Azmiro Dosage

Important Dosage Information

• Injectable testosterone products may have different doses, strengths, or administration instructions and they are not substitutable on a milligram-per-milligram basis.

• Administer AZMIRO by deep gluteal intramuscular injection only.

Confirmation of Hypogonadism before Initiation of AZMIRO

Prior to initiating AZMIRO, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.

Recommended Dosage

The recommended dosage of AZMIRO is 50 mg to 400 mg administered every two to four weeks as a deep intramuscular injection in the gluteal muscle.

Individualize the dose and schedule of AZMIRO based on the patient’s age, diagnosis, response to treatment, and the appearance of adverse reactions.

Administration Instructions for AZMIRO Single-dose Vial

• Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit.
• Discard any unused portions of drug remaining in the single-dose vial.

Important Administration Information and Administration Instructions for AZMIRO Prefilled Syringe

Important Administration Information
• The prefilled syringe should be administered as an intramuscular injection by a healthcare professional only.
• The prefilled syringe should only be used to administer doses of 200 mg. For administration of doses other than 200 mg, use the AZMIRO single-dose vial.
• AZMIRO 200 mg/mL is supplied as single-dose prefilled syringe with luer lock connector.
• The prefilled syringe carton does not contain a needle. Obtain suitable needle separately.
• Do not use if the packaging appears to be damaged.
• Do not use the prefilled syringe if it appears to be damaged or the syringe cap is detached from the Luer lock.
Administration Instructions
Hold the syringe upright while gripping the ribbed part of the luer lock. Then with the other hand unscrew the syringe cap in a counter-clockwise direction (Figure A). Once the syringe cap is removed, avoid any hand contact with the tip of the glass syringe, to maintain the sterility.

• Screw the needle onto the luer lock end of the syringe in a clockwise direction until it is firmly attached (Figure B).

• Remove the needle cap by pulling it straight off.
• Check syringe for air bubbles. If there are air bubbles: Gently tap the syringe with your fingers until the bubbles rise to the top of the syringe. Then press the plunger up to slowly expel the air.
• Clean the injection site for injection into the gluteal muscle with an alcohol swab and allow the skin to dry.
• Insert the needle straight into the skin at a 90° angle (Figure C). Push the plunger down to inject the entire contents (1 mL) of the prefilled syringe (Figure D).

• After administration of the injection, discard the syringe into a sharps disposal container or in accordance with local requirements (Figure E).