Lupron Depot
leuprolide acetate · KIT · AbbVie Inc.
Lupron Depot is a kit containing leuprolide acetate. Manufactured by AbbVie Inc..
Key Facts
- Brand Name
- Lupron Depot
- Generic Name
- leuprolide acetate
- NDC Code (Product)
0074-3473- Manufacturer
- AbbVie Inc.
- Dosage Form
- KIT
- Marketing Status
- Application #
- NDA020517
- Marketing Start
- 12/22/1995
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE LUPRON DEPOT 3.75 mg is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Endometriosis Management of endometriosis, including pain relief and reduction of endometriotic lesions. ( 1.1 ) In combination with a norethindrone acetate for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms. ( 1.1 ) Limitations of Use: The total duration of therapy with LUPRON DEPOT 3.75 mg plus add-back therapy should not exceed 12 months due to concerns about adverse impact on bone mineral density. ( 1.1 , 2.1 , 5.1 ) Uterine Leiomyomata (Fibroids) Concomitant use with iron therapy for preoperative hematologic improvement of women with anemia caused by fibroids for whom three months of hormonal suppression is deemed necessary. ( 1.2 ) Limitations of Use: LUPRON DEPOT 3.75 mg is not indicated for combination use with norethindrone acetate add-back therapy for the preoperative hematologic improvement of women with anemia caused by heavy menstrual bleeding due to fibroids. ( 1.2 ) 1.1 Endometriosis Monotherapy LUPRON DEPOT 3.75 mg is indicated for management of endometriosis, including pain relief and reduction of e…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION LUPRON DEPOT 3.75 mg for 1-month administration, given by a healthcare provider as a single intramuscular injection. LUPRON DEPOT 3.75 mg has different release characteristics than LUPRON 11.25 mg and is dosed differently. ( 2.1 ) Do not substitute LUPRON DEPOT 3.75 mg for LUPRON DEPOT 11.25 mg. Do not administer LUPRON DEPOT 3.75 mg more frequently than once a month. Do not give a fractional dose of the LUPRON DEPOT 11.25 mg 3-month formulation, as it is not equivalent to a single dose of the LUPRON DEPOT 3.75 mg. Do not give a triple dose of the LUPRON DEPOT 3.75 mg, as it is not equivalent to a single dose of the LUPRON DEPOT 11.25 mg 3- month formulation. Reconstitute LUPRON DEPOT 3.75 mg prior to use. ( 2.2 ) Endometriosis: LUPRON DEPOT 3.75 mg administered as a single intramuscular (IM) injection once every month for up to six injections (6 months of therapy). LUPRON DEPOT may be administered alone or in combination with daily 5 mg tablet of norethindrone acetate (add-back). ( 2.1 ) If endometriosis symptoms recur after initial course of therapy, retreatment for no more than six months may be considered but only with the addition of norethindrone a…
Contraindications
4 CONTRAINDICATIONS LUPRON DEPOT 3.75 mg is contraindicated in women with the following: Hypersensitivity to gonadotropin-releasing hormone (GnRH), GnRH agonist analogs, including leuprolide acetate, or any of the excipients in LUPRON DEPOT 3.75 mg [see Warnings and Precautions ( 5.4 ) and Adverse Reactions ( 6.2 ) ] Undiagnosed abnormal uterine bleeding Pregnancy [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.1 ) ] When norethindrone acetate is administered with LUPRON DEPOT 3.75 mg, the contraindications to the use of norethindrone acetate also apply to this combination regimen. Refer to the norethindrone acetate prescribing information for a list of contraindications for norethindrone acetate. Hypersensitivity to GnRH, GnRH agonist analogs, including leuprolide acetate, or any of the excipients in LUPRON DEPOT 3.75 mg. ( 4 , 5.4 ) Undiagnosed abnormal uterine bleeding. ( 4 ) Pregnancy. ( 4 , 8.1 ) If LUPRON DEPOT 3.75 mg is administered with norethindrone acetate, the contraindications for norethindrone acetate also apply. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS No drug-drug interaction studies have been conducted with LUPRON DEPOT 3.75 mg.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Loss of Bone Mineral Density [see Warnings and Precautions ( 5.1 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 ) ] Initial Flare of Symptoms with Management of Endometriosis [see Warnings and Precautions ( 5.5 ) ] Convulsions [see Warnings and Precautions ( 5.6 ) ] Clinical Depression [see Warnings and Precautions ( 5.7 ) ] Most common adverse reactions (>10%) in clinical trials were hot flashes/sweats, headache/migraine, vaginitis, depression/emotional lability, general pain, weight gain/loss, nausea/vomiting, decreased libido, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. LU…
Frequently Asked Questions
What is Lupron Depot used for?
Lupron Depot contains leuprolide acetate. It is a kit taken as directed. Consult your doctor for specific uses.
Is Lupron Depot a controlled substance?
Lupron Depot is not classified as a controlled substance by the DEA.
What is the generic name for Lupron Depot?
The generic name for Lupron Depot is leuprolide acetate. There are 12 other brand versions of leuprolide acetate.
What is the NDC code for Lupron Depot ?
The NDC (National Drug Code) for Lupron Depot is 0074-3473, listed by AbbVie Inc..