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FORTESTA
Hypogonadism
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Drug Name:

FORTESTA CIII

Generic Name and Formulations:
Testosterone 10mg/0.5g actuation; metered-dose pump; topical gel.

Company:
Endo Pharmaceuticals

Therapeutic Use:

Indications for FORTESTA:

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

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. Advise patients to strictly adhere to recommended instructions. ≥18yrs: Apply to clean, dry, intact skin on front and inner thighs only. Initially 40mg (4 pump actuations) once daily in the AM. Adjust based on serum testosterone levels (see full labeling); min: 10mg/day, max: 70mg/day. Wash hands after application; do not wash site for 2hrs after application; cover site with clothing. Prime pump before 1st use. Not interchangeable with other testosterone products.

Children:

<18yrs: not established.

Contraindications:

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

Warnings/Precautions:

Not for use in women. Secondary exposure to testosterone; promptly discontinue if signs of virilization in children and women occurs until cause is identified. Children and women must avoid contact with unwashed or unclothed application sites. Increased risk for worsening BPH; monitor for signs/symptoms. Evaluate for prostate cancer prior to and during therapy. Monitor hematocrit prior to initiation, at 3–6 months after starting therapy, then annually; if elevation occurs, withhold until acceptable level. Pre-existing cardiac, renal, or hepatic disease. Possible sleep apnea in patients with obesity or chronic lung diseases. Testosterone and/or other anabolic androgenic steroid abuse. Monitor serum testosterone, PSA, liver function, cholesterol, lipid profile, serum calcium (in cancer patients at risk for hypercalcemia/hypercalciuria) periodically. Monitor for venous thromboembolism; discontinue if suspected. Inform patients of possible increased risk of MI, stroke. Product is flammable. Elderly.

Interactions:

May affect insulin requirements. Monitor INR, PT with anticoagulants. Concomitant ACTH or corticosteroids may increase fluid retention. May affect thyroid levels.

Pharmacological Class:

Androgen.

Adverse Reactions:

Application site reactions, increased PSA, abnormal dreams; edema, azoospermia, gynecomastia, sleep apnea, polycythemia.

REMS:

YES

How Supplied:

Pump (120 actuations)—1, 2, 3

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