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Indication

VANTAS^® (histrelin acetate) implant is a drug-delivery system that contains the medicine histrelin and is placed under the skin. After it is placed under the skin, VANTAS delivers histrelin to your body continuously for 12 months. VANTAS may help relieve the symptoms of prostate cancer. VANTAS is not a cure for prostate cancer.

Important Safety Information

• Do not use VANTAS if you are allergic to the medicine histrelin or other medicines called gonadotropin releasing hormone (GnRH) agonists, are a woman or are a child under 18 years of age.
• Before using VANTAS, tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
• VANTAS is placed under the skin of your upper arm. Your doctor will numb your arm, make a small cut (incision), and place VANTAS under the skin. The cut will be closed with stitches and special surgical tape and covered with a bandage. Keep your arm clean and dry for 24 hours. Your doctor will give you complete instructions. You may have some pain, bruising, and redness at the insertion site during and after VANTAS is inserted and removed. These usually go away without treatment within 2 weeks.
• Your doctor will do blood tests to check on your response to treatment with VANTAS. For example, your doctor may check your prostate specific antigen (PSA) or testosterone levels.
• The most common side effects of VANTAS are hot flashes, tiredness, skin reactions at the implant site, testicles become smaller, urination problems, breasts become larger, erectile dysfunction (impotence), and constipation.
• VANTAS can cause a loss in bone mineral density. Low bone mineral density can lead to thinning of the bones (osteoporosis).
• VANTAS can increase your blood sugar and your risk of developing diabetes. Your doctor may check your blood sugar.
• Your risk of heart attack, sudden death due to heart attack and stroke can increase with VANTAS. Your doctor may monitor you for heart disease.
• VANTAS can cause an increase in testosterone during the first week after it is implanted. Your symptoms may get worse during the first few weeks of treatment or you may get new symptoms. If your cancer has spread to the spine or urinary tract, urinary blockage or pressure in the spine may occur and can sometimes lead to paralysis, which may be life-threatening. Call your doctor right away if you get new or worse bone pain, weakness or lose feeling in your legs, have blood in your urine, or you have trouble urinating or cannot urinate.
• These are not all of the side effects of VANTAS. For more information, ask your doctor or pharmacist.
• VANTAS can be expelled from your body through the original incision site. This occurs infrequently. Remember to see your doctor for routine checks on your condition to ensure that VANTAS is present and functioning in your body.
• VANTAS may be difficult to feel under your skin. If VANTAS cannot be felt under your skin at the time for removal, your doctor may order special tests, such as ultrasound or CT scan, in order to locate it for removal
• If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about VANTAS that is written for health professionals. More information about VANTAS is available on the internet at www.vantasimplant.com.

For more product information, please see the VANTAS full Prescribing Information, which includes the patient information leaflet.

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