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testosterone (Rx)Brand and Other Names:Aveed, Depo-Testosterone, more...Delatestryl, Testopel

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution (cypionate): Schedule III

  • 100mg/mL (Depo-Testosterone)
  • 200mg/mL (Depo-Testosterone)

injectable solution (enanthate): Schedule III

  • 200mg/mL (Delatestryl)

injectable solution (undecanoate): Schedule III

  • 250mg/mL (Aveed)

pellet implant: Schedule III

  • 75mg (Testopel)
  • 12.5mg, 25mg, 37.5mg, 50mg (generic)
more...

Hypogonadism

Primary hypogonadism (congenital or acquired): Testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter Syndrome, chemotherapy, or toxic damage from alcohol or heavy metals; these men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above normal range

Hypogonadotropic hypogonadism (congenital or acquired): Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation; these men have low testosterone serum concentrations but have gonadotropins in the normal or low range

Testosterone cypionate: 50-400 mg IM every 2-4 weeks

Testosterone enanthate: 50-400 mg IM every 2-4 weeks

Testosterone undecanoate (restricted availability): 750 mg IM initial dose, repeat after 4 weeks, and then q10wk thereafter

Pellet: 150-450 mg SC every 3-6 months; 150 mg of pellet approximately equivalent to 25 mg of testosterone propionate weekly

Delayed Puberty in Males

50-200 mg IM every 2-4 weeks for 4-6 months

Alternative: 150-450 mg SC every 3-6 months

Inoperable Mammary Cancer in Women

200-400 mg enanthate IM every 2-4 weeks

Androgen Deficiency in HIV+ Patients (Orphan)

Physiologic testosterone replacement in androgen-deficient HIV+ patients with associated weight loss

Orphan sponsor

  • Watson Laboratories, Research Park, 417 Wakara Way, Salt Lake City, UT 8410

Delayed Growth (Orphan)

Treatment of constitutional delay in growth and puberty in adolescent boys aged 14-17 years (testosterone undecanoate)

Orphan sponsor

  • SOV Therapeutics, Inc, 101 Guymon Court, Morrisville, NC 27560

Administration

Prior to initiating therapy, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range

The aluminum metal ring or crimp seal around the gray rubber stopper from the vial, should not be removed prior to the administration of the injection

For IM use, should be administered deep in gluteal muscle

Dosages >400 mg/month not recommended

Limitations of use

Safety and efficacy of testosterone in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

Safety and efficacy of testosterone in males less than 18 years old have not been established

Dosage Forms & Strengths

injectable solution (cypionate): Schedule III

  • 100mg/mL (Depo-Testosterone)
  • 200mg/mL (Depo-Testosterone)

injectable solution (enanthate): Schedule III

  • 200mg/mL (Delatestryl)

injectable solution (undecanoate): Schedule III

  • 250mg/mL (Aveed)

pellet implant: Schedule III

  • 75mg (Testopel)
  • 12.5mg, 25mg, 37.5mg, 50mg (generic)
more...

Hypogonadism

<12 years

  • Safety and efficacy not established

≥12 years

  • Testosterone cypionate: 50-400 mg IM every 2-4 weeks
  • Testosterone enanthate: 50-400 mg IM every 2-4 weeks
  • Testosterone undecanoate (restricted availability): 750 mg IM initial dose, repeat after 4 weeks, and then q10wk thereafter
  • Pellet: 150-450 mg SC every 3-6 months; 150 mg of pellet approximately equivalent to 25 mg of testosterone propionate weekly

Delayed Puberty in Males

<12 years

  • Safety and efficacy not established

≥12 years

  • 50-200 mg IM every 2-4 weeks for 4-6 months
  • Alternate dosing schedule: 150-450 mg SC every 3-6 months
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Interactions

Interaction Checker

testosterone and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Acne

            Abnormal dreams

            Aggressive behavior

            Alopecia

            Anaphylaxis

            Anger

            Amnesia

            Anxiety

            Bladder irritability

            Breast soreness

            Deep venous thrombosis

            Excessive frequency and duration of erection

            Fatigue

            Growth acceleration

            Gynecomastia

            Headache

            Hirsutism

            Hot flashes

            Hypersensitivity

            Hypercholesterolemia

            Hypertension

            Insomnia

            Liver function alterations

            Male pattern baldness

            Menstrual irregularities

            Priapism

            Pruritus

            Rash

            Seborrhea

            Suppression of factors II, V, VII, X

            Vasodilation

            Virilization

            Water retention

            Postmarketing Reports

            Vascular Disorders: Venous thromboembolism

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            Warnings

            Black Box Warnings

            Serious pulmonary oil microembolism reactions, involving urge to cough, dyspnea, throat tightening, chest pain, dizziness, and syncope (POME) reactions and episodes of anaphylaxis reported during or immediately after administration of testosterone undecanoate injection; may occur after first dose

            Observe patients for 30 minutes in healthcare setting to provide immediate medical treatment in event of serious POME reactions or anyphylaxis

            Because of risks of serious POME reactions and anaphylaxis, testosterone undecanoate is available through restricted program under a risk evaluation and mitigation strategy (REMS) called the Aveed REMS Program

            Contraindications

            Hypersensitivity to product or formulation components

            Cancer of breast or known or suspected carcinoma of prostate in men

            Severe cardiac, hepatic, or renal disease

            Women: Pregnancy or prospect of pregnancy

            Cautions

            Do not use testosterone cypionate interchangeably with testosterone propionate

            Breast cancer patients: Risk of hypercalcemia; discontinue if this condition develops

            Long term use (>10 years) of parenteral testosterone for male hypogonadism may increase the risk of breast cancer

            Observe women for signs of virilization during treatment for metastatic breast cancer; if such signs are noted, discontinue to prevent irreversible virilization

            Caution in history of myocardial infarction (MI) or coronary artery disease (CAD); some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with use of testosterone replacement therapy

            Anabolic steroids may be abused; dependence may occur when used outside of approved dosage/indication

            Prolonged use of high-dose androgens associated with peliosis hepatitis and hepatic neoplasms (including hepatic cancer)

            Risk of cholestatic hepatitis with jaundice; discontinue if this condition develops

            Geriatric patients: Increased risk of benign prostatic hyperplasia (BPH) and prostate cancer; monitor patients with BPH for worsening of signs and symptoms of BPH

            Risk of gynecomastia

            May alter serum lipid profile (use caution in history of MI or coronary artery disease)

            May increase sensitivity to oral anticoagulants and decreases blood glucose; adjust dosages accordingly

            May cause hypercalcemia in patients with prolonged immobilization or cancer

            Use with caution in patients with diseases that may be exacerbated by fluid retention, including cardiac, hepatic, or renal dysfunction; testosterone may cause fluid retention; treatment of androgen deficiency syndromes is not recommended for men with uncontrolled or poorly controlled heart failure

            May accelerate bone maturation and premature closure of epiphyses in children; in prebubertal children perform radiographic examination

            Large doses may suppress spermatogenesis

            May potentiate sleep apnea in some patients

            Risk of priapism, excessive sexual stimulation, or acute urethral obstruction in patients with BPH

            Increased hematocrit (polycythemia), reflective of increased red blood cell mass, may require discontinuation; increases risk for thromboemolism; monitor serum testosterone, prostate specific antigen (PSA), liver function, lipid concentrations, hematocrit and hemoglobin periodically

            Skin burns reported at application site in patients wearing an aluminized transdermal system during a magnetic resonance imaging scan (MRI); because transdermal testosterone patch contains aluminum, it is recommended to remove system before undergoing MRI

            Venous thromboembolism, including DVT and PE reported in patients using testosterone products; these observations have included patients with and without polycythemia; evaluate signs or symptoms consistent with DVT or PE; if venous thromboembolic event suspected, discontinue treatment with testosterone and initiate appropriate workup and management

            Cardiovascular risks

            • Evaluate patients for cardiovascular risk factors prior to initiating therapy and monitor closely for cardiovascular events during therapy; it may be prudent to avoid testosterone therapy in men who have experienced a cardiovascular event
            • January 31, 2014: FDA is investigating risk of stroke, MI, and death in men taking prescription testosterone drugs; investigation was prompted by findings from 2 studies suggesting increased risk of MI in men who take testosterone
            • In one study, analysis of 55,593 men with history of MI showed that men >65 years had 2-fold increase in MI risk within 90 days of filling initial prescription for testosterone drug; among younger men (<65 years) with history of heart disease, MI risk was increased 2- to 3-fold
            • This study confirmed results of earlier, much smaller study, which found that older men, many with underlying heart disease, had 30% increased chance of death, MI, and stroke after receiving testosterone therapy

            Edema

            • Risk of edema; edema with or without congestive heart failure, may be a complication in patients with pre-existing cardiac, renal, or hepatic disease
            • Diuretic treatment may be necessary in addition to discontinuance of drug
            • If drug therapy is restarted, use lower dosage

            Healthy males with delayed puberty

            • Monitor bone maturation by assessing bone age of wrist and hand every 6 months
            • May accelerate bone maturation, compromising final adult height
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            Pregnancy & Lactation

            Pregnancy category: X

            Lactation: Drug is excreted into breast milk; avoid using

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Endogenous androgen; promotes growth and development of male sex organs and maintains secondary sex characteristics in androgen-deficient males

            Absorption

            Bioavailability: IM, slowly absorbed

            Duration: 2-4 wk (IM)

            Peak plasma time: 24 hr (IM)

            Distribution

            Protein bound: 98%

            Vd: 75-122 L/kg

            Metabolism

            Metabolized in liver to glucuronic and sulfuric acid conjugates

            Metabolites: Testosterone glucuronic conjugate (activity unknown), testosterone sulfuric acid conjugate (activity unknown), testosterone-19-d3

            Elimination

            Half-life: 10-100 min

            Renal clearance: 2 L/min

            Excretion: Urine (90%), feces (6%)

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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