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10/12/2020

Leuprolide Acetate Long-Acting Suspension for Intramuscular Injection

Products Affected - Description

    • Lupron Depot intramuscular powder for suspension for injection, AbbVie, 11.25 mg (3 month), single dose administration kit, dual chamber prefilled syringe, 1 count, NDC 00074-3663-03
    • Lupron Depot intramuscular powder for suspension for injection, AbbVie, 22.5 mg (3 month), single dose administration kit, dual chamber prefilled syringe, 1 count, NDC 00074-3346-03
    • Lupron Depot intramuscular powder for suspension for injection, AbbVie, 30 mg (4 month), single dose administration kit, dual chamber prefilled syringe, 1 count, NDC 00074-3683-03
    • Lupron Depot intramuscular powder for suspension for injection, AbbVie, 45 mg (6 month), single dose administration kit, dual chamber prefilled syringe, 1 count, NDC 00074-3473-03

Reason for the Shortage

    • AbbVie has Lupron Depot on shortage due to manufacturing delays. The Lupron-Peds Depot is not affected by this shortage at this time.[1]

Available Products

    • Lupron Depot intramuscular powder for suspension for injection, AbbVie, 3.75 mg (1 month), single dose administration kit, dual chamber prefilled syringe, 1 count, NDC 00074-3641-03
    • Lupron Depot intramuscular powder for suspension for injection, AbbVie, 7.5 mg (1 month), single dose administration kit, dual chamber prefilled syringe, 1 count, NDC 00074-3642-03

Estimated Resupply Dates

    • AbbVie has Lupron Depot 11.25 mg (3 month) gynecological kits, 22.5 mg (3 month) urological kits, and 45 mg (6 month) urological kits on back order and the company estimates a release date of late-October 2020. The 30 mg (4 month) urological kits are on back order and the company cannot estimate a release date.[1]

Alternative Agents & Management

    • Alternative agents and management - Endometriosis
    • Published data are extremely limited for switching endometriosis patients who are stable on leuprolide 3.75 mg monthly depot to an alternative dosage regimen, GnRH agonist, or GnRH antagonist.
    • Leuprolide 3.75 mg IM monthly injection is not equivalent to 1/3 of the 11.25 mg IM every 3 month injection due to different drug release properties. However, pharmacodynamic studies described in the product labeling support therapeutic equivalence of the 2 dosage regimens for the treatment of endometriosis. Consider switching patients from the 3.75 mg monthly to the 11.25 mg every 3 month regimen if necessary. Note that, due to the recommendation not to exceed 6 months of total therapy, patients should not switch to the 11.25 mg regimen if fewer than 3 months of therapy remain.[2]
    • A small (N = 48) crossover study followed patients for 6 months of GnRH agonist therapy for endometriosis. One group received 3 injections of leuprolide 3.75 mg IM every month followed by triptorelin 3.75 mg IM every month for injections while the other group received the reverse (note there was no washout period between drugs). Results suggested that patients could switch from leuprolide 3.75 mg monthly to triptorelin 3.75 mg monthly without compromising safety or efficacy. [3]
    • There are no published data for using Eligard brand of leuprolide depot for endometriosis. Eligard is labeled for subcutaneous administration to treat prostate cancer.[4] The commercial dosage forms do not match the doses used for Lupron Depot brand of intramuscular leuprolide for endometriosis.
    • Elagolix is an oral GnRH antagonist labeled to treat endometriosis and is not affected by this shortage.[5]
    Table 1. Dosage Regimens of GnRH Agonists Used for Endometriosis^
    GnRH AgonistEndometriosis Dosage Regimen(s)
    ^Data derived from Zoladex, Lupron Depot, and Synarel package inserts; and Lexicomp2,7-9
    Goserelin (Zoladex; TerSera Therapeutics)* 3.6 mg subcutaneous every 28 days for 6 months
    Leuprolide (Lupron Depot; AbbVie)
    * 3.75 mg intramuscular every month for up to 6 months
    * 11.25 mg intramuscular every 3 months for up to 6 months (ie, 2 doses)
    Nafarelin (Synarel; GD Searle Division of Pfizer)* 200 mcg intranasal in alternating nares twice daily (400 mcg daily dose) for up to 6 months
    * May increase dose to 200 mcg in each nostril twice daily (800 mcg daily dose) after 2 months if regular menstruation persists
    Triptorelin (Trelstar; Verity Pharmaceuticals)Off-label
    * 3.75 mg intramuscular every 4 weeks for up to 6 months
    * 3.75 mg every 6 weeks for up to 6 months (ie, 4 doses)
    * 11.25 mg every 3 months for up to 6 months (ie, 2 doses)

    Table 2. Alternative agents and management - Prostate Cancer
    ^Data derived from Zoladex, Vantas, Lupron Depot, Eligard, and Trelstar package inserts; and Lexicomp.4,8-10
    GnRH Agonist
    Prostate Cancer Dosage Regimen(s)
    Goserelin (Zoladex; TerSera Therapeutics)
    Advanced:
    * 3.6 mg subcutaneous every 28 days
    * 10.8 mg subcutaneous every 12 weeks

    Stage B2 to C (in combination with antiandrogen and radiotherapy):
    * 3.6 mg subcutaneous initially, then 10.8 mg subcutaneous 28 days later
    * 3.6 mg subcutaneous every 28 days for 4 doses
    Histrelin (Vantas; Endo Pharmaceuticals)
    Advanced:
    * 50 mg subcutaneous every 12 months
    Leuprolide Intramuscular depot (Lupron Depot; AbbVie)
    Advanced:
    * 7.5 mg intramuscular every month
    * 22.5 mg intramuscular every 12 weeks
    * 30 mg intramuscular every 16 weeks
    * 45 mg intramuscular every 24 weeks
    Leuprolide Subcutaneous depot (Eligard; Tolmar Pharmaceuticals)
    Advanced:
    * 7.5 mg subcutaneous every month
    * 22.5 mg subcutaneous every 3 months
    * 30 mg subcutaneous every 4 months
    * 45 mg subcutaneous every 6 months
    Leuprolide 5 mg/mL generic solution
    Advanced:
    * 1 mg subcutaneous daily
    Triptorelin (Trelstar; Verity Pharmaceuticals)
    Advanced:
    * 3.75 mg intramuscular every 4 weeks
    * 11.25 mg intramuscular every 12 weeks
    * 22.5 mg intramuscular every 24 weeks

    Table 3. Alternative agents and management - Breast Cancer
    ^Data derived from Zoladex, package insert; DrugDex, AHFS, Gold Standard, and Lexicomp.8-13
    GnRH Agonist
    Breast Cancer Dosage Regimen(s)
    Goserelin (Zoladex; TerSera Therapeutics)
    Advanced:
    * 3.6 mg subcutaneous every 28 days

    Off-label
    Prevention of early menopause during chemotherapy:
    * 3.6 mg subcutaneous every 28 days
    Leuprolide Intramuscular depot (Lupron Depot; AbbVie)
    Off-label
    Ovarian suppression in premenopausal women:
    * 3.75 mg intramuscular every 28 days
    * 11.25 mg intramuscular every 3 months

    Fertility preservation prior to chemotherapy:
    * 3.75 mg intramuscular every 4 weeks
    Triptorelin (Trelstar; Verity Pharmaceuticals)
    Off-label
    Premenopausal women with hormone-sensitive advanced cancer:
    * 3.75 mg intramuscular every 4 weeks

    Prophylaxis against premature ovarian failure in premenopausal women has been studied with triptorelin, but data do not meet CMS-approve criteria:
    * 3.75 mg intramuscular every 4 weeks

References

    1. AbbVie (personal communication). July 29, August 25, and October 12, 2020.
    2. Lupron Depot 11.25 mg [package insert]. North Chicago, IL: AbbVie Inc; 2020.
    3. Cheung TK, Lo KW, Lam CW, Lau W, Lam PK. A crossover study of triptorelin and leuprorelin acetate. Fertil Steril. 2000;74(2):299-305.
    4. Eligard [package insert]. Fort Collins, CO: Tolmar Pharmaceuticals; 2020
    5. Orilissa [package insert]. North Chicago. IL: AbbVie Inc; 2020.
    6. Acs N, O'Brien C, Jiang P, et al. Treatment of endometriosis-associated pain with elagolix, an oral GnRH antagonist: results from a phase 2, randomized controlled study. Journal of Endometriosis and Pelvic Pain Disorders. 2015;7(2):56-62.
    7. Synarel [package insert]. New York, NY: GD Searle Division of Pfizer Inc; 2018.
    8. Zoladex [package insert]. Deerfield, IL: TerSera Therapeutics; 2020.
    9. Lexicomp Online: Wolters Kluwer Clinical Drug Information, Inc; 2020.
    10. Lupron Depot 22.5 mg [package insert]. North Chicago, IL: AbbVie Inc; 2020.
    11. McEvoy GK, Snow EK, Kester L, Litvak K, Miller J, Welsh OH, eds. AHFS DI (Lexi-Comp Online). Bethesda, MD: American Society of Health-System Pharmacists; 2020.
    12. Drugdex system. IBM Micromedex [database online]. http://www.micromedexsolutions.com. Updated July 28, 2020. Greenwood Village, CO, USA: Truven Health Analytics; Accessed July 30, 2020.
    13. Gold Standard. ClinicalKey [database online]. http://www.clinicalkey.com. Updated January 7, 2019. Tampa, FL: Elsevier; Accessed July 30, 2020.

Updated

Updated October 12, 2020 by Michelle Wheeler, PharmD, Drug Information Specialist. Created July 23, 2020 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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