Cabergoline

Cabergoline is an FDA-registered drug product whose active ingredient is CABERGOLINE. It is labelled by Mylan Pharmaceuticals Inc. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 59762-1005, application NDA020664, label effective 20260630. It is one of 5 FDA drug label records sharing the active ingredient CABERGOLINE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CABERGOLINE are most often described in connection with: cabergoline ergot, derivative indicated, treatment hyperprolactinemic, disorders either, idiopathic due, pituitary adenomas, adults limitations, inhibition suppression. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE CABERGOLINE is 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 for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions [see Warnings and Precautions (5.4) ] . CABERGOLINE is 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 for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions. ( 5.4 )

2 DOSAGE AND ADMINISTRATION • Before initiating CABERGOLINE evaluate for valvular heart disease, including with an echocardiogram. If valvular disease is detected, do not administer CABERGOLINE. ( 2.1 ) • Recommended starting dosage of CABERGOLINE is 0.25 mg orally twice weekly. ( 2.2 ) • Titrate CABERGOLINE to achieve normal serum prolactin levels by increasing CABERGOLINE by 0.25 mg orally twice weekly at intervals of no less than 4 weeks. ( 2.2 ) • Maximum recommended dosage is 1 mg orally, twice weekly. ( 2.2 ) 2.1 Recommended Evaluation Before Initiating CABERGOLINE Before initiating CABERGOLINE evaluate for valvular heart disease, including with an echocardiogram. If valvular disease is detected, do not administer CABERGOLINE [see Contraindications (4) and Warnings and Precautions (5.1) ] . 2.2 Recommended Dosage The recommended starting dosage of CABERGOLINE is 0.25 mg orally twice weekly. Titrate CABERGOLINE to achieve normal serum prolactin levels by increasing CABERGOLINE by 0.25 mg orally twice weekly at intervals of no less than 4 weeks. The maximum recommended dosage is 1 mg orally, twice weekly [see Warnings and Precautions (5.2) ] . Administer CABERGOLINE with or without food [see Clinical Pharmacology (12.3) ] . If CABERGOLINE is discontinued, monitor the serum prolactin level periodically to determine whether CABERGOLINE should be reinstituted.

4 CONTRAINDICATIONS CABERGOLINE is contraindicated in patients with: • Uncontrolled hypertension. • Known hypersensitivity to ergot derivatives. • History of cardiac valvular disorders, as suggested by anatomical evidence of valvulopathy of any valve, determined by pre-treatment evaluation including echocardiographic demonstration of valve leaflet thickening, valve restriction, or mixed valve restriction-stenosis, or history of pericardial fibrosis [see Warnings and Precautions (5.1) ] . • History of pleural, pulmonary, or retroperitoneal fibrotic disorders [see Warnings and Precautions (5.2) ] . • Uncontrolled hypertension. ( 4 ) • Known hypersensitivity to ergot derivatives. ( 4 ) • History of cardiac valvular disorders, or pericardial fibrosis. ( 5.1 ) • History of pleural, pulmonary, or retroperitoneal fibrotic disorders. ( 5.2 )

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 Viatris at 1-877-446-3679 (1‑877‑4‑INFO‑RX) 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 has been evaluated in more than 900 patients with hyperprolactinemic disorders. In a 4-week, double-blind, placebo-controlled trial (CABERGOLINE 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 (%)) Adverse reactions that occurred ≥1% in the CABERGOLINE group and frequency more than that reported in the placebo group. During the 4-Week, Double-Blind, Placebo-Controlled Trial in Hyperprolactinemic Females CABERGOLINE (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% In the 8-week, double-blind period of the comparative trial with bromocriptine, 2% (4/221) of CABERGOLINE-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 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 Adverse events reported ≥1% in the CABERGOLINE group. Abbreviation: n=number of patients. During the 8-Week, Double-Blind Period of the Comparative Trial in Hyperprolactinemic Females CABERGOLINE (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% 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. 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

FDA lists 5 drug label records with CABERGOLINE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Cabergoline used for?
1 INDICATIONS AND USAGE CABERGOLINE is 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 for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions [see Warnings and Precautions (5.4) ] . CABERGOLINE is an …

Who makes Cabergoline?
Mylan Pharmaceuticals Inc. is the labeler of record for Cabergoline. 5 FDA label records share the active ingredient CABERGOLINE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Cabergoline come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Cabergoline prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CABERGOLINE?
Yes. 5 FDA drug label records list CABERGOLINE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Cabergoline been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.