LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg for 1‑month and 11.25 mg for 3‑month administration are prescription medications used for the management of endometriosis, including pain relief and reduction of endometriotic lesions. LUPRON DEPOT 3.75 mg for 1‑month and 11.25 mg for 3‑month administration may be used with daily norethindrone acetate 5 mg as add‑back therapy for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms. Add‑back therapy is intended to reduce the thinning of bone and reduce hot flashes associated with LUPRON DEPOT. For safe and effective use of norethindrone acetate and LUPRON DEPOT 11.25 mg, refer to the norethindrone prescribing information. Show
Initial treatment course of LUPRON DEPOT (whether used alone or with add‑back therapy) is limited to 6 months. A single retreatment course of not more than 6 months of LUPRON DEPOT plus add‑back therapy may be used if symptoms recur. LUPRON DEPOT should not be used alone for retreatment. The total duration of therapy with LUPRON DEPOT plus add‑back therapy should not exceed 12 months due to concerns about adverse impact on bone thinning. Important Safety InformationDo not take LUPRON DEPOT if you are, may be, or are planning to become pregnant, are breast‑feeding, have undiagnosed uterine bleeding, or if you have experienced any type of allergic reaction to LUPRON DEPOT, or similar drugs. If your doctor prescribes you norethindrone acetate in combination with LUPRON DEPOT 11.25 mg, please refer to the norethindrone acetate prescribing information for more information about its safe and effective use. You should not take norethindrone acetate and LUPRON DEPOT 3.75 mg 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 healthcare provider before beginning treatment with norethindrone acetate and LUPRON DEPOT 3.75 mg if you currently have or have previously had high cholesterol, migraines, epilepsy, or depression, or if you smoke. During treatment with norethindrone acetate and LUPRON DEPOT 3.75 mg, 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, or 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. 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. 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. Asthma was reported in women with a history of asthma, sinusitis, and environmental or drug allergies. Serious allergic reactions have also occurred. 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 worsen while taking norethindrone acetate. Patients who have a history of depression should be carefully observed during treatment. Talk to your doctor if you are experiencing any new or worsening signs of depression. 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 treatment of endometriosis 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. 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. For more information, talk with your healthcare provider. If you cannot afford your medication, contact www.pparx.org for assistance. Reference: LUPRON DEPOT [package insert]. North Chicago, IL: AbbVie Inc.
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This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider. Camcevi; Eligard; Fensolvi (6 Month); Lupron Depot (1-Month); Lupron Depot (3-Month); Lupron Depot (4-Month); Lupron Depot (6-Month); Lupron Depot-Ped (1-Month); Lupron Depot-Ped (3-Month) Eligard; Lupron; Lupron Depot; Lupron Depot (1-Month); Lupron Depot (3-Month); Lupron Depot 3 Month Kit; Zeulide Depot For all patients taking this drug:
Females:
This is not a list of all drugs or health problems that interact with this drug. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. For all patients taking this drug:
Males:
Females:
What are some side effects that I need to call my doctor about right away?WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: For all patients taking this drug:
Females:
What are some other side effects of this drug?All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: For all patients taking this drug:
Females:
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to your national health agency. You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch. How is this drug best taken?Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
What do I do if I miss a dose?
How do I store and/or throw out this drug?
General drug facts
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