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.
LUPRON DEPOT 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.
IMPORTANT SAFETY INFORMATION
General Safety Information
Do not take LUPRON DEPOT 3.75 mg and 11.25 mg if you are or may be pregnant, have undiagnosed uterine 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. 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.
Seizures have been observed in patients taking LUPRON DEPOT, 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.
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.
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 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-10881-800-FDA-1088.
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