DELATESTRYL CIII

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DELATESTRYL

Breast cancer
Hypogonadism
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Generic Name and Formulations:

Testosterone enanthate 200mg/mL; IM inj; in sesame oil; contains chlorobutanol.

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Indications for DELATESTRYL:

Advancing inoperable metastatic mammary cancer in females who are 1–5 years postmenopausal.

Adult:

Give by deep IM inj into gluteal muscle. 200–400mg once every 2–4 weeks. Max 400mg/month. Monitor closely.

Children:

Not established.

Contraindications:

Male breast or prostate cancer. Pregnancy (Cat.X).

Warnings/Precautions:

Discontinue if jaundice, abnormal liver function, hypercalcemia, or edema occurs. Monitor liver function, hemoglobin, hematocrit, cholesterol, urine and serum calcium. Preexisting cardiac, renal or hepatic disease (discontinue if edema occurs). History of MI or coronary artery disease. Monitor for venous thromboembolism; discontinue if suspected. Elderly. Nursing mothers: not recommended.

Interactions:

May potentiate oral anticoagulants, oxyphenbutazone. May alter insulin requirements. Increased risk of edema with ACTH, corticosteroids. May affect thyroid levels.

Pharmacological Class:

Androgen.

Adverse Reactions:

Amenorrhea, menstrual irregularities, inhibition of gonadotropin secretion, virilization; others: inj site reactions, peliosis hepatis, edema, hepatic carcinoma, nausea, jaundice, hirsutism, acne, polycythemia, headache, anxiety, depression, paresthesia, altered libido, fluid and electrolyte disturbances, suppression of clotting factors, increased serum cholesterol.

How Supplied:

Multidose vial (5mL)—1

DELATESTRYL 5ml of 200mg/ml vials (Qty:1)

appx. price $91.00

Indications for DELATESTRYL:

Testosterone replacement therapy in adult males with congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism. To stimulate puberty in males with delayed puberty.

Limitations Of use:

Not established in men with age-related hypogonadism.

Adult:

Prior to treatment, confirm diagnosis by ensuring serum testosterone is below normal range as measured in the AM on at least 2 separate days. Give by deep IM inj into gluteal muscle once every 2–4 weeks. Male hypogonadism: 50–400mg. Delayed puberty: 50–200mg. Max 400mg/month.

Children:

See full labeling.

Contraindications:

Male breast or prostate cancer. Pregnancy (Cat.X).

Warnings/Precautions:

Discontinue if jaundice, abnormal liver function, hypercalcemia, or edema occurs. Monitor liver function, hemoglobin, hematocrit, prostate specific antigen (PSA), cholesterol, bone age (every 6 months for pre-pubertal males). Preexisting cardiac, renal or hepatic disease (discontinue if edema occurs). History of MI or coronary artery disease. May increase risk of prostatic hypertrophy or carcinoma in elderly. Testosterone and/or other anabolic androgenic steroid abuse. Monitor for venous thromboembolism; discontinue if suspected. Inform patients of possible increased risk of MI, stroke. Elderly. Young children. Nursing mothers: not recommended.

Interactions:

May potentiate oral anticoagulants, oxyphenbutazone. May alter insulin requirements. Increased risk of edema with ACTH, corticosteroids. May affect thyroid levels.

Pharmacological Class:

Androgen.

Adverse Reactions:

Inj site reactions, peliosis hepatis, edema, hepatic carcinoma, prostatic hypertrophy or carcinoma, gynecomastia, priapism, oligospermia, nausea, jaundice, hirsutism, virilization, male pattern baldness, acne, polycythemia, headache, anxiety, depression, paresthesia, altered libido, fluid and electrolyte disturbances, suppression of clotting factors, increased serum cholesterol.

How Supplied:

Multidose vial (5mL)—1

DELATESTRYL 5ml of 200mg/ml vials (Qty:1)

appx. price $91.00