziness 38 (17) 42 (18)
Vertigo 9 (4) 10 (4)
Paresthesia 5 (2) 6 (3)
Body As A Whole
Asthenia 13 (6) 15 (6)
Fatigue 10 (5) 18 (8)
Syncope 3 (1) 3 (1)
Influenza-like symptoms 2 (1) 0
Malaise 2 (1) 0
Periorbital edema 2 (1) 2 (1)
Peripheral edema 2 (1) 1
Psychiatric
Depression 7 (3) 5 (2)
Somnolence 5 (2) 5 (2)
Anorexia 3 (1) 3 (1)
Anxiety 3 (1) 3 (1)
Insomnia 3 (1) 2 (1)
Impaired concentration 2 (1) 1
Nervousness 2 (1) 5 (2)
Cardiovascular
Hot flashes 6 (3) 3 (1)
Hypotension 3 (1) 4 (2)
Dependent edema 2 (1) 1
Palpitation 2 (1) 5 (2)
Reproductive Female
Breast pain 5 (2) 8 (3)
Dysmenorrhea 2 (1) 1
Skin and Appendages
Acne 3 (1) 0
Pruritus 2 (1) 1
Musculoskeletal
Pain 4 (2) 6 (3)
Arthralgia 2 (1) 0
Respiratory
Rhinitis 2 (1) 9 (4)
Vision
Abnormal Vision 2 (1) 2 (1)

Other adverse events that were reported at an incidence of <1.0% in the overall clinical studies follow.

facial edema, influenza-like symptoms, malaise Body as a Whole: facial edema, influenza-like symptoms, malaise

hypotension, syncope, palpitations Cardiovascular System: hypotension, syncope, palpitations

dry mouth, flatulence, diarrhea, anorexia Digestive System: dry mouth, flatulence, diarrhea, anorexia

weight loss, weight gain Metabolic and Nutritional System: weight loss, weight gain

somnolence, nervousness, paresthesia, insomnia, anxiety Nervous System: somnolence, nervousness, paresthesia, insomnia, anxiety

nasal stuffiness, epistaxis Respiratory System: nasal stuffiness, epistaxis

acne, pruritus Skin and Appendages: acne, pruritus

abnormal vision Special Senses: abnormal vision

dysmenorrhea, increased libido Urogenital System: dysmenorrhea, increased libido

The safety of cabergoline has been evaluated in approximately 1,200 patients with Parkinson’s disease in controlled and uncontrolled studies at dosages of up to 11.5 mg/day which greatly exceeds the maximum recommended dosage of cabergoline for hyperprolactinemic disorders. In addition to the adverse events that occurred in the patients with hyperprolactinemic disorders, the most common adverse events in patients with Parkinson’s disease were dyskinesia, hallucinations, confusion, and peripheral edema. Heart failure, pleural effusion, pulmonary fibrosis, and gastric or duodenal ulcer occurred rarely. One case of constrictive pericarditis has been reported.The safety of cabergoline has been evaluated in approximately 1,200 patients with Parkinson’s disease in controlled and uncontrolled studies at dosages of up to 11.5 mg/day which greatly exceeds the maximum recommended dosage of cabergoline for hyperprolactinemic disorders. In addition to the adverse events that occurred in the patients with hyperprolactinemic disorders, the most common adverse events in patients with Parkinson’s disease were dyskinesia, hallucinations, confusion, and peripheral edema. Heart failure, pleural effusion, pulmonary fibrosis, and gastric or duodenal ulcer occurred rarely. One case of constrictive pericarditis has been reported.

Post-marketing Surveillance data: The following events have been reported in association with cabergoline: Cardiac valvulopathy and extracardiac fibrotic reactions, (see WARNINGS, Cardiac Valvulopathy and Extracardiac Fibrotic Reactions).

Other events have been reported in association with cabergoline: hypersexuality, increased libido, pathological gambling (see PRECAUTIONS, Psychiatric). In addition, cases of alopecia, aggression and psychotic disorder have been reported in patients taking cabergoline. Some of these reports have been in patients who have had prior adverse reactions to dopamine agonist products.

To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals, LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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