Use and Important Safety Information

CHILDREN Central Precocious Puberty

Use

LUPRON DEPOT‑PED® (leuprolide acetate for depot suspension) 7.5 mg, 11.25 mg and 15 mg 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. Doctors will also perform tests to rule out possible causes of CPP that would require different treatment (e.g., tumors).

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

Important Safety Information

Your child should not receive LUPRON DEPOT‑PED if he/she has experienced any type of allergic reaction to LUPRON DEPOT, or similar drugs.

Females who may be pregnant, are breast-feeding, or have undiagnosed vaginal bleeding should not receive LUPRON DEPOT‑PED.

After starting LUPRON DEPOT‑PED therapy, your child may experience increased signs and symptoms of CPP during the first few weeks of treatment.

You should notify the doctor if your child has menstrual bleeding that continues beyond the second month of treatment, has irritation at the injection site, develops mood swings or behavioral changes, or has any other unusual signs or symptoms.

It is important that you keep your child’s doctor appointments. If your child misses a shot or is a week late, your child’s pubertal development could begin again.

Response to LUPRON DEPOT‑PED should be monitored 1-2 months after the start of therapy to determine if your child’s current dose is at the right level. You should know that your doctor should also be measuring your child’s bone age every 6-12 months.

Studies have not been completed in children to determine the full reversibility of fertility suppression.

The most common side effects of LUPRON DEPOT‑PED include injection site reactions including abscess, general pain, acne, rash and vaginitis/vaginal bleeding or discharge.

LUPRON DEPOT‑PED must be administered under the supervision of a physician.

This is the most important information to know about LUPRON DEPOT‑PED. For more information, talk with your child’s health care provider.

Reference: LUPRON DEPOT‑PED [package insert]. North Chicago, IL: Abbott Laboratories.

WOMEN Endometriosis

Use

LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg and –3 Month 11.25 mg 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.

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

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.

LUPRON DEPOT given with norethindrone acetate may lower your HDL-cholesterol level (the “good” cholesterol). You should not take norethindrone acetate with LUPRON DEPOT if you currently have or have previously had any clotting disorder, heart disease, stroke, 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, epilepsy, 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 repeat treatment with LUPRON DEPOT alone is not advisable if you have these conditions.

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 an 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.

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.

This is the most important information to know about LUPRON DEPOT. For more information, talk with your health care provider.

Reference: LUPRON DEPOT 3.75 mg and –3 Month 11.25 mg [package insert]. North Chicago, IL: Abbott Laboratories.

WOMEN Fibroids

Use

LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg and –3 Month 11.25 mg 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.

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

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 an 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.

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.

This is the most important information to know about LUPRON DEPOT. For more information, talk with your health care provider.

Reference: LUPRON DEPOT 3.75 mg and –3 Month 11.25 mg [package insert]. North Chicago, IL: Abbott Laboratories.

MEN Prostate Cancer

Use

LUPRON DEPOT® (leuprolide acetate for depot suspension) 7.5 mg, −3 Month 22.5 mg and −4 Month 30 mg are prescribed for the palliative treatment of advanced prostate cancer.

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

Important Safety Information

Do not take LUPRON DEPOT if you have experienced any type of allergic reaction to LUPRON DEPOT or similar drugs.

LUPRON DEPOT 7.5 mg, −3 Month 22.5 mg and −4 Month 30 mg should not be used in women.

An increase in testosterone will generally occur during the first few weeks of therapy. In some men, this may cause a temporary increase in urinary symptoms and/or pain. If your cancer has spread to the spine or urinary tract, you may require close medical attention during the first few weeks of therapy. You should also know that LUPRON DEPOT may cause impotence. You should notify your doctor if you develop any new or worsened symptoms after beginning LUPRON DEPOT treatment.

It is recommended that your PSA and serum testosterone levels be monitored at regular intervals.

The most common side effects of LUPRON DEPOT include hot flashes or sweats, injection site reactions, general pain, edema, testicular atrophy, urinary disorders, joint disorder and GI disorders.

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

This is the most important information to know about LUPRON DEPOT. For more information, talk with your health care provider.

Reference: LUPRON DEPOT 7.5 mg, −3 Month 22.5 mg and −4 Month 30 mg [package insert]. North Chicago, IL: Abbott Laboratories.