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The prostate gland is an organ that is located at the base or outlet (neck) of the urinary bladder. (See the diagram that follows.) The gland surrounds the first part of the urethra. The urethra is the passage through which urine drains from the bladder to exit from the penis. One function of the prostate gland is to help control urination by pressing directly against the part of the urethra that it surrounds. The main function of the prostate gland is to produce some of the substances that are found in normal semen, such as minerals and sugar. Semen is the fluid that transports the sperm to assist with reproduction. A man can manage quite well, however, without his prostate gland. (See the section on surgical treatment for prostate cancer.)
In a young man, the normal prostate gland is the size of a walnut (<30g). During normal aging, however, the gland usually grows larger. This hormone-related enlargement with aging is called b...30g).
VANTAS®
(histrelin acetate)
VANTAS® (histrelin acetate) implant is a sterile, non-biodegradable, diffusion-controlled MedLaunchTM polymer reservoir containing histrelin acetate, a synthetic nonapeptide analog of the naturally occurring gonadotropin releasing hormone (GnRH). VANTAS is designed to deliver approximately 50 mcg histrelin acetate per day (equivalent to approximately 41 mcg histrelin per day) over 12 months.
The sterile VANTAS (histrelin acetate) implant looks like a small thin flexible tube and consists of a 50-mg histrelin acetate drug core inside a 3.5 cm by 3 mm, cylindrical MedLaunchTM polymer reservoir (Figure A).
Figure A: VANTAS (histrelin acetate) Implant diagram (not to scale)
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Histrelin acetate is chemically described as: 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-Ntbenzyl-D-histidyl-Lleucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) [C66H86N18O12 (1.7-2.8 moles) CH3COOH, (0.6-7.0 moles) H2O], with the molecular weight of 1443.70 (or 1323.50 as histrelin base).
Histrelin acetate has the following structural formula:
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The drug core also contains the inactive ingredient stearic acid NF. The MedLaunch™ polymer reservoir is a hydrophilic cartridge composed of 2-hydroxyethyl methacrylate, 2-hydroxypropyl methacrylate, trimethylolpropane trimethacrylate, benzoin methyl ether, Perkadox-16, and Triton X-100. Each implant is packaged hydrated in a glass vial containing 2 mL of sterile 1.8% sodium chloride solution. The implant is primed for immediate release of the drug upon insertion.
A single use, sterile Insertion Tool is provided along with the implant that may be used for the placement of the implant into the subcutaneous tissue of the inner aspect of the upper arm. The Insertion Tool is enclosed in a sterile bag and is provided separately from the implant in the Implantation Kit [see DOSAGE AND ADMINISTRATION].
Before using histrelin, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (e.g., leuprolide); 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, family history of sudden cardiac death.
If you are a man using this medication for prostate cancer, histrelin 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...
Last reviewed on RxList: 4/14/2011
This monograph has been modified to include the generic and brand name in many instances.
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