TESTOSTERONE

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).

4 CONTRAINDICATIONS Testosterone Cypionate Injection is contraindicated in: • Known hypersensitivity to Testosterone Cypionate Injection 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 (5.2) ]. • 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 Testosterone Cypionate Injection 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).

11 DESCRIPTION Testosterone Cypionate Injection, USP 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 shown in the following figure: Testosterone Cypionate Injection, USP is provided as sterile, clear colorless to pale yellow solution containing 200 mg/mL testosterone cypionate in vials. Each mL of solution contains: Testosterone cypionate………………………………………..200 mg Benzyl alcohol………………………………………………….20 mg Benzyl benzoate……………………………………………….0.2 mL Cottonseed oil…………………………………………………542 mg Testosteron structure

2 DOSAGE & ADMINISTRATION • Injectable testosterone products may have different doses, strengths, or administration instructions and they are not substitutable on a milligram-per-milligram basis. Administer Testosterone Cypionate Injection by deep gluteal intramuscular injection only (2.1). • 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 concentrations are below the normal range (2.2). • Recommended dosage 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 based on the patient’s age, diagnosis, response to treatment, and the appearance of adverse reactions (2.3). 2.1 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 Testosterone Cypionate Injection by deep gluteal intramuscular injection only. 2.2 Confirmation of Hypogonadism before Initiation of Testosterone Cypionate 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. 2.3 Recommended Dosage and Administration The recommended dosage of Testosterone Cypionate Injection 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 Testosterone Cypionate Injection based on the patient’s age, diagnosis, response to treatment, and the appearance of adverse reactions. 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.

1 INDICATIONS & USAGE Testosterone Cypionate Injection is indicated for testosterone replacement therapy in males in conditions associated with a deficiency or absence of endogenous testosterone: • Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchiectomy, Klinefelter’s syndrome, or toxic damage from alcohol or heavy metals, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range [ see Dosage and Administration (2.2) ]. • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range [ see Dosage and Administration (2.2) ]. Limitations of Use • Safety and efficacy of Testosterone Cypionate Injection in men with “age- related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. • Safety and efficacy of Testosterone Cypionate Injection in pediatric patients below the age of 12 years have not been established [ see Use in Specific Populations (8.4) ]. Testosterone Cypionate Injection is an androgen indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone (1): Limitations of Use: • Safety and efficacy of Testosterone Cypionate Injection in men with “age- related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established (1). • Safety and effectiveness in pediatric patients below the age of 12 years have not been established (8.4).

9.2 Abuse Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice. Abuse-Related Adverse Reactions Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids, and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility, and aggression. The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities. The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

9.1 Controlled Substance Testosterone Cypionate Injection contains testosterone, a Schedule III controlled substance.

9.3 Dependence Behaviors Associated with Addiction Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors: • Taking greater dosages than prescribed • Continued drug use despite medical and social problems due to drug use • Spending significant time to obtain the drug when supplies of the drug are interrupted • Giving a higher priority to drug use than other obligations • Having difficulty in discontinuing the drug despite desires and attempts to do so • Experiencing withdrawal symptoms upon abrupt discontinuation of use Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism. Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

9 DRUG ABUSE AND DEPENDENCE 9.1 Controlled Substance Testosterone Cypionate Injection contains testosterone, a Schedule III controlled substance. 9.2 Abuse Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice. Abuse-Related Adverse Reactions Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids, and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility, and aggression. The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities. The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 9.3 Dependence Behaviors Associated with Addiction Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors: • Taking greater dosages than prescribed • Continued drug use despite medical and social problems due to drug use • Spending significant time to obtain the drug when supplies of the drug are interrupted • Giving a higher priority to drug use than other obligations • Having difficulty in discontinuing the drug despite desires and attempts to do so • Experiencing withdrawal symptoms upon abrupt discontinuation of use Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism. Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.

10 OVERDOSAGE There is one report of acute overdosage with use of an approved injectable testosterone product: this subject had serum testosterone levels of up to 11,400 ng/dL with a cerebrovascular accident. Treatment of overdosage consists of discontinuation of Testosterone Cypionate Injection and appropriate symptomatic and supportive care.

7 DRUG INTERACTIONS • Insulin: In patients with diabetes, concomitant use with Testosterone Cypionate Injection may decrease blood glucose and insulin requirements (7.1). • Oral Anticoagulants: Concomitant use with Testosterone Cypionate Injection may cause changes in anticoagulant activity. Monitor International Normalized Ratio and prothrombin time frequently (7.2). • Corticosteroids: Concomitant use with Testosterone Cypionate Injection 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.

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of the prostate, seminal vesicles, penis, and scrotum; the development of male hair distribution, such as facial, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH). 12.2 Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of testosterone have not been fully characterized. 12.3 Pharmacokinetics Absorption Testosterone esters are less polar than free testosterone. Testosterone esters in oil injected intramuscularly are absorbed slowly from the lipid phase; thus, testosterone cypionate can be given at intervals of two to four weeks. Pharmacokinetic parameters of baseline-corrected testosterone obtained following a single-dose intramuscular administration of testosterone cypionate 200 mg in prefilled syringe in 26 hypogonadal adult males are summarized in Table 1 below. Table 1: Mean (±SD) Baseline-corrected Testosterone Pharmacokinetic Parameters Following a Single-dose Intramuscular Administration of Testosterone Cypionate 200 mg in Hypogonadal Males (N=26) Parameter Mean (±SD) AUC 0-t (hr·ng/dL) 137218.7 (±62360.0) C max (ng/dL) 758.0 (±288.7) T max (hr) 71.7 (24.0, 191.0) a a Reported in median (min, max). Distribution Circulating testosterone is primarily bound in serum to sex hormone-binding globulin (SHBG) and albumin. Approximately 40% of testosterone in plasma is bound to SHBG, 2% remains unbound (free) and the rest is bound to albumin and other proteins. Elimination The half-life of testosterone cypionate when injected intramuscularly is approximately eight days. Metabolism Inactivation of testosterone occurs primarily in the liver. Testosterone is metabolized to various 17-keto steroids through two different pathways. The major active metabolites of testosterone are dihydrotestosterone (DHT) and estradiol. Excretion About 90 percent of a dose of testosterone is excreted in the urine as glucuronic and sulfuric acid conjugates of testosterone and its metabolites. About 6 percent of a dose is excreted in the feces, mostly in the unconjugated form.

12.1 Mechanism of Action Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include growth and maturation of the prostate, seminal vesicles, penis, and scrotum; the development of male hair distribution, such as facial, pubic, chest, and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).

12.2 Pharmacodynamics The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of testosterone have not been fully characterized.

12.3 Pharmacokinetics Absorption Testosterone esters are less polar than free testosterone. Testosterone esters in oil injected intramuscularly are absorbed slowly from the lipid phase; thus, testosterone cypionate can be given at intervals of two to four weeks. Pharmacokinetic parameters of baseline-corrected testosterone obtained following a single-dose intramuscular administration of testosterone cypionate 200 mg in prefilled syringe in 26 hypogonadal adult males are summarized in Table 1 below. Table 1: Mean (±SD) Baseline-corrected Testosterone Pharmacokinetic Parameters Following a Single-dose Intramuscular Administration of Testosterone Cypionate 200 mg in Hypogonadal Males (N=26) Parameter Mean (±SD) AUC 0-t (hr·ng/dL) 137218.7 (±62360.0) C max (ng/dL) 758.0 (±288.7) T max (hr) 71.7 (24.0, 191.0) a a Reported in median (min, max). Distribution Circulating testosterone is primarily bound in serum to sex hormone-binding globulin (SHBG) and albumin. Approximately 40% of testosterone in plasma is bound to SHBG, 2% remains unbound (free) and the rest is bound to albumin and other proteins. Elimination The half-life of testosterone cypionate when injected intramuscularly is approximately eight days. Metabolism Inactivation of testosterone occurs primarily in the liver. Testosterone is metabolized to various 17-keto steroids through two different pathways. The major active metabolites of testosterone are dihydrotestosterone (DHT) and estradiol. Excretion About 90 percent of a dose of testosterone is excreted in the urine as glucuronic and sulfuric acid conjugates of testosterone and its metabolites. About 6 percent of a dose is excreted in the feces, mostly in the unconjugated form.

20220612

7

3 DOSAGE FORMS & STRENGTHS Injection: 200 mg/mL available as 1 mL of clear colorless to pale yellow solution filled in a single-dose glass vial. Injection: 200 mg/mL in a single-dose vial (3)

TESTOSTERONE TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE TESTOSTERONE BENZYL BENZOATE COTTONSEED OIL BENZYL ALCOHOL

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats. Mutagenicity Testosterone was negative in the in vitro Ames and in the in vivo mouse micronucleus assays. Impairment of Fertility The administration of exogenous testosterone suppresses spermatogenesis in the rat, dog and non-human primates, which was reversible on cessation of the treatment.

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats. Mutagenicity Testosterone was negative in the in vitro Ames and in the in vivo mouse micronucleus assays. Impairment of Fertility The administration of exogenous testosterone suppresses spermatogenesis in the rat, dog and non-human primates, which was reversible on cessation of the treatment.

NDA216318

TESTOSTERONE

TESTOSTERONE CYPIONATE

71225-127

HUMAN PRESCRIPTION DRUG

INTRAMUSCULAR

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 200 MG/ML - VIAL LABEL NDC 71225-127-01 1 mL Single-Dose Vial Testosterone Cypionate Injection, USP CIII For intramuscular use only Rx only Prinicipal Display Panel - 200 MG/ML - VIAL CARTON NDC 71225-127-01 1 mL Single-Dose Vial Testosterone Cypionate Injection, USP CIII For intramuscular use only Rx only Testosterone Vial Label Testo Vial Carton Label

17 PATIENT COUNSELING INFORMATION Polycythemia Advise patients that Testosterone Cypionate Injection can cause an increase in hematocrit levels that may increase the risk of thromboembolic events. Advise patients about the importance of completing laboratory testing as instructed by their health care provider while on Testosterone Cypionate Injection [ see Warnings and Precautions (5.1) ]. Cardiovascular Risk Advise patients that Testosterone Cypionate Injection may increase in the risk of major adverse cardiovascular events (MACE), including myocardial infarction, stroke, and cardiovascular death. [ see Warnings and Precautions (5.2) ]. Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer Advise patients that Testosterone Cypionate Injection can cause increased symptoms of BPH and can increase the risk for prostate cancer. Advise patients to contact their health care provider if they have any prostate-related symptoms [ see Warnings and Precautions (5.3) ]. Edema Advise patients with preexisting cardiac, renal, or hepatic disease that Testosterone Cypionate Injection can cause edema. Advise patients to notify their health care provider if edema develops or worsens [ see Warnings and Precautions (5.9) ]. Sleep Apnea Advise patients that Testosterone Cypionate Injection can worsen sleep apnea especially in patients with risk factors such as obesity or chronic lung diseases [ see Warnings and Precautions (5.10) ]. Gynecomastia Advise patients that Testosterone Cypionate Injection can cause gynecomastia [ see Warnings and Precautions (5.11) ]. Manufactured for: Slayback Pharma LLC, Princeton, NJ 08540 Manufactured by: LSNE-LEON SLU Calle nicostrato vela (pq. Tecchnologico leon), S/N – M1.1-M1.2, Leon, 24009, Spain (ESP) Revised:6/2022 MEDICATION GUIDE Testosterone Cypionate (tes tos' ter one cy·p·i·onate) Injection injection, for intramuscular use, CIII What is the most important information I should know about Testosterone Cypionate Injection? Testosterone Cypionate Injection can cause serious side effects, including: • Increase in red blood cell counts (hematocrit) or hemoglobin. o Testosterone Cypionate Injection increases red blood cell counts in some people. High red blood cell counts increase the risk of blood clots, strokes, and heart attacks. o You may need to stop Testosterone Cypionate Injection if your red blood cell count increases. o Your healthcare provider should check your red blood cell count and hemoglobin while you receive Testosterone Cypionate Injection. What is Testosterone Cypionate Injection? Testosterone Cypionate Injection is a prescription medicine that contains testosterone. Testosterone Cypionate Injection is used to treat adult men who have low or no testosterone due to certain medical conditions. • It is not known if Testosterone Cypionate Injection is safe or effective to treat men who have low testosterone due to aging. • It is not known if Testosterone Cypionate Injection is safe or effective in children younger than 12 years old. Improper use of testosterone may affect bone growth in children. • Testosterone Cypionate Injection is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Selling or giving away this medicine may harm others and it is against the law. • Testosterone Cypionate Injection is not meant for use in women. Do not receive Testosterone Cypionate Injection if you: • are allergic to Testosterone Cypionate Injection or to any ingredients in Testosterone Cypionate Injection. See the end of this Medication Guide for a complete list of ingredients in Testosterone Cypionate Injection. • have breast cancer. • have or might have prostate cancer. • are a woman who is pregnant. Testosterone Cypionate Injection may harm your unborn baby. What should I tell my healthcare provider before receiving Testosterone Cypionate Injection? Before receiving Testosterone Cypionate Injection, tell your healthcare provider about all of your medical conditions including if you: • have high red blood cell count (hematocrit) or high hemoglobin laboratory value. • have breast cancer. • have or might have prostate cancer. • have urinary problems due to an enlarged prostate. • have heart problems. • have liver or kidney problems. • have problems breathing while you sleep (sleep apnea). Tell your healthcare provider about all the medicines you take, including prescription and over-the­ counter medicines, vitamins, and herbal supplements. Using Testosterone Cypionate Injection with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: • insulin. • medicines that decrease blood clotting (blood thinners). • corticosteroids. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of your medicines and show them to your healthcare provider and pharmacist when you get a new medicine. How will I receive Testosterone Cypionate Injection? • Your healthcare provider will inject Testosterone Cypionate Injection deep into the muscle of your buttock. • Your healthcare provider will test your blood before you receive and while you are receiving Testosterone Cypionate Injection. What are the possible side effects of Testosterone Cypionate Injection? Testosterone Cypionate Injection may cause serious side effects including: See “What is the most important information I should know about Testosterone Cypionate Injection?” • Possible increased risk of heart attack or stroke that may or may not lead to death. • If you already have an enlarged prostate, your signs and symptoms may worsen while receiving Testosterone Cypionate Injection. This may include: o increased urination at night. o trouble starting your urine stream. o urinating many times during the day. o urge to go to the bathroom right away. o a urine accident. o inability to pass urine or weak urine flow. • Increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you receive Testosterone Cypionate Injection. • Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain. • Abuse . Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic steroids. Abuse can cause serious heart and psychological side effects. Your healthcare provider should check you for signs of abuse before and during treatment with Testosterone Cypionate Injection. • Testosterone Cypionate Injection may lower your sperm count. • Liver problems. Symptoms of liver problems may include: o nausea or vomiting. o yellowing of your skin or whites of your eyes. o dark urine. o pain on the right side of your stomach area (abdominal pain). • Swelling of your ankles, feet, or body (edema), with or without heart failure. This may cause serious problems for people who have heart, kidney or liver disease. • Breathing problems while you sleep (sleep apnea). • Enlarged or painful breasts. • Changes in certain blood tests. These changes include changes in liver tests, increased calcium, decreased thyroid hormones, and increased prolactin hormones (hormone made by pituitary gland) levels. • Increased risk in children of bone growth problems. Testosterone Cypionate Injection may affect a child’s final adult height (stature). The child’s bone growth should be checked every 6 months while they are receiving Testosterone Cypionate Injection. Call your healthcare provider right away if you have any of the serious side effects listed above. The most common side effects of Testosterone Cypionate Injection include: • injection site reactions including: bruising, bleeding, redness, hardness. • increased red blood cell count. • enlarged or painful breasts. • headache. • depression. Other side effects include more erections than are normal for you or erections that last a long time. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Testosterone Cypionate Injection. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800­FDA-1088. General information about the safe and effective use of Testosterone Cypionate Injection. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about Testosterone Cypionate Injection that is written for healthcare professionals. What are the ingredients in Testosterone Cypionate Injection? Active ingredient: testosterone Inactive ingredients: benzyl alcohol, benzyl benzoate and cottonseed oil. Manufactured for: Slayback Pharma LLC, Princeton, NJ 08540 Manufactured by: LSNE-LEON SLU Calle nicostrato vela (pq. Tecchnologico leon), S/N – M1.1-M1.2, Leon, 24009, Spain (ESP) This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 6/2022

8.5 Geriatric Use Geriatric patients treated with androgens may be at an increased risk of developing BPH and prostatic carcinoma [see Warnings and Precautions (5.3)].

8.3 Females and Males of Reproductive Potential Infertility Males During treatment with large doses of exogenous androgens, including testosterone cypionate injection, 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) ].

8.4 Pediatric Use Improper use may result in acceleration of bone age and premature closure of epiphyses. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months. In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child the greater the risk of compromising final mature height. Precocious puberty has also been reported with use of testosterone. The safety and effectiveness of Testosterone Cypionate Injection have not been established in pediatric patients young than 12 years of age.

8.1 Pregnancy Risk Summary Testosterone Cypionate Injection 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.

8 USE IN SPECIFIC POPULATIONS Geriatric Patients: Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and prostatic carcinoma (8.5). 8.1 Pregnancy Risk Summary Testosterone Cypionate Injection 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. 8.2 Lactation Risk Summary Testosterone Cypionate Injection is not indicated for use in females. 8.3 Females and Males of Reproductive Potential Infertility Males During treatment with large doses of exogenous androgens, including testosterone cypionate injection, 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) ]. 8.4 Pediatric Use Improper use may result in acceleration of bone age and premature closure of epiphyses. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months. In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child the greater the risk of compromising final mature height. Precocious puberty has also been reported with use of testosterone. The safety and effectiveness of Testosterone Cypionate Injection have not been established in pediatric patients young than 12 years of age. 8.5 Geriatric Use Geriatric patients treated with androgens may be at an increased risk of developing BPH and prostatic carcinoma [see Warnings and Precautions (5.3)].

16 HOW SUPPLIED/STORAGE AND HANDLING Testosterone Cypionate Injection is supplied as a sterile, clear colorless to pale yellow solution in single-dose vials as 200 mg/mL testosterone cypionate. NDC Number Package Size 71225-127-01 1 mL vials Store at 15°C to 25°C (59°F to 77°F); excursions permitted to 2°C to 30°C (36°F to 86°F). Store product in carton to protect contents from light.