Prescribing Information

USES

Endometriosis

Taking LUPRON DEPOT Alone

LUPRON DEPOT^® (leuprolide acetate for depot suspension) 3.75 mg or 11.25 mg is used for the management of endometriosis, including pain relief and reduction of endometriotic lesions.

Taking LUPRON DEPOT in Combination with Norethindrone Acetate

LUPRON DEPOT 3.75 mg or 11.25 mg in combination with norethindrone acetate is used for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms.
Use of norethindrone acetate in combination with LUPRON DEPOT 3.75 mg or 11.25 mg is referred to as add-back therapy, and is intended to reduce the thinning of bone and reduce hot flashes associated with use of LUPRON DEPOT 3.75 mg or 11.25 mg.

Limitations of Use

The total duration of therapy with LUPRON DEPOT 3.75 mg or 11.25 mg plus add-back therapy should not exceed 12 months due to concerns of bone thinning.

Uterine Fibroids

LUPRON DEPOT^® (leuprolide acetate for depot suspension) 3.75 mg or 11.25 mg with iron therapy is used before fibroid surgery to improve anemia due to vaginal bleeding from fibroids for patients in whom 3 months of hormonal suppression is deemed necessary. The duration of therapy with LUPRON DEPOT is limited to 3 months. The symptoms associated with fibroids will return after stopping therapy.

Your doctor may consider a 1-month trial of iron alone, as some women will respond to iron alone. LUPRON DEPOT 3.75 mg or 11.25 mg may be added if the response to iron alone is considered inadequate.

Limitations of Use

LUPRON DEPOT 3.75 mg or 11.25 mg is not used in combination with norethindrone acetate add-back therapy before fibroid surgery to improve anemia due to vaginal bleeding from fibroids.

Advanced Prostate Cancer

LUPRON DEPOT^® (leuprolide acetate for depot suspension) 7.5 mg for 1-month, 22.5 mg for 3-month, 30 mg for 4-month, and 45 mg for 6-month administration are prescribed for the treatment of advanced prostate cancer. LUPRON DEPOT is a prescription medication that must be administered in your doctor’s office.

Central Precocious Puberty (CPP)

LUPRON DEPOT-PED^® (leuprolide acetate for depot suspension) 7.5 mg, 11.25 mg, and 15 mg for 1-month, 11.25 mg and 30 mg for 3-month, and 45 mg for 6-month administration are prescribed for the treatment of children with central precocious puberty (CPP). It is not known if LUPRON DEPOT-PED is safe and effective in children less than 1 year old.

IMPORTANT SAFETY INFORMATION

General Information

• People who have experienced any type of allergic reaction to LUPRON DEPOT or similar drugs should not take LUPRON DEPOT or LUPRON DEPOT-PED.
• Females who are or may be pregnant or have undiagnosed uterine bleeding should not receive LUPRON DEPOT or LUPRON DEPOT-PED.
• Seizures have been observed in patients taking LUPRON DEPOT or LUPRON DEPOT-PED, including patients who have a history of seizures or conditions related to seizures or in patients who are taking medications that are connected to seizures. Seizures have also been reported in patients without any of these conditions.

Safety Information for Use in Endometriosis or Uterine Fibroids

• Thinning of the bones may occur during therapy with LUPRON DEPOT, which may 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 in excess, have a family history of osteoporosis (thinning of the bones with fractures), or are taking other medications that can cause thinning of the bones. You should be aware that if you have these conditions, treatment with LUPRON DEPOT alone for endometriosis is not advisable and combination with norethindrone acetate should be considered. Add-back therapy can help reduce the bone loss that occurs with the use of LUPRON DEPOT alone. If a second course of treatment with LUPRON DEPOT is being considered, bone mineral testing is recommended and retreatment should include combination with norethindrone acetate. If your doctor prescribes you norethindrone acetate in combination with LUPRON DEPOT 3.75 mg or 11.25 mg for endometriosis, please refer to the norethindrone acetate prescribing information for more information about its safe and effective use.
• LUPRON DEPOT may cause harm to your unborn child. LUPRON DEPOT is not a method of birth control. Even though you may not have periods, 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. If you think you have become pregnant while on LUPRON DEPOT, talk to your doctor immediately.
• Serious sudden allergic reactions have been reported with LUPRON DEPOT use. Asthma was reported in women with a history of asthma, sinusitis, and environmental or drug allergies. Serious allergic reactions have also occurred.
• Rare cases of delayed serious skin reactions that included a rash containing blisters with and without peeling have been reported in patients receiving leuprolide-containing therapy. Immediately contact your doctor or get emergency care if skin reactions appear.
• After beginning LUPRON DEPOT, your estrogen levels will increase during the first days of therapy. 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.
• Depression may occur or worsen while taking LUPRON DEPOT, especially in patients who have a history of depression. Patients should be carefully observed during treatment. Immediately report thoughts and behaviors of concern to your doctor.
• The most common side effects of LUPRON DEPOT included hot flashes/sweats, headache/migraine, decreased libido (interest in sex), depression/emotional lability (changes in mood), dizziness, nausea/vomiting, pain, vaginitis, and weight gain. These are not all of the possible side effects of LUPRON DEPOT. Talk to your doctor for medical advice about side effects.
• LUPRON DEPOT for endometriosis or anemia associated with uterine fibroids has been limited to women 18 years of age and older. LUPRON DEPOT is not indicated in postmenopausal women.

Safety Information for Use in Advanced Prostate Cancer

• LUPRON DEPOT causes an increase in testosterone during the first few weeks of therapy.
  • Some men may experience temporary new or worsening symptoms of prostate cancer, including urinary symptoms and/or bone pain.
  • If your cancer has spread to the urinary tract, urinary blockage may occur. If your cancer has spread to the spine, this may lead to paralysis, which may be life threatening.
  • You may require close medical attention during the first few weeks of therapy. Notify your doctor if you develop any new or worsened symptoms after beginning LUPRON DEPOT treatment.
• High blood sugar, increased risk of diabetes, high lipids (such as cholesterol and triglycerides), and/or the accumulation of liver fat without drinking alcohol can occur in men using LUPRON DEPOT. Your doctor will monitor for these changes.
• Increased risk of heart attack, sudden death, and stroke can occur in men using LUPRON DEPOT. Discuss this increased risk with your doctor before starting treatment and report any new symptoms during treatment.
• LUPRON DEPOT can affect the electrical activity of your heart. Your doctor must determine if the benefits of using LUPRON DEPOT outweigh the risks, especially if you have congenital long QT syndrome, abnormal blood tests for electrolytes, congestive heart failure, or if you take medications to regulate your heartbeat.
• Regular blood tests are needed to check your testosterone and prostate-specific antigen (PSA) levels.
• LUPRON DEPOT may cause fetal harm if administered to a pregnant woman.
• LUPRON DEPOT may cause impotence.
• The most common side effects of LUPRON DEPOT include hot flashes/sweats; injection site reaction/pain; general pain; swelling; testicular shrinkage; difficulty urinating; fatigue/weakness; headache; and joint, gastrointestinal, and respiratory problems.

Safety Information for Use in Central Precocious Puberty

• During the first 2 to 4 weeks of treatment, LUPRON DEPOT-PED can cause an increase in some hormones. During this time, you may notice more signs of puberty in your child, including vaginal bleeding. Call your doctor if these signs continue after the second month of treatment with LUPRON DEPOT-PED.
• Some people taking gonadotropin-releasing hormone (GnRH) agonists like LUPRON DEPOT-PED have had new or worsened mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as crying, irritability, restlessness (impatience), anger, and acting aggressive.
• Call your child’s doctor right away if your child has any new or worsening mental symptoms or problems, experiences a seizure, or becomes pregnant while taking LUPRON DEPOT-PED.
• Increased pressure in the fluid around the brain can happen in children taking gonadotropin-releasing hormone (GnRH) agonist medicines, including LUPRON DEPOT-PED. Call your child’s doctor right away if your child develops any of the following symptoms during treatment with LUPRON DEPOT-PED: headache, eye problems (including blurred vision, double vision, and decreased eyesight), eye pain, ringing in the ears, dizziness, or nausea.
• Before your child receives LUPRON DEPOT-PED, tell their doctor about all of your child’s medical conditions, including if they have a history of mental (psychiatric) problems, seizures, epilepsy, brain or brain vessel (cerebrovascular) problems or tumors; if they are taking a medicine that has been connected to seizures, such as bupropion or selective serotonin reuptake inhibitors (SSRIs); and if they are breastfeeding or plan to breastfeed. It is not known if LUPRON DEPOT-PED passes into the breast milk. Tell your child’s doctor about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• LUPRON DEPOT-PED is given as a single-dose injection into your child’s muscle each month, every 3 months, or every 6 months by a doctor or trained nurse. Your doctor will decide how often your child will receive the injection.
• Keep all scheduled visits to the doctor. If a scheduled dose is missed, your child may start having signs of puberty again. The doctor will do regular exams and blood tests to check for signs of puberty.
• The most common side effects of LUPRON DEPOT-PED received 1 time each month include: injection site reactions such as pain, swelling, and abscess; weight gain; pain throughout body; headache; acne or red, itchy rash and white scales (seborrhea); serious skin rash (erythema multiforme); mood changes; and swelling of vagina (vaginitis), vaginal bleeding, and vaginal discharge. The most common side effects of LUPRON DEPOT-PED received every 3 months include: injection site reactions such as pain and swelling, weight gain, headache, and mood changes. The most common side effects of LUPRON DEPOT-PED received every 6 months include: injection site reactions such as pain, swelling, and abscess; headache; mood changes; upper stomach pain; diarrhea; bleeding; nausea and vomiting; fever; itching; pain in extremities; rash; back pain; ligament sprain; weight gain; fracture; breast tenderness; difficulty sleeping; chest pain; and excessive sweating. These are not all of the possible side effects of LUPRON DEPOT-PED. Call your doctor or your child’s doctor for medical advice about side effects.

This is the most important information to know about LUPRON DEPOT and LUPRON DEPOT-PED. For more information, talk to your doctor or healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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