XYOSTED 100 mg/.5mL
testosterone enanthate · INJECTION · Antares Pharma, Inc.
XYOSTED is a injection containing testosterone enanthate at 100 mg/.5mL, taken subcutaneous. Manufactured by Antares Pharma, Inc..
Key Facts
- Brand Name
- XYOSTED
- Generic Name
- testosterone enanthate
- NDC Code (Product)
54436-200- Manufacturer
- Antares Pharma, Inc.
- Strength
- 100 mg/.5mL
- Dosage Form
- INJECTION
- Route
- SUBCUTANEOUS
- Marketing Status
- DEA Schedule
- Schedule III (Controlled)
- Application #
- NDA209863
- Marketing Start
- 11/15/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE XYOSTED (testosterone enanthate) injection is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, 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. 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. Limitations of Use: Safety and efficacy of XYOSTED in men with “age-related hypogonadism” has not been established. Safety and efficacy of XYOSTED in males less than 18 years old have not been established [see Use in Specific Populations ( 8.4 )] . XYOSTED (testost…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Prior to initiating XYOSTED : confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range ( 2.1 ). Starting dose: 75 mg subcutaneously in the abdominal region once weekly. Avoid intramuscular and intravascular administration ( 2.2 , 2.3 ). Dose Adjustment: Based upon total testosterone trough concentrations (measured 7 days after most recent dose) obtained following 6 weeks of dosing and periodically thereafter ( 2.2 ). Discard unused portion ( 2.3 ) 2.1 Confirmation of Hypogonadism Before Initiation of XYOSTED Prior to initiating XYOSTED, 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. 2.2 Starting Dose and Dose Adjustment The starting dose of XYOSTED is 75 mg, administered subcutaneously in the abdominal region once a week. Dose adjustment Measure total testosterone trough concentrations (measured 7 days after the most recent dose) following …
Contraindications
4 CONTRAINDICATIONS XYOSTED is contraindicated in: Men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions ( 5.4 )] . 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 )] . Men with known hypersensitivity to XYOSTED or any of its ingredients (testosterone enanthate and sesame oil). Men with carcinoma of the breast or known or suspected carcinoma of the prostate ( 4 , 5.4 ). Women who are pregnant ( 4 , 8.1 ). Testosterone may cause fetal harm ( 4 , 5.7 , 8.1 , and 8.2 ). Known hypersensitivity to XYOSTED or its ingredients ( 4 ).
Drug Interactions
7 DRUG INTERACTIONS Androgens may decrease blood glucose, and therefore may decrease insulin requirements in diabetic patients ( 7.1 ). Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of international normalized ratio (INR) and prothrombin time is recommended in patients taking warfarin ( 7.2 ). Use of testosterone with corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease ( 7.3 ). Concomitant administration of medications that are known to increase BP with XYOSTED may lead to additional increases in BP ( 7.4 ). 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, may necessitate a decrease in the dose of anti-diabetic medication. 7.2 Oral Anticoagulants Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking warfarin, especially at the initiation and termination of andro…
Adverse Reactions
6 ADVERSE REACTIONS The most commonly reported adverse reactions (>5%) were: hematocrit increased, hypertension, PSA increased, injection site bruising, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Antares at 1-844-XYOSTED (1-844-996-7833) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of XYOSTED was evaluated in 2 clinical studies in a total of 283 men who received weekly subcutaneous doses for up to one year. All patients were started on 75 mg weekly, then the dose was titrated to 50 mg or 100 mg weekly, as needed, to achieve pre-dose total testosterone concentrations of ≥350 ng/dL and <650 ng/dL. Table 1 summarizes adverse reactions (≥2%) reported in a one-year study with XYOSTED. Table 1. Number (%) of Patients with Adverse Reactions ≥2% in a 1 Year study with XYOSTED Preferred Term Overall (N=150) n (%) Hematocrit increased 21 (14.0) Hypertension …
Frequently Asked Questions
What is XYOSTED used for?
XYOSTED contains testosterone enanthate. It is a injection taken subcutaneous. Consult your doctor for specific uses.
Is XYOSTED a controlled substance?
Yes, XYOSTED is classified as CIII under the DEA Controlled Substances Act.
What is the generic name for XYOSTED?
The generic name for XYOSTED is testosterone enanthate. There are 2 other brand versions of testosterone enanthate.
What is the NDC code for XYOSTED 100 mg/.5mL?
The NDC (National Drug Code) for XYOSTED 100 mg/.5mL is 54436-200, listed by Antares Pharma, Inc..