Important new update to the prescribing information for
Important Changes to the Prescribing Information for LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg for 1-month and 11.25 mg for 3-month administration
In October 2013, the following safety information was added to the LUPRON DEPOT full Prescribing Information:
WARNINGS AND PRECAUTIONS Convulsions have been observed in patients taking leuprolide acetate. These included patients with medical conditions or those taking medications associated with convulsions. Convulsions have also been reported in patients without any of these conditions.
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Please see Uses and Important Safety Information on the following page. Pleafor full Prescribing Information.
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.
Pleafor full Prescribing Information. Reference: 1. LUPRON DEPOT [package insert].
2013 AbbVie Inc. North Chicago, IL 60064 201-1255417 October 2013 Printed in the U.S.A.
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