important information regarding safety update
Important Safety Information|Prescribing Information
Important information regarding safety update

LUPRON DEPOT for Endometriosis

Jump to: Understanding Endometriosis Treatment Options Patient Brochure

Understanding Endometriosis

Learn more about endometriosis, its common symptoms, and how it is treated.

Endometriosis is one of the most common gynecological disorders, affecting approximately 10% of all women in their childbearing years2,3

It's not clear why endometriosis occurs, but we can help you understand what happens in your body. Endometriosis occurs when the endometrial lining normally found inside the uterus begins to grow outside the uterus. These growths are called lesions. They may grow on the ovaries, fallopian tubes, or other areas near the uterus. The lesions can bleed and break down each cycle, causing scar tissue and adhesions (scarring that binds tissues together).2,4

Where can endometriosis occur?2,4

the five spots endometriosis can occur on a woman's body within the regions of her back, front and pelvic region

=  Endometrial lesions

1. Ovary

2. Fallopian tube

3. Uterus

4. Bladder

5. Vagina

6. Rectum


Endometrial tissue builds up in the uterus every cycle, but when it grows outside the uterus, it can cause painful symptoms4

Hormones, such as estrogen, can stimulate the growth of endometriosis. When endometrial tissue grows outside the uterus, it reacts to cyclic changes in hormones, but doesn’t necessarily respond the same way normal endometrial tissue inside the uterus does. Unlike the lining inside the uterus that sheds and leaves the body with each menstrual period, endometrial tissue can grow, bleed, and possibly form scar tissue on areas outside the uterus.2,4,5

These events can cause painful endometriosis symptoms, such as4,5:

  • Recurring pelvic pain
  • Painful intercourse
  • Painful and/or heavy periods

Many women with endometriosis have no symptoms.4

How endometrial lesions grow2,4,5

Hormones, including estrogen, are released by the ovaries.

Estrogen causes endometrial tissue to grow.

Endometrial tissue growth can lead to painful symptoms and scarring.

Treatment Considerations

Surgically

Patients with endometriosis may have a surgery called a laparoscopy to diagnose and/or treat their endometriosis. This procedure enables your doctor to examine the condition of the patient's reproductive organs and look for locations of endometriotic lesions. The doctor may also take a tissue sample called a biopsy to confirm the diagnosis.2

During the surgery, a doctor will often remove endometriotic lesions by excision (cutting) or laser ablation (dissolving them with a laser). However, some endometriotic lesions may be hard for doctors to see due to their size, location, or depth, and the patient could continue to experience endometriosis pain.2,6,7

Medically

Many women who have endometriosis initially go to their doctors because of chronic pelvic pain. Your doctor may initially prescribe medications such as contraceptives (OCs) or nonsteroidal anti-inflammatory drugs (NSAIDs) to treat that pelvic pain after ruling out other causes, such as infections.4,5,8

After confirming a diagnosis of endometriosis, your doctor may decide that a gonadotropin-releasing hormone agonist (GnRHa) medication such as LUPRON DEPOT may help relieve your pain.1,5

What is LUPRON DEPOT?

LUPRON DEPOT is a prescription medication for the management of endometriosis, given as an injection by a healthcare professional. It can help relieve the pain of endometriosis and reduce endometriotic lesions.1 LUPRON DEPOT has been prescribed by doctors since 1990.9

LUPRON DEPOT offers 2 different dosing options for treatment, both of which can be combined with Add-back* therapy from day 1 in appropriate patients1:

  • Injected once every 3 months (11.25 mg dose)
  • Injected once each month (3.75 mg dose)

How does LUPRON DEPOT work?

LUPRON DEPOT suppresses the hormones that cause endometrial tissue to grow.1


LUPRON DEPOT therapy suppresses the signals from the pituitary gland in the brain to the ovaries, which stimulate estrogen production.1 By doing this, LUPRON DEPOT injections also suppress the hormones that cause endometriosis to grow. Suppressing the hormones helps1,4:

  • Provide endometriosis pain relief
  • Reduce endometriotic lesions

What can you expect during a 6-month course of LUPRON DEPOT therapy?1,5,10

How do estrogen levels shift over a six-month period of LUPRON DEPOT therapy? When treatment begins in month 1, estrogen levels temporarily increase, which could lead to a temporary worsening of symptoms. From months 2-6 when the period stops, estrogen levels decrease after 1-2 weeks and you start to feel relief from endometriosis pain.
A
Treatment begins
B
Estrogen levels temporarily increase after treatment
C
Increased estrogen levels may temporarily worsen your symptoms
D
Period Stops
E
Estrogen levels decrease after 1 to 2 weeks, and you start to feel relief from endometriosis pain

For illustrative purposes only. Responses may vary in individual patients.

Since ovulation and menstruation usually stop with effective doses of LUPRON DEPOT, you should notify your doctor if regular menstruation persists. If you miss successive doses of LUPRON DEPOT, you may experience breakthrough bleeding. You should notify your doctor immediately if you develop any new or worsened symptoms after beginning LUPRON DEPOT.1

Things to keep in mind

Your estrogen levels will increase for 1 or 2 weeks after beginning LUPRON DEPOT. During this time, you may notice an increase in your current symptoms. You should notify your doctor if you develop any new or worsened symptoms after beginning LUPRON DEPOT treatment.1

LUPRON DEPOT is not a method of birth control. Even though you may not have a period, unprotected intercourse could result in pregnancy. You should use non-hormonal birth control such as condoms, a diaphragm with contraceptive jelly, or a copper IUD to prevent pregnancy. Contact your doctor immediately if you think you may be pregnant.1

Who should not take LUPRON DEPOT?

You should not receive LUPRON DEPOT if you1:

  • Are or may become pregnant
  • Have undiagnosed vaginal bleeding
  • Have experienced any type of allergic reaction to LUPRON DEPOT, or similar drugs
  • Also do not take LUPRON DEPOT 3.75 mg if you are breastfeeding

You should not receive Add-back* plus LUPRON DEPOT if you have or have had any of the following conditions1:

  • Clotting disorder
  • Stroke
  • Impaired liver function or liver disease
  • Breast cancer

Endometriosis pain relief and lesion reduction with LUPRON DEPOT.

LUPRON DEPOT can help reduce endometriosis pain1

By suppressing the hormones that feed endometriosis, LUPRON DEPOT injections can help reduce your endometriosis pain and reduce the size of endometriotic lesions. In 2 studies of women undergoing endometriosis treatment with LUPRON DEPOT 3.75 mg for 6 months, 96% of women had relief from painful periods after their initial 6 months of therapy. Many also experienced relief from painful intercourse, pelvic tenderness, and pelvic pain.1,11

Study Design

One hundred and twenty-five patients from two 6-month, double-blind, randomized clinical studies entered a 1-year follow-up study. This study grouped patients who received 3.75 mg LUPRON DEPOT during previous trials and assessed recurrence of endometriosis signs and symptoms and safety parameters after discontinuation of treatment. The primary endometriosis signs and symptoms assessed were dysmenorrhea (painful periods), non-menstrual pelvic pain (NMPP) (pain in the pelvic area before or after periods), dyspareunia (pain during sex), pelvic tenderness (pain during the pelvic examination), and induration (hardening of pelvic tissues). The first day of the study was considered to be 29 days after the final study injection. Return of pain was defined to have occurred during the month for which pain levels returned to baseline (prior to treatment) levels or worse. At each study visit, an evaluation was made of dysmenorrhea, NMPP, and dyspareunia by patient interview. Pelvic tenderness and induration were evaluated by pelvic examination.12

Percent of women who FOUND RELIEF within 30 days of completing treatment with LUPRON DEPOT
(6 months of therapy)1,11

Percent of women who FOUND RELIEF 12 months after completing treatment with LUPRON DEPOT
(6 months of therapy)1,11

Patient interviews
Relief from painful periods
96%
of 155 patients
23%
of 30 patients
Relief from pelvic pain
53%
of 155 patients
53%
of 30 patients
Relief from pain during intercourse
56%
of 129 patients
76%
of 25 patients
Pelvic examinations: decrease in
pelvic tenderness
66%
of 152 patients
61%
of 28 patients
Reduction in the severity of induration
(hardened endometrial tissue)
71%
of 152 patients
71%
of 28 patients

Common side effects

In clinical trials, the most common side effects of LUPRON DEPOT, occurring in >10% of patients, include hot flashes/sweats, headache/migraine, decreased libido, depression/emotional lability, dizziness, nausea/vomiting, pain, vaginitis, and weight gain.1

About Add-back* therapy and side effects

When LUPRON DEPOT is used alone, bone thinning and hot flashes can occur. Along with LUPRON DEPOT injections, your doctor may prescribe Add-back* therapy. Add-back* is a daily pill that you take while on LUPRON DEPOT therapy to add back a small amount of the hormone progestin, which can help you manage certain side effects, without interfering with the way LUPRON DEPOT works.1,5

Add-back* may be prescribed from Day 1 of initial treatment with LUPRON DEPOT. Add-back* is not for everyone and should not be taken by women who currently have or have had any clotting disorder, heart disease, stroke, impaired liver function or liver disease, or breast cancer.1


*Norethindrone acetate 5 mg daily.1

What can you expect after discontinuing LUPRON DEPOT?

  • After completion of a full course of treatment with LUPRON DEPOT therapy, the hormonal effects you may have experienced should subside.1
  • Your normal menstrual cycle should return. The amount of time for your menstrual cycle to return is different for each woman.1
    • In one study of 166 patients treated with LUPRON DEPOT 3.75 each month for 6 months, 95% of women resumed their cycle within 3 months after completion of therapy.1
  • Bone loss might not be completely reversible in some patients. Since some conditions may increase the possibility of bone thinning, you should tell your doctor if you smoke, use alcohol heavily, have a family history of osteoporosis (thinning of the bones with fractures), or are taking other medications that cause thinning of the bones.1

Educational brochure

Learn about LUPRON DEPOT for endometriosis.

Download an education brochure to learn about LUPRON DEPOT® for endometriosis

Download brochure

Download an education brochure to learn about LUPRON DEPOT® for endometriosis

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References:

  1. LUPRON DEPOT 3.75 mg and –3 Month 11.25 mg [package insert]. North Chicago, IL: AbbVie Inc.
  2. National Institute of Child Health & Human Development. Facts About Endometriosis. Washington, DC: US Department of Health and Human Services, National Institutes of Health; 2002. NIH publication 02-2413.
  3. Asante A, Taylor RN. Endometriosis: the role of neuroangiogenesis. Annu Rev Physiol. 2011;73:163-182.
  4. The American College of Obstetricians and Gynecologists. Frequently asked questions (FAQ013) Gynecologic problems: Endometriosis. https://www.acog.org/patient-resources/faqs/gynecologic-problems/endometriosis. Published January 2019. Accessed August 20, 2020.
  5. Olive DL. Gonadotropin-releasing hormone agonists for endometriosis. N Engl J Med. 2008;359(11):1136-1142.
  6. Giudice LC. Clinical practice. Endometriosis. N Engl J Med. 2010;362:(25)2389-2398.
  7. Koninckx PR, Martin DC. Deep endometriosis: a consequence of infiltration or retraction or possibly adenomyosis externa? Fertil Steril. 1992;58(5):924-928.
  8. Frye CA. An overview of oral contraceptives: mechanism of action and clinical use. Neurology. 2006;66(66 suppl 3):S29-S36.
  9. US Food and Drug Administration. Drugs@FDA: LUPRON DEPOT. NDA 020011. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020011. Accessed August 20, 2020.
  10. Sturpe DA, Patel AD. Endometriosis. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM, eds. Pharmacotherapy: A Pathophysiologic Approach. 6th ed. New York, NY: McGraw-Hill; 2005:1485-1491.
  11. Data on File. ABVRRTI62821. AbbVie Inc.
  12. Data on file ABVRRTI62822. AbbVie Inc.
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