(histrelin acetate) Subcutaneous Implant
VANTAS® (histrelin acetate) implant is a sterile, non-biodegradable, diffusion-controlled hydrogel 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 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 hydrogel polymer reservoir (Figure A).
Figure A: VANTAS Implant diagram (not to scale)
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:
The drug core also contains the inactive ingredient stearic acid NF. The hydrogel 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].
What are the possible side effects of histrelin (Supprelin LA, Vantas)?
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:
- fever, chills, body aches, flu symptoms;
- swelling, redness, oozing, or other signs of infection around the implant;
- severe bone pain, severe numbness or tingling in your legs or feet;
- blood in your urine, pain when you urinate;
- painful or difficult urination, urinating less than usual or not at...
What are the precautions when taking histrelin acetate (Vantas)?
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, high cholesterol, 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...
Last reviewed on RxList: 4/22/2013
This monograph has been modified to include the generic and brand name in many instances.
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