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|Histrelin Implant

Histrelin Implant

Histrelin Implant is used for:

Relieving the symptoms of prostate cancer in men. Histrelin Implant is not a cure for prostate cancer.

Histrelin Implant is a synthetic analogue of gonadotropin-releasing hormone (GnRH) agonist. It works by decreasing the production of certain hormones, which reduces testosterone levels in the body.

Do NOT use Histrelin Implant if:

• you are allergic to any ingredient in Histrelin Implant or other medicines containing GnRH
• you are female

Contact your doctor or health care provider right away if any of these apply to you.

Before using Histrelin Implant:

Some medical conditions may interact with Histrelin Implant. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have urinary tract blockage or metastatic vertebral lesions

Some MEDICINES MAY INTERACT with Histrelin Implant. However, no specific interactions with Histrelin Implant are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Histrelin Implant may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Histrelin Implant:

Use Histrelin Implant as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Histrelin Implant comes with an additional patient leaflet. Read it carefully.
• Histrelin Implant is inserted in a doctor"s office, hospital, or clinic.
• This implant is a small, thin, flexible tube that is placed under the skin of the inside of your upper arm. It delivers medicine to your body continuously for 12 months.
• If you miss a dose of Histrelin Implant, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Histrelin Implant.

Important safety information:

• The cut where the implant is placed will be covered with stitches, surgical tape, and a bandage. Do not remove the surgical strips. Allow the strips to fall off on their own after a few days.
• After the implant is placed, keep your arm clean and dry for 24 hours. Do not bathe or swim for 24 hours. Keep the bandage in place for a few days until the cut heals. Avoid heavy lifting and exercise for 7 days. Avoid bumping the site for a few days.
• You may have pain, redness, or some bruising at the insertion site of the implant. This usually goes away without treatment within 2 weeks. Call your doctor if you have unusual or prolonged bleeding, redness, or pain.
• After 12 months, your doctor will remove the implant. Your doctor may insert a new implant to continue treatment.
• Histrelin Implant may cause a loss in bone mineral density. This can lead to thin and/or weak bones.
• Your doctor will check your condition during treatment to be sure the implant is present and functioning.
• Rarely, the implant may be expelled through the insertion site. If you think this may have occurred, call your doctor at once.
• LAB TESTS, including prostate-specific antigen (PSA) or testosterone levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Histrelin Implant is not recommended for use in CHILDREN younger than 18 years of age; safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Histrelin Implant is not for WOMEN and may cause harm to an unborn baby in a woman who is pregnant or may become pregnant.

Possible side effects of Histrelin Implant:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Breast growth; bruising; constipation; decreased sex drive; erectile dysfunction (impotence); headache; hot flashes; sleeplessness; soreness, pain, tenderness, or redness at the insertion site; testicles become smaller; tiredness; weight gain.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bone pain; numbness or tingling of the skin; trouble urinating or inability to urinate; weakness or loss of feeling in the legs; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Histrelin Implant in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C) in the unopened glass vial in the plastic pouch and carton. Protect from light. Do not freeze. Keep Histrelin Implant out of the reach of children and away from pets.

General information:

• If you have any questions about Histrelin Implant, please talk with your doctor, pharmacist, or other health care provider.
• Histrelin Implant is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Histrelin Implant. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.