Use and Important Safety Information

CHILDREN Central Precocious Puberty

Use for LUPRON DEPOT-PED® (leuprolide acetate for depot suspension)

LUPRON DEPOT‑PED® 7.5 mg, 11.25 mg, and 15 mg for 1-month and 11.25 mg and 30 mg for 3-month administration are prescribed for the treatment of children with central precocious puberty (CPP).

Doctors may diagnose children with CPP when signs of sexual maturity begin to develop in girls under the age of 8 or boys under the age of 9. Your doctor should perform tests to rule out possible causes of early puberty that would require different treatment (e.g., tumors).

It is not known if LUPRON DEPOT-PED is safe and effective in children under 2 years of age.

Important Safety Information for LUPRON DEPOT-PED

What is the most important information I should know about LUPRON DEPOT-PED?

  • 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
    • Acting aggressive

Call your child’s doctor right away if your child has any new or worsening mental symptoms or problems while taking LUPRON DEPOT-PED.

  • Some people taking GnRH agonists like LUPRON DEPOT-PED have had seizures. The risk of seizures may be higher in people who:
    • Have a history of seizures
    • Have a history of epilepsy
    • Have a history of brain or brain vessel (cerebrovascular) problems or tumors
    • Are taking a medicine that has been connected to seizures, such as bupropion or selective serotonin reuptake inhibitors (SSRIs)

Seizures have also happened in people who have not had any of these problems. Call your child’s doctor right away if your child has a seizure while taking LUPRON DEPOT-PED.

LUPRON DEPOT-PED should not be taken if your child is:

  • Allergic to GnRH, GnRH agonist medicines, or any ingredients in LUPRON DEPOT-PED
  • Pregnant or becomes pregnant. LUPRON DEPOT-PED can cause birth defects or loss of the baby. If your child becomes pregnant, call your doctor.

Before your child receives LUPRON DEPOT-PED, tell your doctor about all of your child’s medical conditions, including if they:

  • Have a history of mental (psychiatric) problems
  • Have a history of seizures
  • Have a history of epilepsy
  • Have a history of brain or brain vessel (cerebrovascular) problems or tumors
  • Are taking a medicine that has been connected to seizures, such as bupropion or selective serotonin reuptake inhibitors (SSRIs)
  • Are breastfeeding or plan to breastfeed. It is not known if LUPRON DEPOT-PED passes into the breast milk

Tell your doctor about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will your child receive LUPRON DEPOT-PED?

  • LUPRON DEPOT-PED is injected into your child’s muscle by a doctor or trained nurse.
  • 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.

What are the common side effects of LUPRON DEPOT-PED?

  • 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
    • 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 pain
    • Weight gain
    • Headache
    • Mood changes
    • Injection site swelling

These are not all the possible side effects of LUPRON DEPOT-PED. Call your doctor for medical advice about side effects.

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.

If you cannot afford your medication, contact www.pparx.org.

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

Please see the full Prescribing Information for Lupron Depot‑PED and discuss it with your doctor.

Reference: LUPRON DEPOT‑PED [package insert]. North Chicago, IL: AbbVie Inc.

WOMEN Endometriosis

Use

LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg for 1-month and 11.25 mg for 3-month administration are used for the management of endometriosis, including pain relief and reduction of endometriotic lesions. LUPRON DEPOT with daily norethindrone acetate 5 mg is also indicated for initial management of endometriosis and for management of recurrence of symptoms. The recommended initial treatment is no more than 6 months. Repeat treatment for endometriosis should be limited to 6 months.

Important Safety Information

Do not take LUPRON DEPOT if you are or may become pregnant, are breast-feeding, have undiagnosed vaginal bleeding, or if you have experienced any type of allergic reaction to LUPRON DEPOT, or similar drugs.

You should not take norethindrone acetate with LUPRON DEPOT if you currently have or have previously had any clotting disorder, heart disease, stroke, impaired liver function or liver disease, or breast cancer.

Tell your health care provider before beginning treatment with norethindrone acetate if you currently have or have previously had high cholesterol, migraines, epilepsy, depression, or smoke.

During treatment with LUPRON DEPOT and norethindrone acetate, immediately tell your doctor if you have a sudden loss of vision, double vision, or if migraine headaches occur. You should notify your doctor if you experience fluid retention, seizure, asthma or worsening of asthmatic symptoms, heart or kidney problems.

Thinning of the bones may occur during therapy with LUPRON DEPOT alone, 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 is not advisable and combination with norethindrone acetate should be considered. 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.

After beginning LUPRON DEPOT, your estrogen levels will increase for 1 or 2 weeks. 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.

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.

There is a possibility of the development or worsening of depression and/or the occurrence of forgetfulness. Patients who have a history of depression should be carefully observed during treatment.

Convulsions have been observed in patients taking leuprolide acetate.

The most common side effects of LUPRON DEPOT include hot flashes, vaginal dryness, headaches, changes in mood, decreased interest in sex, depression, and/or the occurrence of forgetfulness.

LUPRON DEPOT must be administered in your doctor’s office.

For more information, talk with your health care provider.

Please see the full Prescribing Information for Lupron Depot and discuss it with your doctor.

Reference: LUPRON DEPOT [package insert]. North Chicago, IL: AbbVie Inc.

WOMEN Fibroids

Use

LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg for 1-month and 11.25 mg for 3-month administration with iron therapy are used before fibroid surgery to improve anemia due to vaginal bleeding from fibroids. Your doctor may consider a one-month trial of iron alone as some patients’ anemia will improve with iron alone. It is recommended that LUPRON DEPOT not be used for more than 3 months in patients with fibroids. Experience with LUPRON DEPOT in females has been limited to women 18 years of age and older.

Important Safety Information

Do not take LUPRON DEPOT if you are or may become pregnant, are breast-feeding, have undiagnosed vaginal bleeding, or if you have experienced any type of allergic reaction to LUPRON DEPOT or similar drugs.

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.

After beginning LUPRON DEPOT, your estrogen levels will increase for 1 or 2 weeks. 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.

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.

There is a possibility of the development or worsening of depression and/or the occurrence of forgetfulness. Patients who have a history of depression should be carefully observed during treatment.

Convulsions have been observed in patients taking leuprolide acetate.

The most common side effects of LUPRON DEPOT include hot flashes, vaginal dryness, headaches, changes in mood, decreased interest in sex, depression, and/or the occurrence of forgetfulness.

LUPRON DEPOT must be administered in your doctor’s office.

For more information, talk with your health care provider.

Please see the full Prescribing Information for Lupron Depot and discuss it with your doctor.

Reference: LUPRON DEPOT [package insert]. North Chicago, IL: AbbVie Inc.

MEN Prostate Cancer

Use

  • 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 palliative treatment of advanced prostate cancer.
  • LUPRON DEPOT is a prescription medication that must be administered in your doctor’s office.

Important Safety Information

  • LUPRON DEPOT is not for people who have had any type of allergic reaction to LUPRON DEPOT or similar drugs.
  • LUPRON DEPOT is not for women who are or may become pregnant.
  • 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 spine or urinary tract, urinary blockage or pressure on the spine may occur and can sometimes 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.
  • Regular blood tests are needed to check your testosterone and prostate-specific antigen (PSA) levels.
  • High blood sugar and increased risk of diabetes can occur in men using LUPRON DEPOT. Your doctor will monitor your blood sugar during treatment.
  • 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.
  • Convulsions have been observed in patients taking leuprolide acetate, including patients who have a history of seizures, epilepsy, or brain disorders (related to blood vessels, nerves, or tumors), and in those taking medications associated with convulsions. Convulsions have also been reported in patients without any of these conditions.
  • 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.

For more information, talk with your healthcare provider.

Please see the complete Prescribing Information for Lupron Depot and discuss it with your doctor.

Reference: LUPRON DEPOT [package insert]. North Chicago, IL: AbbVie Inc.