August 23, 2016
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Lupron Depot

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Lupron Depot




Indications
Dosage
How Supplied

INDICATIONS

LUPRON DEPOT 7.5 mg for 1-month administration, 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.

In patients treated with GnRH analogues for prostate cancer, treatment is usually continued upon development of metastatic castration-resistant prostate cancer.

Table 1: LUPRON DEPOT Recommended Dosing

Dosage 7.5 mg for 1-Month Administration 22.5 mg for 3-Month Administration 30 mg for 4-Month Administration 45 mg for 6-Month Administration
Recommended dose 1 injection every 4 weeks 1 injection every 12 weeks 1 injection every 16 weeks 1 injection every 24 weeks

LUPRON DEPOT 7.5 mg For 1-Month Administration

The recommended dose of LUPRON DEPOT 7.5 mg for 1-month administration is one injection every 4 weeks. Do not use concurrently a fractional dose, or a combination of doses of this or any depot formulation due to different release characteristics.

Incorporated in a depot formulation, the lyophilized microspheres must be reconstituted and should be administered every 4 weeks as a single intramuscular injection.

For optimal performance of the prefilled dual chamber syringe (PDS), read and follow the instructions in Section 2.5.

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. Do not use concurrently a fractional dose, or a combination of doses of this or any depot formulation due to different release characteristics.

Incorporated in a depot formulation, the lyophilized microspheres must be reconstituted and should be 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 2.5.

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. Do not use concurrently a fractional dose, or a combination of doses of this or any depot formulation due to different release characteristics.

Incorporated in a depot formulation, the lyophilized microspheres must be reconstituted and should be 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 2.5.

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. Do not use concurrently a fractional dose, or a combination of doses of this or any depot formulation due to different release characteristics.

Incorporated in a depot formulation, the lyophilized microspheres must be reconstituted and should be 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 Reconstitution and Administration for Injection of LUPRON DEPOT.

Reconstitution And Administration For Injection Of LUPRON DEPOT

  • Reconstitute and administer the lyophilized microspheres as a single intramuscular injection.
  • Inject the suspension immediately or discard if not used within two hours, because LUPRON DEPOT does not contain a preservative.

1. Visually inspect the LUPRON DEPOT powder. DO NOT USE the syringe 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 and colorless.

2. To prepare for injection, screw the white plunger into the end stopper until the stopper begins to turn (see Figure 1 and Figure 2).

Figure 1

White plunger and the end stopper - Illustration

Figure 2

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 middle stopper is at the blue line in the middle of the barrel (see Figure 3).

Figure 3

The blue line in the middle of the barrel - Illustration

4. Keep the syringe UPRIGHT. Mix the microspheres (powder) thoroughly by gently shaking the syringe until the powder forms 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 (see Figure 4).

Figure 4

Mix the microspheres - Illustration

5. Keep 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. Now the syringe is ready for injection.

7. After cleaning the injection site with an alcohol swab, administer the intramuscular injection by inserting the needle at a 90 degree angle into the gluteal area, anterior thigh, or deltoid; injection sites should be alternated (see Figure 5).

Figure 5

Injection sites and administration - Illustration

NOTE: If a blood vessel is accidentally penetrated, aspirated blood will be visible just below the luer lock (see Figure 6) and can be seen through the transparent LuproLoc® safety device. If blood is present, remove the needle immediately. Do not inject the medication.

Figure 6

Visible aspirated blood - Illustration

8. Inject the entire contents of the syringe intramuscularly.

9. Withdraw the needle. Once the syringe has been withdrawn, immediately activate the LuproLoc® safety device by pushing the arrow on the lock upward towards the needle tip with the thumb or finger, as illustrated, until the needle cover of the safety device over the needle is fully extended and a CLICK is heard or felt (see Figure 7).

Figure 7

Activate the LuproLoc® safety device - Illustration

10. Dispose of the syringe according to local regulations/procedures.

HOW SUPPLIED

Dosage Forms And Strengths

LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration are each supplied as a kit with prefilled dual chamber syringe.

Storage And Handling

Each LUPRON DEPOT 7.5 mg for 1-month administration kit (NDC 0074-3642-03), 22.5 mg for 3-month administration kit (NDC 0074-3346-03), 30 mg for 4-month administration kit (NDC 0074-3683-03), 45 mg for 6-month administration kit (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 of LUPRON DEPOT 7.5 mg for 1-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid/glycolic acid copolymer.

The prefilled dual-chamber syringe of LUPRON DEPOT 22.5 mg for 3-month administration, 30 mg for 4-month administration, 45 mg for 6-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid polymer.

When mixed with 1 mL of accompanying diluent, LUPRON DEPOT 7.5 mg for 1-month administration is administered as a single monthly intramuscular injection.

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°C–30°C (59°F–86°F) [See USP Controlled Room Temperature].

Manufactured for : AbbVie Inc. North Chicago, IL 60064 by Takeda Pharmaceutical Company Limited Osaka, Japan 540-8645. Revised: June 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/28/2016

Indications
Dosage
How Supplied

Lupron Depot - User Reviews

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