Vantas (Histrelin Acetate)

They need to know if you have any of these conditions: -diabetes -heart disease -history of irregular heartbeat -history of stroke -pain or trouble passing urine -spinal cord metastasis -an unusual or allergic reaction to histrelin, other medicines, foods, dyes, or preservatives -pregnant or trying to get pregnant -breast-feeding

This medicine is placed under the skin of your arm by a health care professional in a clinic or office. After the implant is placed, keep the insertion site clean and dry for 24 hours. Avoid heavy lifting and strenuous exercise for 7 days after implant insertion. The surgical strips over the site should be allowed to fall off on their own over several days. The implant must be removed after 12 months. At this time, a new implant may be inserted to continue therapy. Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

This does not apply. After 1 year, the implant will have to be removed. If you need to continue this medicine, the implant will be replaced at that time.

Do not take this medicine with any of the following medications: -cisapride -dofetilide -dronedarone -pimozide -thioridazine -ziprasidone This medicine may also interact with the following medications: -female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections -other medicines that prolong the QT interval (cause an abnormal heart rhythm) -testosterone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

Visit your doctor or health care professional for regular checks on your progress. During the first week, your symptoms may get worse but then will start to get better as you continue your treatment. You may get hot flashes, increased bone pain, increased difficulty passing urine, or an aggravation of nerve symptoms. Discuss these effects with your doctor or health care professional. Some of these may get better with continued use of this medicine. Rarely, the implant can be expelled from the body through the original incision site. It is possible that you may see the implant being expelled, or rarely, the implant may be expelled without you noticing it. If you believe the implant has been expelled from your body, call your doctor.

Side effects that you should report to your doctor or health care professional as soon as possible: -allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue -loss of bladder or bowel control -signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems -signs and symptoms of high blood sugar such as dizziness; dry mouth; dry skin; fruity breath; nausea; stomach pain; increased hunger or thirst; increased urination -signs and symptoms of a stroke like changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination -trouble passing urine or change in the amount of urine Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome): -blood in the urine -bone pain -breast enlargement -change in sex drive or performance -hot flashes -pain, redness, or irritation at site where injected -pain, tingling, numbness in the hands or feet -trouble sleeping -unusually weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.