INDICATIONS AND USAGE
LUPRON DEPOT–3 Month 11.25 mg is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions. LUPRON DEPOT 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 Month 11.25 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, CLINICAL STUDIES
section.) LUPRON may be added if the response to iron alone is considered inadequate. Recommended therapy is a single injection of LUPRON DEPOT–3 Month 11.25 mg. This dosage form is indicated only for women for whom three months of hormonal suppression is deemed necessary.
Experience with LUPRON DEPOT–3 Month 11.25 mg in females has been limited to women 18 years of age and older treated for no more than 6 months.
DOSAGE AND ADMINISTRATION
LUPRON DEPOT Must Be Administered Under the Supervision of a Physician.
The recommended duration of treatment with LUPRON DEPOT–3 Month 11.25 mg alone or in combination with norethindrone acetate is six months. The choice of LUPRON DEPOT alone or LUPRON DEPOT plus norethindrone acetate therapy for initial management of the symptoms and signs of endometriosis should be made by the health care professional in consultation with the patient and should take into consideration the risks and benefits of the addition of norethindrone to LUPRON DEPOT alone.
If the symptoms of endometriosis recur after a course of therapy, retreatment with a six-month course of LUPRON DEPOT-3 Month 11.25 mg administered every three months and norethindrone acetate 5 mg daily may be considered. Retreatment beyond this one six-month course cannot be recommended. It is recommended that bone density be assessed before retreatment begins to ensure that values are within normal limits. LUPRON DEPOT alone is not recommended for retreatment. If norethindrone acetate is contraindicated for the individual patient, then retreatment is not recommended.
An assessment of cardiovascular risk and management of risk factors such as cigarette smoking is recommended before beginning treatment with LUPRON DEPOT and norethindrone acetate.
Uterine Leiomyomata (Fibroids)
The recommended dose of LUPRON DEPOT–3 Month 11.25 mg is one injection. The symptoms associated with uterine leiomyomata will recur following discontinuation of therapy. If additional treatment with LUPRON DEPOT–3 Month 11.25 mg is contemplated, bone density should be assessed prior to initiation of therapy to ensure that values are within normal limits.
Due to different release characteristics, a fractional dose of the 3-month depot formulation is not equivalent to the same dose of the monthly formulation and should not be given.
For optimal performance of the prefilled dual chamber syringe (PDS), read and follow the following instructions:
Reconstitution and Administration Instructions
- The lyophilized microspheres are to be reconstituted and administered as a single intramuscular injection.
- Since LUPRON DEPOT does not contain a preservative, the suspension should be injected immediately or discarded if not used within two hours.
- As with other drugs administered by injection, the injection site should be varied periodically.
- Dispose of the syringe according to local regulations/procedures.
Each LUPRON DEPOT – 3 Month 11.25 mg kit (NDC 0074-3663-03) contains:
- one prefilled dual-chamber syringe
- one plunger
- two alcohol swabs
- a complete prescribing information enclosure
Each syringe contains sterile lyophilized microspheres which are leuprolide acetate incorporated in a biodegradable polymer of polylactic acid. When mixed with 1.5 mL of the diluent, LUPRON DEPOT–3 Month 11.25 mg is administered as a single IM injection EVERY THREE MONTHS.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]
- NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.
- OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
- American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63; 1172-1193.
- Polovich, M., White, J.M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. Ed.) Pittsburgh, PA: Oncology Nursing Society.
North Chicago, IL 60064
by Takeda Pharmaceutical Company Limited
Osaka, Japan 540-8645
03-A892 October, 2013
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