Lupron Depot

Product manufactured by Abbvie Inc.

Application Nr Approved Date Route Status External Links
NDA020011 None None None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Endometriosis Lupron Depot 3.75 Mg Is Indicated For Management Of Endometriosis, Including Pain Relief And Reduction Of Endometriotic Lesions. Lupron Depot Monthly With Norethindrone Acetate 5 Mg Daily Is Also Indicated For Initial Management Of Endometriosis And For Management Of Recurrence Of Symptoms. (Refer Also To Norethindrone Acetate Prescribing Information For Warnings , Precautions , Contraindications And Adverse Reactions Associated With Norethindrone Acetate). Duration Of Initial Treatment Or Retreatment Should Be Limited To 6 Months. Uterine Leiomyomata (Fibroids) Lupron Depot 3.75 Mg Concomitantly With Iron Therapy Is Indicated For The Preoperative Hematologic Improvement Of Patients With Anemia Caused By Uterine Leiomyomata. The Clinician May Wish To Consider A One-Month Trial Period On Iron Alone Inasmuch As Some Of The Patients Will Respond To Iron Alone. (See Table 1 .) Lupron May Be Added If The Response To Iron Alone Is Considered Inadequate. Recommended Duration Of Therapy With Lupron Depot 3.75 Mg Is Up To Three Months. Experience With Lupron Depot In Females Has Been Limited To Women 18 Years Of Age And Older. Table 1 Percent Of Patients Achieving Hemoglobin ≥ 12 Gm/dl Treatment Group Week 4 Week 8 Week 12 Lupron Depot 3.75 Mg With Iron 41* 71† 79* Iron Alone 17 40 56 * P-Value < 0.01 † P-Value < 0.001

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Leuprolide Acetate

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