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IMPORTANT SAFETY INFORMATION1
IMPORTANT SAFETY INFORMATION1
LUPRON DEPOT® is not for people who have had any type of allergic reaction to LUPRON DEPOT or similar drugs. LUPRON DEPOT causes an increase in testosterone during the first few weeks of therapy.
Research Data Missing For Decades Raise Concerns On Morning Sickness Drug
Adverse event reports are effective at flagging simple conditions that doctors recognize as an immediate consequence of taking a drug, such as vomiting or nausea. They are less prone to be filed and less effective at identifying longer-range problems, according to critics of the FDAs oversight of approved drugs.
As a parent, I kick myself, says Jeanne Walsh, a Temecula, Calif., resident who filed an adverse event report years ago, as did several other mothers interviewed recently for this story because their children took Lupron. Walshs daughter took Lupron for precocious puberty and now struggles with fibromyalgia and has had jaw-joint surgery. What was I thinking?
In 1999, the FDA examined 6,000 adverse-event reports about Lupron filed by doctors, patients, and researchers. Although the FDA couldnt locate its 1999 report on the matter, a court document that summarized the findings of the report said it found high prevalence rates for serious side effects including depression, joint pain, and weakness, and noted similar effects in men and women with very different ailments suggested the drug was causing the problems rather than underlying medical conditions.
The FDA made no major change, but reviewed the drug labels to determine whether the side effects were covered.
The settlement resulted in a corporate guilty plea for conspiracy to violate prescribing laws and one of the largest fines at the time $875 million.
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Surgical procedures to remove the diseased prostate are usually necessary. Surgical procedures are not always necessary. If the disease is caused by bacterial infections, a doctor can treat the symptoms using alpha-blockers or surgery. Physical therapy, relaxation exercises, and warm baths are all recommended. A physician may also prescribe antibiotics to cure the infection. A bacterial infection can also cause a recurrence of the condition.
An enlarged prostate can be uncomfortable for both men and women. Some of the symptoms of an enlarged male reproductive organ include a weakened urine stream, urgent need to urinate, and urinary tract infections. BPH can also cause damage to the kidneys. A sudden inability to urinate can be life-threatening, as it can lead to bladder and kidney damage. Unfortunately, most men with enlarged prostrates put up with the symptoms for years before they seek treatment. However, many of the men with symptoms finally decide to go to a doctor for proper gynecological evaluation and to begin enlarged prostatic therapy.
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How Lupron Depot Is Given
LUPRON DEPOT is a prescription medicine that must be administered under the supervision of a physician. Its given as a single intramuscular injection, which means it is injected into one of your muscles, instead of under the skin or into a vein. Your doctor will determine the most appropriate injection site for you.1
Treatment By Stage Of Prostate Cancer
Different treatments may be recommended for each stage of prostate cancer. Your doctor will work with you to develop a specific treatment plan based on the cancers stage and other factors. Detailed descriptions of each type of treatment are provided earlier on this same page. Clinical trials may also be a treatment option for each stage.
Early-stage prostate cancer
Early-stage prostate cancer usually grows very slowly and may take years to cause any symptoms or other health problems, if it ever does at all. As a result, active surveillance or watchful waiting may be recommended. Radiation therapy or surgery may also be suggested, as well as treatment in clinical trials. For those with a higher Gleason score, the cancer may be faster growing, so radical prostatectomy and radiation therapy are often recommended. Your doctor will consider your age and general health before recommending a treatment plan.
ASCO, the American Urological Association, American Society of Radiation Oncology, and the Society of Urologic Oncology recommend that patients with high-risk early-stage prostate cancer that has not spread to other areas of the body should receive radical prostatectomy or radiation therapy with hormonal therapy as standard treatment options.
Locally advanced prostate cancer
Watchful waiting may be considered for older adults who are not expected to live for a long time and whose cancer is not causing symptoms or for those who have another, more serious illness.
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What Is Lupron Depot
LUPRON DEPOT is in the class of hormonal therapy drugs called gonadotropin-releasing hormone agonists .1 While Lupron is not a cure for advanced prostate cancer, you and your doctor may choose LUPRON DEPOT as part of your treatment plan to suppress testosterone that may cause testosterone-dependent prostate cancer cells to grow.1,4
How To Use Lupron Solution
Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using leuprolide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
This medication is given by injection under the skin as directed by your doctor, usually once a day.
In children, the dosage is based on weight and response to treatment. The doctor should consider stopping treatment before age 11 for girls and age 12 for boys. Consult the doctor for details.
If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Learn how to store and discard medical supplies safely.
Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.
Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.
During the first few weeks of treatment, your hormone levels will actually go up before they go down. This is a normal response to this medication. Your symptoms may get worse for a few weeks.
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Why Does Hormone Therapy Cause Side Effects
If testosterone is taken away or blocked by hormone therapy, prostate cancer cells will usually shrink, wherever they are in the body. But reducing or blocking testosterone can cause other things to change in your body too.
Testosterone controls the development and growth of the sexual organs, including the prostate, and affects the way you think and feel. It also controls other male characteristics, such as erections and muscle strength. So when testosterone is reduced, or taken away by hormone therapy, all of these things can change.
The diagram below shows how testosterone affects a man’s body. Knowing this can help you understand what side effects you might get when you’re having hormone therapy.
The side effects of hormone therapy are caused by lowered testosterone levels. Side effects will usually last for as long as you are on hormone therapy. If you stop your hormone therapy, your testosterone levels will gradually rise again and some side effects will reduce. Your side effects wont stop as soon as you finish hormone therapy it may take several months.
Surgery to remove the testicles cant be reversed, so the side effects are permanent. But there are treatments that can help reduce or manage some of the side effects.
Side Effects Of Lupron Injections For Prostate Cancer
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Intermittent Versus Continuous Hormone Therapy
Most prostate cancers treated with hormone therapy become resistant to this treatment over a period of months or years. Some doctors believe that constant androgen suppression might not be needed, so they advise intermittent treatment. This can allow for a break from side effects like decreased energy, sexual problems, and hot flashes.
In one form of intermittent hormone therapy, treatment is stopped once the PSA drops to a very low level. If the PSA level begins to rise, the drugs are started again. Another form of intermittent therapy uses hormone therapy for fixed periods of time for example, 6 months on followed by 6 months off.
At this time, it isnt clear how this approach compares to continuous hormone therapy. Some studies have found that continuous therapy might help men live longer, but other studies have not found such a difference.
Risk Of Other Health Problems
Evidence suggests that having hormone therapy might increase the chance of developing heart disease, stroke and type-2 diabetes. There is also some research that suggests having hormone therapy can increase your risk of getting blood clots and anaemia. But more research is needed to help us understand the links between these conditions.
Research shows that hormone therapy can cause:
- an increase in weight, particularly around the waist
- an increase in cholesterol levels
- changes in insulin.
Talk to your hospital doctor and GP about how often you should have general health checks. You may be weighed and have your blood pressure checked regularly. You may also have blood tests to check for diabetes and to measure your cholesterol levels. Your GP may suggest you have these checks about every six months. Or you can ask for them yourself at your GP surgery.
If you already have heart problems or diabetes, talk to your doctor before you start hormone therapy. They will work with you to manage these conditions.
While the risk of getting these conditions may be worrying, its important to remember that hormone therapy helps men to live longer by controlling the cancer.
What can help?
A healthy lifestyle can help reduce your risk of heart disease, stroke and type-2 diabetes. This includes:
- eating a healthy diet
Read more about diet and physical activity.
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Options In Hormone Therapy
Testosterone levels in the body can be reduced either surgically or with drugs. The surgical option is castration, achieved by removing the testicles during a bilateral orchiectomy. Once the only option, it has since been supplanted by drugs that lower testosterone levels to amounts achieved by surgery.
For men, normal testosterone levels range from 300 to 1,000 ng/dl. The FDA requires that any new drug used in hormone therapy for prostate cancer lower testosterone levels to 50 ng/dl or less. In my practice, I usually try to lower levels even further, to 20 ng/dl.
When Is Hormone Therapy Used
Hormone therapy may be used:
- If the cancer has spread too far to be cured by surgery or radiation, or if you cant have these treatments for some other reason
- If the cancer remains or comes back after treatment with surgery or radiation therapy
- Along with radiation therapy as the initial treatment, if you are at higher risk of the cancer coming back after treatment
- Before radiation to try to shrink the cancer to make treatment more effective
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When To Consider Hormone Therapy
Hormone therapy is a treatment option for men with prostate cancer in any of the following situations:
- when cancer has metastasized beyond the prostate
- when cancer is confined to the prostate, but hormone therapy is used to boost the effectiveness of radiation therapy or to shrink the size of a tumor before brachytherapy
- when PSA begins to rise sometime after initial treatment with surgery or radiation therapy, indicating the cancer may have recurred.
Not all doctors agree on when to use hormone therapy, or how to administer it. Indeed, this is an area that requires a physician to exercise as much art as science in clinical practice. You should also be aware that side effects can be daunting, although most men tolerate treatment reasonably well .
How Is Hormone Therapy Used To Treat Hormone
Hormone therapy may be used in several ways to treat hormone-sensitive prostate cancer, including:
Early-stage prostate cancer with an intermediate or high risk of recurrence. Men with early-stage prostate cancer that has an intermediate or high risk of recurrence often receive hormone therapy before, during, and/or after radiation therapy, or after prostatectomy . Factors that are used to determine the risk of prostate cancer recurrence include the grade of the tumor , the extent to which the tumor has spread into surrounding tissue, and whether tumor cells are found in nearby lymph nodes during surgery.
The use of hormone therapy before prostatectomy has not been shown to be of benefit and is not a standard treatment. More intensive androgen blockade prior to prostatectomy is being studied in clinical trials.
Relapsed/recurrent prostate cancer. Hormone therapy used alone is the standard treatment for men who have a prostate cancer recurrence as documented by CT, MRI, or bone scan after treatment with radiation therapy or prostatectomy.
Hormone therapy is sometimes recommended for men who have a “biochemical” recurrencea rise in prostate-specific antigen level following primary local treatment with surgery or radiationespecially if the PSA level doubles in fewer than 3 months.
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Quality Of Life On Hormone Therapy
Here, I’d like to make 2 quick points. First, Id like to mention the general quality of life for those who are taking Lupron. If youre not having any side effects and your PC treatment is working, that is excellent news. If youre suffering from side effects of Lupron, how is your overall quality of life? While the medication is doing its job, is it making your life miserable? From what I have read about Lupron from the men on this site, something is not right. Yes…this medication is saving your life but at what cost?
Secondly, with any medication, you should ask the doctor to tell and explain the side effects. Most medications come with the fold-out sheet, written in 2-font, that is tough on the eyes to read and comprehend, which explains all the side effects. You should ask the doctor about the major side effects and what said medication will do to various aspects of your life . This way, you can make an informed decision and ask about other available treatments.
Removing a piece of a mans sexuality can have major mental and physical repercussions, including an effect on his relationship and lover. From reading the comments here, I read too many times where the lover didn’t want to stay with a man who cannot perform sexually. Treating cancer is one thing, losing a is another.
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Symptomatic treatment of an enlarged prostate usually involves a combination of medication and lifestyle changes. A diet rich in fruits and vegetables may be the best option if you suffer from chronic urination. It will help the body adjust to the increased size of the prostate. Also, taking regular urination intervals will help retrain the bladder to function properly. Inactivity also contributes to urine retention, and cold temperatures can increase the urge to urinate.
Invasive treatment of enlarged prostate includes medication that relieves the pressure on the urethra and bladder. However, if the condition is severe, it may require surgical intervention. If treatment is not successful, the enlarged prostate can become a potentially life-threatening disease. As the hormone levels in the body change, the enlarged prostate can lead to various complications, including urinary retention and even cancer. This is why it is critical to see a doctor for further evaluation.
A physician can recommend a number of treatments to address an enlarged prostate. An enlarged prostate will require surgery to relieve the symptoms. In most cases, surgical treatment for an enlargement of the penis is enough. Moreover, a doctor may recommend a course of treatment based on symptoms. A TURP procedure is not painful and requires less recovery time than open surgery. The recovery period will be shorter and less traumatic.
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What Do I Need To Tell My Doctor Before I Take This Drug
For all patients taking this drug:
- If you are allergic to this drug any part of this drug or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you have unexplained vaginal bleeding.
- If you are pregnant or may be pregnant. Do not take this drug if you are pregnant.
This is not a list of all drugs or health problems that interact with this drug.
Tell your doctor and pharmacist about all of your drugs and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.