So finally after much deliberation , decided to start dad on Relugolix. Since a few months a reputed indian Pharma company is making it too and it is quite reasonable but since it is still relatively new , I am a little nervous if it will be effective.
I am doing a baseline testosterone test for dad today. When is the earliest I should retest the testosterone to see if this indian brand of relugolix is being effective ?
One week is too less or doable ?
i may get the imported orgovyx here too but that is much more expensive.
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Tinkudi
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Relugolix works very rapidly when stated with the loading dose (2-3X) and Testosterone should be substantially reduced within a few days. So one week may indicate if it is the real deal. 2 weeks may be even better. It is not a molecule easy to reproduce so would be skeptical about a new generic. Can they send you a small quantity to test at a low price?
An Indian company is making it since January 2024. Selling it as relugolix itself. It’s not expensive here - around 90 dollars for 30 tablets. I have bought one bottle and done a baseline testosterone and will do the next after around 10-12 days Do you know appx how much should T fall by then to see if it is proving efficacy ?
Btw , do you know if loading dose is necessary or can one just take one and continue. Since dad is 83 giving 3 together is making me little nervous. I am assuming if we don’t do loading dose , the T would go down slower ?
It has a half life of 25 hours, consequently, after one week it will have achieved, within few percents off 100%, it's steady state concentration without front loading. Adapting my experience with Bicalutamide, which has a half life of 6-7 days and also the fact that I was measuring PSA and not T that you will do (there is a couple of days. worth of delay for the cells to react to the T decline and register a PSA decline), my very wild gestimate is that at 10-12 days your dad's total T must have declined by at least 90%.
wow your comment came just when I am about to give first dose of relugolix to dad.
So basically you are saying that giving 3 upfront and then 1 daily or giving 1 daily from the start will not make much of a difference right. How about if I give 2 on day 1 instead of 3
By starting with just one, the concentration on day #1 will be ~48%. It goes without saying that for two this jumps up to 96% and for three 144%, provided all taken at the same time. I wouldn't go for three as this is more than 100%. Two is ok and if staggered (take one and the second after 12 hours) so much the better. But, if it were for me I would have gone without front loading.
No, it is the opposite. Decreases the peak concentration, because at the time the second is given the first one has already decayed by some. The idea is not to give a sock-dose but ramp it up as smoothly as possible. Nature doesn't like socks.
No much difference than giving the three at the same time. One hour is too short a period to have some reasonable decay of the earlier two. If you noticed, I proposed a staggering period of 12 hours. This wasn't at random.
The prescription is for one daily and at the same time. This is the long term dosage. The additional one is a one-off. Scheduling it at 12 hours places it equidistantly from the long term ones, hence, lower peak concentration.
How do you drive your car? Do you step on the pedal to hear the wheels squeak? Or you accelerate smoothly? The final speed will be the same, but the stress imposed on the mechanical parts way different. Do you regard your dad as more durable compared to your car?
I routinely test for testosterone with every blood draw which includes the CMP and CBC tests along with PSA testing. These are all important to track while on ADT meds.
CMP = Complete Metabolic Panel. The reason for this test is that ADT meds can play havoc with one's metabolic system. Metabolic Syndrome is a common result of losing testosterone through ADT treatment. Right now my blood draws are done every three months. I am on both Orgovyx and Xtandi.
If he is not seeing a PCa specialist, please try to find one. Every man's body and response to Orgovyx/Relugolix will vary slightly, but again follow the dosing guidelines.
The original manufacturer funded the HERO study:
Results: A total of 622 patients received relugolix and 308 received leuprolide. Of men who received relugolix, 96.7% (95% confidence interval [CI], 94.9 to 97.9) maintained castration through 48 weeks, as compared with 88.8% (95% CI, 84.6 to 91.8) of men receiving leuprolide. The difference of 7.9 percentage points (95% CI, 4.1 to 11.8) showed noninferiority and superiority of relugolix (P<0.001 for superiority). All other key secondary end points showed superiority of relugolix over leuprolide (P<0.001). The percentage of patients with castrate levels of testosterone on day 4 was 56.0% with relugolix and 0% with leuprolide. In the subgroup of 184 patients followed for testosterone recovery, the mean testosterone levels 90 days after treatment discontinuation were 288.4 ng per deciliter in the relugolix group and 58.6 ng per deciliter in the leuprolide group. Among all the patients, the incidence of major adverse cardiovascular events was 2.9% in the relugolix group and 6.2% in the leuprolide group (hazard ratio, 0.46; 95% CI, 0.24 to 0.88). (SOURCE= pubmed.ncbi.nlm.nih.gov/324....
If able, always test PSA and testosterone together. I may have missed it but I didn't see the starting PSA nor your father's health, stage of PCa. I would wait two weeks for the testing.
Now 76, I was diagnosed at age 48 when it was already in a few lymph nodes. My treatments have varied throughout the disease. Eventually, Orgovix will fail and you will need to add Extandi (enzalutamide) under a doctor's supervision, which has a bigger impact on the quality of life. If those side effects become too much to bear, studies show that half-dosing is nearly as effective for metastases (from 4 pills to 2). It is insanely expensive ($1,000 per day!) and you will need the manufacturer's financial support. But it is working well for me at the moment.
I'm new here so I missed your father's profile, age 83 etc. By all means, get a new doctor. When there are metastases, you have to get aggressive in treatment immediately. See my post, please.
Tinkudi, I believe testing for PSA level—not testosterone —is what most MOs are interested in. It gives a better tell on how active the PCa is, as I understand it—am not a doctor.
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