testosterone cypionate

INDICATIONS AND USAGE Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

DOSAGE AND ADMINISTRATION Prior to initiating testosterone cypionate injection, 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. Testosterone cypionate injection is for intramuscular use only. It should not be given intravenously. Intramuscular injections should be given deep in the gluteal muscle. The suggested dosage for testosterone cypionate injection varies depending on the age, sex, and diagnosis of the individual patient. Dosage is adjusted according to the patient's response and the appearance of adverse reactions. Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower dosages initially, gradually increasing the dose as puberty progresses, with or without a decrease to maintenance levels. Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose. For replacement in the hypogonadal male, 50 - 400 mg should be administered every two to four weeks. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended.

CONTRAINDICATIONS 1. Known hypersensitivity to the drug 2. Males with carcinoma of the breast 3. Males with known or suspected carcinoma of the prostate gland 4. Women who are pregnant (see PRECAUTIONS, Pregnancy ) 5. Patients with serious cardiac, hepatic or renal disease (see WARNINGS )

ADVERSE REACTIONS The following adverse reactions in the male have occurred with some androgens: Endocrine and urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages. Skin and appendages: Hirsutism, male pattern of baldness, seborrhea, and acne. Cardiovascular Disorders: Myocardial infarction, stroke Fluid and electrolyte disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates. Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis (see WARNINGS ). Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia. Nervous system: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia. Allergic: Hypersensitivity, including skin manifestations and anaphylactoid reactions. Vascular Disorders: Venous thromboembolism. Special senses: Rare cases of central serous chorioretinopathy (CSCR). Miscellaneous: Inflammation and pain at the site of intramuscular injection. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Drug interactions Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia. Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.

DESCRIPTION Testosterone cypionate, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl- 1-oxopropoxy)-, (17ß)-. Its molecular formula is C 27 H 40 O 3 , and the molecular weight 412.61. The structural formula is represented below: Testosterone cypionate injection, USP is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate. Each mL of the 100 mg/mL solution contains: Testosterone cypionate............................................................................................100 mg Benzyl benzoate ......................................................................................................0.1 mL Cottonseed oil .........................................................................................................736 mg Benzyl alcohol (as preservative) .............................................................................9.45 mg Each mL of the 200 mg/mL solution contains: Testosterone cypionate .............................................................................................200 mg Benzyl benzoate ........................................................................................................0.2 mL Cottonseed oil ...........................................................................................................560 mg Benzyl alcohol (as preservative) ...............................................................................9.45 mg Image

OVERDOSAGE There have been no reports of acute overdosage with the androgens.

HOW SUPPLIED Testosterone cypionate injection, USP is a clear colourless to pale yellow solution and is available as: 100 mg/mL 10 mL vials NDC 69097-536-37 200 mg/mL 1 mL vials NDC 69097-537-31 10 mL vials NDC 69097-537-37 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from light. This product's label may have been updated. For current full prescribing information, please visit www.ciplausa.com Rx only Manufactured by: Cipla Ltd. At M/s LSNE-Le n SLU C/Nicostrato Vela s/n 24009 Le n, Spain Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059 Revised: 01/2022