Xyosted

Last reviewed on RxList: 1/13/2021
Xyosted Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Xyosted?

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 such as primary or hypogonadotropic hypogonadism (congenital or acquired).

What Are Side Effects of Xyosted?

Common side effects of Xyosted include:

Dosage for Xyosted

The starting dose of Xyosted is 75 mg, administered subcutaneously in the abdominal region once a week.

What Drugs, Substances, or Supplements Interact with Xyosted?

Xyosted may interact with insulin, oral anticoagulants, and medications that can increase blood pressure. Tell your doctor all medications and supplements you use.

Xyosted During Pregnancy and Breastfeeding

Xyosted is not indicated for use in women and so is unlikely to be used by women who are pregnant or breastfeeding.

Additional Information

Our Xyosted (testosterone enanthate) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Low Testosterone (Low T) Treatments See Slideshow
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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have a tight feeling in your throat, a sudden urge to cough, or if you feel light-headed or short of breath during or shortly after receiving the injection.

You will be watched closely for at least 30 minutes to make sure you do not have a reaction to the injection.

Call your doctor at once if you have:

  • chest pain or pressure, pain spreading to your jaw or shoulder;
  • shortness of breath, breathing problems at night (sleep apnea);
  • swelling in your ankles or feet, rapid weight gain;
  • a seizure;
  • unusual changes in mood or behavior;
  • increased or ongoing erection of the penis, ejaculation problems, decreased amounts of semen, decrease in testicle size;
  • painful or difficult urination, increased urination at night, loss of bladder control;
  • high levels of calcium in the blood--stomach pain, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless; or
  • high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
  • liver problems--right-sided upper stomach pain, vomiting, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).
  • signs of a blood clot deep in the body--swelling, warmth, or redness in an arm or leg;
  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems.

Women receiving testosterone may develop male characteristics, which could be irreversible if treatment is continued. Call your doctor at once if you notice any of these signs of excess testosterone:

  • acne;
  • changes in your menstrual periods (including missed periods);
  • male-pattern hair growth (such as on the chin or chest);
  • hoarse or deepened voice; or
  • enlarged clitoris.

Your testosterone injections may be delayed or permanently discontinued if you have certain side effects.

Common side effects (in men or women) may include:

  • breast swelling;
  • acne, increased facial or body hair growth, male-pattern baldness;
  • increased or decreased interest in sex;
  • headache, anxiety, depressed mood;
  • increased blood pressure;
  • numbness or tingly feeling;
  • abnormal liver function tests;
  • high red blood cell counts (hematocrit or hemoglobin);
  • increased PSA (prostate-specific antigen); or
  • pain, bruising, bleeding, redness, or a hard lump where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Xyosted (Testosterone Enanthate Injection)

QUESTION

Testosterone is a chemical found only in men. See Answer
Xyosted Professional Information

SIDE EFFECTS

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 19 (12.7)
Prostatic specific antigen (PSA) increased 18 (12.0)
Injection site bruising 10 (6.7)
Headache 8 (5.3)
Back pain 5 (3.3)
Blood creatine phosphokinase increased 5 (3.3)
Injection site hemorrhage 5 (3.3)
Acne 4 (2.7)
Blood testosterone increased 4 (2.7)
Cough 4 (2.7)
Edema peripheral 4 (2.7)
Injection site erythema 4 (2.7)
Prostatitis 4 (2.7)
Urinary tract infection 4 (2.7)
Abdominal pain 3 (2.0)
Arthralgia 3 (2.0)
Fatigue 3 (2.0)
Hematuria 3 (2.0)
Polycythemia 3 (2.0)
Sleep apnea syndrome 3 (2.0)
Note: Includes events that started on or after the first dosing, or existed prior to the first dose and worsened in severity or relatedness after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.

Table 2 summarizes the adverse reactions (≥2%) reported in a 6-month study with XYOSTED.

Table 2: Number (%) of Patients with Adverse Reactions ≥2% in a 6-Month Study with XYOSTED

Preferred Term Overall
(N = 133) n (%)
Hematocrit increased 11 (8.3)
Injection site hemorrhage 8 (6.0)
Blood creatine phosphokinase increased 5 (3.8)
Injection site bruising 5 (3.8)
Prostatitis 4 (3.0)
Prostatic specific antigen (PSA) increased 4 (3.0)
Urinary tract infection 4 (3.0)
Fatigue 3 (2.3)
Hypertension 3 (2.3)
Insomnia 3 (2.3)
Nausea 3 (2.3)
Note: Includes events that started on or after the first dosing, or existed prior to the first dose and worsened in severity or relatedness after dosing. Percentage was calculated using the number of patients in the column heading as the denominator.

BP Increases In The 6-Month Clinical Study

In the 6-month clinical study, 24-hour ambulatory blood pressure monitoring (ABPM) was conducted in 133 patients, 113 of whom completed the study. ABPM was conducted at 3 distinct 24-hour time periods: at Baseline and following 6 and 12 weeks of XYOSTED therapy. A total of 62 patients had acceptable ABPM recordings at baseline and Week 12. In that group, the mean change in systolic BP from baseline to Week 12 was + 3.9 mmHg (95% CI 1.4-6.4) and the mean change in diastolic BP was + 1.5 mmHg (95% CI 0.4-2.6).

Increases In Hematocrit

Increases in hematocrit to ≥55% were reported for 12 of the 283 patients in the 2 clinical studies, representing 4.2% of patients who received XYOSTED for up to one year. While the studies did not pre-define clinical adverse events related to increased hematocrit, polycythemia was reported as a medically significant adverse event in the investigator's clinical judgment in 1.8% of treated patients. XYOSTED dosing resulted in mean hemoglobin increases of 1.0 ± 1.1 g/dL at 6 months and 1.1 ± 1.4 g/dL at 1 year and mean hematocrit increases of 3.8 ± 3.4% at 6 months and 5.4 ± 3.4% at 1 year.

Injection Site Reactions

Injection site reactions, including injection site bruising, injection site hemorrhage, injection site erythema and injection site induration were reported in 36 of the 283 patients in the 2 clinical studies, representing 12.7% of patients who received XYOSTED for up to one year. No patients discontinued XYOSTED because of injection site reactions.

Depression And Suicide Attempts

Depression requiring discontinuation was reported in 2 of the 283 patients in the two clinical studies and suicide attempts (one complete and one incomplete) were reported in 2 additional patients, comprising a total of 4 patients, representing 1.4% of patients who received XYOSTED for up to one year.

Increases In Serum PSA

Increases in serum PSA concentrations, defined as an increase from baseline of at least 1.4 ng/mL, or PSA greater than 4 ng/mL, led to discontinuation in 4.6% of the 283 patients in the 2 clinical studies.

Read the entire FDA prescribing information for Xyosted (Testosterone Enanthate Injection)

© Xyosted Patient Information is supplied by Cerner Multum, Inc. and Xyosted Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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