Rosconow
Well-known 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.
MESO-Rx
Anabolic Steroids
Injecting testosterone subcutaneously
- Thread starter frankwhardy
- Start date
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.
Holidaypay
Well-known 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
I think it depends on carrier oil also. going to try with mct keep you posted
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.
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.
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
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
[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
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
[OA] Safety of a New Subcutaneous Testosterone Enanthate Auto-Injector: Results of a 26-Week Study
Introduction - Patients with testosterone deficiency (TD) can be treated with exogenous testosterone (T) to achieve and maintain physiologic T levels and prevent negative clinical symptoms; with many testosterone replacement therapies currently available, this registration safety study was conducted to further characterize the clinical profile of chronically administered, concentration-guided subcutaneous testosterone enanthate (TE) dosing.
Aim - The purpose of this study was to confirm the safety and characterize the pharmacokinetic (PK) profile of the subcutaneous TE auto-injector (SCTE-AI) in adult men with TD.
Methods - In this phase III, 26-week study, 133 men 18−75 years of age with symptomatic TD self-administered SCTE-AI 75 mg once weekly for 6 weeks from July 2015 to June 2016. Dosing was adjusted when indicated to 50 mg or 100 mg to maintain T trough levels between 350 and 650 ng/dL (12.1−22.5 nmol/L).
PK data were collected from a subgroup of patients receiving 75 mg SCTE-AI through week 12. Safety, including ambulatory blood pressure monitoring (ABPM), lipid levels, and adverse drug reactions, and PK were assessed.
Main Outcome Measures - The main outcomes were the documentation of the reproducibility of trough concentration-guided exposure to SCTE, 6-month safety profile, and PK data for the 75 mg dose SCTE.
Results - In total, 34 patients (25.6%) experienced adverse drug reactions; the most frequently reported were
· increased hematocrit (≥52%) in 10 patients (7.5%),
· injection-site hemorrhage in 6 patients (4.5%),
· injection-site bruising in 4 patients (3.0%), and
· increased prostate-specific antigen in 4 patients (3.0%).
By week 26, mean systolic and diastolic blood pressure (BP) measured in the clinic increased by 3.4 mmHg (125.6−129.0 mmHg) and 1.8 mmHg (78.2−80.0 mmHg), respectively, from baseline.
At week 12, ABPM showed 24-hour mean systolic and diastolic BP increases of 3.7 mmHg and 1.3 mmHg, respectively. All measured lipid fractions were below baseline levels at week 26. T, TE, dihydrotestosterone, and estradiol increased from weeks 1−12. T trough levels ranged from 300−650 ng/dL (10.4−22.5 nmol/L) in 82.4% and 83.2% of patients at weeks 12 and 26, respectively. Of the 965 assessed injections, mild pain was reported by 1 patient.
Clinical Implications - Dosing with SCTE is well-tolerated overall, yet associated with a numerically small mean systolic BP increase.
Strengths & Implications - This study used a standardized ABPM protocol, confirming a numerically small systolic BP increase may be associated with reintroducing therapeutic T exposure in hypogonadal men. It is unknown at this time whether this applies with all routes of T supplementation.
Conclusion - SCTE-AI has a favorable safety profile and is well-tolerated, with a stable PK profile.
Gittelman M, Jaffe JS, Kaminetsky JC. Safety of a New Subcutaneous Testosterone Enanthate Auto-Injector: Results of a 26-Week Study. J Sex Med 2019. https://www.jsm.jsexmed.org/article/S1743-6095(19)31376-1/fulltext
Introduction - Patients with testosterone deficiency (TD) can be treated with exogenous testosterone (T) to achieve and maintain physiologic T levels and prevent negative clinical symptoms; with many testosterone replacement therapies currently available, this registration safety study was conducted to further characterize the clinical profile of chronically administered, concentration-guided subcutaneous testosterone enanthate (TE) dosing.
Aim - The purpose of this study was to confirm the safety and characterize the pharmacokinetic (PK) profile of the subcutaneous TE auto-injector (SCTE-AI) in adult men with TD.
Methods - In this phase III, 26-week study, 133 men 18−75 years of age with symptomatic TD self-administered SCTE-AI 75 mg once weekly for 6 weeks from July 2015 to June 2016. Dosing was adjusted when indicated to 50 mg or 100 mg to maintain T trough levels between 350 and 650 ng/dL (12.1−22.5 nmol/L).
PK data were collected from a subgroup of patients receiving 75 mg SCTE-AI through week 12. Safety, including ambulatory blood pressure monitoring (ABPM), lipid levels, and adverse drug reactions, and PK were assessed.
Main Outcome Measures - The main outcomes were the documentation of the reproducibility of trough concentration-guided exposure to SCTE, 6-month safety profile, and PK data for the 75 mg dose SCTE.
Results - In total, 34 patients (25.6%) experienced adverse drug reactions; the most frequently reported were
· increased hematocrit (≥52%) in 10 patients (7.5%),
· injection-site hemorrhage in 6 patients (4.5%),
· injection-site bruising in 4 patients (3.0%), and
· increased prostate-specific antigen in 4 patients (3.0%).
By week 26, mean systolic and diastolic blood pressure (BP) measured in the clinic increased by 3.4 mmHg (125.6−129.0 mmHg) and 1.8 mmHg (78.2−80.0 mmHg), respectively, from baseline.
At week 12, ABPM showed 24-hour mean systolic and diastolic BP increases of 3.7 mmHg and 1.3 mmHg, respectively. All measured lipid fractions were below baseline levels at week 26. T, TE, dihydrotestosterone, and estradiol increased from weeks 1−12. T trough levels ranged from 300−650 ng/dL (10.4−22.5 nmol/L) in 82.4% and 83.2% of patients at weeks 12 and 26, respectively. Of the 965 assessed injections, mild pain was reported by 1 patient.
Clinical Implications - Dosing with SCTE is well-tolerated overall, yet associated with a numerically small mean systolic BP increase.
Strengths & Implications - This study used a standardized ABPM protocol, confirming a numerically small systolic BP increase may be associated with reintroducing therapeutic T exposure in hypogonadal men. It is unknown at this time whether this applies with all routes of T supplementation.
Conclusion - SCTE-AI has a favorable safety profile and is well-tolerated, with a stable PK profile.
Gittelman M, Jaffe JS, Kaminetsky JC. Safety of a New Subcutaneous Testosterone Enanthate Auto-Injector: Results of a 26-Week Study. J Sex Med 2019. https://www.jsm.jsexmed.org/article/S1743-6095(19)31376-1/fulltext
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