Testosterone cypionate
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
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. If these occur, promptly discontinue AZMIRO while the cause is evaluated. 5.9 Edema Androgens, including AZMIRO, may promote retention of sodium and water.
Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease [ see Adverse Reactions ].
Preparation and administration
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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). Figure-A Figure-B Figure-C Figure-D Figure-E
Drug interactions
Check testosterone cypionate against a medication listLabel text (4 paragraphs)
7 DRUG INTERACTIONS • Insulin: In patients with diabetes, concomitant use with AZMIRO may decrease blood glucose and insulin requirements ( 7.1 ). • Oral Anticoagulants: Concomitant use with AZMIRO may cause changes in anticoagulant activity. Monitor International Normalized Ratio and prothrombin time frequently ( 7.2 ). • Corticosteroids: Concomitant use with AZMIRO may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease ( 7.3 ).
7.1 Insulin Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.
7.2 Oral Anticoagulants Changes in anticoagulant activity may be seen with androgens. Frequent monitoring of INR and prothrombin time may be necessary in patients taking anticoagulants, especially at the initiation and termination of androgen therapy.
7.3 Corticosteroids The concurrent use of testosterone with corticosteroids may result in increased fluid retention and should be monitored cautiously, particularly in patients with cardiac, renal or hepatic disease.
Contraindications
4 CONTRAINDICATIONS AZMIRO is contraindicated in: • Known hypersensitivity to AZMIRO or to any of its components [see Description ( 11 )]. Hypersensitivity, including skin manifestations and anaphylactoid reactions have been reported [ see Adverse Reactions ( 6.2 ) ]. • Men with carcinoma of the breast or known or suspected carcinoma of the prostate gland [ see Warnings and Precautions ( 5.3 ) ]. • Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman [ see Use in Specific Populations ( 8.1 ) ].
• Known hypersensitivity to AZMIRO or any of its components, skin manifestations and anaphylactoid reactions have been reported ( 4 ) • Men with carcinoma of the breast or known or suspected carcinoma of the prostate ( 4 ). • Women who are pregnant. Testosterone may cause fetal harm ( 4 ).
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary AZMIRO is contraindicated in pregnant women and not indicated for use in females [see Contraindications ( 4 )]. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies ( see Data ) and its mechanism of action [ see Clinical Pharmacology ( 12.1 ) ]. Exposure of a female fetus to androgens may result in varying degrees of virilization. In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring.
These studies did not meet current standards for nonclinical development toxicity studies. Data Animal Data In developmental studies conducted in rats, rabbits, pigs, sheep and rhesus monkeys, pregnant animals received intramuscular injection of testosterone during the period of organogenesis. Testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring.
Structural impairments observed in females included increased anogenital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. Structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen. Increased pituitary weight was seen in both sexes. Testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring.
Hypertension was observed in pregnant females and offspring in rats exposed to doses approximately twice those used for testosterone replacement therapy.
Lactation
8.3 Females and Males of Reproductive Potential Infertility Males During treatment with large doses of exogenous androgens, including AZMIRO, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular-axis [ see Warnings and Precautions ( 5.7 ) ]. Reduced fertility is observed in some men taking testosterone replacement therapy. The impact on fertility may be irreversible. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids [ see Drug Abuse and Dependence ( 9.2 ) ].
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
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