FDA label 2c4e19ad-8324-dd6e-e063-6394a90aead0

5 WARNINGS AND PRECAUTIONS • Polycythemia : Monitor hematocrit periodically during treatment. Discontinue Testosterone Cypionate Injection, if necessary (5.1). • Cardiovacular Risk : Testosterone Cypionate Injection may increase the risk of major adverse cardiovascular events (MACE). Inform patients of this risk when deciding whether to use or to continue treatment (5.2). • 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 (5.3). • Venous thromboembolism (VTE) : VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products. Discontinue Testosterone Cypionate Injection if VTE is suspected and initiate appropriate workup and management (5.4). • 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 (5.5). • Potential for Adverse Effects on Spermatogenesis : Testosterone Cypionate Injection may cause azoospermia (5.7, 8.3). • Edema : Edema, with or without congestive heart failure (CHF) may occur in patients with pre-existing cardiac, renal, or hepatic disease. Discontinue Testosterone Cypionate Injection and initiate appropriate workup (5.9). • Sleep Apnea : Testosterone Cypionate Injection may potentiate sleep apnea in those with risk factors (5.10). • Lipid Changes : Testosterone may affect serum lipid profile. Monitor patient lipid concentrations; if necessary, adjust dosage of lipid lowering drug(s) or discontinue Testosterone Cypionate Injection (5.12). • 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. 5.1 Polycythemia Increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of Testosterone Cypionate Injection. Check that hematocrit is not elevated prior to initiating Testosterone Cypionate Injection. Periodically monitor hematocrit levels during treatment. If hematocrit becomes elevated, stop Testosterone Cypionate Injection until hematocrit decreases to an acceptable concentration. If Testosterone Cypionate Injection is restarted and again causes hematocrit to become elevated, stop Testosterone Cypionate Injection permanently. An increase in red blood cell mass may increase the risk of thromboembolic events [ see Warnings and Precautions (5.4) ]. 5.2 Cardiovascular Risk Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non- fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Inform patients of this possible risk when deciding whether to use or to continue Testosterone Cypionate Injection. 5.3 Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer • Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms. • Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating and during treatment with androgens [ see Contraindications (4) ]. 5.4 Venous Thromboembolism (VTE) There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone replacement products, such as testosterone cypionate. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with testosterone cypionate and initiate appropriate workup and management [ see Adverse Reactions (6.2) ]. 5.5 Abuse of Testosterone and Monitoring of Serum Testosterone Concentrations Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions [ see Drug Abuse And Dependence (9) ]. If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. 5.6 Not for Use in Women Due to lack of controlled studies in women and the potential for virilizing effects, Testosterone Cypionate Injection is not indicated for use in women [ see Use in Specific Populations (8.1, 8.2) ]. 5.7 Potential for Adverse Effects on Spermatogenesis With large doses of exogenous androgens, including Testosterone Cypionate Injection, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) possibly leading to adverse effects on semen parameters including sperm count [ see Use in Specific Populations (8.3) and Adverse Reactions (6.2) ]. Patients should be informed of this possible risk when deciding whether to use or to continue to use Testosterone Cypionate Injection. 5.8 Hepatic Adverse Effects Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. Testosterone Cypionate Injection is not a 17 alpha-alkyl androgen and is not known to produce hepatic adverse effects associated with 17-alpha-alkyl androgens. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). If these occur, promptly discontinue Testosterone Cypionate Injection while the cause is evaluated. 5.9 Edema Androgens, including Testosterone Cypionate Injection, 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 (6.2) ]. In addition to discontinuation of the drug, appropriate work up and management of edema may be required. 5.10 Sleep Apnea The treatment of hypogonadal men with testosterone products may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases. 5.11 Gynecomastia Gynecomastia may develop and occasionally persists in patients being treated for hypogonadism. 5.12 Lipid Changes Changes in serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of testosterone therapy. Monitor the lipid profile periodically after starting testosterone therapy. 5.13 Hypercalcemia Androgens, including Testosterone Cypionate Injection, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Monitor serum calcium concentrations periodically in these patients. 5.14 Decreased Thyroxine-binding Globulin Androgens, including Testosterone Cypionate Injection, may decrease concentrations of thyroxine-binding globulin, resulting in decreased total T 4 serum levels and increased resin uptake of T 3 and T 4 . Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. 5.15 Increases in Prolactin Increases in serum prolactin have been reported in patients treated with testosterone products, such as Testosterone Cypionate Injection. Evaluate serum prolactin levels prior to initiating treatment with Testosterone Cypionate Injection. Re-evaluate serum prolactin levels 3 to 4 months after starting treatment. If serum prolactin remains elevated, discontinue Testosterone Cypionate Injection. 5.16 Adverse Effects on Bone Maturation Testosterone use may result in acceleration of bone age and premature closure of epiphyses in pediatric patients. This adverse effect may result in compromised adult stature. The younger the pediatric patient the greater the risk of compromising final mature height. Monitor the effect on bone maturation by assessing bone age of the wrist and hand every 6 months.

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in the labeling: • Polycythemia [ see Warnings and Precautions (5.1) ] • Cardiovascular Risk [ see Warnings and Precautions (5.2)] • Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer [ see Warnings and Precautions (5.3) ] • Venous Thromboembolism [ see Warnings and Precautions (5.4) ] • Hepatic Adverse Effects [ see Warnings and Precautions (5.8) ] • Edema [ see Warnings and Precautions (5.9) ] • Sleep Apnea [ see Warnings and Precautions (5.10) ] • Gynecomastia [ see Warnings and Precautions (5.11) ] • Lipid Changes [ see Warnings and Precautions (5.12) ] • Hypercalcemia [ see Warnings and Precautions (5.13) ] • Decreased Thyroxine-binding Globulin [ see Warnings and Precautions (5.14) ] • Increases in Prolactin [ see Warnings and Precautions (5.15) ] • Adverse Effects on Bone Maturation [ see Warnings and Precautions (5.16) ] Common adverse reactions (incidence ≥4%) are injection site erythema and injection site reaction (6.1). Other adverse reactions include: polycythemia, gynecomastia, headache, and depression (6.2). To report SUSPECTED ADVERSE REACTIONS, contact Slayback Pharma at 1-844-566-2505 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Testosterone Cypionate Injection was evaluated, in Study 1, a randomized, single-dose, open-label study conducted in 27 adult males with hypogonadism. Patients were 18 to 65 years of age with a body mass index of 18 to 35 kg/m 2 . Patients received a single intramuscular dose Testosterone Cypionate Injection 200 mg or comparator intramuscular testosterone replacement therapy product and were observed for adverse reactions and injection site reactions over 31 days. The most common adverse reactions in patients who received Testosterone Cypionate Injection were injection site erythema (26%) and injection site reaction (4%). All cases of injection site erythema and injection site reaction were categorized as mild based on a pre-defined injection site assessment scale that defined injection site reactions as mild if they were slight or barely perceptible. 6.2 Other Adverse Reactions The following adverse reactions associated with the use of testosterone were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Administration site reactions : Inflammation and pain at the site of intramuscular injection. Allergic : Hypersensitivity, including skin manifestations and anaphylactoid reactions. Cardiovascular disorders : myocardial infarction, stroke. Endocrine and urogenital : Gynecomastia premature closure of bony epiphyses with termination of growth, precocious puberty. 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. 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. Reproductive system : Excessive frequency and duration of penile erections, oligospermia, and priapism Vascular disorders : Venous thromboembolism. Skin and appendages : Male pattern baldness, seborrhea, and acne. Special senses : Rare cases of central serous chorioretinopathy (CSCR).