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The company, OncBioMune Pharnaceuticals, Inc, in Baton Rouge, is planning t"...
(leuprolide acetate) Suspension for Subcutaneous Injection
ELIGARD® is a sterile polymeric matrix formulation of leuprolide acetate, a GnRH agonist, for subcutaneous injection. It is designed to deliver leuprolide acetate at a controlled rate over a one-, three-, four- or six-month therapeutic period.
Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH) that, when given continuously, inhibits pituitary gonadotropin secretion and suppresses testicular and ovarian steroidogenesis. The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-Dleucyl- L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:
ELIGARD® is prefilled and supplied in two separate, sterile syringes whose contents are mixed immediately prior to administration. The two syringes are joined and the single dose product is mixed until it is homogenous. ELIGARD® is administered subcutaneously, where it forms a solid drug delivery depot.
One syringe contains the ATRIGEL Delivery System and the other contains leuprolide acetate. ATRIGEL is a polymeric (non-gelatin containing) delivery system consisting of a biodegradable poly (DL-lactide-co-glycolide) (PLGH or PLG) polymer formulation dissolved in a biocompatible solvent, N-methyl-2-pyrrolidone (NMP).
Refer to Table 5 for the delivery system composition and constituted product formulation for each ELIGARD® product.
Table 5: ELIGARD® Delivery System
Composition and Constituted Product Formulation
|ELIGARD®||7.5 mg||22.5 mg||30 mg||45 mg|
|ATRIGEL® Delivery System syringe||Polymer||PLGH||PLG||PLG||PLG|
|Polymer description||Copolymer containing carboxyl endgroups||Copolymer with hexanediol||Copolymer with hexanediol||Copolymer with hexanediol|
|Polymer DL-lactide to glycolide molar ratio||50:50||75:25||75:25||85:15|
|Constituted product||Polymer delivered||82.5 mg||158.6 mg||211.5 mg||165 mg|
|NMP delivered||160.0 mg||193.9 mg||258.5 mg||165 mg|
|Leuprolide acetate delivered||7.5 mg||22.5 mg||30 mg||45 mg|
|Approximate Leuprolide free base equivalent||7.0 mg||21 mg||28 mg||42 mg|
|Approximate administered formulation weight||250 mg||375 mg||500 mg||375 mg|
|Approximate injection volume||0.25 mL||0.375 mL||0.5 mL||0.375 mL|
What are the possible side effects of leuprolide (Eligard, Lupron, Lupron Depot, Lupron Depot-Ped)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- bone pain, loss of movement in any part of your body;
- swelling, rapid weight gain;
- pain, burning, stinging, bruising, or redness where the medication was injected;
- feeling like you might pass out;
- sudden chest pain or discomfort, wheezing, dry cough or hack;
What are the precautions when taking leuprolide acetate (Eligard)?
Before using leuprolide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart disease (such as heart attack), stroke, high cholesterol.
Leuprolide may weaken your bones and increase your risk for bone loss (osteoporosis) if used for a long time. Before using this medication, tell your doctor or pharmacist if you have osteoporosis or if you have any of the following risk factors for osteoporosis: long-term alcohol use, smoking, family history of osteoporosis and broken bones, use...
Last reviewed on RxList: 4/25/2016
This monograph has been modified to include the generic and brand name in many instances.
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