Androgens and Anabolic Steroids Prior Authorization with Quantity Limit Program Summary – Through Generic FDA APPROVED INDICATIONS AND DOSAGE1-20 Topical Androgen Agents Agent(s) Indication(s) Dosage Androderm® For replacement therapy in Hypogonadism (testosterone transdermal adult males for conditions 2 mg/day and 4 mg/day system system) associated with a deficiency -Recommended starting dose is one 4 or absence of endogenous mg/day system (not two 2 mg/day 2 mg/day, 4 mg/day testosterone systems) applied nightly for 24 hours. transdermal system -Dose may be decreased to 2 mg (i.e., -Primary hypogonadism one 2 mg/day system) or increased to 6 (congenital or acquired): mg (i.e., one 4 mg/day and one 2 testicular failure due to mg/day system) cryptorchidism, bilateral torsion, orchitis, vanishing Switching from 2.5 mg/day, 5 mg/day, testis syndrome, and 7.5 mg/day to 2 mg/day, 4 mg/day orchiectomy, Klinefelter and 6 mg/day dosage syndrome, chemotherapy, or -Patients using 2.5 mg daily may be toxic damage from alcohol switched to 2 mg/day systems at the or heavy metals. next scheduled dose -Patients using 5 mg daily may be -Hypogonadotropic switched to 4 mg/day systems at the hypogonadism (congenital or next scheduled dose acquired): gonadotropin or -Patients using 7.5 mg daily may be luteinizing hormone- switched to 6 mg (2 mg/day and 4 releasing hormone (LHRH) mg/day systems) at the next scheduled deficiency or pituitary- dose KS_PS_Androgens_Anabolic_Steroids_PAQL_thruGen_ProgSum_AR0920_r0421 Page 1 of 28 © Copyright Prime Therapeutics LLC. 04/2021 All Rights Reserved Effective: 07/01/2021 Topical Androgen Agents Agent(s) Indication(s) Dosage AndroGel® / Testosterone hypothalamic injury from 1% gel: (testosterone gel) tumors, trauma, or -Initial dose is 50 mg of testosterone (4 radiation. pump actuations, two 25 mg packets, or 1% gel: one 50 mg packet) once daily in the 25 mg/2.5 g packeta Limitations of use: morning. 50 mg/5 g packeta -Safety and efficacy in men -Dose may be increased to 75 mg and 75 g pump with “age-related 100 mg daily based on measured serum (12.5 mg hypogonadism” (also testosterone levels. testosterone/actuation; referred to as “late-onset -If serum testosterone level exceeds 60 actuations/pump)a hypogonadism”) have not normal range at 50 mg dose, therapy been established should be discontinued. -Safety and efficacy in males less than 18 years old have 1.62% gel: not been established -40.5 mg of testosterone (2 pump 1.62% gel: actuations or 1 40.5 mg packet) applied 75 g pump (20.25 mg topically once daily in the morning. testosterone/actuation; 60 -Dose may be adjusted between a actuations/pump)a minimum of 20.25 mg testosterone (1 20.25 mg/1.25 g packeta pump actuation or 1 packet) or 40.5 mg/2.5 g packeta maximum 81 mg testosterone (4 pump actuations or 2 40.5 mg packets) based on measured serum testosterone levels. testosterone solutiona -Initial dose is 60 mg testosterone (2 pump actuations) applied once daily. 30 mg/1.5 mL, 90 mL pump -Dose of testosterone may be decreased to 30 mg (1 pump actuation) or increased to 90 mg (3 pump actuations) or 120 mg (4 pump actuations) based on the measured serum testosterone. -If serum testosterone concentration exceeds 1050 ng/dL at 30 mg, therapy should be discontinued. Fortesta™ / Testosterone -Initial dose is 40 mg of testosterone (4 (testosterone gel)a pump actuations) once daily in the morning. 2% gel -Dose may be adjusted between a minimum of 10 mg of testosterone and a maximum of 70 mg of testosterone based on measured serum testosterone levels. KS_PS_Androgens_Anabolic_Steroids_PAQL_thruGen_ProgSum_AR0920_r0421 Page 2 of 28 © Copyright Prime Therapeutics LLC. 04/2021 All Rights Reserved Effective: 07/01/2021 Topical Androgen Agents Agent(s) Indication(s) Dosage Natesto™ Recommended dose of 11 mg (2 pump (testosterone nasal gel) actuations, one per nostril), applied intranasally 3 times daily. Nasal metered-dose pump If total testosterone concentrations consistently exceed 1040 ng/dL, therapy should be discontinued. If total testosterone concentrations are consistently below 300 ng/dL, an alternative treatment should be considered. Not recommended for use with nasally administered drugs other than sympathomimetic decongestants (e.g., oxymetazoline) Striant® Usual dose is one buccal system (30 mg) (testosterone buccal system) to the gum region twice daily, morning and evening (about 12 hours apart). 30 mg buccal system Testim® /Testosterone -Initial dose is 50 mg of testosterone (testosterone gel)a (one tube) once daily in the morning. -Dose may be increased to 100 mg 1% gel testosterone (two tubes) once daily 50 mg/5 g packeta based on measured serum testosterone. Vogelxo™/Testosterone For testosterone -Recommended starting dose is 50 mg (testosterone gel) replacement therapy in adult testosterone (5 g gel) once daily at the males for conditions same time each day. 1% gel associated with a deficiency -Dose may be increased to 100 mg daily 50 mg/5 g packeta or absence of endogenous based on measured serum testosterone 50 mg/5 g tube testosterone: levels. 75 g pump -The maximum recommended dose is (12.5 mg -Primary hypogonadism 100 mg once daily. testosterone/actuation; (congenital or acquired) 60 actuations/pump)a -Hypogonadotropic hypogonadism (congenital or acquired) a – Generic available. KS_PS_Androgens_Anabolic_Steroids_PAQL_thruGen_ProgSum_AR0920_r0421 Page 3 of 28 © Copyright Prime Therapeutics LLC. 04/2021 All Rights Reserved Effective: 07/01/2021 Oral Androgen and Anabolic Agents Agent(s) Indication(s) Dosage Anadrol-50® Treatment of anemias caused by Adults and children (oxymetholone) deficient red cell production. -1 to 5 mg/kg body weight per day. Acquired aplastic anemia, -Usual effective dose is 1 to 2 50 mg tablet congenital aplastic anemia, mg/kg/day; higher doses may be myelofibrosis and the hypoplastic required; dose should be individualized. anemias due to the administration -Response is not often immediate; of myelotoxic drugs often respond minimum trial of 3 to 6 months should be given -Following remission, some patients may be maintained without the drugs; others may be maintained on an established lower daily dosage -A continued maintenance dose is usually necessary in patients with congenital aplastic anemia danazola -Endometriosis amenable to Endometriosis: In moderate/severe hormone management disease or patients infertile due to 50 mg, 100 mg, 200 endometriosis: starting dose of 800 mg mg capsule -Prevention of attacks of given in two divided doses. Gradual angioedema of all types downward titration to dose sufficient to maintain amenorrhea may be considered. In mild disease: starting dose of 200 mg to 400 mg given in two divided doses; adjust depending on patient response. Continue therapy for 3 to 6 months, may be extended to 9 months if necessary. Angioedema prophylaxis: Initial 200 mg two to three times daily. If a favorable response achieved, dose may be reduced by half at intervals of 1-3 months. If unfavorable response (attack of angioedema during treatment), dose may be increased by up to 200 mg/day. KS_PS_Androgens_Anabolic_Steroids_PAQL_thruGen_ProgSum_AR0920_r0421 Page 4 of 28 © Copyright Prime Therapeutics LLC. 04/2021 All Rights Reserved Effective: 07/01/2021 Oral Androgen and Anabolic Agents Agent(s) Indication(s) Dosage Jatenzo® Testosterone replacement therapy The recommended starting dose is 237 (testosterone in adult males for conditions mg orally once in the morning and once undecanoate) associated with a deficiency or in the evening. absence of endogenous 158, 198, 237 mg testosterone: Adjust the dose to a minimum of 158 mg capsules -Primary hypogonadism twice daily and a maximum of 396 mg -Hypogonadotropic hypogonadism twice daily. Limitations of use: Safety and efficacy in males less than 18 years old have not been established. Methitest® Males: Males: (methyltestosterone) Androgen replacement therapy -Androgen replacement therapy related related to the following: to hypogonadism: 10 mg to 50 mg/day 10 mg tablet -Primary hypogonadism -Androgen replacement therapy related Methyltestosterone (congenital or acquired) - to cryptorchidism: 10 mg 3 times daily testicular failure due to -Delayed puberty (adolescents only): in 10 mg capsule cryptorchidism, bilateral torsions, the lower range of 10-50 mg/day for a orchitis, vanishing testis limited duration, usually for 4 to 6 syndrome; or orchidectomy months -Hypogonadotropic hypogonadism (congenital or acquired) - Females: idiopathic gonadotropin or LHRH -50 to 200 mg daily deficiency, or pituitary hypothalamic injury from tumors, trauma, or radiation -Delayed puberty in males Females: Palliative treatment of breast cancer in women KS_PS_Androgens_Anabolic_Steroids_PAQL_thruGen_ProgSum_AR0920_r0421 Page 5 of 28 © Copyright Prime Therapeutics LLC. 04/2021 All Rights Reserved Effective: 07/01/2021 Oral Androgen and Anabolic Agents Agent(s) Indication(s) Dosage Oxandrin® Adjunctive therapy to promote Adults (oxandrolone)a weight gain after weight loss -Daily adult dosage is 2.5 mg to 20 mg following extensive surgery, given in 2 to 4 divided doses. 2.5 mg, 10 mg tablet chronic infections, severe trauma, -Desired response may be achieved with and in some patients without as little as 2.5 mg or as much as 20 mg definite pathophysiologic reasons daily. who fail to gain or to maintain -A course of therapy of 2 to 4 weeks is normal weight, to offset the usually adequate. This may be repeated protein catabolism associated intermittently as indicated. with prolonged