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Drug overview for TESTOSTERONE-ANASTROZOLE (testosterone/anastrozole):
Generic name: TESTOSTERONE/ANASTROZOLE
Drug class: Androgens/Anabolic Steroids
Therapeutic class: Endocrine
Anastrozole, an aromatase inhibitor, is an antineoplastic agent. Testosterone, the principal endogenous androgen, is a naturally occurring androgenic anabolic steroid hormone.
Testosterone is used for replacement or substitution of diminished or absent endogenous testicular hormone caused by certain medical conditions. Diagnosis of hypogonadism must be confirmed by laboratory testing prior to initiation of testosterone therapy. (See Dosage and Administration.) The safety and efficacy of testosterone replacement therapy in men with low testosterone concentrations related to aging have not been established. (See Late-onset Hypogonadism under Uses: Uses in Males.)
Generic name: TESTOSTERONE/ANASTROZOLE
Drug class: Androgens/Anabolic Steroids
Therapeutic class: Endocrine
Anastrozole, an aromatase inhibitor, is an antineoplastic agent. Testosterone, the principal endogenous androgen, is a naturally occurring androgenic anabolic steroid hormone.
Testosterone is used for replacement or substitution of diminished or absent endogenous testicular hormone caused by certain medical conditions. Diagnosis of hypogonadism must be confirmed by laboratory testing prior to initiation of testosterone therapy. (See Dosage and Administration.) The safety and efficacy of testosterone replacement therapy in men with low testosterone concentrations related to aging have not been established. (See Late-onset Hypogonadism under Uses: Uses in Males.)
DRUG IMAGES
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The following indications for TESTOSTERONE-ANASTROZOLE (testosterone/anastrozole) have been approved by the FDA:
Indications:
None.
Professional Synonyms:
None.
Indications:
None.
Professional Synonyms:
None.
The following dosing information is available for TESTOSTERONE-ANASTROZOLE (testosterone/anastrozole):
Diagnosis of hypogonadism must be confirmed by laboratory testing prior to initiation of testosterone therapy. To confirm this diagnosis, serum testosterone concentrations should be measured in the morning on at least 2 separate days and must be consistently below the normal range. Serum testosterone concentrations may be low later in the day in men with or without hypogonadism; therefore, measuring testosterone concentrations later in the day should be avoided.
Dosage of testosterone is variable and should be individualized according to the condition being treated; the severity of symptoms; the patient's age, gender, and history of prior androgenic therapy; and the specific testosterone preparation being used.
Various dosage regimens have been used to induce pubertal changes in hypogonadal males. Some clinicians recommend that lower dosages be used initially, followed by gradual increases in dosage as puberty progresses; subsequently, the dosage may be decreased to maintenance levels. Other clinicians state that higher dosages are required initially to induce pubertal changes and lower dosages can then be used for maintenance therapy after puberty.
The chronologic and skeletal ages of the patient must be considered when determining the initial dosage and subsequent dosage adjustment.
For replacement of endogenous testicular hormone in androgen-deficient males, the usual dosage of testosterone pellets is 150-450 mg implanted subcutaneously every 3-6 months. Dosage adjustment should be made according to the patient's tolerance and therapeutic response.
For delayed puberty, the dosage of testosterone pellets is generally less than the dosage used for male hypogonadism and for a limited period of time (e.g., 4-6 months).
Transdermal testosterone (Androderm(R)) is commercially available as a system delivering 2 mg/24 hours or 4 mg/24 hours. Dosage should be adjusted according to determinations of serum testosterone concentrations.
When Androderm(R) is used for the treatment of male hypogonadism, the usual initial transdermal dosage is 4 mg once daily administered nightly as one system delivering 4 mg/24 hours. Dosage should be adjusted according to morning serum testosterone concentrations approximately 2 weeks following initiation of therapy. Depending on requirements, dosage can be increased to 6 mg once daily administered nightly as one system delivering 4 mg/24 hours plus one delivering 2 mg/24 hours or can be decreased to 2 mg once daily administered nightly as one system delivering 2 mg/24 hours.
Patients currently maintained on a transdermal dosage of 2.5 mg once daily may be switched to one system delivering 2 mg/24 hours at the next scheduled dose. Patients currently maintained on a transdermal dosage of 5 mg once daily may be switched to one system delivering 4 mg/24 hours at the next scheduled dose.
Patients currently maintained on a transdermal dosage of 7.5 mg once daily may be switched to 6 mg once daily with one system delivering 4 mg/24 hours plus one delivering 2 mg/24 hours.
Approximately 2 weeks after switching therapy, the early morning serum testosterone concentrations should be measured in patients following system application the previous evening to ensure proper dosing.
Topical testosterone is commercially available as a 1% gel in unit-dose packets containing a 25-mg dose of testosterone (2.5 g of gel) (AndroGel(R)) or a 50-mg dose of testosterone (5 g of gel) (AndroGel(R), Vogelxo(R)); as a 1.62% gel in unit-dose packets (AndroGel(R)) containing a 20.25- or 40.5-mg
dose of testosterone (1.25 or 2.5 g of gel, respectively); as a nonaerosol metered-dose pump (AndroGel(R) (each actuation of the pump delivers 1.25 g of gel containing 20.25 mg of testosterone after priming), Fortesta(R) (each actuation of the pump delivers 0.5 g of gel containing 10 mg of testosterone after priming), Vogelxo(R) (each actuation of the pump delivers 1.25 g of gel containing 12.5 mg of testosterone after priming)); or in unit-dose tubes (Testim(R), Vogelxo(R)) containing a 50-mg dose (5 g of gel).
For the treatment of male hypogonadism, the usual initial dosage of testosterone gel 1% (AndroGel(R) 1%, Testim(R), Vogelxo(R)) is the entire contents of a packet or tube containing 50 mg of testosterone, the entire contents of 2 packets containing 25 mg of testosterone, or 4 actuations of the pump (5 g of gel) applied topically once daily, preferably in the morning; this dose delivers about 5 mg of testosterone systemically. The usual initial dosage of testosterone gel 1.62% (AndroGel(R) 1.62%)
is the entire contents of a packet containing 40.5 mg of testosterone or 2 actuations of the pump (2.5 g of gel) applied topically once daily in the morning. The usual initial dosage of Fortesta(R) is 40 mg of testosterone or 4 actuations of the pump (2 g of gel) applied topically once daily in the morning.
Dosage should be adjusted according to serum testosterone concentrations obtained at regular intervals following initiation of AndroGel(R) 1% therapy, approximately 14 days after initiating daily application of Testim(R) or Vogelxo(R), approximately 14 and 28 days after initiating daily application or dosage adjustment of AndroGel 1.62%, and approximately 14 and 35 days after initiating daily application or dosage adjustment of Fortesta(R).
If serum testosterone concentrations are below the normal range in a patient receiving AndroGel(R) 1%, the dosage can be increased initially to 75 mg of testosterone (7.5 g of gel) and, if necessary, subsequently to 100 mg of testosterone (10 g of gel). If serum testosterone concentrations exceed the normal range in a patient receiving AndroGel(R) 1% therapy, the daily dosage may be decreased. AndroGel(R) 1% should be discontinued if the serum testosterone concentrations consistently exceed the normal range at a daily dosage of 50 mg of testosterone (5 g of gel).
If serum testosterone concentrations are below the normal range in a patient receiving Testim(R) or Vogelxo(R), the dosage can be increased to 100 mg of testosterone (10 g of gel, 8 actuations of the pump).
If serum testosterone concentrations exceed 750 ng/dL in a patient receiving AndroGel(R) 1.62%, the dosage should be decreased to 20.25 mg of testosterone (1.25 g of gel, 1 actuation of the pump).
If serum testosterone concentrations are below 350 ng/dL in a patient receiving AndroGel(R) 1.62%, the dosage should be increased initially to 60.75 mg of testosterone (3.75 g of gel, 3 actuations of the pump) and, if necessary, subsequently to 81 mg of testosterone (5 g of gel, 4 actuations of the pump).
In patients receiving Fortesta(R), the dosage should be decreased by 20 mg of testosterone (2 actuations of the pump) if serum testosterone concentrations reach or exceed 2500 ng/dL or by 10 mg of testosterone (1 actuation of the pump) if serum testosterone concentrations are 1250 ng/dL or greater, but less than 2500 ng/dL; however, if a 10-mg dosage of testosterone requires further reduction, Fortesta(R) should be discontinued. If serum testosterone concentrations are below 500 ng/dL in a patient receiving Fortesta(R), the dosage of testosterone can be adjusted in 10-mg increments (1 actuation of the pump); however, the daily dosage should not exceed 70 mg of testosterone (7 actuations of the pump).
Topical testosterone is commercially available as a solution in a metered-dose pump (Axiron(R); each actuation of the pump delivers 1.5 mL of solution containing 30 mg of testosterone after priming). For the treatment of male hypogonadism, the recommended initial dosage of testosterone solution is 60 mg (2 actuations of the pump) applied topically once daily.
Dosage should be adjusted according to serum testosterone concentrations obtained following initiation of therapy and at least 14 days after initiating daily application or dosage adjustment of testosterone solution. If serum testosterone concentrations exceed 1050 ng/dL in a patient receiving testosterone topical solution, the dosage should be decreased from 60 mg (2 actuations of the pump) to 30 mg (1 actuation of the pump); however, if a 30-mg dosage of testosterone requires further reduction, testosterone topical solution should be discontinued. If serum testosterone concentrations are below 300 ng/dL in a patient receiving testosterone topical solution, the dosage of testosterone can be adjusted in 30-mg increments (1 actuation of the pump); however, the daily dosage should not exceed 120 mg of testosterone (4 actuations of the pump).
When testosterone buccal (transmucosal) tablets (Striant(R)) are used for the treatment of male hypogonadism, the usual dosage is 30 mg (one extended-release tablet) twice daily, morning and evening (about 12 hours apart). Serum testosterone concentrations should be obtained just prior to the morning dose 4-12 weeks after initiation of therapy with testosterone buccal tablets. If total serum testosterone concentrations are consistently outside of the normal range, testosterone buccal tablets should be discontinued.
Intranasal testosterone is commercially available as a gel in a metered-dose nasal pump (Natesto(R); each actuation of the pump delivers 0.122 g of gel containing 5.5 mg of testosterone after priming).
For the treatment of male hypogonadism, the recommended initial dosage of testosterone nasal gel is 1 actuation of the pump per nostril for a total dosage of 11 mg 3 times daily. Dosage should be adjusted according to serum testosterone concentrations obtained at least 1 month after initiating therapy and periodically thereafter. If serum testosterone concentrations consistently exceed 1050 ng/dL, testosterone nasal gel should be discontinued.
If serum testosterone concentrations are consistently below 300 ng/dL, testosterone nasal gel should be discontinued and alternative therapy considered. If severe rhinitis occurs, testosterone nasal gel should be temporarily interrupted until resolution of symptoms; however, if severe rhinitis persists, testosterone nasal gel should be discontinued and alternative therapy considered.
The manufacturers of testosterone enanthate injection, testosterone undecanoate injection, and testosterone transdermal system, topical gel, topical solution, nasal gel, and buccal tablets state that clinical studies involving patients with renal or hepatic impairment have not been conducted. Therefore, there are no special population dosage recommendations at this time.
Dosage of testosterone is variable and should be individualized according to the condition being treated; the severity of symptoms; the patient's age, gender, and history of prior androgenic therapy; and the specific testosterone preparation being used.
Various dosage regimens have been used to induce pubertal changes in hypogonadal males. Some clinicians recommend that lower dosages be used initially, followed by gradual increases in dosage as puberty progresses; subsequently, the dosage may be decreased to maintenance levels. Other clinicians state that higher dosages are required initially to induce pubertal changes and lower dosages can then be used for maintenance therapy after puberty.
The chronologic and skeletal ages of the patient must be considered when determining the initial dosage and subsequent dosage adjustment.
For replacement of endogenous testicular hormone in androgen-deficient males, the usual dosage of testosterone pellets is 150-450 mg implanted subcutaneously every 3-6 months. Dosage adjustment should be made according to the patient's tolerance and therapeutic response.
For delayed puberty, the dosage of testosterone pellets is generally less than the dosage used for male hypogonadism and for a limited period of time (e.g., 4-6 months).
Transdermal testosterone (Androderm(R)) is commercially available as a system delivering 2 mg/24 hours or 4 mg/24 hours. Dosage should be adjusted according to determinations of serum testosterone concentrations.
When Androderm(R) is used for the treatment of male hypogonadism, the usual initial transdermal dosage is 4 mg once daily administered nightly as one system delivering 4 mg/24 hours. Dosage should be adjusted according to morning serum testosterone concentrations approximately 2 weeks following initiation of therapy. Depending on requirements, dosage can be increased to 6 mg once daily administered nightly as one system delivering 4 mg/24 hours plus one delivering 2 mg/24 hours or can be decreased to 2 mg once daily administered nightly as one system delivering 2 mg/24 hours.
Patients currently maintained on a transdermal dosage of 2.5 mg once daily may be switched to one system delivering 2 mg/24 hours at the next scheduled dose. Patients currently maintained on a transdermal dosage of 5 mg once daily may be switched to one system delivering 4 mg/24 hours at the next scheduled dose.
Patients currently maintained on a transdermal dosage of 7.5 mg once daily may be switched to 6 mg once daily with one system delivering 4 mg/24 hours plus one delivering 2 mg/24 hours.
Approximately 2 weeks after switching therapy, the early morning serum testosterone concentrations should be measured in patients following system application the previous evening to ensure proper dosing.
Topical testosterone is commercially available as a 1% gel in unit-dose packets containing a 25-mg dose of testosterone (2.5 g of gel) (AndroGel(R)) or a 50-mg dose of testosterone (5 g of gel) (AndroGel(R), Vogelxo(R)); as a 1.62% gel in unit-dose packets (AndroGel(R)) containing a 20.25- or 40.5-mg
dose of testosterone (1.25 or 2.5 g of gel, respectively); as a nonaerosol metered-dose pump (AndroGel(R) (each actuation of the pump delivers 1.25 g of gel containing 20.25 mg of testosterone after priming), Fortesta(R) (each actuation of the pump delivers 0.5 g of gel containing 10 mg of testosterone after priming), Vogelxo(R) (each actuation of the pump delivers 1.25 g of gel containing 12.5 mg of testosterone after priming)); or in unit-dose tubes (Testim(R), Vogelxo(R)) containing a 50-mg dose (5 g of gel).
For the treatment of male hypogonadism, the usual initial dosage of testosterone gel 1% (AndroGel(R) 1%, Testim(R), Vogelxo(R)) is the entire contents of a packet or tube containing 50 mg of testosterone, the entire contents of 2 packets containing 25 mg of testosterone, or 4 actuations of the pump (5 g of gel) applied topically once daily, preferably in the morning; this dose delivers about 5 mg of testosterone systemically. The usual initial dosage of testosterone gel 1.62% (AndroGel(R) 1.62%)
is the entire contents of a packet containing 40.5 mg of testosterone or 2 actuations of the pump (2.5 g of gel) applied topically once daily in the morning. The usual initial dosage of Fortesta(R) is 40 mg of testosterone or 4 actuations of the pump (2 g of gel) applied topically once daily in the morning.
Dosage should be adjusted according to serum testosterone concentrations obtained at regular intervals following initiation of AndroGel(R) 1% therapy, approximately 14 days after initiating daily application of Testim(R) or Vogelxo(R), approximately 14 and 28 days after initiating daily application or dosage adjustment of AndroGel 1.62%, and approximately 14 and 35 days after initiating daily application or dosage adjustment of Fortesta(R).
If serum testosterone concentrations are below the normal range in a patient receiving AndroGel(R) 1%, the dosage can be increased initially to 75 mg of testosterone (7.5 g of gel) and, if necessary, subsequently to 100 mg of testosterone (10 g of gel). If serum testosterone concentrations exceed the normal range in a patient receiving AndroGel(R) 1% therapy, the daily dosage may be decreased. AndroGel(R) 1% should be discontinued if the serum testosterone concentrations consistently exceed the normal range at a daily dosage of 50 mg of testosterone (5 g of gel).
If serum testosterone concentrations are below the normal range in a patient receiving Testim(R) or Vogelxo(R), the dosage can be increased to 100 mg of testosterone (10 g of gel, 8 actuations of the pump).
If serum testosterone concentrations exceed 750 ng/dL in a patient receiving AndroGel(R) 1.62%, the dosage should be decreased to 20.25 mg of testosterone (1.25 g of gel, 1 actuation of the pump).
If serum testosterone concentrations are below 350 ng/dL in a patient receiving AndroGel(R) 1.62%, the dosage should be increased initially to 60.75 mg of testosterone (3.75 g of gel, 3 actuations of the pump) and, if necessary, subsequently to 81 mg of testosterone (5 g of gel, 4 actuations of the pump).
In patients receiving Fortesta(R), the dosage should be decreased by 20 mg of testosterone (2 actuations of the pump) if serum testosterone concentrations reach or exceed 2500 ng/dL or by 10 mg of testosterone (1 actuation of the pump) if serum testosterone concentrations are 1250 ng/dL or greater, but less than 2500 ng/dL; however, if a 10-mg dosage of testosterone requires further reduction, Fortesta(R) should be discontinued. If serum testosterone concentrations are below 500 ng/dL in a patient receiving Fortesta(R), the dosage of testosterone can be adjusted in 10-mg increments (1 actuation of the pump); however, the daily dosage should not exceed 70 mg of testosterone (7 actuations of the pump).
Topical testosterone is commercially available as a solution in a metered-dose pump (Axiron(R); each actuation of the pump delivers 1.5 mL of solution containing 30 mg of testosterone after priming). For the treatment of male hypogonadism, the recommended initial dosage of testosterone solution is 60 mg (2 actuations of the pump) applied topically once daily.
Dosage should be adjusted according to serum testosterone concentrations obtained following initiation of therapy and at least 14 days after initiating daily application or dosage adjustment of testosterone solution. If serum testosterone concentrations exceed 1050 ng/dL in a patient receiving testosterone topical solution, the dosage should be decreased from 60 mg (2 actuations of the pump) to 30 mg (1 actuation of the pump); however, if a 30-mg dosage of testosterone requires further reduction, testosterone topical solution should be discontinued. If serum testosterone concentrations are below 300 ng/dL in a patient receiving testosterone topical solution, the dosage of testosterone can be adjusted in 30-mg increments (1 actuation of the pump); however, the daily dosage should not exceed 120 mg of testosterone (4 actuations of the pump).
When testosterone buccal (transmucosal) tablets (Striant(R)) are used for the treatment of male hypogonadism, the usual dosage is 30 mg (one extended-release tablet) twice daily, morning and evening (about 12 hours apart). Serum testosterone concentrations should be obtained just prior to the morning dose 4-12 weeks after initiation of therapy with testosterone buccal tablets. If total serum testosterone concentrations are consistently outside of the normal range, testosterone buccal tablets should be discontinued.
Intranasal testosterone is commercially available as a gel in a metered-dose nasal pump (Natesto(R); each actuation of the pump delivers 0.122 g of gel containing 5.5 mg of testosterone after priming).
For the treatment of male hypogonadism, the recommended initial dosage of testosterone nasal gel is 1 actuation of the pump per nostril for a total dosage of 11 mg 3 times daily. Dosage should be adjusted according to serum testosterone concentrations obtained at least 1 month after initiating therapy and periodically thereafter. If serum testosterone concentrations consistently exceed 1050 ng/dL, testosterone nasal gel should be discontinued.
If serum testosterone concentrations are consistently below 300 ng/dL, testosterone nasal gel should be discontinued and alternative therapy considered. If severe rhinitis occurs, testosterone nasal gel should be temporarily interrupted until resolution of symptoms; however, if severe rhinitis persists, testosterone nasal gel should be discontinued and alternative therapy considered.
The manufacturers of testosterone enanthate injection, testosterone undecanoate injection, and testosterone transdermal system, topical gel, topical solution, nasal gel, and buccal tablets state that clinical studies involving patients with renal or hepatic impairment have not been conducted. Therefore, there are no special population dosage recommendations at this time.
Testosterone is administered by IM injection; percutaneously by topical application of a transdermal system, solution, or gel to the skin; intranasally; subcutaneously as a biodegradable implant; and intrabuccally (transmucosally) as a buccal tablet. Anastrozole is administered orally. Food does not affect the absorption of anastrozole, and the drug may be administered without regard to meals. Commercially available anastrozole tablets should be stored at a controlled room temperature of 20-25degreesC.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for TESTOSTERONE-ANASTROZOLE (testosterone/anastrozole):
There are 2 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Anastrozole; Letrozole/Tamoxifen SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Tamoxifen may induce the metabolism of anastrozole(1) and letrozole(2) by induction of CYP3A4. CLINICAL EFFECTS: Concurrent use of tamoxifen may result in decreased plasma levels and effectiveness of anastrozole(1,3) and letrozole.(2,3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturers of anastrozole(1) and tamoxifen(3) state that these agents should not be coadministered. The manufacturer of letrozole does not recommend concurrent therapy with tamoxifen(4) and the manufacturer of tamoxifen states they should not be used concurrently.(3) Patients may benefit more from sequential therapy, rather than concurrent therapy.(2,5) DISCUSSION: Based on clinical and pharmacokinetic data from the ATAC trial, tamoxifen should not be administered with anastrozole. Concurrent use decreased anastrozole plasma levels by 27%. The combination had no efficacy benefit when compared to tamoxifen administration alone. Tamoxifen pharmacokinetics were not affected.(1,3) A study in 12 subjects examined the concurrent administration of tamoxifen and letrozole for six weeks. Concurrent use decreased the mean concentration of letrozole by 37.6%.(3,4) Although suppression of estradiol, estrone, and estrone sulfate were not effected, the authors speculated that patients may not receive the full benefit of combination therapy.(4) A study in 23 patients found that letrozole had no effect on tamoxifen levels. However, the antitumor effects of combination therapy were less than expected.(6) The therapeutic effect of letrozole is not affected if letrozole is administered immediately after tamoxifen.(5) |
SOLTAMOX, TAMOXIFEN CITRATE |
| Selected Anti-Aromatase Agents/Estrogens SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Aromatase inhibitors(1-6) and inactivators(7-10) treat breast cancer by inhibiting estrogen synthesis therefore lowering serum estrone and estradiol levels. In postmenopausal women, androgens are metabolized to estrogens via the primary pathway of the aromatase enzyme. CLINICAL EFFECTS: Concurrent administration of estrogen may decrease the effectiveness of aromatase inhibitors.(1-6) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The Canadian,(1) UK,(2) and US(3) manufacturers of anastrozole state that estrogen containing therapies should not be used during anastrozole therapy. The Australian,(7) Canadian,(8) UK,(9) and US(10) manufacturers of exemestane state that exemestane should not be administered with estrogen containing therapies. The Canadian(4) and UK(5) manufacturer of letrozole state that estrogen containing therapies should be avoided during letrozole therapy. DISCUSSION: Many breast cancers have estrogen receptors and their growth can be stimulated by estrogen. Anastrozole is a potent and selective non-steroidal aromatase inhibitor that lowers serum estradiol levels. Concurrent use of estrogen may diminish the effects of anastrozole.(1-3) Exemestane is a steroidal aromatase inactivator that lowers serum estradiol levels. Concurrent use of estrogen may diminish the effects of exemestane.(7-10) |
2-METHOXYESTRADIOL, ACTIVELLA, AFIRMELLE, ALTAVERA, ALYACEN, AMETHIA, AMETHYST, ANGELIQ, ANNOVERA, APRI, ARANELLE, ASHLYNA, AUBRA, AUBRA EQ, AUROVELA, AUROVELA 24 FE, AUROVELA FE, AVIANE, AYUNA, AZURETTE, BALCOLTRA, BALZIVA, BEYAZ, BIJUVA, BLISOVI 24 FE, BLISOVI FE, BRIELLYN, CAMRESE, CAMRESE LO, CAZIANT, CHARLOTTE 24 FE, CHATEAL EQ, CLIMARA, CLIMARA PRO, COMBIPATCH, COVARYX, COVARYX H.S., CRYSELLE, CYRED, CYRED EQ, DASETTA, DAYSEE, DELESTROGEN, DEPO-ESTRADIOL, DESOGESTR-ETH ESTRAD ETH ESTRA, DIETHYLSTILBESTROL, DIVIGEL, DOLISHALE, DOTTI, DROSPIRENONE-ETH ESTRA-LEVOMEF, DROSPIRENONE-ETHINYL ESTRADIOL, DUAVEE, EEMT, EEMT H.S., ELESTRIN, ELINEST, ELURYNG, ENILLORING, ENPRESSE, ENSKYCE, ESTARYLLA, ESTRACE, ESTRADIOL, ESTRADIOL (ONCE WEEKLY), ESTRADIOL (TWICE WEEKLY), ESTRADIOL BENZOATE, ESTRADIOL CYPIONATE, ESTRADIOL HEMIHYDRATE, ESTRADIOL HEMIHYDRATE MICRO, ESTRADIOL MICRONIZED, ESTRADIOL VALERATE, ESTRADIOL-NORETHINDRONE ACETAT, ESTRATEST F.S., ESTRATEST H.S., ESTRING, ESTRIOL, ESTRIOL MICRONIZED, ESTROGEL, ESTROGEN-METHYLTESTOSTERONE, ESTRONE, ETHINYL ESTRADIOL, ETHYNODIOL-ETHINYL ESTRADIOL, ETONOGESTREL-ETHINYL ESTRADIOL, EVAMIST, FALMINA, FEIRZA, FEMLYV, FEMRING, FINZALA, FYAVOLV, GEMMILY, HAILEY, HAILEY 24 FE, HAILEY FE, HALOETTE, ICLEVIA, IMVEXXY, ISIBLOOM, JAIMIESS, JASMIEL, JINTELI, JOLESSA, JOYEAUX, JULEBER, JUNEL, JUNEL FE, JUNEL FE 24, KAITLIB FE, KALLIGA, KARIVA, KELNOR 1-35, KELNOR 1-50, KURVELO, LARIN, LARIN 24 FE, LARIN FE, LAYOLIS FE, LEENA, LESSINA, LEVONEST, LEVONORG-ETH ESTRAD ETH ESTRAD, LEVONORG-ETH ESTRAD-FE BISGLYC, LEVONORGESTREL-ETH ESTRADIOL, LEVORA-28, LO LOESTRIN FE, LO-ZUMANDIMINE, LOESTRIN, LOESTRIN FE, LOJAIMIESS, LORYNA, LOW-OGESTREL, LUTERA, LYLLANA, MARLISSA, MENEST, MENOSTAR, MERZEE, MIBELAS 24 FE, MICROGESTIN, MICROGESTIN FE, MILI, MIMVEY, MINIVELLE, MINZOYA, MONO-LINYAH, MYFEMBREE, NATAZIA, NECON, NEXTSTELLIS, NIKKI, NORELGESTROMIN-ETH ESTRADIOL, NORETHIN-ETH ESTRA-FERROUS FUM, NORETHINDRON-ETHINYL ESTRADIOL, NORETHINDRONE-E.ESTRADIOL-IRON, NORGESTIMATE-ETHINYL ESTRADIOL, NORTREL, NUVARING, NYLIA, OCELLA, ORIAHNN, ORTHO TRI-CYCLEN, ORTHO-NOVUM, PHILITH, PIMTREA, PORTIA, PREMARIN, PREMPHASE, PREMPRO, RECLIPSEN, RIVELSA, SAFYRAL, SETLAKIN, SIMLIYA, SIMPESSE, SPRINTEC, SRONYX, SYEDA, TARINA 24 FE, TARINA FE, TARINA FE 1-20 EQ, TAYTULLA, TILIA FE, TRI-ESTARYLLA, TRI-LEGEST FE, TRI-LINYAH, TRI-LO-ESTARYLLA, TRI-LO-MARZIA, TRI-LO-MILI, TRI-LO-SPRINTEC, TRI-MILI, TRI-SPRINTEC, TRI-VYLIBRA, TRI-VYLIBRA LO, TRIVORA-28, TURQOZ, TWIRLA, TYBLUME, VAGIFEM, VALTYA, VELIVET, VESTURA, VIENVA, VIORELE, VIVELLE-DOT, VOLNEA, VYFEMLA, VYLIBRA, WERA, WYMZYA FE, XARAH FE, XELRIA FE, XULANE, YASMIN 28, YAZ, YUVAFEM, ZAFEMY, ZARAH, ZOVIA 1-35, ZUMANDIMINE |
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Deferiprone/Selected Myelosuppressive Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis may increase the frequency or risk for severe toxicity.(1) CLINICAL EFFECTS: Concurrent use of deferiprone and myelosuppressive agents may result in severe neutropenia or agranulocytosis, which may be fatal. PREDISPOSING FACTORS: Agranulocytosis may be less common in patients receiving deferiprone for thalassemia, and more common in patients treated for other systemic iron overload conditions (e.g. myelodysplastic syndromes, sickle cell disease).(2,3) Inadequate monitoring appears to increase the risk for severe outcomes. Manufacturer post market surveillance found that in all fatal cases of agranulocytosis reported between 1999 and 2005, data on weekly white blood count (WBC) monitoring was missing. In three fatal cases, deferiprone was continued for two to seven days after the detection of neutropenia or agranulocytosis.(2) PATIENT MANAGEMENT: If possible, discontinue one of the drugs associated with risk for neutropenia or agranulocytosis. If alternative therapy is not available, documentation and adherence to the deferiprone monitoring protocol is essential. Baseline absolute neutrophil count (ANC) must be at least 1,500/uL prior to starting deferiprone. Monitor ANC weekly during therapy. If infection develops, interrupt deferiprone therapy and monitor ANC more frequently. If ANC is less than 1,500/uL but greater than 500/uL, discontinue deferiprone and any other drugs possibly associated with neutropenia. Initiate ANC and platelet counts daily until recovery (i.e. ANC at least 1,500/uL). If ANC is less than 500/uL, discontinue deferiprone, evaluate patient and hospitalize if appropriate. Do not resume deferiprone unless potential benefits outweigh potential risks.(1) DISCUSSION: Drugs linked to this monograph have an FDA Boxed Warning for risk of neutropenia, agranulocytosis, or pancytopenia, or have > 5% risk for neutropenia and/or warnings describing risk for myelosuppression in manufacturer prescribing information.(1-25) In pooled clinical studies submitted to the FDA, 6.1% of deferiprone patients met criteria for neutropenia and 1.7% of patients developed agranulocytosis.(1) The time to onset of agranulocytosis was highly variable with a range of 65 days to 9.2 years (median, 161 days).(3) |
DEFERIPRONE, DEFERIPRONE (3 TIMES A DAY), FERRIPROX, FERRIPROX (2 TIMES A DAY), FERRIPROX (3 TIMES A DAY) |
| Clozapine/Selected Myelosuppressive Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Clozapine and other myelosuppressive agents may be associated with neutropenia or agranulocytosis.(2) CLINICAL EFFECTS: Moderate neutropenia, even if due to combination therapy, may require abrupt discontinuation of clozapine resulting in decompensation of the patient's psychiatric disorder (e.g. schizophrenia). The disease treated by the myelosuppressive agent may be compromised if myelosuppression requires dose reduction, delay, or discontinuation of the myelosuppressive agent. Undetected severe neutropenia or agranulocytosis may be fatal. PREDISPOSING FACTORS: Low white blood counts prior to initiation of the myelosuppressive agent may increase risk for clinically significant neutropenia. PATIENT MANAGEMENT: If a patient stabilized on clozapine therapy requires treatment with a myelosuppressive agent, the clozapine prescriber should consult with prescriber of the myelosuppressive agent (e.g. oncologist) to discuss treatment and monitoring options.(2) More frequent ANC monitoring or treatment alternatives secondary to neutropenic episodes may need to be considered. Clozapine is only available through a restricted distribution system which requires documentation of the absolute neutrophil count (ANC) prior to dispensing.(1-2) For most clozapine patients, clozapine treatment must be interrupted for a suspected clozapine-induced ANC < 1000 cells/microliter. For patients with benign ethnic neutropenia (BEN), treatment must be interrupted for suspected clozapine-induced neutropenia < 500 cells/microliter.(2) DISCUSSION: Clozapine is only available through a restricted distribution system which requires documentation of the ANC prior to dispensing.(1) Agents linked to this interaction generally have > 5% risk for neutropenia and/or warnings describing risk for myelosuppression in manufacturer prescribing information.(3-26) |
CLOZAPINE, CLOZAPINE ODT, CLOZARIL, VERSACLOZ |
There are 0 moderate interactions.
The following contraindication information is available for TESTOSTERONE-ANASTROZOLE (testosterone/anastrozole):
Drug contraindication overview.
* Known hypersensitivity to anastrozole or any ingredient in the formulation.
* Known hypersensitivity to anastrozole or any ingredient in the formulation.
There are 4 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
| Malignant tumor of male breast |
| Pregnancy |
| Prostatic carcinoma |
There are 11 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Acute myocardial infarction |
| Acutely decompensated chronic heart failure |
| Benign prostatic hyperplasia |
| Cerebrovascular accident |
| Erythrocytosis |
| Hyperlipidemia |
| Myocardial ischemia |
| Polycythemia vera |
| Pregnancy |
| Pulmonary thromboembolism |
| Venous thrombosis |
There are 13 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Chronic heart failure |
| Chronic obstructive pulmonary disease |
| Diabetes mellitus |
| Disease of liver |
| Edema |
| Gynecomastia |
| Humoral hypercalcemia of malignancy |
| Hypercholesterolemia |
| Hypertension |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
| Obesity |
| Osteopenia |
| Sleep apnea |
The following adverse reaction information is available for TESTOSTERONE-ANASTROZOLE (testosterone/anastrozole):
Adverse reaction overview.
In the early breast cancer study (ATAC), the most common adverse effects (occurring in 10% or more of patients) included hot flashes, asthenia, arthritis, pain, arthralgia, pharyngitis, hypertension, depression, nausea, vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, peripheral edema, and lymphedema. In advanced breast cancer studies, the most common adverse effects (occurring in 10% or more of patients) included hot flashes, nausea, asthenia, pain, headache, back pain, bone pain, increased cough, dyspnea, pharyngitis, and peripheral edema.
In the early breast cancer study (ATAC), the most common adverse effects (occurring in 10% or more of patients) included hot flashes, asthenia, arthritis, pain, arthralgia, pharyngitis, hypertension, depression, nausea, vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, peripheral edema, and lymphedema. In advanced breast cancer studies, the most common adverse effects (occurring in 10% or more of patients) included hot flashes, nausea, asthenia, pain, headache, back pain, bone pain, increased cough, dyspnea, pharyngitis, and peripheral edema.
There are 35 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Amenorrhea Bladder irritability Irregular menstrual periods Priapism Urinary tract infection Virilism |
Benign prostatic hyperplasia Dizziness Edema Epididymitis Fatigue Flushing Hypercalcemia Hypertension Nausea Prostatic carcinoma Raised prostate specific antigen Sleep apnea Vomiting |
| Rare/Very Rare |
|---|
|
Acute myocardial infarction Acute respiratory distress syndrome Cerebrovascular accident Cholestatic hepatitis Deep venous thrombosis Drug-induced hepatitis Erythrocytosis Heart failure Hepatic necrosis Jaundice Leukopenia Malignant neoplasm of liver Peliosis hepatis Pulmonary thromboembolism Suicidal ideation Venous thrombosis |
There are 20 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Gynecomastia Mastalgia |
Abdominal pain with cramps Acne vulgaris Diarrhea Erectile dysfunction Headache disorder Increased pubic hair Injection site infection Injection site sequelae Insomnia Libido changes Testicular atrophy |
| Rare/Very Rare |
|---|
|
Aggressive behavior Anorexia Depression Hostility Hypercholesterolemia Irritability Oligospermia |
The following precautions are available for TESTOSTERONE-ANASTROZOLE (testosterone/anastrozole):
Efficacy of anastrozole for the treatment of pubertal gynecomastia+ in adolescent males and for the treatment of progressive precocious puberty associated with McCune-Albright syndrome+ in girls has not been established. Results of a randomized, double-blind, placebo-controlled trial in 80 adolescent males 11-18 years of age with pubertal gynecomastia failed to establish efficacy of anastrozole (1 mg daily for 6 months) in reducing gynecomastia or relieving breast pain. Serum estradiol concentrations were reduced by 15.4
or 4.5% in patients receiving anastrozole or placebo, respectively. Patients receiving anastrozole were more likely to experience treatment-related adverse effects (16.3 versus 8.1%), and the difference was related mainly to higher rates of acne and headache in those receiving anastrozole.
One patient discontinued anastrozole therapy because of testicular enlargement. Results of a noncomparative open-label trial of anastrozole (1 mg daily for 12 months) in 28 girls (2 to less than 10 years of age) with McCune-Albright syndrome and progressive precocious puberty showed no reduction from baseline in the frequency of vaginal bleeding days or in the rate of increase in bone age and no clinically important changes in Tanner staging, mean ovarian or uterine volume, or mean predicted adult height. A small reduction in growth rate was observed; however, because the study was uncontrolled, it is unclear whether this effect was related to anastrozole or to other confounding factors (e.g., variations in endogenous estrogen levels commonly observed in patients with McCune-Albright syndrome).
Adverse effects (i.e., nausea, acne, extremity pain, increased aminotransferase concentrations, allergic dermatitis) were reported in 18% of patients. Pharmacokinetics of anastrozole were similar in adolescent males with pubertal gynecomastia and in girls with McCune-Albright syndrome, and the elimination half-life in these pediatric populations (about 47 hours) was similar to that observed in postmenopausal women with breast cancer.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
or 4.5% in patients receiving anastrozole or placebo, respectively. Patients receiving anastrozole were more likely to experience treatment-related adverse effects (16.3 versus 8.1%), and the difference was related mainly to higher rates of acne and headache in those receiving anastrozole.
One patient discontinued anastrozole therapy because of testicular enlargement. Results of a noncomparative open-label trial of anastrozole (1 mg daily for 12 months) in 28 girls (2 to less than 10 years of age) with McCune-Albright syndrome and progressive precocious puberty showed no reduction from baseline in the frequency of vaginal bleeding days or in the rate of increase in bone age and no clinically important changes in Tanner staging, mean ovarian or uterine volume, or mean predicted adult height. A small reduction in growth rate was observed; however, because the study was uncontrolled, it is unclear whether this effect was related to anastrozole or to other confounding factors (e.g., variations in endogenous estrogen levels commonly observed in patients with McCune-Albright syndrome).
Adverse effects (i.e., nausea, acne, extremity pain, increased aminotransferase concentrations, allergic dermatitis) were reported in 18% of patients. Pharmacokinetics of anastrozole were similar in adolescent males with pubertal gynecomastia and in girls with McCune-Albright syndrome, and the elimination half-life in these pediatric populations (about 47 hours) was similar to that observed in postmenopausal women with breast cancer.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Anastrozole may cause fetal harm; the drug has been shown to be embryotoxic, fetotoxic, and abortifacient in animals. The manufacturer states that a pregnancy test should be performed prior to initiation of anastrozole therapy in females of reproductive potential and that such women should be advised to use effective contraceptive methods while receiving the drug and for at least 3 weeks after discontinuance of therapy. If the drug is administered during pregnancy or if the patient becomes pregnant while receiving the drug, the patient should be informed of the potential hazard to the fetus and the potential risk for loss of the pregnancy.
Adequate, well-controlled studies of anastrozole in pregnant women have not been conducted. Anastrozole has been shown to cross the placenta in rats and rabbits receiving oral doses of 0.1 mg/kg (approximately 1 and 1.9 times the recommended human dose, respectively, on a mg/m2 basis).
Increased pregnancy loss (increased preimplantation and/or postimplantation loss, increased resorption, and decreased numbers of live fetuses) was demonstrated in rats and rabbits receiving anastrozole dosages equal to or exceeding 0.1 and 0.02 mg/kg daily, respectively (about one and one-third times the recommended human dosage, respectively, on a mg/m2 basis), during the period of organogenesis; in rats, this effect was dose-related.
In rats receiving dosages equal to or exceeding 0.1 mg/kg daily, placental weights were increased. In rats, anastrozole dosages of 1 mg/kg daily (which produced steady-state peak plasma anastrozole concentrations and AUC0-24h values that were 19 and 9 times higher, respectively, than those observed in healthy postmenopausal women receiving the recommended dose) resulted in fetotoxicity, including delayed fetal development (i.e., incomplete ossification and depressed fetal body weights).
In rats, no evidence of teratogenicity was observed at dosages of up to 1 mg/kg daily. In rabbits, anastrozole dosages equal to or exceeding 1 mg/kg daily (about 16 times the recommended human dosage on a mg/m2 basis) caused pregnancy failure. No evidence of teratogenicity was observed in rabbits receiving anastrozole 0.2
mg/kg daily (about 3 times the recommended human dosage on a mg/m2 basis). Testosterone may cause fetal harm when administered to pregnant women due to the potential for virilization of a female fetus. Androgenic effects including clitoral hypertrophy, labial fusion of the external genital fold to form a scrotal-like structure, abnormal vaginal development, and persistence of a urogenital sinus have occurred in the female offspring of women who were given androgens during pregnancy.
The degree of masculinization is related to the amount of drug given to the woman and the age of the fetus; masculinization is most likely to occur in a female fetus when exposure to androgens occurs during the first trimester. Since the risks clearly outweigh the possible benefits in women who are or may become pregnant, testosterone is contraindicated in such women. Women who become pregnant while receiving the drug should be informed of the potential hazard to the fetus.
Pregnant women or those who may become pregnant should be aware of the possibility that testosterone could be transferred from patients treated with topical preparations of the drug such as their sexual partners or other individuals in close physical contact. (See Cautions: Precautions and Contraindications.) Testosterone transdermal system (Androderm(R)) has an occlusive backing that prevents the partner from coming in contact with active ingredient in the system. Transdermal systems that inadvertently are transferred to a sexual partner should be removed immediately and the contacted skin washed.
Pregnant women should avoid skin contact with testosterone topical gel application sites in men. (See Cautions: Precautions and Contraindications.) If unwashed or unclothed skin to which testosterone topical gel has been applied comes in direct contact with the skin of a pregnant woman, the general area of contact by the woman should be washed with soap and water immediately. In vitro studies show that residual testosterone is removed by such washing.
Adequate, well-controlled studies of anastrozole in pregnant women have not been conducted. Anastrozole has been shown to cross the placenta in rats and rabbits receiving oral doses of 0.1 mg/kg (approximately 1 and 1.9 times the recommended human dose, respectively, on a mg/m2 basis).
Increased pregnancy loss (increased preimplantation and/or postimplantation loss, increased resorption, and decreased numbers of live fetuses) was demonstrated in rats and rabbits receiving anastrozole dosages equal to or exceeding 0.1 and 0.02 mg/kg daily, respectively (about one and one-third times the recommended human dosage, respectively, on a mg/m2 basis), during the period of organogenesis; in rats, this effect was dose-related.
In rats receiving dosages equal to or exceeding 0.1 mg/kg daily, placental weights were increased. In rats, anastrozole dosages of 1 mg/kg daily (which produced steady-state peak plasma anastrozole concentrations and AUC0-24h values that were 19 and 9 times higher, respectively, than those observed in healthy postmenopausal women receiving the recommended dose) resulted in fetotoxicity, including delayed fetal development (i.e., incomplete ossification and depressed fetal body weights).
In rats, no evidence of teratogenicity was observed at dosages of up to 1 mg/kg daily. In rabbits, anastrozole dosages equal to or exceeding 1 mg/kg daily (about 16 times the recommended human dosage on a mg/m2 basis) caused pregnancy failure. No evidence of teratogenicity was observed in rabbits receiving anastrozole 0.2
mg/kg daily (about 3 times the recommended human dosage on a mg/m2 basis). Testosterone may cause fetal harm when administered to pregnant women due to the potential for virilization of a female fetus. Androgenic effects including clitoral hypertrophy, labial fusion of the external genital fold to form a scrotal-like structure, abnormal vaginal development, and persistence of a urogenital sinus have occurred in the female offspring of women who were given androgens during pregnancy.
The degree of masculinization is related to the amount of drug given to the woman and the age of the fetus; masculinization is most likely to occur in a female fetus when exposure to androgens occurs during the first trimester. Since the risks clearly outweigh the possible benefits in women who are or may become pregnant, testosterone is contraindicated in such women. Women who become pregnant while receiving the drug should be informed of the potential hazard to the fetus.
Pregnant women or those who may become pregnant should be aware of the possibility that testosterone could be transferred from patients treated with topical preparations of the drug such as their sexual partners or other individuals in close physical contact. (See Cautions: Precautions and Contraindications.) Testosterone transdermal system (Androderm(R)) has an occlusive backing that prevents the partner from coming in contact with active ingredient in the system. Transdermal systems that inadvertently are transferred to a sexual partner should be removed immediately and the contacted skin washed.
Pregnant women should avoid skin contact with testosterone topical gel application sites in men. (See Cautions: Precautions and Contraindications.) If unwashed or unclothed skin to which testosterone topical gel has been applied comes in direct contact with the skin of a pregnant woman, the general area of contact by the woman should be washed with soap and water immediately. In vitro studies show that residual testosterone is removed by such washing.
It is not known whether anastrozole or its metabolites are distributed into human milk or if the drug has any effect on nursing infants or on milk production. Because many drugs are distributed into milk and because tumorigenic effects of anastrozole have been observed in animals and anastrozole has the potential to cause serious adverse reactions in nursing infants, women should be advised to discontinue breast-feeding during anastrozole therapy and for 2 weeks after discontinuance of the drug. It is not known whether testosterone is distributed into milk.
The manufacturers of testosterone enanthate injection (Delatestryl(R)) and testosterone pellets (Testopel(R)) state that because of the potential for serious adverse reactions to androgens in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman. The manufacturer of testosterone cypionate injection (Depo(R)-testosterone) states that use in nursing women is not recommended. Testosterone topical gel, topical solution, nasal gel, transdermal system, and buccal tablets and testosterone undecanoate injection (Aveed(R)) are not indicated for use in women.
Testosterone topical gel, topical solution, nasal gel, and buccal tablets and testosterone undecanoate injection also are contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. Exposure of a female nursing infant to androgens may result in varying degrees of virilization. Testosterone and other androgens also may adversely affect lactation.
The manufacturers of testosterone enanthate injection (Delatestryl(R)) and testosterone pellets (Testopel(R)) state that because of the potential for serious adverse reactions to androgens in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman. The manufacturer of testosterone cypionate injection (Depo(R)-testosterone) states that use in nursing women is not recommended. Testosterone topical gel, topical solution, nasal gel, transdermal system, and buccal tablets and testosterone undecanoate injection (Aveed(R)) are not indicated for use in women.
Testosterone topical gel, topical solution, nasal gel, and buccal tablets and testosterone undecanoate injection also are contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. Exposure of a female nursing infant to androgens may result in varying degrees of virilization. Testosterone and other androgens also may adversely affect lactation.
Among patients receiving anastrozole as adjuvant therapy for early-stage breast cancer in the ATAC trial, 45% were 65 years of age or older. Subgroup analysis showed that anastrozole did not provide the same benefit for disease-free survival in women 65 years of age or older (hazard ratio of 0.93 with a 95% confidence interval of 0.8-1.08) that it provided in postmenopausal women younger than 65 years of age (hazard ratio of 0.79 with a 95% confidence interval of 0.67-0.94). Among patients receiving anastrozole as first-line or second-line therapy in clinical trials, about 50% were 65 years of age or older. No difference in efficacy was observed for geriatric patients (65 years or older) compared with younger patients receiving anastrozole as second-line therapy for advanced breast cancer; moderately greater efficacy was observed for geriatric patients (65 years or older) receiving either anastrozole or tamoxifen as first-line therapy for advanced breast cancer.
The following prioritized warning is available for TESTOSTERONE-ANASTROZOLE (testosterone/anastrozole):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for TESTOSTERONE-ANASTROZOLE (testosterone/anastrozole)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
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