Recommended Topic Related To:

Lupron Depot 22.5

"The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for"...

Lupron Depot 22.5

Lupron Depot 22.5

INDICATIONS

LUPRON DEPOT (leuprolide acetate for depot suspension injection) –3 Month 22.5 mg is indicated in the palliative treatment of advanced prostatic cancer. It offers an alternative treatment of prostatic cancer when orchiectomy or estrogen administration are either not indicated or unacceptable to the patient. In clinical trials, the safety and efficacy of LUPRON DEPOT (leuprolide acetate for depot suspension injection) –3 Month 22.5 mg were similar to that of the original daily subcutaneous injection and the monthly depot formulation.

DOSAGE AND ADMINISTRATION

LUPRON DEPOT (leuprolide acetate for depot suspension injection) Must Be Administered Under The Supervision Of A Physician.

The recommended dose of LUPRON DEPOT (leuprolide acetate for depot suspension injection) –3 Month 22.5 mg to be administered is one injection every three months (84 days). Due to different release characteristics, a fractional dose of this 3-month depot formulation is not equivalent to the same dose of the monthly formulation and should not be given.

Incorporated in a depot formulation, the lyophilized microspheres are to be reconstituted and administered every three months as a single intramuscular injection. For optimal performance of the prefilled dual chamber syringe (PDS), read and follow the following instructions:

  1. The LUPRON DEPOT (leuprolide acetate for depot suspension injection) powder should be visually inspected and the syringe should NOT BE USED if clumping or caking is evident. A thin layer of powder on the wall of the syringe is considered normal. The diluent should appear clear.
  2. To prepare for injection, screw the white plunger into the end stopper until the stopper begins to turn.
  3. Hold the syringe UPRIGHT. Release the diluent by SLOWLY PUSHING (6 to 8 seconds) the plunger until the first stopper is at the blue line in the middle of the barrel.
  4. Keep the syringe UPRIGHT. Gently mix the microspheres (powder) thoroughly to form a uniform suspension. The suspension will appear milky. If the powder adheres to the stopper or caking/clumping is present, tap the syringe with your finger to disperse. DO NOT USE if any of the powder has not gone into suspension.
  5. Hold the syringe UPRIGHT. With the opposite hand pull the needle cap upward without twisting.
  6. Keep the syringe UPRIGHT. Advance the plunger to expel the air from the syringe.
  7. Inject the entire contents of the syringe intramuscularly at the time of reconstitution. The suspension settles very quickly following reconstitution; therefore, LUPRON DEPOT (leuprolide acetate for depot suspension injection) should be mixed and used immediately.
    NOTE: Aspirated blood would be visible just below the luer lock connection if a blood vessel is accidentally penetrated. If present, blood can be seen through the transparent LuproLoc™ safety device. AFTER INJECTION
  8. Withdraw the needle. Immediately activate the LuproLoc™ safety device by pushing the arrow

forward with the thumb or finger until the device is fully extended and a CLICK is heard or felt. Since the product does not contain a preservative, the suspension should be discarded if not used immediately.

As with other drugs administered by injection, the injection site should be varied periodically.

HOW SUPPLIED

Each LUPRON DEPOT (leuprolide acetate for depot suspension injection) - 3 Month 22.5 mg kit (NDC 0074-3346-03) contains:

  • One prefilled dual-chamber syringe,
  • One plunger,
  • Two alcohol swabs,
  • Instructions for how to mix and administer,
  • An information pamphlet for patients, and
  • A complete prescribing information enclosure.

The prefilled dual-chamber syringe contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid polymer. When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT (leuprolide acetate for depot suspension injection) - 3 Month 22.5 mg is administered as a single monthly intramuscular injection EVERY THREE MONTHS (84 days)

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]

REFERENCES

1. 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.

2. 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

3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63:1172-1193.

4. 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.

Manufactured for Abbott Laboratories, North Chicago, IL 60064, by Takeda Pharmaceutical Company Limited, Osaka, JAPAN 540-8645.

Last reviewed on RxList: 6/2/2010
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Cancer

Get the latest treatment options.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations