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What is ELIGARD?
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-D-leucyl-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
What does ELIGARD look like?
What are the available doses of ELIGARD?
ELIGARD is an injectable suspension of leuprolide acetate available in a single use kit. The kit consists of a two-syringe mixing system, a sterile needle or a sterile safety needle (Table 2), a silica gel desiccant pouch to control moisture uptake, and a package insert for constitution and administration procedures. Each syringe is individually packaged. One contains the ATRIGEL Delivery System and the other contains leuprolide acetate powder. When constituted, ELIGARD is administered as a single dose.
Table 2. ELIGARD Needle Specifications
What should I talk to my health care provider before I take ELIGARD?
How should I use ELIGARD?
ELIGARD is indicated for the palliative treatment of advanced prostate cancer.
As with other similar agents, the use of gloves is recommended during mixing and administration.
ELIGARD is administered and provides continuous release of leuprolide acetate over a one-, three-, four-, or six-month treatment period (Table 1). The injection delivers the dose of leuprolide acetate incorporated in a polymer formulation.
Table 1. ELIGARD Recommended Dosing
As with other drugs administered by subcutaneous injection, the injection site should vary periodically. The specific injection location chosen should be an area with sufficient soft or loose subcutaneous tissue. In clinical trials, the injection was administered in the upper- or mid-abdominal area. Avoid areas with brawny or fibrous subcutaneous tissue or locations that could be rubbed or compressed (i.e., with a belt or clothing waistband).
What interacts with ELIGARD?
Sorry No Records found
What are the warnings of ELIGARD?
Sorry No Records found
What are the precautions of ELIGARD?
Sorry No Records found
What are the side effects of ELIGARD?
Sorry No records found
What should I look out for while using ELIGARD?
Known hypersensitivity to GnRH, GnRH agonist analogs or any of the components of ELIGARD ()
What might happen if I take too much ELIGARD?
In clinical trials using daily subcutaneous injections of leuprolide acetate in patients with prostate cancer, doses as high as 20 mg/day for up to two years caused no adverse effects differing from those observed with the 1 mg/day dose.
How should I store and handle ELIGARD?
Store at 20°C to 25°C (68°F to 77°F) [See USP controlled room temperature]. Protect from moisture.Product: 50090-2949NDC: 50090-2949-0 60 TABLET, FILM COATED in a BOTTLEProduct: 50090-2949NDC: 50090-2949-0 60 TABLET, FILM COATED in a BOTTLE
Chemical StructureNo Image found
Leuprolide acetate, a gonadotropin releasing hormone (GnRH) agonist, acts as a potent inhibitor of gonadotropin secretion when given continuously in therapeutic doses. Animal and human studies indicate that after an initial stimulation, chronic administration of leuprolide acetate results in suppression of testicular and ovarian steroidogenesis. This effect is reversible upon discontinuation of drug therapy.
In humans, administration of leuprolide acetate results in an initial increase in circulating levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH), leading to a transient increase in levels of the gonadal steroids (testosterone and dihydrotestosterone in males, and estrone and estradiol in premenopausal females). However, continuous administration of leuprolide acetate results in decreased levels of LH and FSH. In males, testosterone is reduced to below castrate threshold (≤50 ng/dL). These decreases occur within two to four weeks after initiation of treatment. Long-term studies have shown that continuation of therapy with leuprolide acetate maintains testosterone below the castrate level for up to seven years.
Non-Clinical ToxicologyKnown hypersensitivity to GnRH, GnRH agonist analogs or any of the components of ELIGARD ()
Lidocaine Hydrochloride Injection, USP should be used with caution in patients with digitalis toxicity accompanied by atrioventricular block. Concomitant use of beta-blocking agents or cimetidine may reduce hepatic blood flow and thereby reduce lidocaine clearance. The concomitant use of these two agents may cause an increased incidence of adverse reactions, including central nervous system adverse reactions such as seizure.
Lidocaine and tocainide are pharmacodynamically similar.
ELIGARD 7.5 mg 22.5 mg 30 mg, like other GnRH agonists, causes a transient increase in serum concentrations of testosterone during the first week of treatment. ELIGARD 45 mg causes a transient increase in serum concentrations of testosterone during the first two weeks of treatment. Patients may experience worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, or bladder outlet obstruction.
Cases of ureteral obstruction and/or spinal cord compression, which may contribute to paralysis with or without fatal complications, have been observed in the palliative treatment of advanced prostate cancer using GnRH agonists.
Patients with metastatic vertebral lesions and/or with urinary tract obstruction should be closely observed during the first few weeks of therapy. If spinal cord compression or ureteral obstruction develops, standard treatment of these complications should be instituted.
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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