AXIRON CIII

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AXIRON

Hypogonadism
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Generic Name and Formulations:

Testosterone 30mg/1.5mL pump or twist actuation; soln; contains alcohol; latex-free.

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Indications for AXIRON:

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. Apply to clean, dry intact skin of the axilla; do not apply to the scrotum, penis, abdomen, shoulders or upper arms. ≥18yrs: Initially apply 60mg (2 pump or 2 twist actuations) to the axilla once daily in the AM; measure serum testosterone levels to ensure response. May adjust dose based on serum testosterone concentration 2–8 hours after applying and at least 14 days after starting therapy or following dose adjustment. May increase dose in 30mg increments if serum testosterone <300ng/dL up to 120mg; reduce dose to 30mg if levels >1050ng/dL, discontinue if serum testosterone remains >1050ng/dL. Wash hands after application. Allow soln to dry before it touches clothing. Not interchangeable with other topical testosterone products.

Children:

<18yrs: not established.

Contraindications:

Male breast or prostate cancer. 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. Monitor for worsening BPH. Evaluate for prostate cancer before starting therapy (esp. elderly). Preexisting cardiac, renal, or hepatic disease (discontinue if edema occurs). Sleep apnea. Monitor hematocrit prior to initiation, at 3–6 months after starting therapy, then annually; if elevation occurs, withhold until acceptable level. 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). Men with BMI >35kg/m2: not established. Monitor for venous thromboembolism; discontinue if suspected. Inform patients of possible increased risk of MI, stroke. Product is flammable. Advise patients to avoid showering or swimming for at least 2hrs after application.

Interactions:

Monitor INR and PT with anticoagulants. May affect insulin requirements. Increased risk of edema with ACTH, corticosteroids. May affect thyroid levels.

Pharmacological Class:

Androgen.

Adverse Reactions:

Local reactions, increased hematocrit, headache, diarrhea, vomiting, increased serum PSA; gynecomastia, virilization in children.

REMS:

YES

Generic Availability:

YES

How Supplied:

Pump—90mL (60 metered pump or twist actuations) (w. applicator)

AXIRON 90ml of 30mg/1.5ml bottle of topical solutions (Qty:1)

appx. price $594.00