PROPECIA (finasteride)

There are 2 contraindications. Absolute contraindication.

Contraindication List
Lactation
Pregnancy

There are 1 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Suicidal ideation

There are 3 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Disease of liver
High-grade prostate cancer
Malignant tumor of male breast

There are 10 severe adverse reactions.

More Frequent	Less Frequent
None.	High-grade prostate cancer Hypersensitivity drug reaction

Rare/Very Rare
Angioedema Malignant tumor of male breast Rhabdomyolysis Seizure disorder Self-injurious ideation Suicidal Suicidal ideation Urticaria

There are 18 less severe adverse reactions.

More Frequent	Less Frequent
Disorder of ejaculation Erectile dysfunction Gynecomastia Libido changes Mastalgia	Decrease ejaculate volume Hypotension Peripheral edema Skin rash

Rare/Very Rare
Depression Hematospermia Muscle weakness Myalgia Myopathy Oligospermia Orgasm disorder Pruritus of skin Testicular pain

Finasteride is contraindicated in women who are or maybecome pregnant. Because of the ability of Type II 5alpha-reductase inhibitors toinhibit the conversion of testosterone to 5alpha-dihydrotestosterone (DHT), finasteridemay cause abnormalities of the external genitalia of a male fetus. If finasteride is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be apprised of the potential hazard to the male fetus.

In animal studies, finasteride caused abnormal development of external genitalia in male fetuses. A dose-dependent increase in hypospadias was observed in 3.6 to 100% of male offspring in an embryo-fetal development study where pregnant rats received oral finasteride at maternal doses of approximately 1 to 684 times the recommended human dose (RHD) of 1mg/day during theperiod of major organogenesis (gestation days 6 to 17); days 16 to 17 ofgestation is a critical period in male fetal rats for differentiation of the external genitalia.

At oral maternal doses approximately 0.2 times the RHD (based on AUC at animal doseof 0.03 mg/kg/day), male offspring had decreased prostatic and seminal vesicularweights, delayed preputial separation, and transient nipple development. Decreasedanogenital distance occurred in male offspring of pregnant rats that receivedapproximately 0.02

times the RHD. No abnormalities were observed in female offspring exposed to any dose of finasteridein utero. In addition, no developmental abnormalities were observed in the offspring of untreated femalesmated with finasteride-treated male rats that received approximately 488 times the RHD. In another study in rhesus monkeys, administration of an oral dose of finasteride (2 mg/kg/day or approximately120,000 times the highest estimated blood levels of finasteride from semen of mentaking 1 mg/day) to pregnant monkeys resulted in external genital abnormalities in malefetuses.

Finasteride is not indicated for use in women. It is not known whether the drug is distributed into human milk.

Clinical studies of finasteridefor androgenetic alopeciadid not include patients 65 years of age and older. Basedon the pharmacokinetics of finasteride 5 mg, the manufacturer states that no dosage adjustment is necessary in theelderly; however, efficacy of the drug has not been established in this population. The elimination rate of finasteride decreases slightly with increasing age of the patient, with a half-liferanging from approximately 5-6 hours in men 18-60 years of age to 8 hours in men older than 70 years of age.