THE NEW PRODUCT — Testosterone cypionate can crystallize in solution when it is stored at lower-than-recommended temperatures (less than 20-25°C; 68-77°F). According to its manufacturer, Azmiro is more stable than testosterone cypionate in multidose formulations and should not crystallize.2 

CLINICAL STUDIES — FDA approval of Azmiro was based on the results of an open-label, single-dose, two-way crossover pharmacokinetic study (summarized in an FDA review document) in 28 hypogonadal men. The new single-dose prefilled testosterone cypionate formulation was bioequivalent to the multidose formulation of injectable testosterone cypionate (Depo-Testosterone).2 

ADVERSE EFFECTS — The most common adverse effects of Azmiro in the single-dose study were mild injection-site reactions; the incidence was similar to that with Depo-Testosterone.

All testosterone products can cause erythrocytosis. Hematocrit levels should be assessed before starting treatment and periodically thereafter; testosterone therapy should be withheld for a first elevation until the hematocrit returns to an acceptable level and permanently discontinued for a second elevation. 

Testosterone replacement therapy can cause venous thromboembolism, azoospermia, edema, gynecomastia, hypercalcemia, hepatic adverse effects, increases in blood pressure, and decreases in both HDL-cholesterol and thyroxine-binding globulin (TBG) levels. It has been associated with new-onset and worsening of sleep apnea, worsening of benign prostatic hyperplasia (BPH), and increases in prostate-specific antigen (PSA) levels; whether it increases the risk of prostate cancer is unclear.3 Like other testosterone products, Azmiro is contraindicated for use in patients with breast or prostate cancer. 

DOSAGE AND ADMINISTRATION — Single-dose vials and prefilled syringes of Azmiro contain 200 mg of testosterone cypionate in 1 mL of solution. The recommended dosage is 50-400 mg administered by a healthcare provider every 2-4 weeks as a deep injection into the gluteal muscle. The prefilled syringes should only be used to administer a 200-mg dose; the single-dose vials can be used for all other doses.

CONCLUSION — Azmiro, a single-dose vial and prefilled syringe formulation of testosterone cypionate, is claimed to be more stable than testosterone cypionate multidose formulations (Depo-Testosterone, and generics) and should not crystallize. It is administered as a deep intragluteal injection by a healthcare provider every 2 to 4 weeks.

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