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TESTIM
Hypogonadism
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Drug Name:

TESTIM CIII

Generic Name and Formulations:
Testosterone 1%; gel.

Company:
Auxilium Pharmaceuticals, Inc.

Therapeutic Use:

Indications for TESTIM:

Testosterone replacement therapy in adult males with congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.

Adult:

Advise patients to strictly adhere to recommended instructions. Apply to clean, dry intact skin of the shoulders and/or upper arms; do not apply to genitals or abdomen. ≥18yrs: initially apply 5g (1 tube) once daily in the AM; measure serum testosterone level to ensure response; may increase to 10g after 2 weeks. Do not wash site for at least 2hrs after application. Not interchangeable with other testosterone products.

Children:

<18yrs: not established.

Contraindications:

Male breast or prostate cancer. Pregnant and nursing women must avoid skin contact with application sites on men. Pregnancy (Cat.X). Nursing mothers.

Warnings/Precautions:

Not for use in women. Other persons (esp. children) must avoid contact with application site. Secondary exposure to testosterone; promptly discontinue if signs of virilization in children and women occurs, until cause is identified. Increased risk for worsening BPH; monitor for signs/symptoms. Evaluate for prostate cancer prior to and during therapy. Pre-existing cardiac, renal, or hepatic disease; discontinue if edema occurs. Obesity. Chronic lung disease. Monitor hematocrit prior to initiation, at 3–6 months after starting therapy, then annually; if elevation occurs, withhold until acceptable level. Monitor hemoglobin, liver function, PSA, cholesterol, lipid profile, serum testosterone, serum calcium (in cancer patients at risk for hypercalcemia). Monitor for venous thromboembolism; discontinue if suspected. Avoid showering or swimming for at least 2hrs after application. Flammable.

Interactions:

May alter insulin sensitivity and glycemic control; reduce dose of antidiabetic agents if needed. Increased fluid retention with concomitant corticosteroids; monitor. Monitor INR and PT with concomitant oral anticoagulants. May affect thyroid levels.

Pharmacological Class:

Androgen.

Adverse Reactions:

Local reactions, headache, increased hemoglobin/hematocrit or BP, depression, hot flushes, insomnia, mood swings, gynecomastia, sleep apnea, dysgeusia; virilization in children, reduced sperm count.

REMS:

YES

How Supplied:

Gel (5g)—30

TESTIM

  • 5g of 50mg tube of gels (Qty:30)
  • appx. price $463.00
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