Rx onlySAVIENT PHARMACEUTICALS, INC.

C III Oxandrin®(oxandrolone tablets, USP)DESCRIPTION

Oxandrin® oral tablets contain 2.5 mg or 10 mg of the anabolic steroid oxandrolone.Oxandrolone is 17β-hydroxy-17α-methyl-2-oxa-5α-androstan-3-one withoxa-5 -androstan-3-one with the followingstructural formula:

Inactive ingredients include cornstarch, lactose,magnesium stearate, and hydroxypropylmethylcellulose.

CLINICAL PHARMACOLOGYAnabolic steroids are synthetic derivatives oftestosterone. Certain clinical effects and adversereactions demonstrate the androgenic propertiesof this class of drugs. Complete dissociation of anabolic and androgenic effects has not beenachieved. The actions of anabolic steroids aretherefore similar to those of male sex hormones with the possibility of causing serious disturbances of growth and sexual development if given to young children. Anabolic steroidssuppress the gonadotropic functions of the pituitary and may exert a direct effect upon thetestes.

During exogenous administration of anabolicandrogens, endogenous testosterone release isinhibited through inhibition of pituitaryluteinizing hormone (LH). At large doses,spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH).

Anabolic steroids have been reported to increaselow-density lipoproteins and decrease high-density lipoproteins. These levels revert tonormal on discontinuation of treatment.

In a single dose pharmacokinetic study ofOxandrin in elderly subjects, the meanelimination half-life was 13.3 hours. In aprevious single dose pharmacokinetic study inyounger volunteers, the mean elimination half-lifewas 10.4 hours. No significant differences between younger and elderly volunteers werefound for time to peak, peak plasma concentrationor AUC after a single dose of Oxandrin. Thecorrelation between plasma level and therapeuticeffect has not been defined.

INDICATIONS AND USAGEOxandrin is indicated as adjunctive therapy topromote weight gain after weight loss followingextensive surgery, chronic infections, or severetrauma, and in some patients who without definitepathophysiologic reasons fail to gain or to

maintain normal weight, to offset the protein catabolism associated with prolongedadministration of corticosteroids, and for the reliefof the bone pain frequently accompanyingosteoporosis (See DOSAGE ANDADMINISTRATION).

DRUG ABUSE AND DEPENDENCEOxandrolone is classified as a controlledsubstance under the Anabolic Steroids Control Act of 1990 and has been assigned to Schedule III(non-narcotic).

CONTRAINDICATIONS1. Known or suspected carcinoma of the

prostate or the male breast.2. Carcinoma of the breast in females with

hypercalcemia (androgenic anabolicsteroids may stimulate osteolytic bone resorption).

3. Pregnancy, because of possible masculinization of the fetus. Oxandrinhas been shown to cause embryotoxicity,fetotoxicity, infertility, andmasculinization of female animaloffspring when given in doses 9 timesthe human dose.

4. Nephrosis, the nephrotic phase ofnephritis.

5. Hypercalcemia.

WARNINGS

PELIOSIS HEPATIS, A CONDITION IN WHICH LIVER AND SOMETIMES SPLENIC TISSUE IS REPLACED WITHBLOOD-FILLED CYSTS, HAS BEEN REPORTED IN PATIENTS RECEIVINGANDROGENIC ANABOLIC STEROID THERAPY. THESE CYSTS ARE SOMETIMES PRESENT WITH MINIMALHEPATIC DYSFUNCTION, BUT AT OTHER TIMES THEY HAVE BEENASSOCIATED WITH LIVER FAILURE.THEY ARE OFTEN NOT RECOGNIZED UNTIL LIFE-THREATENING LIVER FAILURE OR INTRA-ABDOMINALHEMORRHAGE DEVELOPS.WITHDRAWAL OF DRUG USUALLYRESULTS IN COMPLETEDISAPPEARANCE OF LESIONS.LIVER CELL TUMORS ARE ALSO REPORTED. MOST OFTEN THESETUMORS ARE BENIGN AND ANDROGEN-DEPENDENT, BUT FATAL MALIGNANT TUMORS HAVE BEEN REPORTED. WITHDRAWAL OF DRUG OFTEN RESULTS IN REGRESSION OR CESSATION OF PROGRESSION OF THE TUMOR. HOWEVER, HEPATIC TUMORSASSOCIATED WITH ANDROGENS OR ANABOLIC STEROIDS ARE MUCH MORE VASCULAR THAN OTHER HEPATIC TUMORS AND MAY BE SILENT UNTIL LIFE-THREATENING INTRA-ABDOMINAL HEMORRHAGEDEVELOPS. BLOOD LIPID CHANGES

THAT ARE KNOWN TO BE ASSOCIATED WITH INCREASED RISK OF ATHEROSCLEROSIS ARE SEEN IN PATIENTS TREATED WITHANDROGENS OR ANABOLIC STEROIDS.THESE CHANGES INCLUDE DECREASED HIGH-DENSITYLIPOPROTEINS AND SOMETIMESINCREASED LOW-DENSITYLIPOPROTEINS. THE CHANGES MAY BE VERY MARKED AND COULD HAVE A SERIOUS IMPACT ON THE RISK OF ATHEROSCLEROSIS AND CORONARYARTERY DISEASE.

In patients with breast cancer, anabolic steroidtherapy may cause hypercalcemia bystimulating osteolysis. Oxandrolone therapyshould be discontinued if hypercalcemiaoccurs.

Edema with or without congestive heart failure may be a serious complication inpatients with pre-existing cardiac, renal, orhepatic disease. Concomitant administrationof adrenal cortical steroid or ACTH mayincrease the edema.

In children, androgen therapy may acceleratebone maturation without producingcompensatory gain in linear growth. Thisadverse effect results in compromised adult height. The younger the child, the greater therisk of compromising final mature height. The effect on bone maturation should be monitored by assessing bone age of the leftwrist and hand every 6 months (SeePRECAUTIONS: Laboratory Tests).

Geriatric patients treated with androgenicanabolic steroids may be at an increased riskfor the development of prostatic hypertrophyand prostatic carcinoma.

ANABOLIC STEROIDS HAVESHOWN TO ENHANCE ATHLETIC

PRECAUTIONSConcurrent dosing of oxandrolone withwarfarin may result in unexpectedly largeincreases in the INR or prothrombin time (PT). When oxandrolone is prescribed topatients being treated with warfarin, doses of warfarin may need to be decreasedsignificantly to maintain the desirable INR

level and diminish the risk of potentiallyserious bleeding (See PRECAUTIONS:Drug Interactions).

General:Women should be observed for signs of virilization (deepening of the voice, hirsutism, acne, clitoromegaly). Discontinuation of drugtherapy at the time of evidence of mildvirilism is necessary to prevent irreversiblevirilization. Some virilizing changes in women are irreversible even after prompt

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January, 2006