Precautions

General

Women should be observed for signs of virilization (deepening of the voice, hirsutism, acne, clitorimegaly and menstrual irregularities). Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization. Such virilization is usual following anabolic steroid use in high doses.The insulin or oral hypoglycemic dosage may need adjustment in diabetic patients who receive anabolic steroids.

Information for patients

The physician should instruct patients to report any of the following side effects of androgenic anabolic steroids:

Hoarseness, acne, changes in menstrual periods, more hair on the face, nausea, vomiting, changes in skin color, or ankle swelling.

Laboratory tests

Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during the course of anabolic therapy. If children are treated, periodic (every six months) X-ray examinations of bone age should be made during treatment to determine the rate of bone maturation and the effects of anabolic therapy on the epiphyseal centers. Hemoglobin and hematocrit should be checked periodically for polycythemia in patients who are receiving high doses of anabolic steroids. Serum lipids and high-density lipoprotein cholesterol should be determined periodically. Because of the hepatotoxicity associated with the use of 17-alpha-alkylated anabolic steroids, liver function tests should be obtained periodically.

Drug interactions

Anticoagulants. Anabolic steroids may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may have to be decreased in order to maintain the prothrombin time at the desired therapeutic level. Patients receiving oral anticoagulant therapy require close monitoring, especially when anabolic steroids are started or stopped.

Drug/laboratory test interactions

Anabolic steroid therapy may decrease thyroxin-binding globulin resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged. Anabolic steroids may cause an increase in prothrombin time.

Carcinogenesis, mutagenesis, impairment of fertility

Nandrolone decanoate has not been tested in laboratory animals for carcinogenic or mutagenic effects. Liver cell tumors have been reported in patients receiving androgenic anabolic steroid therapy (see WARNINGS section). Geriatric patients treated with anabolics may be at an increased risk for prostatic hypertrophy and prostatic carcinoma.

Pregnancy

Pregnancy Category X.

Nursing mothers

It is not known whether anabolic steroids are excreted in human milk. Many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from anabolic steroids, 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.

Pediatric use

The safety and efficacy of Nandrolone decanoate in children with metastatic breast cancer (rarely found) has not been established. Anabolic agents may accelerate epiphyseal maturation more rapidly than linear growth in children, and the effect may continue for six months after the drug has been stopped. Therefore, therapy should be monitored by X-ray studies at six month intervals in order to avoid the risk of compromising the adult height.

                       
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