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PROPECIA (FINASTERIDE): PRECAUTIONS

General

Caution should be used in the administration of Propecia (Finasteride) in patients with liver function abnormalities, as finasteride is metabolized extensively in the liver.

Information for Patients

Women should not handle crushed or broken Finasteride (Propecia) tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. Finasteride (Propecia) tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.

Physicians should instruct their patients to promptly report any changes in their breasts such as lumps, pain or nipple discharge. Breast changes including breast enlargement, tenderness and neoplasm have been reported.

See also Patient Package Insert.

Physicians should instruct their patients to read the patient package insert before starting therapy with Propecia (Finasteride) 1 mg tablets and to read it again each time the prescription is renewed so that they are aware of current information for patients regarding Propecia (Finasteride).

Increased Risk of High-Grade Prostate Cancer with 5-Alpha Reductase Inhibitors

Men aged 55 and over with a normal digital rectal examination and PSA <= 3.0 ng/mL at baseline taking finasteride 5 mg/day (5 times the dose of Propecia) in the 7-year Prostate Cancer Prevention Trial (PCPT) had an increased risk of Gleason score 8-10 prostate cancer (finasteride 1.8% vs placebo 1.1%). Similar results were observed in a 4-year placebo-controlled clinical trial with another 5-alpha-reductase inhibitor (dutasteride, Avodart) (1% dutasteride vs 0.5% placebo). 5-alpha-reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5-alpha-reductase inhibitors to reduce to reduce prostate volume, or study-related factors, impacted the results of these studies has not been established.

Drug/Laboratory Test Interactions

Finasteride had no effect on circulating levels of cortisol, thyroid-stimulating hormone, or thyroxine, nor did it affect the plasma lipid profile (e.g., total cholesterol, low-density lipoproteins, high-density lipoproteins and triglycerides) or bone mineral density. In studies with finasteride, no clinically meaningful changes in luteinizing hormone (LH), follicle-stimulating hormone (FSH) or prolactin were detected. In healthy volunteers, treatment with finasteride did not alter the response of LH and FSH to gonadotropin- releasing hormone indicating that the hypothalamic-pituitary-testicular axis was not affected.

In clinical studies with Propecia (Finasteride, 1 mg) in men 18-41 years of age, the mean value of serum prostate specific antigen (PSA) decreased from 0.7 ng/mL at baseline to 0.5 ng/mL at Month 12. Further, in clinical studies with Proscar (Finasteride, 5 mg) when used in older men who have benign prostatic hyperplasia (BPH), PSA levels are decreased by approximately 50%. Other studies with Proscar showed it may also cause decreases in serum PSA in the presence of prostate cancer. These findings should be taken into account for proper interpretation of serum PSA when evaluating men treated with finasteride. Any confirmed increase from the lowest PSA value while on Propecia may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range for men not taking a 5-alpha-reductase inhibitor. Non-compliance to therapy with Propecia (Finasteride) tablets may also affect PSA test results.

Drug Interactions

No drug interactions of clinical importance have been identified. Finasteride does not appear to affect the cytochrome P450-linked drug-metabolizing enzyme system. Compounds that have been tested in man include antipyrine, propranolol, digoxin, theophylline, and warfarin and no clinically meaningful interactions were found.

Other concomitant therapy

Although specific interaction studies were not performed, finasteride doses of 1 mg or more were concomitantly used in clinical studies with acetaminophen, alphablockers, acetylsalicylic acid, analgesics, anticonvulsants, angiotensin-converting enzyme (ACE) inhibitors, benzodiazepines, calcium-channel blockers, beta blockers, cardiac nitrates, H2 antagonists, diuretics, HMG-CoA reductase inhibitors, prostaglandin synthetase inhibitors (also referred to as NSAIDs), and quinolone anti-infectives without evidence of clinically significant adverse interactions.

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