phalloguy100
Active Member
I showed this TRT dosing guideline from the American Urological Association to my doctor. He’s going to look it over and clarify with his testopel rep, because it is clearly much higher starting dosing than the FDA packet insert says. He conceded he hasn’t used brand name testopel because insurance doesn’t like to cover it, so people have to pay out of pocket. He uses compounded pellets that only run around $200-$250 per treatment.
www.auanet.org
Table 2: Dosing Profiles of Testosterone Formulations
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Pharmacokinetics and Pharmacodynamics. The unique pharmacokinetic profile of testosterone pellets is due to their crystalline structure, which dissolves slowly in SQ spaces. Individual pellets consist of 75 mg of testosterone and may be combined to deliver variable doses of testosterone therapy.
Initial pharmacokinetic data were provided by Kaminetsky et al.446 who selected the number of pellets inserted based on testosterone levels and BMI: six pellets for baseline total testosterone level <315 ng/dL and BMI <18.5, eight pellets for BMI 18.5-24.9, 10 pellets for BMI 25-30, and 12 pellets for BMI >30. Men with total testosterone level <225 ng/dL received 10 pellets for BMI <25 and 12 pellets for BMI ≥25. Of the 30 patients enrolled, none met criteria for 6 pellets, and a median of 10 pellets were implanted. Peak total testosterone levels were achieved 1 week after implantation (845 ng/dL) and were conserved until at least week 4 (838 ng/dL), with LH suppressed by week 4. The percentage of men with total testosterone values >315 ng/dL declined from 100% at 4 weeks to 86%, 75%, and 14% by 12, 20, and 24 weeks, respectively.
Mean peak total testosterone levels are dose-dependent, with a mean of 746, 866, and 913 ng/dL noted with 8, 10, and 12 pellets administered (not BMI adjusted).446The duration of effect is similar, however, and is relatively independent of dosing. These findings are supported by a multi-institutional study that reported that with variable dosing and clinical protocols, most men required re-implantation after four months, with all men returning to sub therapeutic levels by six months.447
Based on these initial data, Kaminetsky and colleagues performed a follow-up re-dosing study with 2 fewer pellets administered if peak testosterone levels were >1,000 ng/dL and 2 additional pellets given for testosterone levels <500 ng/dL. With new dosing, mean testosterone levels declined to 275 ng/dL by week 16, with only 32% having levels >315 ng/dL at that time point.
Dosing Strategies. Currently, the FDA recommends placement of two to six pellets every three to six months, which has been the recommendation since the approval of pellets in 1972. These recommendations, however, are not based on current testosterone pellet formulations and contrast with pharmacokinetic data available. Definitive dosing protocols have not been described.446,447, 448
Testosterone levels should be obtained at one to four weeks after insertion.446 These 'peak' levels facilitate adjustment of future pellet number: peak level >1,000 ng/dL, reduce by 2 pellets at next insertion; <500 ng/dL, increase by 2 pellets. Subsequent testosterone levels should be assessed around three months after implantation and re-checked every two to four weeks thereafter if persistently therapeutic levels are found. Although no consensus exists, it is reasonable to perform re-implantation when total testosterone levels are <400 ng/dL. Due to variations within the same individual, it is recommended to obtain end-of-cycle testosterone measurements prior to implantation to ensure that levels are sub-therapeutic.446
Efficacy. Data from a large, multi-institutional series using varied protocols (inserted pellet number ranged from 6 to >10 pellets), demonstrated therapeutic levels in 100% of men at 4 weeks and maintained levels >300 ng/dL at 4 months. It is notable that the majority of providers elected to utilize ≥10 pellets (63%), with 27% of cases including 8-9 pellets, and only 10% of cases using 6-7 pellets. No providers utilized five or fewer pellets, which contrasts with the FDA recommended dosing.221
Adverse Effects. Mild level adverse events specific to SQ pellet insertion includes polycythemia (48-50%), ecchymosis (32-36%), tenderness (20-32%), pain (28-29%), and swelling (16-18%), all of which resolve by 4 months post-insertion.446 Moderate level adverse events were less common (e.g., pain 3%, erythema 3%, ecchymoses 7%) and improved within 1 week. Pellet extrusions are also possible and may be reduced by the use of a V technique whereby 2 channels are created for pellet insertion, thus keeping the most superficial pellet >1cm away from the skin.449 Results of the modified technique resulted in reduced extrusion (7.5% down to 0.8%), infection (5% down to 1.2%), pain (5% down to 1.2%), but an increase in hematoma occurrence (0% up to 1.2%). Of note, hematoma rates were not impacted by the use of anti-coagulants (1.7%), although many practitioners are cautious about pellet use in this population. In one retrospective comparative series, the rate of polycthemia (Hct >52%) with pellets was also higher (13%) than topical gels (5%) but lower than IM testosterone agents (19%) (p=0.03).220”
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Based on those guidelines, I would need to be between 10-12 Testopel pellets! Ouch! I’m not sure I want that many grains of rice under the skin of my butt!!!
Suddenly those subq injections or natesto aren’t sounding so bad anymore…
Testosterone Deficiency Guideline - American Urological Association
Testosterone testing and prescriptions have nearly tripled in recent years; however, it is clear from clinical practice that there are many men using testosterone without a clear indication. AUA identified a need to produce an evidence-based document that informs clinicians on the proper...
www.auanet.org
Table 2: Dosing Profiles of Testosterone Formulations
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“
SUBCUTANEOUS PELLETS
SQ testosterone pellets were initially developed and FDA approved in 1972 and were reformulated in the USA in 2008.Pharmacokinetics and Pharmacodynamics. The unique pharmacokinetic profile of testosterone pellets is due to their crystalline structure, which dissolves slowly in SQ spaces. Individual pellets consist of 75 mg of testosterone and may be combined to deliver variable doses of testosterone therapy.
Initial pharmacokinetic data were provided by Kaminetsky et al.446 who selected the number of pellets inserted based on testosterone levels and BMI: six pellets for baseline total testosterone level <315 ng/dL and BMI <18.5, eight pellets for BMI 18.5-24.9, 10 pellets for BMI 25-30, and 12 pellets for BMI >30. Men with total testosterone level <225 ng/dL received 10 pellets for BMI <25 and 12 pellets for BMI ≥25. Of the 30 patients enrolled, none met criteria for 6 pellets, and a median of 10 pellets were implanted. Peak total testosterone levels were achieved 1 week after implantation (845 ng/dL) and were conserved until at least week 4 (838 ng/dL), with LH suppressed by week 4. The percentage of men with total testosterone values >315 ng/dL declined from 100% at 4 weeks to 86%, 75%, and 14% by 12, 20, and 24 weeks, respectively.
Mean peak total testosterone levels are dose-dependent, with a mean of 746, 866, and 913 ng/dL noted with 8, 10, and 12 pellets administered (not BMI adjusted).446The duration of effect is similar, however, and is relatively independent of dosing. These findings are supported by a multi-institutional study that reported that with variable dosing and clinical protocols, most men required re-implantation after four months, with all men returning to sub therapeutic levels by six months.447
Based on these initial data, Kaminetsky and colleagues performed a follow-up re-dosing study with 2 fewer pellets administered if peak testosterone levels were >1,000 ng/dL and 2 additional pellets given for testosterone levels <500 ng/dL. With new dosing, mean testosterone levels declined to 275 ng/dL by week 16, with only 32% having levels >315 ng/dL at that time point.
Dosing Strategies. Currently, the FDA recommends placement of two to six pellets every three to six months, which has been the recommendation since the approval of pellets in 1972. These recommendations, however, are not based on current testosterone pellet formulations and contrast with pharmacokinetic data available. Definitive dosing protocols have not been described.446,447, 448
Testosterone levels should be obtained at one to four weeks after insertion.446 These 'peak' levels facilitate adjustment of future pellet number: peak level >1,000 ng/dL, reduce by 2 pellets at next insertion; <500 ng/dL, increase by 2 pellets. Subsequent testosterone levels should be assessed around three months after implantation and re-checked every two to four weeks thereafter if persistently therapeutic levels are found. Although no consensus exists, it is reasonable to perform re-implantation when total testosterone levels are <400 ng/dL. Due to variations within the same individual, it is recommended to obtain end-of-cycle testosterone measurements prior to implantation to ensure that levels are sub-therapeutic.446
Efficacy. Data from a large, multi-institutional series using varied protocols (inserted pellet number ranged from 6 to >10 pellets), demonstrated therapeutic levels in 100% of men at 4 weeks and maintained levels >300 ng/dL at 4 months. It is notable that the majority of providers elected to utilize ≥10 pellets (63%), with 27% of cases including 8-9 pellets, and only 10% of cases using 6-7 pellets. No providers utilized five or fewer pellets, which contrasts with the FDA recommended dosing.221
Adverse Effects. Mild level adverse events specific to SQ pellet insertion includes polycythemia (48-50%), ecchymosis (32-36%), tenderness (20-32%), pain (28-29%), and swelling (16-18%), all of which resolve by 4 months post-insertion.446 Moderate level adverse events were less common (e.g., pain 3%, erythema 3%, ecchymoses 7%) and improved within 1 week. Pellet extrusions are also possible and may be reduced by the use of a V technique whereby 2 channels are created for pellet insertion, thus keeping the most superficial pellet >1cm away from the skin.449 Results of the modified technique resulted in reduced extrusion (7.5% down to 0.8%), infection (5% down to 1.2%), pain (5% down to 1.2%), but an increase in hematoma occurrence (0% up to 1.2%). Of note, hematoma rates were not impacted by the use of anti-coagulants (1.7%), although many practitioners are cautious about pellet use in this population. In one retrospective comparative series, the rate of polycthemia (Hct >52%) with pellets was also higher (13%) than topical gels (5%) but lower than IM testosterone agents (19%) (p=0.03).220”
————————————-
Based on those guidelines, I would need to be between 10-12 Testopel pellets! Ouch! I’m not sure I want that many grains of rice under the skin of my butt!!!
Suddenly those subq injections or natesto aren’t sounding so bad anymore…
