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Generic Name
Cypionate
Brand Names
Azmiro, Depo-Estradiol, Depo-Testosterone
FDA approval date: July 25, 1979
Classification: Androgen
Form: Injection, Kit
What is Azmiro (Cypionate)?
AZMIRO is indicated for testosterone replacement therapy in males in conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism : testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchiectomy, Klinefelter’s syndrome, or toxic damage from alcohol or heavy metals, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone , luteinizing hormone ) above the normal range [ see Dosage and Administration.
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Brand Information
AZMIRO (TESTOSTERONE CYPIONATE)
1INDICATIONS & USAGE
AZMIRO is indicated for testosterone replacement therapy in males in conditions associated with a deficiency or absence of endogenous testosterone:
2DOSAGE FORMS & STRENGTHS
Injection:
3CONTRAINDICATIONS
AZMIRO is contraindicated in:
4ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed elsewhere in the labeling:
4.1Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Cardiovascular Outcomes
TRAVERSE was a randomized, double-blind, cardiovascular outcomes study to assess the cardiovascular (CV) safety of topical testosterone gel compared to placebo in 5198 hypogonadal men aged 45 to 80 years with a history of CV disease or with multiple CV risk factors. The primary outcome was the incidence of the composite endpoint of major adverse cardiovascular events (MACE), consisting of CV death, non-fatal myocardial infarction (MI), and non-fatal stroke The mean duration of therapy was approximately 22 months. The mean duration of follow-up was 33 months. Approximately 61% of all patients discontinued topical testosterone gel or placebo therapy.
The mean patient age (±SD) was 63.3 (7.9) years, with 2452 patients aged 65 years or more (47%); 2847 (about 55%) patients had pre-existing cardiovascular disease, whereas 2357 patients (about 45%) had an elevated cardiovascular risk at baseline, and mean BMI was 35 kg/m2. Approximately 80% of patients were White, 17% were Black, and 3% were of other races or ethnic groups. Approximately 69%, 84%, and 93% had diabetes mellitus, hyperlipidemia, and hypertension, respectively.
The mean serum testosterone concentration at baseline in patients receiving topical testosterone gel was 220.4 ng/dL (n=2596). The mean serum testosterone concentrations at 12 months, 24 months, 36 months, and 48 months in patients receiving topical testosterone gel were 440.5 ng/dL (n=1683), 420.9 ng/dl (n=1125), 428.7 ng/dL (n=731), and 365.2 ng/dL (n=220), respectively.
For patients treated with topical testosterone gel, the incidence of MACE was 7.0% (n=182 events) and for those receiving placebo, the incidence of MACE was 7.3% (n=190 events). The study demonstrated non-inferiority of topical testosterone gel versus placebo because the upper bound of 95% CI was less than the pre-specified risk margin, of 1.5 for MACE (Hazard Ratio 0.96 [95% CI: 0.78, 1.17]).
Additional Adverse Reactions Reported in TRAVERSE
Additional adverse reactions reported in TRAVERSE at an incidence rate >2% in either treatment group and greater in topical testosterone gel versus placebo included: nonfatal arrythmias warranting intervention (5.2% vs 3.3%), atrial fibrillation (3.5% vs 2.4%), acute kidney injury (2.3% vs 1.5%) and bone fracture (3.5% vs 2.5%). For the adverse reaction of bone fracture, each event was adjudicated by clinical review.
TRAVERSE was a randomized, double-blind, cardiovascular outcomes study to assess the cardiovascular (CV) safety of topical testosterone gel compared to placebo in 5198 hypogonadal men aged 45 to 80 years with a history of CV disease or with multiple CV risk factors. The primary outcome was the incidence of the composite endpoint of major adverse cardiovascular events (MACE), consisting of CV death, non-fatal myocardial infarction (MI), and non-fatal stroke The mean duration of therapy was approximately 22 months. The mean duration of follow-up was 33 months. Approximately 61% of all patients discontinued topical testosterone gel or placebo therapy.
The mean patient age (±SD) was 63.3 (7.9) years, with 2452 patients aged 65 years or more (47%); 2847 (about 55%) patients had pre-existing cardiovascular disease, whereas 2357 patients (about 45%) had an elevated cardiovascular risk at baseline, and mean BMI was 35 kg/m2. Approximately 80% of patients were White, 17% were Black, and 3% were of other races or ethnic groups. Approximately 69%, 84%, and 93% had diabetes mellitus, hyperlipidemia, and hypertension, respectively.
The mean serum testosterone concentration at baseline in patients receiving topical testosterone gel was 220.4 ng/dL (n=2596). The mean serum testosterone concentrations at 12 months, 24 months, 36 months, and 48 months in patients receiving topical testosterone gel were 440.5 ng/dL (n=1683), 420.9 ng/dl (n=1125), 428.7 ng/dL (n=731), and 365.2 ng/dL (n=220), respectively.
For patients treated with topical testosterone gel, the incidence of MACE was 7.0% (n=182 events) and for those receiving placebo, the incidence of MACE was 7.3% (n=190 events). The study demonstrated non-inferiority of topical testosterone gel versus placebo because the upper bound of 95% CI was less than the pre-specified risk margin, of 1.5 for MACE (Hazard Ratio 0.96 [95% CI: 0.78, 1.17]).
Additional Adverse Reactions Reported in TRAVERSE
Additional adverse reactions reported in TRAVERSE at an incidence rate >2% in either treatment group and greater in topical testosterone gel versus placebo included: nonfatal arrythmias warranting intervention (5.2% vs 3.3%), atrial fibrillation (3.5% vs 2.4%), acute kidney injury (2.3% vs 1.5%) and bone fracture (3.5% vs 2.5%). For the adverse reaction of bone fracture, each event was adjudicated by clinical review.
4.2Other Adverse Reactions
The following adverse reactions associated with the use of testosterone were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Vascular disorders: Venous thromboembolism.
Skin and appendages: Male pattern baldness, seborrhea, and acne.
Special senses: Rare cases of central serous chorioretinopathy (CSCR).
5OVERDOSAGE
There is one report of acute overdosage with use of an approved injectable testosterone product: this subject had serum testosterone levels of up to 11,400 ng/dL with a cerebrovascular accident. Treatment of overdosage consists of discontinuation of AZMIRO and appropriate symptomatic and supportive care.
6DESCRIPTION
AZMIRO (testosterone cypionate) injection for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
AZMIRO (testosterone cypionate) injection is provided as sterile, clear colorless to pale yellow solution containing 200 mg/mL testosterone cypionate in vials and prefilled syringes.
Each mL of solution contains:
Testosterone cypionate………………………………………..200 mg
Benzyl alcohol………………………………………………….20 mg
Benzyl benzoate……………………………………………….0.2 mL
Cottonseed oil…………………………………………………542 mg
7HOW SUPPLIED/STORAGE AND HANDLING
AZMIRO (testosterone cypionate) injection is supplied as a sterile, clear colorless to pale yellow solution in single-dose vials and single-dose prefilled syringes as 200 mg/mL testosterone cypionate.
Store at 15°C to 25°C (59°F to 77°F); excursions permitted to 2°C to 30°C (36°F to 86°F). Store product in carton to protect contents from light.
8PATIENT COUNSELING INFORMATION
Polycythemia
Advise patients that AZMIRO can cause an increase in hematocrit levels that may increase the risk of thromboembolic events. Advise patients about the importance of completing laboratory testing as instructed by their health care provider while on AZMIRO [ see Warnings and Precautions ( ].
Advise patients that AZMIRO can cause an increase in hematocrit levels that may increase the risk of thromboembolic events. Advise patients about the importance of completing laboratory testing as instructed by their health care provider while on AZMIRO [ see Warnings and Precautions ( ].
Venous Thromboembolism
Advise patients that AZMIRO can cause venous thromboembolism. Advise patients of the signs and symptoms of venous thromboembolism, which may include the following: lower limb pain, edema, or erythema; and dyspnea or chest pain. Advise patients to promptly report the signs and symptoms of venous thromboembolism, discontinue use of AZMIRO, and seek urgent medical care.
Advise patients that AZMIRO can cause venous thromboembolism. Advise patients of the signs and symptoms of venous thromboembolism, which may include the following: lower limb pain, edema, or erythema; and dyspnea or chest pain. Advise patients to promptly report the signs and symptoms of venous thromboembolism, discontinue use of AZMIRO, and seek urgent medical care.
Increase in Blood Pressure
Advise patients that AZMIRO can increase BP which can increase cardiovascular risk over time. Instruct patients about the importance of monitoring BP periodically while on AZMIRO. If BP increases while on AZMIRO, antihypertensive medications may need to be started, added, or adjusted to control BP, or AZMIRO may need to be discontinued.
Advise patients that AZMIRO can increase BP which can increase cardiovascular risk over time. Instruct patients about the importance of monitoring BP periodically while on AZMIRO. If BP increases while on AZMIRO, antihypertensive medications may need to be started, added, or adjusted to control BP, or AZMIRO may need to be discontinued.
Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer
Advise patients that AZMIRO can cause increased symptoms of BPH and can increase the risk for prostate cancer. Advise patients to contact their health care provider if they have any prostate-related symptoms [ see Warnings and Precautions ( ].
Edema
Advise patients with preexisting cardiac, renal, or hepatic disease that AZMIRO can cause edema. Advise patients to notify their health care provider if edema develops or worsens [ see Warnings and Precautions ( ].
Sleep Apnea
Advise patients that AZMIRO can worsen sleep apnea especially in patients with risk factors such as obesity or chronic lung diseases [ see Warnings and Precautions ( ].
Gynecomastia
Advise patients that AZMIRO can cause gynecomastia [ see Warnings and Precautions ( ].
Manufactured for:
Azurity Pharmaceuticals, Inc.
Woburn, MA 01801
Manufactured by:
LSNE-LEON SLU
Calle nicostrato vela
(pq. Tecchnologico leon),
S/N – M1.1-M1.2, Leon, 24009,
Spain (ESP)
Patent: https://azurity.com/patents_and_trademarks/
This product's labeling may have been updated. For current Full Prescribing Information, please visit www.azmiro.com
AZM-PI-01 Rev. JULY2025
Advise patients that AZMIRO can cause increased symptoms of BPH and can increase the risk for prostate cancer. Advise patients to contact their health care provider if they have any prostate-related symptoms [ see Warnings and Precautions ( ].
Edema
Advise patients with preexisting cardiac, renal, or hepatic disease that AZMIRO can cause edema. Advise patients to notify their health care provider if edema develops or worsens [ see Warnings and Precautions ( ].
Sleep Apnea
Advise patients that AZMIRO can worsen sleep apnea especially in patients with risk factors such as obesity or chronic lung diseases [ see Warnings and Precautions ( ].
Gynecomastia
Advise patients that AZMIRO can cause gynecomastia [ see Warnings and Precautions ( ].
Manufactured for:
Azurity Pharmaceuticals, Inc.
Woburn, MA 01801
Manufactured by:
LSNE-LEON SLU
Calle nicostrato vela
(pq. Tecchnologico leon),
S/N – M1.1-M1.2, Leon, 24009,
Spain (ESP)
Patent: https://azurity.com/patents_and_trademarks/
This product's labeling may have been updated. For current Full Prescribing Information, please visit www.azmiro.com
AZM-PI-01 Rev. JULY2025
9PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
200 MG/ML - VIAL LABEL
NDC 24338-056-01
For intramuscular use only
Principal Display Panel - 200 MG/ML - VIAL CARTON
NDC 24338-056-01
CIII
For intramuscular use only
Rx only
NDC 24338-056-01
CIII
For intramuscular use only
Rx only
200 MG/ML -
NDC 24338-055-01
CIII
For intramuscular use only
Rx only
CIII
For intramuscular use only
Rx only
Principal Display Panel - 200 MG/ML - PREFILLED SYRINGE CARTON
NDC 24338-055-01
CIII
For intramuscular use only
Rx only
NDC 24338-055-01
CIII
For intramuscular use only
Rx only
