AZMIRO: The first and only FDA-approved prefilled testosterone cypionate injection1,2
Convenient; 200 mg/mL in a single-dose prefilled syringe Accurate and consistent fixed dose every time Fewer steps saves you time3,a
aCompared with vials.
AZMIRO vs Depo-testosterone & generic testosterone cypionates1,4-6
bSee Prescribing Information for full administration.
This chart is offered as a side-by-side comparison based on the product labels. Azurity does not confirm other products' labels. Reporting of any adverse effects, product quality complaints, or medical information request regarding testosterone replacement therapy (TRT) options should be directed to their respective manufacturer.
Prefilled syringes provide4
- Greater safety by reducing the potential for inadvertent needle sticks and exposure to products that can occur while drawing medication from vials
- Accuracy with pre-measured doses, reducing dosing and medication errors
- Reduced risk of microbial contamination
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TWO WAYS TO PRESCRIBE AZMIRO
Don't let treatment costs prevent your patients from accessing AZMIRO. Our co-pay program may help reduce out-of-pocket costs for eligible commercially insured patients.
Learn More
Purchase AZMIRO for physician offices, clinics, and institutions
Interested in Buy and Bill? AZMIRO is available through authorized wholesalers
Learn More
Benefits of Prescribing AZMIRO Through Sterling Specialty Pharmacy
May pay as little as
$0 co-pay
for eligible patientsc
- Sterling will assist in completing all Benefit Investigation activities
- May help commercially insured eligible patients save on their out-of-pocket costs
- AZMIRO will be shipped to the patient's home for healthcare provider administration and refill reminders sent via text message
THE PROCESS IS SIMPLE THROUGH STERLING SPECIALTY PHARMACY
Sterling Specialty Pharmacy will contact your patients to finalize shipment to their home.
HOW TO PRESCRIBE AZMIRO
Submit via eSCRIPT
Submit your eScript to Sterling
Specialty Pharmacy: 1312 Northland
Drive, Suite 500, Mondota Heights,
MN 55120.
NPI: 1225548480
eSCRIPT: 2433693
Submit via Fax
Fax the completed enrollment form,
recent chart notes, and insurance
information to Sterling Specialty
Pharmacy.
866.588.0371
Submit via Phone
Call Sterling Specialty Pharmacy to
provide a verbal prescription.
888.618.4126
Interested in Buy and Bill? AZMIRO is available through authorized wholesalers.
Purchase AZMIRO for physician offices, clinics, and institutions
Authorized Wholesalers
ASD Healthcare / Besse Medical
Cardinal Health Full - line
McKesson Corporation Full - line
AZMIRO Product Codes
NDC: 24338-055-01
J CODE: J0172 (Injection, testosterone cypionate [AZMIRO], 1 mg). Be sure to code for 200 billing units per injection.
CPT CODE: 96372 Therapeutic, prophylactic or diagnostic injection (specify substance or drug); subcutaneous or intramuscular
ADMINISTRATION INSTRUCTIONS
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Fill out an information request form to learn more about AZMIRO, or to become a part of our provider network and get listed in the Shield directory.
IMPORTANT SAFETY INFORMATION
INDICATION
AZMIROâ„¢ (testosterone cypionate) injection, for intramuscular use
AZMIRO is an androgen indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
ADDITIONAL IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- Known hypersensitivity to AZMIRO or any of its components, skin manifestations and anaphylactoid reactions have been reported.
- Men with carcinoma of the breast or known or suspected carcinoma of the prostate.
- Women who are pregnant. Testosterone may cause fetal harm.
WARNINGS AND PRECAUTIONS
Polycythemia: Monitor hematocrit periodically during treatment. Discontinue AZMIRO, if necessary.
Cardiovascular Risk: AZMIRO may increase the risk of major adverse cardiovascular events (MACE). Inform patients of this risk when deciding whether to use or to continue treatment.
Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer: Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. Evaluate patients for prostate cancer, including monitoring prostate specific antigen (PSA) prior to initiating and during treatment with androgens.
Venous thromboembolism (VTE): VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products. Discontinue AZMIRO if VTE is suspected and initiate appropriate workup and management.
Abuse of Testosterone and Monitoring of Serum Testosterone: If testosterone use at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids is suspected, check serum testosterone concentration.
Potential for Adverse Effects on Spermatogenesis: AZMIRO may cause azoospermia.
Edema: Edema, with or without congestive heart failure (CHF), may occur in patients with pre-existing cardiac, renal, or hepatic disease. Discontinue AZMIRO and initiate appropriate workup.
Sleep Apnea: AZMIRO may potentiate sleep apnea in those with risk factors.
Lipid Changes: Testosterone may affect serum lipid profile. Monitor patient lipid concentrations; if necessary, adjust dosage of lipid-lowering drug(s) or discontinue AZMIRO.
Adverse Effects on Bone Maturation: Testosterone may result in acceleration of bone age and premature closure of epiphyses in pediatric patients which may result in compromised adult stature. Monitor the effect on bone maturation by assessing bone age of the wrist and hand every 6 months.
ADVERSE REACTIONS
Common adverse reactions (incidence ≥4%) are injection site erythema and injection site reaction.
Other adverse reactions include: polycythemia, gynecomastia, headache, and depression.
These are not all the possible side effects of AZMIRO. Please see Full Prescribing Information for a full list.
DRUG INTERACTIONS
Insulin: In patients with diabetes, concomitant use with AZMIRO may decrease blood glucose and insulin requirements.
Oral Anticoagulants: Concomitant use with AZMIRO may cause changes in anticoagulant activity. Monitor International Normalized Ratio and prothrombin time frequently.
Corticosteroids: Concomitant use with AZMIRO may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease.
See full prescribing information for Specific Drugs and Interactions.
USE IN SPECIFIC POPULATIONS
Geriatric Use: Geriatric patients treated with androgens may be at an increased risk of developing BPH and prostatic carcinoma.
The Important Safety Information does not include all the information needed to use AZMIRO safely and effectively. Please see accompanying full Prescribing Information for AZMIRO.
To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
References: 1. AZMIRO [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc; 2024. 2. Orange Book: approved drug products with therapeutic equivalence evaluations. Accessed November 5, 2024. https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm3. Benhamou D, Weiss M, Borms M et al. Assessing the clinical, economic, and health resource utilization impacts of prefilled syringes versus conventional medication administration methods: results from a systematic literature review. Ann Pharmacother. 2024;58(9):921-934. 4. Makwana S, Basu B, Makasana Y, et al. Prefilled syringes: an innovation in parenteral packaging. Int J Pharm Investig. 2011;1(4):200-206. 5. Depo-Testosterone [package insert]. New York, NY: Pfizer; 2018. 6. Data on File. Azurity Pharmaceuticals, Inc. 2024.