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Lupron Depot

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Lupron Depot

Indications
Dosage
How Supplied

INDICATIONS

LUPRON DEPOT 22.5 mg for 3–month administration, 30 mg for 4–month administration, and 45 mg for 6– month administration (leuprolide acetate) are indicated in the palliative treatment of advanced prostatic cancer.

LUPRON DEPOT is a gonadotropin releasing hormone (GnRH) agonist.

DOSAGE AND ADMINISTRATION

LUPRON DEPOT must be administered under the supervision of a physician.

Table 1 : LUPRON DEPOT Recommended Dosing

Dosage 22.5 mg for 3-Month Administration 30 mg for 4-Month Administration 45 mg for 6-Month Administration
Recommended dose 1 injection every 12 weeks 1 injection every 16 weeks 1 injection every 24 weeks

LUPRON DEPOT 22.5 mg for 3-Month Administration

The recommended dose of LUPRON DEPOT 22.5 mg for 3-month administration is one injection every 12 weeks. Due to different release characteristics, a fractional dose, or a combination of doses of this 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 12 weeks as a single intramuscular injection.

For optimal performance of the prefilled dual chamber syringe (PDS), read and follow the instructions in Section 2.4.

LUPRON DEPOT 30 mg for 4-Month Administration

The recommended dose of LUPRON DEPOT 30 mg for 4-month administration is one injection every 16 weeks. Due to different release characteristics, a fractional dose, or a combination of doses of this 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 16 weeks as a single intramuscular injection.

For optimal performance of the prefilled dual chamber syringe (PDS), read and follow the instructions in Section 2.4.

LUPRON DEPOT 45 mg for 6-Month Administration

The recommended dose of LUPRON DEPOT 45 mg for 6-month administration is one injection every 24 weeks. Due to different release characteristics, a fractional dose, or a combination of doses of this 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 24 weeks as a single intramuscular injection.

For optimal performance of the prefilled dual chamber syringe (PDS), read and follow the instructions in Section 2.4.

Administration of Injection

  • 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.

1. The LUPRON DEPOT 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 prior to mixing with the diluent. The diluent should appear clear.

2. To prepare for injection, screw the white plunger into the end stopper until the stopper begins to turn.

screw the white plunger into the end stopper - Illustration

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.

Hold the syringe upright -  Illustration

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.

Gently mix the microspheres - Illustration

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. After cleaning the injection site with an alcohol swab, insert the needle completely at a 90 degree angle.

Insert the needle completely at a 90 degree angle -  Illustration

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. If blood is present remove the needle immediately. Do not inject the medication

Luer lock connection - Illustration

8. Inject the entire contents of the syringe intramuscularly at the time of reconstitution. The suspension settles very quickly following reconstitution; therefore, LUPRON DEPOT should be mixed and used immediately.

After Injection

9. Withdraw the needle. Immediately activate the LuproLoc® safety device by pushing the arrow forward with the thumb or finger, as illustrated, until the device is fully extended and a CLICK is heard or felt.

Activate the LuproLoc® safety device - Illustration

Additional Information

  • Please see the handling information in the Reference.
  • Dispose of the syringe according to local regulations/procedures.

HOW SUPPLIED

Dosage Forms And Strengths

LUPRON DEPOT 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6month administration are each supplied as a kit with prefilled dual chamber syringe.

Storage And Handling

Each LUPRON DEPOT 22.5 mg for 3-month administration (NDC 0074-3346-03), 30 mg for 4-month administration (NDC 0074-3683-03), 45 mg for 6-month administration (NDC 0074-3473-03) contains:

  • one prefilled dual-chamber syringe containing needle with LuproLoc® safety device
  • one plunger
  • two alcohol swabs
  • 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 22.5 mg for 3-month administration is administered as a single intramuscular injection EVERY 12 WEEKS.

When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 30 mg for 4-month administration is administered as a single intramuscular injection EVERY 16 WEEKS. When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 45 mg for 6-month administration is administered as a single intramuscular injection EVERY 24 WEEKS.

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. Rev. 07/2012

Last reviewed on RxList: 8/3/2012
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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