Application Information

This drug has been submitted to the FDA under the reference 020715/001.

Names and composition

"TRELSTAR" is the commercial name of a drug composed of TRIPTORELIN PAMOATE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
020715/001 TRELSTAR TRIPTORELIN PAMOATE INJECTABLE/INTRAMUSCULAR EQ 3.75MG BASE per VIAL
021288/001 TRELSTAR TRIPTORELIN PAMOATE INJECTABLE/INTRAMUSCULAR EQ 11.25MG BASE per VIAL
022437/001 TRELSTAR TRIPTORELIN PAMOATE INJECTABLE/INTRAMUSCULAR EQ 22.5MG BASE per VIAL

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
020715/001 TRELSTAR TRIPTORELIN PAMOATE INJECTABLE/INTRAMUSCULAR EQ 3.75MG BASE per VIAL
021288/001 TRELSTAR TRIPTORELIN PAMOATE INJECTABLE/INTRAMUSCULAR EQ 11.25MG BASE per VIAL
022437/001 TRELSTAR TRIPTORELIN PAMOATE INJECTABLE/INTRAMUSCULAR EQ 22.5MG BASE per VIAL
208956/001 TRIPTODUR KIT TRIPTORELIN PAMOATE FOR SUSPENSION, EXTENDED RELEASE/INTRAMUSCULAR EQ 22.5MG BASE per VIAL

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Answered questions

Prostate cancer? Has anyone ever taken Trelstar LA?
This is a once every three months shot, to be taken no more than three times. Along with this shot, I must take 500mg calcium and 1000mg of vitiman D. It seems that with more than three shots, brittle bones occur. Asked by Mel Neat 1 year ago.

Trelstar LA is similar to lupron which I took for three years.It is designed to restrict the production of testosterone and has the intended effect of slowing or even( hopefully )stopping the growth of the cancer.Side effects will include hot flashes,enlargement of the breasts,fatigue,muscle soreness,and other side effects commonly associated with hormonal therapies.I also had a "radical"and 44 radiation treatments.My cancer had entered my seminal vesicles.The side effects for me were mild and only occasionally problematic.I would expect the goal of your therapy is somewhat different than mine,given your prognosis,but would also delay considerably the end result.Years,not months or days.I was originally diagnosed in January of 2003. Answered by Lane Iwami 1 year ago.

Hi! I do not have specific answers to your questions but this will help.There are no known cures for cancer. I do have a friend, Herb that is 77 years old that was diagnosed with prostate cancer last year. His PSA was 3,360. Yes this is the highest I have ever heard of. The cancer had metastasized and was in his lungs, bones, spine and lymph nodes. Needless to say the doc said there was nothing to be done, the cancer was everywhere. 1 ½ years later, no treatment other than hormone shots and a product called Immunocal and the cancer is not to be found. The Product Immunocal will help. Immunocal is not a cure. It is clinically proven to raise Glutathione in the body and the body does what it was designed to do - fight off pathogens and diseases. In a nutshell, Glutathione is a molecule found and produced in every cell of the body. It is responsible for the proper functioning of the immune system, detoxification, recycling of antioxidants and several other things. Glutathione is the first line defense against diseases. And along with liver, lungs are the largest user of Glutathione in the body. Best resource of information is in the book "Glutathione (GSH). Your body's most powerful protector" by Jimmy Gutman, MD, researcher and emergency physician. Chapter 5 of this book addresses Cancer and the role of Glutathione in cancer prevention, treatment and recovery. It also explains how to raise Glutathione safely and effectively (there are different ways including taking Immunocal) since you can't get Glutathione in your system by eating Glutathione. Or email me from my profile page if you want more information. I lost my mom to breast cancer in 2000. I didn't know all this back then. I am trying to educate people. Olga Answered by Monroe Martinell 1 year ago.

this is all about donations, undeniable and straightforward. Breast maximum cancers is the tremendous funds maker. are you able to pass into any save and by no ability come across a product with a pink ribbon on it everywhere. Komen has raised a ton of money and presented expertise to the affliction which has helped the analysis of breast maximum cancers sufferers fairly. you may not take something faraway from what they have performed. My project is that even the yank maximum cancers Society which ought to comprise all cancers both also makes use of breast maximum cancers to get maximum individuals of their donations. i turned right into a volunteer for the ACS for 7 years till the disappointment were given to me. If I had volunteered for Strides i'd are growing more beneficial help from them. that's now time to do an same for different cancers. Answered by Shenita Minix 1 year ago.


Trelstar vs lupron, is it true medicare is reimbursing them the same?
or is lupron still higher? Asked by Emogene Mauffray 1 year ago.

Lupron is still higher Answered by Maple Peightal 1 year ago.


Has anyone tried the triptorelin injection?
- did it work (did u get pregnant? - were there any side effects? Asked by Ela Lausen 1 year ago.

This product is still in the clinical trial stage. This is a report of those trials. Contraindications Hypersensitivity Trelstar may cause fetal harm when administered to a pregnant woman. Expected hormonal changes that occur with Trelstar treatment increase the risk for pregnancy loss and fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Trelstar is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Warnings and Precautions Hypersensitivity Reactions Anaphylactic shock, hypersensitivity, and angioedema related to triptorelin administration have been reported. In the event of a hypersensitivity reaction, therapy with Trelstar should be discontinued immediately and the appropriate supportive and symptomatic care should be administered. Transient Increase in Serum Testosterone Initially, triptorelin, like other GnRH agonists, causes a transient increase in serum testosterone levels. As a result, isolated cases of worsening of signs and symptoms of prostate cancer during the first weeks of treatment have been reported with GnRH agonists. Metastatic Vertebral Lesions and Urinary Tract Obstruction Cases of spinal cord compression, which may contribute to weakness or paralysis with or without fatal complications, have been reported with GnRH agonists. Patients with metastatic vertebral lesions and/or with upper or lower urinary tract obstruction should be closely observed during the first few weeks of therapy. Hyperglycemia and Diabetes Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Hyperglycemia may represent development of diabetes mellitus or worsening of glycemic control in patients with diabetes. Monitor blood glucose and/or glycosylated hemoglobin (HbA1c) periodically in patients receiving a GnRH agonist and manage with current practice for treatment of hyperglycemia or diabetes. Cardiovascular Diseases Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men. The risk appears low based on the reported odds ratios, and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice. Laboratory Tests Response to Trelstar should be monitored by measuring serum levels of testosterone periodically or as indicated. Laboratory Test Interactions Chronic or continuous administration of triptorelin in therapeutic doses results in suppression of pituitary-gonadal axis. Diagnostic tests of the pituitary-gonadal function conducted during treatment and after cessation of therapy may therefore be misleading. Adverse Reactions 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 the three Trelstar formulations was evaluated in clinical trials involving patients with advanced prostate cancer. Mean testosterone levels increased above baseline during the first week following the initial injection, declining thereafter to baseline levels or below by the end of the second week of treatment. The transient increase in testosterone levels may be associated with temporary worsening of disease signs and symptoms, including bone pain, neuropathy, hematuria, and urethral or bladder outlet obstruction. Isolated cases of spinal cord compression with weakness or paralysis of the lower extremities have occurred [see Warnings and Precautions (5.3)]. Adverse reactions reported for each of the three Trelstar formulations in the clinical trials, are presented in Table 2, Table 3, and Table 4. Often, causality is difficult to assess in patients with metastatic prostate cancer. The majority of adverse reactions related to triptorelin are a result of its pharmacological action, i.e., the induced variation in serum testosterone levels, either an increase in testosterone at the initiation of treatment, or a decrease in testosterone once castration is achieved. Local reactions at the injection site or allergic reactions may occur. Answered by Cristie Walchak 1 year ago.


Will I ever return to normal, my last radiation treartment was August 8th?
My radiologist says no more radiation in the prostate area. I had 41 treatments, from 5 different angles at 47 seconds each angle. I did the numbers and the are scary: Thats over 2.67 hours.My Oncologist says everything is looking good, although my hemo count shows I'm anemic. I just started Iron... Asked by Lynnette Obin 1 year ago.

My radiologist says no more radiation in the prostate area. I had 41 treatments, from 5 different angles at 47 seconds each angle. I did the numbers and the are scary: Thats over 2.67 hours. My Oncologist says everything is looking good, although my hemo count shows I'm anemic. I just started Iron pills. I went to my GP and he gave me three new pills, one for restless leg syndrome, another for IBS, trying to straighten out my bowels I can't control and a pill for depression. All those seem to help except the IBS, that comes and goes. My radiation burns have finally all peeled off, so I guess the burns on the inside will go away also. I went back to my GP because I'm tired all the time. I get 8 hours sleep each night and after breakfast I'm ready for a nap. My GP took me off blood pressure medicine, 40 mg Lisinopril. After none for 3 days my bp is 105/65. I've had three hormone treatments of Trelstar LA. Hot flashes have stopped, Im just tired. Is the end near? Answered by Enda Kohrt 1 year ago.

In fifth year of survival. Not pleasant.But I made it----and so will you! Welcome back! Answered by Sadie Ingalls 1 year ago.

no you will live many more years even with prostate cancer, its a slow growing cancer and we had a friend that lived over a decade with it....change your diet though...look at prostatecancer.org good site! Good luck and good health.... Answered by Melodi Weder 1 year ago.


Prostate cancer. I was treated with seed implants in Sept 1994?
I PRESENTLY HAVE NO PROBLEMS. MY PROSTATE IS SMALL AND I HAVE BEEN TAKING FLOMAX 4 MG. FOR THE PAST 3 YEARS. I QUIT TAKING THE FLOMAX FOUR DAYS AGO. I FEEL GREAT, NO PROBLEM URINATING, AND BLOOD PRESSURE REMAINS 125/70. ARE THERE ANY REASONS I SHOULD TAKE FLOMAX?I TAKE THE FOLLOWING MEDS: TRELSTAR... Asked by Dori Bonefield 1 year ago.

I PRESENTLY HAVE NO PROBLEMS. MY PROSTATE IS SMALL AND I HAVE BEEN TAKING FLOMAX 4 MG. FOR THE PAST 3 YEARS. I QUIT TAKING THE FLOMAX FOUR DAYS AGO. I FEEL GREAT, NO PROBLEM URINATING, AND BLOOD PRESSURE REMAINS 125/70. ARE THERE ANY REASONS I SHOULD TAKE FLOMAX? I TAKE THE FOLLOWING MEDS: TRELSTAR SHOT EVERY 90 DAYS TENORMIN 50 MG PER DAY VYTORIN 10/40 PER DAY LOTRIN 5/20 ONE AM AND ONE PM 81 MG ASPIRIN 200 MG MAGESIUM CENTRUM 1000 MG OMEGA 3 I AM 70 YEARS OLD AND FAIRLY ACTIVE, BUT NOT ATHLETIC. THANKS Answered by Mozella Laycock 1 year ago.

Wouldn't that be a question for your doctor rather than a bunch of layman? Answered by Noma Cone 1 year ago.

I would seriously investigate whether or not taking Centrum is a good idea with a history of cancer. There are substances in Centrum - albeit in small doses - which are known carcinogens. Check out www.centrumistoxic.com for more information. Answered by Cornelia Schwarzlose 1 year ago.


For men who have had hormone Therapy for cancer, HELP!?
Thank you everyone, I went to my G.P. yesterday and he informed me that my reaction to the hormone shots, Trelstar LA is normal and it will go away when I am taken off hormone therapy. Thanks again Asked by Cristopher Goh 1 year ago.

I have advanced prostate cancer and have completed my external beam radiation, both full pelvic treatment and boost targeting the prostate only. I have had my second hormone shot, every three months, and can't get a straight answer out of either my Urologist or Oncologist. I have hot flashes, as most do, and chills, but my problem is the stickyness. I feel sticky, I feel that I have an odor, my wife insists I don't, and if I lick my fingers, as you might as if you are dealing cards, my fingers stick togeather. I see my GP next week, should I ask him to send me to OB/GYN? I know that sounds silly, a man going to one, but no one else has an answer. Maybe someone who deals with womens problems may have the answer. Have you had this problem? How did you deal with it? Answered by Sharyl Ficenec 1 year ago.

Hello, I have been on Lupron for the past three years and on Casodex for the past two years. I definitely understand the hot flashes, chills and random pain. I haven't felt the stickiness. My family Doctor is a woman and when asked how I was doing I mentioned my nipples hurt. She stated that I had very little Testosterone left in my body so my Estrogen levels are elevated in relation. She stated her nipples hurt also so join the club. It probably couldn't hurt to get the opinion of someone who deals with Women's problems. The problem I have had with the medication is I now have excessively dry skin, am allergic to most soaps and body washes, and the only Stickiness seems to be in the groin area where the thighs meet the hips. Almost like Jock itch. Good luck and hopefully the Doctor will have another idea. Robert T Answered by Kennith Malton 1 year ago.

I also take hormone therapy for breast cancer, the hot flashes are awful. Ive been taking them since Feb. 2007 and i too felt nauseated and sometimes I will now. The tell me that this is normal and will eventually pass. I have been put on anti-depressant to help with the hot flashes. Not sure if it works, they also say the hot flashes will eventually get better. As far as odors, once you have chemo nothing is ever the same. Your sense of smell is greater and sometimes you cant stand certain scents. Also food sometimes taste different now. Frankly I don't think anyone can get a straight answer of their oncologist. I ask questions and never seem to get a straight answer. I also had radiation it made me weak and at times now i feel week. God Bless! Hope things get better for you. I decided that we just have to live and keep on going, because they don't know anything, but trial and error and odds. Answered by Lisha Stackhouse 1 year ago.

Sorry you are having such difficulty. I hope you don't mind me posting here.. the hormone therapy caught my eye because I've used it for cancer though you are probably using different hormones. I just thought I'd say that perhaps some of these things are perceptual changes vs physical ones. I remember my Mom saying that during chemo, foods tasted different.. chocolate and sweet things weren't the same, etc. Good luck. Answered by Aletha Pachelo 1 year ago.


Is a sudden rise in psa levels indicative of spreading cancer?
His psa has always been pretty static after radiotherapy 4/5 years ago, but over last few months it has shot up to nearly 28 from mid-teens. We are waiting for a bone scan to see if the cancer has spread. Could it have spread with no pain anywhere? What are the options? It is all quite frightening - he is... Asked by Tobie Orbeck 1 year ago.

His psa has always been pretty static after radiotherapy 4/5 years ago, but over last few months it has shot up to nearly 28 from mid-teens. We are waiting for a bone scan to see if the cancer has spread. Could it have spread with no pain anywhere? What are the options? It is all quite frightening - he is 71. Any info in words of one syllable would be appreciated. Answered by Ronda Wacht 1 year ago.

Unfortunately, this usually suggests growth of the cancer, though any spread may not be detectable at this time. A bone scan is a logical next step. If it shows disease, and assuming he is not on any other therapy, his options generally are: 1) Clinical trial 2) GnRH agonist like Lupron or Trelstar If he is on Lupron or similar shot, then the addition of an anti-androgen like Casodex is usually next step (again, outside of a clinical trial option). If his PSA is higher, but NO evidence of disease spread can be found, then it is perfectly resaonable to just watch. Why? Wouldn't starting therapy now possibly prevent something? Well, maybe, but also it may be a year or more before any disease pops up. If he has side effects from the shot he will be enduring those for nothing till then, so it is a trade-off. In my experience most men succumb to "PSA anxiety" and want to do something, not watch. In any case, he may go years with successful Lupron-type therapy and do very well. Blessings Answered by Waldo Noegel 1 year ago.

Increasing PSA can indicate reoccurrence of cancer in the prostate, or spread of cancer to other areas of the body, most frequwntly the bones. It can also be elevated by infection of the prostate as well. Early spread could happen without pain symptoms in the bones. If the cancer is still located just in the prostate, surgery might be an option. If ti has already spread to the bones, there are a couple medications that can slow the growth of the tumors. hope this helps, and good luck! Answered by Patria Hanzlik 1 year ago.

Rising PSA indicates that the cancer has spread. Continue with all tests and treatments. Treatment will address quality of life issues. Do not give up hope. Keep fighting. He has not failed until he stops trying. Answered by Cheryl Marchell 1 year ago.

It could have spread, but one spike in PSA means nothing and bone scans are horrible. around 60 % accurate. check another PSA and get Pet/CT if a second is abnormal. Answered by Douglass Shauf 1 year ago.


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