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Common Questions

If you have questions about endometriosis and Lupron Depot®, the following information may help you get the answers you seek. Please note that these answers are not meant to replace the advice and care of a doctor. Talk to your doctor if you have any further questions.

Questions About Endometriosis

1) What is endometriosis?
2) What causes endometriosis?
3) What are the symptoms of endometriosis?
4) Who gets endometriosis?
5) How is endometriosis diagnosed?
6) How is endometriosis treated?
7) If I have a laparoscopy for endometriosis, do I need any other treatment?
8) Is using a GnRHa for first-line therapy before doing a laparoscopy effective treatment for endometriosis?
9) If oral contraceptives are not working as treatment for my chronic pelvic pain, can GnRHa therapy work?
10) Is there a cure for endometriosis?

Questions About Lupron Depot

11) What is Lupron Depot?
12) How does Lupron Depot work?
13) Is treatment with Lupron Depot effective?
14) Does treatment with Lupron Depot last?
15) If I am feeling better should I complete a full course of Lupron Depot therapy?
16) What are some of the side effects of Lupron Depot?
17) What is add-back therapy?
18) Should I be concerned about bone density loss with Lupron Depot?
19) What happens if I miss an appointment?
20) Can I get pregnant while taking Lupron Depot?
21) If my pain returns, can I repeat Lupron Depot therapy?


Questions About Endometriosis

1) What is endometriosis?

Endometriosis occurs when endometrial tissue, the tissue that lines the uterus and is shed during menstruation, grows outside of the uterus— on the ovaries, fallopian tubes, ligaments supporting the uterus, and other areas in the pelvic cavity. Endometriosis can also appear in a woman’s bladder, bowel, vagina, or other places in her body.

Like the lining of the uterus, these areas of endometriosis respond to the hormones of the menstrual cycle—they build up tissue each month, then break down and bleed during menstruation. But unlike the uterus lining, when these endometrial growths outside the uterus bleed, they can cause irritation, inflammation, and scarring.

2) What causes endometriosis?

Despite continued medical research and investigation, the exact cause of endometriosis is unclear. But, there are several theories including:

The Retrograde Menstruation Theory

This is the most widely accepted theory for the cause of endometriosis. During "retrograde menstruation," a woman’s menstrual flow backs up through her fallopian tubes, implants in her abdomen, and grows. Some experts believe that all women experience retrograde menstruation, but that women with endometriosis may have either a hormonal or an immune system problem, and as a result, the implants are allowed to grow.

The Genetic Predisposition Theory

This theory suggests that endometriosis may be inherited—a woman who has female relatives with endometriosis may be more likely to develop the condition herself.

Other Theories

Another theory suggests that endometrial tissue is distributed from a woman’s uterus to other parts of her body by the blood or the lymphatic system.

Yet another theory suggests that endometriosis is caused by coelemic metaplasia or cells transforming into endometrial cells, perhaps after stimulation by menstrual blood.

3) What are the symptoms of endometriosis?

Some of the most common signs and symptoms of the disease are:

It is also important to know that the amount of pain a woman may experience is not related to the number or size of her endometrial growths. Some women with visible disease at laparoscopy have no pain, while others without visible disease experience severe pain.

4) Who gets endometriosis?

Endometriosis affects women of all racial backgrounds, reproductive age, and all educational and income levels.

5) How is endometriosis diagnosed?

Endometriosis can be diagnosed through a procedure called laparoscopy. During this outpatient surgical procedure, a slender light-transmitting tube is inserted into a woman’s abdomen through her navel. This procedure lets the doctor examine the condition of a woman’s abdominal organs and check for the presence, the size, and location of endometrial growths. If a doctor sees any growths, he or she may treat them surgically. However, growths may be hidden. A woman can have few visible lesions and experience severe pain, or have many visible lesions and feel little or no pain.

Many doctors rely on a history of a woman’s symptoms and a clinical workup using a 3-month trial of a GnRH agonist (GnRHa) such as Lupron Depot to diagnose suspected endometriosis. Often this is all the doctor needs to make a diagnosis and then continue with GnRHa therapy—without laparoscopic surgery.

6) How is endometriosis treated?

A doctor may recommend treating endometriosis with surgical therapy (surgically removing or destroying growths or lesions), or medical therapy (reducing growth size and providing symptom relief). In some cases, a doctor may suggest a combination of surgical and medical therapy. See question 7, below.

To surgically remove endometrial growths, a doctor will usually perform a procedure called laparoscopy. During laparoscopy, a slender, light-transmitting tube is inserted into a woman’s abdomen through her navel. The laparoscope allows doctors to see the size and extent of endometrial growths, and to remove as many of them as possible.

Medical therapy with a GnRH agonist (GnRHa) such as Lupron Depot temporarily lowers the levels of estrogen in a woman’s body. Lupron Depot reduces endometriotic growths, and may provide pain relief. GnRHa can be used either with or without surgery, and can be effective regardless of whether a woman has few visible lesions or many.

7) If I have a laparoscopy for endometriosis, do I need any other treatment?

Doctors often prescribe medical therapy such as Lupron Depot following laparoscopy. This is because even the most skilled surgeon may not be able to remove all endometrial growths due to their size, depth, and location. Over time, the growths may recur, causing a return of the same symptoms that led to the original surgery. Lupron Depot not only relieves symptoms, but also works to reduce the size of endometrial growths. This is particularly important in cases where the doctor can’t treat them during surgery. GnRH agonist (GnRHa) therapy can treat lesions remaining after surgery, potentially extending a symptom-free phase.

8) Is using a GnRHa for first-line therapy before doing a laparoscopy effective treatment for endometriosis?

Yes. Doctors can also begin treatment with a GnRH agonist (GnRHa) such as Lupron Depot based on symptomology. During this time, a doctor starts you on a 3-month trial of Lupron Depot to treat suspected endometriosis. If it is working to manage the disease, the doctor may continue with an entire 6-month regimen.

9) If oral contraceptives are not working as treatment for my chronic pelvic pain, can GnRHa therapy work?

Doctors commonly treat chronic pelvic pain with oral contraceptives. In many cases, this method of therapy is successful. Lupron Depot works differently than birth control pills. If oral contraceptives do not ease or eliminate endometriosis pain, it may be because your endometriosis does not respond to this type of hormonal manipulation. If birth control pills fail to control your endometriosis, ask your doctor about Lupron Depot.

If you have been using oral contraceptives for more than 3 months without feeling relief, it may be time to discuss other treatment options such as Lupron Depot with your doctor.

10) Is there a cure for endometriosis?

Unfortunately, even after apparently successful treatment of endometriosis, recurrence of pain is common. Surgical removal of endometriosis may relieve symptoms for a while, but the hormones that regulate a woman’s period will continue to trigger the existing endometrial growths and any new ones.

Treatment with a GnRH agonist (GnRHa) such as Lupron Depot may alleviate symptoms of endometriosis for a long period of time.

Questions About Lupron Depot

11) What is Lupron Depot?

Lupron Depot belongs to a class of drugs called gonadotropin-releasing hormone agonists (GnRHa). It is the number one prescribed* drug in its class, and has been used to manage endometriosis for more than a decade.

Lupron Depot is available as an injection, to be given to you by your doctor. It can be given once every 3 months (11.25 mg) or once each month (3.75 mg) for a 6-month treatment period.

12) How does Lupron Depot work?

Lupron Depot works to manage endometriosis by lowering your hormone levels. It is this lowering of hormone levels that decreases endometrial growths and provides symptom relief.

13) Is treatment with Lupron Depot effective?

Lupron Depot may be very effective in reducing the pain associated with endometriosis. In fact, after completing a full 6-month course of therapy, 96% of patients reported no painful periods (dysmenorrhea), 66% reported no pelvic tenderness, and 53% reported no pelvic pain. Individual results may vary.

14) Does treatment with Lupron Depot last?

Symptom relief may extend well beyond the treatment period for many women. In women who completed the 12-month follow-up after the end of Lupron Depot therapy, 76% of patients previously reporting painful sexual intercourse (dyspareunia) were still symptom-free. Of women who had pelvic tenderness before using Lupron Depot, 61% were symptom-free after a year. Over half the women with pelvic pain were symptom-free a year after Lupron Depot therapy.

15) If I am feeling better should I complete a full course of Lupron Depot therapy?

In order to determine whether or not Lupron Depot is going to work for you, your doctor may recommend a trial of therapy for 3 months. If it is working for you, he or she may have you complete the entire 6-month regimen.

It is important that you complete the full course of Lupron Depot therapy that your doctor prescribes for up to 6 months. Research has shown that 6 months of Lupron Depot therapy offers effective, long-lasting relief from the symptoms of endometriosis.

16) What are some of the side effects of Lupron Depot?

Lupron Depot works by significantly lowering the level of estrogen that the ovaries produce. This effect is reversible after the treatment course is completed. The low estrogen levels can result in side effects, including:

You may also experience a light period or spotting, but most women will have complete absence of menstruation after the second month of therapy.

Side effects that may be experienced during the 6 months of therapy should diminish soon after therapy ends. For example, your monthly period should return within two months after you have stopped Lupron Depot, and bone mineral loss experienced during therapy may be partially or completely recovered after you stop taking Lupron Depot.

If you are concerned about the side effects of Lupron Depot, add-back therapy can help. See question 17, below.

17) What is add-back therapy?

Add-back therapy is a pill (norethindrone acetate 5 mg daily) that adds back low levels of a hormone without interfering with the effectiveness of Lupron Depot. It reduces the bone density loss associated with the use of Lupron Depot. It can also reduce hot flashes.

When you discuss Lupron Depot as a treatment option, make sure to ask your doctor about whether add-back therapy is appropriate for you.

18) Should I be concerned about bone density loss with Lupron Depot?

A small amount of bone density loss may occur during Lupron Depot therapy. This may be partially or completely recovered after you stop therapy.

If bone density loss is a particular concern, or if your family has a history of osteoporosis, talk with your doctor about add-back therapy (see question 17, above). In clinical studies, Lupron Depot plus norethindrone acetate 5 mg daily was proven effective in significantly reducing bone density loss as compared to Lupron Depot treatment alone.

19) What happens if I miss an appointment?

Getting your Lupron Depot injection as scheduled is important. Missing an injection by a couple of days should not disrupt the overall benefits of the treatment, but maintaining a consistent schedule is an important part of your therapy. Missing successive doses may cause breakthrough bleeding or ovulation. Because it is possible to become pregnant while on Lupron Depot, if you are sexually active, it is necessary to use a nonhormonal contraceptive to prevent pregnancy (see question 20, below). If you are not already on the 3-month dose of Lupron Depot, ask your doctor to consider this option.

20) Can I get pregnant while taking Lupron Depot?

Lupron Depot is not a contraceptive. Even though your periods may stop completely during your treatment with Lupron Depot, you can still become pregnant. If you are sexually active, be sure to use a nonhormonal birth control method, such as a condom, diaphragm with contraceptive jelly, or an IUD, to prevent pregnancy. If you think that you have become pregnant while on Lupron Depot, talk with your doctor immediately.

21) If my pain returns, can I repeat Lupron Depot therapy?

If your symptoms return after you stop using Lupron Depot, your doctor can prescribe an additional 6 months of treatment along with add-back therapy.





* Based on IMS Health, DDD™ and NDC Health, NDC Non-Retail™, February 2004 for the U.S. market.

IMS Health, DDD™ and NDC Health, NDC Non-Retail™ are not trademarks of TAP Pharmaceutical Products Inc.

Please see below for important information on Lupron Depot®, including side effects.

*Norethindrone acetate 5mg daily


 

Important Safety and Other Information:

Lupron Depot® is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions. Lupron Depot with norethindrone acetate 5 mg daily is also indicated for initial management of endometriosis and for management of recurrence of symptoms. Duration of initial treatment or retreatment should be limited to 6 months.

Most common side effects with Lupron Depot are generally those related to low estrogen levels, including hot flashes, headaches, and vaginal dryness. A small amount of bone loss (average 3.2% at month 6) may also occur during therapy with Lupron Depot alone.

The most commonly reported side effects of Lupron Depot plus norethindrone acetate 5 mg daily are hot flashes, headache, nausea/vomiting, depression/emotional liability, and asthenia. In addition, Lupron Depot plus norethindrone acetate-treated patients had significantly decreased HDL levels and significantly increased LDL/HDL rations. After treatment, mean serum lipid levels in patients with follow-up data returned to pretreatment values. Norethindrone acetate should be used with caution in women with cardiovascular risk factors including lipid abnormalities and cigarette smoking. Please refer to the norethindrone acetate prescribing information for warnings, precautions, contraindications, and adverse reactions.

Please see Complete Prescribing Information, as well as the Patient Product Information for Lupron Depot.

 
©2007, 2008 Abbott Laboratories, Abbott Park, Illinois, U.S.A.