testosterone topical (Rx)

Brand and Other Names:Androderm, AndroGel, more...Testim, Axiron, Fortesta, Vogelxo

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

patch, transdermal: Schedule III

  • 2mg/24hr
  • 4mg/24hr

gel, transdermal: Schedule III

  • 1% (12.5mg/actuation) (Androgel)
  • 1.62% (20.25mg/actuation) (Androgel)
  • 10mg/actuation (1 pump actuation dispenses 0.5 g of gel) (Fortesta)
  • 12.5mg/actuation (Vogelxo)
  • 20.25mg/1.25g
  • 25mg/2.5g
  • 40.5mg/2.5g
  • 50mg/5g (Testim)
  • 50mg/unit dose pack (Vogelxo)

ointment, topical: Schedule III

  • 2%

solution, topical: Schedule III

  • 30mg/actuation (90mL) (Axiron)

cream, transdermal: Schedule III

  • 2%

Testosterone Deficiency

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

Androderm

  • 4 mg/day initially, applied patch to back, abdomen, arm, or thigh (not to scrotum) at bedtime; do not use 2 mg/day patches to achieve 4 mg dose
  • Nonvirilized: 2 mg/day initially
  • Usual dosing range: 2-6 mg/day

AndroGel

  • 1%: 50 mg/day initially, applied topically to shoulders, upper arms, or abdomen (not to genitals) each morning; titrated PRN according to predose serum testosterone levels (25 mg/2.5 g, 50 mg/5 g); not to exceed 100 mg/day
  • 1.62%: 40.5 mg (2 pump actuations) daily initially, applied topically to shoulders or upper arms (not to abdomen or genitals) each morning; titrated between 20.25 mg (1 pump actuation) and 81 mg (4 pump actuations) according to predose serum testosterone levels; not to excee 81 mg/day
  • Measure serum testosterone levels 14 and 28 days after initiation, then periodically thereafter

Testim

  • 50 mg/day, applied topically to shoulders and upper arms (not to genitals) each morning; may be increased to 100 mg PRN (50 mg/5 g)

Axiron

  • 60 mg/day, applied topically to axilla (1 pump actuation applied to each axilla) each morning; titrated according to serum testosterone levels obtained from single blood draw 2-8 hours after application and ≥14 days after treatment initiation or dosage adjustment

Fortesta

  • 40 mg (4 pump actuations) daily initially, applied topically to thighs each morning; titrated according to serum testosterone levels obtained from single blood draw 2 hours after application and approximately 14 and 35 days after treatment initiation or dosage adjustment
  • Measure serum testosterone concentrations periodically

Vogelxo

  • 50 mg (1 unit dose pack or 4 pump actuations) topically qDay at about the same time each day

Dose Adjustment Based on Testosterone Levels

Androderm

  • >930 ng/dL: Decrease to 2 mg/day
  • 400-930 ng/dL: Continue 4 mg/day
  • <400 ng/dL: Increase dose to 6 mg/day (as one 4 mg/day and one 2 mg/day)

Androgel 1%

  • Less than normal range: Increase dose from 50 mg to 75 mg or from 75 mg to 100 mg once daily
  • Greater than normal range: Decrease dose; discontinue if consistently above normal at dose of 50 mg/day

Androgel 1.62%

  • >750 ng/dL: Decrease dose by 20.25 mg/day
  • >350 ng/dL: Maintain current dose
  • <350 ng/dL: Increase dose by 20.25 mg/day

Fortesta

  • Base adjustment on total serum testosterone concentrations 2 hours after application
  • ≥2500 ng/dL: Decrease by 20 mg/day
  • ≥1250 ng/dL to <2500 ng/dL: Decrease dose by 10 mg/day
  • ≥500 ng/dL to <1250 ng/dL: Maintain current dose
  • <500 ng/dL: Increase dose by 10 mg/day

Axiron

  • >1050 ng/dL: Decrease 60 mg daily dose (2 pump actuation) to 30 mg/day (1 pump actuation); discontinue if levels >1050 ng/dL persist after dose reduction
  • <300 ng/dL: Increase current dose by 1 pump actuation/day (30 mg)

Testim

  • Less than normal range: Increase dose from 50 mg/day to 100 mg/day
  • Greater than normal range: Decrease daily dose

Vogelxo

  • Measure morning (predose) serum testosterone concentrations ~14 days after initiation of therapy to ensure proper serum testosterone concentrations are achieved
  • If level is below normal range (ie, 300-1,000 ng/dL), increase dose to 100 mg qDay; not to exceed 100 mg/day

Vulvar Dystrophy (Orphan)

Orphan indication sponsor

  • Star Pharmaceuticals, Inc, 1990 NW 44th Street, Pompano Beach, FL 33064

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

Do not apply any transdermal testosterone product to genitals

Androderm

  • Apply to back, abdomen, arm, or thigh

Testim

  • Apply to shoulders or upper arms

AndroGel

  • 1%: Apply to shoulders, upper arms, or abdomen (not to genitals)
  • 1.62%: Apply to shoulders or upper arms (not to abdomen or genitals)

Axiron

  • Apply to clean, dry intact skin of axilla, not to any other body regions (including abdomen and genitals)
  • Patients should wash hands with soap and water immediately after application and should cover application site with clothing after solution has dried
  • Wash application site thoroughly with soap and water before any situation in which skin-to-skin contact of application site with another person is anticipated
  • Application site and dose are not interchangeable with those of other topical testosterone products

Fortesta

  • Apply to clean, dry, intact skin of thighs, not to genitals or any other body regions
  • Patients should wash hands with soap and water immediately after application and should cover application site with clothing after gel has dried
  • Wash application site thoroughly with soap and water before any situation in which skin-to-skin contact of application site with another person is anticipated
  • Application site and dose are not interchangeable with those of other topical testosterone products

Vogelxo

  • Apply to clean, dry, intact skin
  • Apply to shoulders and/or upper arms
  • Do not apply to the genitals or abdomen
  • f morning pre-dose serum testosterone concentration is below the normal range, increase dose to 100 mg

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

Safety and efficacy not established

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Interactions

Interaction Checker

and testosterone topical

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      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (5)

              • cyclosporine

                testosterone topical increases effects of cyclosporine by decreasing metabolism. Avoid or Use Alternate Drug.

              • lonafarnib

                testosterone topical will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarnib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to, or continue lonafarnib at starting dose. Closely monitor for arrhythmias and events (eg, syncope, heart palpitations) since lonafarnib effect on QT interval is unknown.

              • pexidartinib

                testosterone topical and pexidartinib both increase Other (see comment). Avoid or Use Alternate Drug. Pexidartinib can cause hepatotoxicity. Avoid coadministration of pexidartinib with other products know to cause hepatoxicity.

              • pretomanid

                testosterone topical, pretomanid. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Pretomanid regimen associated with hepatotoxicity. Avoid alcohol and hepatotoxic agents, including herbal supplements and drugs other than bedaquiline and linezolid.

              • sotorasib

                sotorasib will decrease the level or effect of testosterone topical by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.

              Monitor Closely (14)

              • atogepant

                testosterone topical will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • avapritinib

                testosterone topical will increase the level or effect of avapritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • axitinib

                testosterone topical increases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • carbamazepine

                testosterone topical increases toxicity of carbamazepine by decreasing metabolism. Use Caution/Monitor.

              • finerenone

                testosterone topical will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.

              • flibanserin

                testosterone topical will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors.

              • insulin degludec

                testosterone topical increases effects of insulin degludec by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of antidiabetic medication.

              • insulin degludec/insulin aspart

                testosterone topical increases effects of insulin degludec/insulin aspart by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of antidiabetic medication.

              • insulin inhaled

                testosterone topical increases effects of insulin inhaled by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of antidiabetic medication.

              • ivacaftor

                testosterone topical increases levels of ivacaftor by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor when coadministered with weak CYP3A4 inhibitors .

              • lemborexant

                testosterone topical will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.

              • mipomersen

                mipomersen, testosterone topical. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Both drugs have potential to increase hepatic enzymes; monitor LFTs.

              • tazemetostat

                testosterone topical will increase the level or effect of tazemetostat by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • tinidazole

                testosterone topical will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              Minor (39)

              • acarbose

                testosterone topical increases effects of acarbose by pharmacodynamic synergism. Minor/Significance Unknown.

              • androstenedione

                androstenedione increases effects of testosterone topical by pharmacodynamic synergism. Minor/Significance Unknown.

              • budesonide

                testosterone topical, budesonide. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • chlorpropamide

                testosterone topical increases effects of chlorpropamide by pharmacodynamic synergism. Minor/Significance Unknown.

              • cortisone

                testosterone topical, cortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • deflazacort

                testosterone topical, deflazacort. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • dexamethasone

                testosterone topical, dexamethasone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • epoetin alfa

                testosterone topical increases effects of epoetin alfa by pharmacodynamic synergism. Minor/Significance Unknown. Androgens may be used to decrease necessary dose of epoetin alfa.

              • fludrocortisone

                testosterone topical, fludrocortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • glimepiride

                testosterone topical increases effects of glimepiride by pharmacodynamic synergism. Minor/Significance Unknown.

              • glipizide

                testosterone topical increases effects of glipizide by pharmacodynamic synergism. Minor/Significance Unknown.

              • glyburide

                testosterone topical increases effects of glyburide by pharmacodynamic synergism. Minor/Significance Unknown.

              • hydrocortisone

                testosterone topical, hydrocortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • insulin aspart

                testosterone topical increases effects of insulin aspart by pharmacodynamic synergism. Minor/Significance Unknown.

              • insulin detemir

                testosterone topical increases effects of insulin detemir by pharmacodynamic synergism. Minor/Significance Unknown.

              • insulin glargine

                testosterone topical increases effects of insulin glargine by pharmacodynamic synergism. Minor/Significance Unknown.

              • insulin glulisine

                testosterone topical increases effects of insulin glulisine by pharmacodynamic synergism. Minor/Significance Unknown.

              • insulin lispro

                testosterone topical increases effects of insulin lispro by pharmacodynamic synergism. Minor/Significance Unknown.

              • insulin NPH

                testosterone topical increases effects of insulin NPH by pharmacodynamic synergism. Minor/Significance Unknown.

              • insulin regular human

                testosterone topical increases effects of insulin regular human by pharmacodynamic synergism. Minor/Significance Unknown.

              • metformin

                testosterone topical increases effects of metformin by pharmacodynamic synergism. Minor/Significance Unknown.

              • methylprednisolone

                testosterone topical, methylprednisolone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • miglitol

                testosterone topical increases effects of miglitol by pharmacodynamic synergism. Minor/Significance Unknown.

              • nateglinide

                testosterone topical increases effects of nateglinide by pharmacodynamic synergism. Minor/Significance Unknown.

              • pioglitazone

                testosterone topical increases effects of pioglitazone by pharmacodynamic synergism. Minor/Significance Unknown.

              • prednisolone

                testosterone topical, prednisolone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • prednisone

                testosterone topical, prednisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • repaglinide

                testosterone topical increases effects of repaglinide by pharmacodynamic synergism. Minor/Significance Unknown.

              • rosiglitazone

                testosterone topical increases effects of rosiglitazone by pharmacodynamic synergism. Minor/Significance Unknown.

              • ruxolitinib

                testosterone topical will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • ruxolitinib topical

                testosterone topical will increase the level or effect of ruxolitinib topical by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • saw palmetto

                saw palmetto decreases effects of testosterone topical by pharmacodynamic antagonism. Minor/Significance Unknown.

              • saxagliptin

                testosterone topical increases effects of saxagliptin by pharmacodynamic synergism. Minor/Significance Unknown.

              • sitagliptin

                testosterone topical increases effects of sitagliptin by pharmacodynamic synergism. Minor/Significance Unknown.

              • tacrolimus

                testosterone topical increases effects of tacrolimus by decreasing metabolism. Minor/Significance Unknown.

              • tolazamide

                testosterone topical increases effects of tolazamide by pharmacodynamic synergism. Minor/Significance Unknown.

              • tolbutamide

                testosterone topical increases effects of tolbutamide by pharmacodynamic synergism. Minor/Significance Unknown.

              • triamcinolone acetonide injectable suspension

                testosterone topical, triamcinolone acetonide injectable suspension. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • vildagliptin

                testosterone topical increases effects of vildagliptin by pharmacodynamic synergism. Minor/Significance Unknown.

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              Adverse Effects

              >10%

              Pruritus at application site (37%)

              Skin reactions at application site (16.1%)

              Blisters under skin (12%)

              1-10%

              Erythema at application site (7%)

              Vesicles at application site (6%)

              Allergic contact dermatitis (4%)

              Burning at application site (3%)

              Induration at application site (3%)

              Frequency Not Defined

              Abnormal dreams

              Acne

              Anaphylaxis

              Bladder irritability

              Breast soreness

              Cholestatic jaundice

              Deep vein thrombosis

              Dry skin

              Fatigue

              Gynecomastia

              Headache

              Insomnia

              Menstrual irregularities

              Priapism

              Suppression of factors II, V, VII

              Virilization

              Postmarketing Reports

              Vascular Disorders: Venous thromboembolism

              Cardiovascular disorders: Myocardial infarction, stroke

              Blood and lymphatic disorders: Polycythemia

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              Warnings

              Black Box Warnings

              Virilization can occur in children and women after secondary exposure to testosterone gel preparations

              Children and women should avoid contact with testosterone application sites on men using testosterone gel

              Testosterone gel users should adhere to recommended instructions for use

              Contraindications

              Males with breast or prostate cancer

              Hypersensitivity

              Breast feeding women

              Pregnancy

              Cautions

              Use with caution in patients with chronic lung disease, obesity, advanced age, or preexisting cardiac, renal, or hepatic disease

              Employ caution with prolonged use of high doses, which may be associated with hepatic effects

              May increase risk of prostate cancer

              Risk of gynecomastia when used for male hypogonadism

              May change serum lipid profile; use with caution in patients who have history of mycoardial infarction (MI) or coronary artery disease (CAD)

              Large doses may suppress spermatogenesis

              May increase hematocrit, which requires dose adjustment or discontinuation; monitor serum testosterone, prostate specific antigen (PSA), liver function, lipid concentrations, hematocrit and hemoglobin periodically

              May cause hypercalcemia in patients with prolonged immolibization or cancer

              Anabolic activity of androgens may enhance hypoglycemia

              Children: Risks of inappropriate genital enlargement, premature pubic hair, advanced bone age, increased libido, and aggressive behavior

              Fortesta: Exogenous administration of androgens may lead to azoospermia; sleep apnea may occur in those with risk factors; preparation is flammable until dry

              Discontinue if urethral obstruction develops in patients with benign prostatic hyperplasia (BPH); monitor patients with BPH for worsening of signs and symptoms of BPH

              Edema with or without congestive heart failure, may be a complication in patients with pre-existing cardiac, renal, or hepatic disease; use with caution

              May worsen sleep apnea in some male patients

              Evaluate patients for cardiovascular risk factors prior to initiating therapy and monitor closely during therapy

              Use caution in patients with diseases that may be exacerbated by fluid retention, including cardiac, hepatic, or renal dysfunction; not recommended for men with poorly controlled heart failure

              Monitor women for virilization when treating for metastatic breast cancer

              Geriatric patients may be at greater risk for prostatic hyperplasia, prostate cancer, fluid retention, and increase in transaminase levels

              Increased hematocrit (polycythemia), reflective of increased red blood cell mass, may require discontinuation; increases risk for thromboemolism

              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

              Testosterone has been subject to abuse, typically at doses higher than recommended for approved indication and in combination with other anabolic androgenic steroids; anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions; if testosterone abuse suspected, check serum testosterone concentrations to ensure they are within therapeutic range; consider possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events

              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

              Cardiovascular risks

              • Some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with the use of testosterone replacement therapy
              • 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
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              Pregnancy & Lactation

              Pregnancy

              Contraindicated in pregnant women; drug is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action; exposure of female fetus to androgens may result in varying degrees of virilization

              Infertility

              • During treatment with large doses of exogenous androgens, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis; reduced fertility is observed in some men taking testosterone replacement therapy; testicular atrophy, subfertility, and infertility have been reported in men who abuse anabolic androgenic steroids; with either type of use, the impact on fertility may be irreversible

              Animal data

              • In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring; these studies did not meet current standards for nonclinical development toxicity studies

              Lactation

              Drug is not indicated for use in women

              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.

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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

              Duration: 24-48 hr (gel)

              Peak plasma time: 2-6 hr

              Peak effect: 3-24 months

              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

              BRAND FORM. UNIT PRICE PILL IMAGE
              Natesto nasal
              -
              5.5 mg/0.122 gram/actuation gel
              Natesto nasal
              -
              5.5 mg/0.122 gram/actuation gel
              AndroGel transdermal
              -
              1.62 % (40.5 mg/2.5 gram) gel
              AndroGel transdermal
              -
              1 % (25 mg/2.5gram) gel
              AndroGel transdermal
              -
              1 % (25 mg/2.5gram) gel
              AndroGel transdermal
              -
              1 % (50 mg/5 gram) gel
              AndroGel transdermal
              -
              20.25 mg/1.25 gram (1.62 %) gel
              AndroGel transdermal
              -
              1.62 % (20.25 mg/1.25 gram) gel
              Fortesta transdermal
              -
              10 mg/0.5 gram /actuation gel
              testosterone transdermal
              -
              1 % (25 mg/2.5gram) gel
              testosterone transdermal
              -
              30 mg/actuation (1.5 mL) solution
              testosterone transdermal
              -
              1.62 % (40.5 mg/2.5 gram) gel
              testosterone transdermal
              -
              1 % (25 mg/2.5gram) gel
              testosterone transdermal
              -
              20.25 mg/1.25 gram (1.62 %) gel
              testosterone transdermal
              -
              50 mg/5 gram (1 %) gel
              testosterone transdermal
              -
              1 % (25 mg/2.5gram) gel
              testosterone transdermal
              -
              20.25 mg/1.25 gram (1.62 %) gel
              testosterone transdermal
              -
              30 mg/actuation (1.5 mL) solution
              testosterone transdermal
              -
              12.5 mg/ 1.25 gram (1 %) gel
              testosterone transdermal
              -
              1 % (50 mg/5 gram) gel
              testosterone transdermal
              -
              50 mg/5 gram (1 %) gel
              testosterone transdermal
              -
              1.62 % (40.5 mg/2.5 gram) gel
              testosterone transdermal
              -
              1 % (50 mg/5 gram) gel
              testosterone transdermal
              -
              1 % (50 mg/5 gram) gel
              testosterone transdermal
              -
              20.25 mg/1.25 gram (1.62 %) gel
              testosterone transdermal
              -
              1 % (25 mg/2.5gram) gel
              testosterone transdermal
              -
              50 mg/5 gram (1 %) gel
              testosterone transdermal
              -
              20.25 mg/1.25 gram (1.62 %) gel
              testosterone transdermal
              -
              30 mg/actuation (1.5 mL) solution
              testosterone transdermal
              -
              30 mg/actuation (1.5 mL) solution
              testosterone transdermal
              -
              20.25 mg/1.25 gram (1.62 %) gel
              testosterone transdermal
              -
              1 % (50 mg/5 gram) gel
              testosterone transdermal
              -
              1 % (50 mg/5 gram) gel
              testosterone transdermal
              -
              12.5 mg/ 1.25 gram (1 %) gel
              testosterone transdermal
              -
              10 mg/0.5 gram /actuation gel
              testosterone transdermal
              -
              50 mg/5 gram (1 %) gel
              testosterone transdermal
              -
              10 mg/0.5 gram /actuation gel
              testosterone transdermal
              -
              50 mg/5 gram (1 %) gel
              Testim transdermal
              -
              50 mg/5 gram (1 %) gel
              Testim transdermal
              -
              50 mg/5 gram (1 %) gel
              Androderm transdermal
              -
              4 mg/24 hr transdermal system
              Androderm transdermal
              -
              2 mg/24 hour transdermal system
              Androderm transdermal
              -
              4 mg/24 hr transdermal system
              Androderm transdermal
              -
              2 mg/24 hour transdermal system
              Testopel implant
              -
              75 mg pellet

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Select a drug:
              Patient Education
              testosterone nasal

              TESTOSTERONE GEL - NASAL

              (tes-TOS-ter-one)

              COMMON BRAND NAME(S): Natesto

              USES: This medication is used by men who do not make enough of a natural substance called testosterone (hypogonadism). Testosterone belongs to a class of drugs known as androgens. Testosterone helps the body to develop and maintain male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire.This drug should not be used by women.

              HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using testosterone and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist.Gently blow your nose before using this medication. Follow the instructions on how to properly prime the bottle if you are using it for the first time.Use this medication in the nose as directed by your doctor, usually 3 times a day (6 to 8 hours apart). After applying the medication into both nostrils, gently squeeze your nostrils together and lightly massage. Do not apply this medication to other areas of your body. If another part of your body comes in contact with this medication, wash the area with warm water and soap.Do not blow your nose or sniff for 1 hour after using this medication. Wipe the tip of the applicator with a clean, dry tissue after each use.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.Misuse or abuse of testosterone can cause serious side effects such as heart disease (including heart attack), stroke, liver disease, mental/mood problems, abnormal drug-seeking behavior, or improper bone growth (in adolescents). Do not increase your dose or use this drug more often or for longer than prescribed. When testosterone is misused or abused, you may have withdrawal symptoms (such as depression, irritability, tiredness) when you suddenly stop using the drug. These symptoms may last from weeks to months.Since this drug can be absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.Tell your doctor if your condition does not improve or if it worsens.

              SIDE EFFECTS: Runny/stuffy nose, nosebleed, nasal dryness/irritation/scabbing or changes in smell may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: difficulty urinating, increased urination (especially at night), signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), swelling hands/ankle/feet, breast pain/enlargement, interrupted breathing during sleep, daytime drowsiness, frequent erections, fast/irregular heartbeat.Get medical help right away if you have any very serious side effects, including: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes.Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before using testosterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: nasal problems (such as runny/stuffy nose, swelling of the lining of your nose), seasonal allergies, history of a broken nose within the past 6 months, a fracture of your nose that caused the inside of your nose to be crooked (deviated anterior nasal septum), sinus problem, nasal or sinus surgery, cancer (especially prostate or breast cancer), prostate problems (such as enlarged prostate or BPH), blood clots (such as in the legs, lungs), heart problems (such as heart failure, heart attack), stroke, breathing trouble during sleep (sleep apnea), kidney disease, liver disease, high cholesterol, diabetes.If you have diabetes, this product may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of low blood sugar. Your doctor may need to adjust your diabetes medication, exercise program, or diet.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Some men, particularly older adults, are at a higher risk for developing enlarged prostate or prostate cancer while using this medication. Your risk of prostate problems should be checked by your doctor before you start testosterone.Children may be more sensitive to the side effects of this drug. In children, it may affect bone growth. Monitor your child's height periodically.This medication can affect fertility in males. Ask your doctor for more details.This medication should not be used by women. Women accidentally exposed to this medication may have side effects due to testosterone gel. If you notice symptoms in a woman such as changes in body hair or a large increase in acne, talk to her doctor and your doctor right away. Women who are pregnant or breast-feeding must avoid contact with this medication. This medication may harm an unborn or breast-feeding baby. Consult your doctor for more details.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: "blood thinners" (such as warfarin).This medication may interfere with certain lab tests (such as thyroid tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Do not share this medication with others. Sharing it is against the law.Lab and/or medical tests (such as PSA, cholesterol, hemoglobin/hematocrit, testosterone blood levels, prostate exams) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

              MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

              Information last revised July 2023. Copyright(c) 2023 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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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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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.