Injecting testosterone subcutaneously

Discussion in 'Men's Health Forum' started by frankwhardy, Sep 29, 2005.

  1. Rosconow

    Rosconow Member

    How much volume did you use? Its my understanding not to use more than .5 cc with subq. Small shots, more frequency. So my research is pointing me towards.
     
    Avies48 likes this.
  2. Holidaypay

    Holidaypay Member

    1.5 ml i was aiming for a IM injection but came up a little short that's prob why my experience sucked so much
     
  3. stevonov

    stevonov Member

    I think it depends on carrier oil also. going to try with mct keep you posted
     
  4. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    ANTARES RECEIVES FDA APPROVAL OF XYOSTED™ (testosterone ENANTHATE) INJECTION FOR TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES
    https://www.antarespharma.com/application/files/2715/3835/7488/XYOSTED_FDA_Approval_Final.pdf

    A Novel Subcutaneous Auto Injector Product Approved For Once-Weekly At-Home Therapy

    Antares Pharma, Inc. (NASDAQ: ATRS) today announced the approval of XYOSTED™ (testosterone enanthate) injection by the U.S. Food and Drug Administration (FDA). XYOSTED™ is the first FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable QuickShot® auto injector. XYOSTED™ has been approved in three dosage strengths, 50 mg, 75 mg and 100 mg and is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (see Indications and Usage below).

    BOXED WARNING: BLOOD PRESSURE INCREASES

    · XYOSTED™ can cause blood pressure increases that can increase the risk for major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death, with greater risk for MACE in patients with cardiovascular risk factors or established cardiovascular disease.

    · Before initiating XYOSTED™, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled.

    · Starting approximately 6 weeks after initiating therapy, periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension in patients on XYOSTED™.

    · Re-evaluate whether the benefits of XYOSTED™ outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease while on treatment.

    · Due to this risk, use XYOSTED™ only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.
     
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  5. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    A 52-Week Study of Dose-Adjusted Subcutaneous testosterone Enanthate in Oil Self-Administered via Disposable Auto-injector

    Purpose - This open-label, single-arm, dose-blinded, 52-week, registration-phase study evaluated the efficacy and safety of subcutaneous testosterone enanthate auto-injector (SCTE-AI) administered weekly to men with hypogonadism.

    Methods - Patients (N=150) were initiated on 75 mg SCTE-AI self-administered weekly. Dose adjustments were made at week 7 to 50, 75, or 100 mg testosterone enanthate (TE) based on week 6 total testosterone (TT) trough concentration. If required, dose adjustments continued through the extended treatment phase. Pharmacokinetic (PK) and clinical laboratory parameters, treatment-emergent adverse events (TEAEs), and injection site reactions were captured.

    Results - The primary endpoint was met: 92.7% of patients achieved an average TT concentration of 300–1100 ng/dL (553.3 ± 127.29 ng/dL, mean ± SD) at week 12. A Cmax of <1500 ng/dL was achieved by 91.3% of patients, and no patients had levels >1800 ng/dL at week 12. Mean TT Ctrough was 487.2 ± 153.33 ng/dL at week 52.

    Most patients (>95%) reported no injection-related pain. The most frequently-reported TEAEs were increased hematocrit, hypertension, and increased prostate-specific antigen, which led to discontinuation in 30 men. There were no study drug-related serious AEs.

    Discussion - Dose-adjusted SCTE-AI demonstrated a steady serum TT PK profile, with small peak and trough fluctuations. SCTE-AI was safe, well tolerated, and virtually painless, indicating that SCTE-AI offers a testosterone delivery system that is a convenient weekly option for treatment of testosterone deficiency.

    Kaminetsky JC, McCullough A, Hwang K, Jaffe JS, Wang C, Swerdloff RS. A 52-Week Study of Dose-Adjusted Subcutaneous Testosterone Enanthate in Oil Self-Administered via Disposable Auto-injector. The Journal of urology. https://doi.org/10.1016/j.juro.2018.09.057
     
  6. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    [OA] Pharmacokinetics and Acceptability of Subcutaneous Injection of testosterone Undecanoate

    Context - Can injectable testosterone undecanoate (TU) be administered effectively and acceptably by the subcutaneous route?

    Objective - To investigate the acceptability and pharmacokinetics (PK) of sc injection of TU

    Design - Randomized sequence, cross-over clinical study of sc vs im TU injections.

    Setting - Ambulatory clinic of an academic Andrology centre

    Participants - Twenty men (11 hypogonadal, 9 transmen) who were long-term users of TU injections

    Intervention - Injection of 1000 mg TU (in 4 ml castor oil vehicle) by sc or im route

    Main Outcome Measures - Patient reported Pain, Acceptability and Preference scales. PK by measurement of serum testosterone, dihydrotestosterone (DHT) and estradiol (E2) concentrations with application of population PK methods and dried blood spot (DBS) sampling.

    Results - Pain was greater after sc compared with im injection 24 hour (but not immediately) after injection but both routes were equally acceptable. Ultimately 11 preferred im, 6 preferred sc and 3 had no preference. The DBS-based PK analysis of serum testosterone revealed a later time of peak testosterone concentration after sc vs im injection (8.0 vs 3.3 days) but no significant route differences in model-predicted peak testosterone concentration (8.4 vs 9.6 ng/ml) or mean resident time (183 vs 110 days). The PK of venous serum testosterone, DHT and E2 did not differ according to route of injection.

    Conclusions - We conclude that sc TU injection is acceptable but produces greater pain 24 hours after injection which may contribute to the overall majority preference for the im injection. The PK of testosterone, DHT or E2 did not differ substantially between sc and im routes. Hence while further studies are required, the sc route represents an alternative to im injections without a need to change dose for men where im injection is not desired or recommended.

    Turner L, Ly LP, Desai R, et al. Pharmacokinetics and Acceptability of Subcutaneous Injection of Testosterone Undecanoate. Journal of the Endocrine Society 2019. https://doi.org/10.1210/js.2019-00134