Histrelin overstimulates the body's own production of certain hormones, which causes that production to shut down temporarily.

The Supprelin LA brand of histrelin is used to treat precocious puberty in both male and female children who are at least 2 years old.

The Vantas brand of histrelin is used to treat symptoms of prostate cancer in men. Vantas treats only the symptoms of prostate cancer but does not treat the cancer itself.

Histrelin may also be used for purposes not listed in this medication guide.

Histrelin can harm an unborn baby or cause a miscarriage. Do not use if you are pregnant.

Histrelin can cause side effects such as crying spells, anger, aggression, and feeling restless or irritable. Call your doctor if you have any new or worsening mental problems.

Histrelin is given in a tiny implant inserted under the skin on the inside of your upper arm. You will receive this implant with a minor surgical procedure in a clinic or doctor's office.

It is best to place the implant into your non-dominant arm (your left arm if you are right-handed). Be sure to tell your doctor which arm you use most often.

The skin of your upper arm will be treated with a numbing medicine to keep you from feeling pain during the insertion. Your doctor will use a scalpel to cut a small incision where the implant will be inserted.

The histrelin implant is inserted using a special tool that pushes the implant into place through the incision in your skin. After injecting the implant and removing the insertion tool, your doctor will then feel your arm to make sure the implant has been correctly placed.

The incision in your skin may be closed with stitches or surgical strips. Follow your doctor's instructions about caring for the incision and keeping it bandaged and clean until it heals completely. Keep your arm dry for at least 24 hours.

You will most likely be able to feel the implant through your skin, but it should not cause pain or discomfort.

Call your doctor if you have any pain, swelling, tenderness, itching, tingling, bruising, or redness where the implant was inserted, or if the implant comes through the skin or falls out.

A histrelin implant is usually left in place for 12 months and then must be removed through a surgical incision. Do not try to remove the implant yourself. Your doctor will determine whether you need another implant for continued treatment.

You may have a temporary increase in precocious puberty symptoms for a week or so after you have received the Supprelin LA implant.

You may need medical tests to help your doctor determine how long to treat you with histrelin.

Histrelin can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using histrelin.

Usual Adult Dose for Prostate Cancer:

VANTAS:
One 50 mg implant inserted subcutaneously in the inner aspect of the upper arm
Duration of therapy: The implant should be removed after 12 months.
NOTE: The implant is designed to allow for a few additional weeks of drug release to allow flexibility of medical appointments); when an implant is removed, another implant may be inserted to continue therapy.

Use: Vantas: Palliative treatment of advanced prostate cancer

Usual Pediatric Dose for Precocious Puberty:

SUPPRELIN LA:
2 years and older:
One 50 mg implant inserted subcutaneously in the inner aspect of the upper arm
Duration of therapy: The implant should be removed after 12 months.
NOTE: When an implant is removed, another implant may be inserted to continue therapy.

Comments:
-Discontinuation of therapy should be considered at the discretion of the physician and at the appropriate time point for the onset of puberty (approximately 11 years for females and 12 years for males).

Use:
Supprelin LA: Treatment of children with central precocious puberty

You should not be treated with histrelin if you are allergic to histrelin or to similar hormone medications such as leuprolide, nafarelin, ganirelix, Eligard, Lupron, Viadur, and others.

Do not use histrelin if you are pregnant. It could harm the unborn baby or cause a miscarriage. Use effective birth control to prevent pregnancy and tell your doctor right away if you become pregnant.

Vantas should not be used in women or children.

To make sure Supprelin LA is safe for you, tell your doctor if you have ever had:

• mental illness or psychosis;

• epilepsy or other seizure disorder;

• a tumor or blood vessel disorder in your brain; or

• if you take a medicine that can cause seizures (such as an antidepressant).

To make sure Vantas is safe for you, tell your doctor if you have ever had:

• a bladder obstruction or other urination problems;

• diabetes;

• heart problems, heart attack, or stroke;

• long QT syndrome (in you or a family member);

• low bone mineral density (osteoporosis); or

• a condition affecting your spine.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Supprelin LA should not be used in a child younger than 2 years old. Vantas is not approved for use by anyone younger than 18 years old.

Since histrelin is given as an implant, it does not have a daily dosing schedule.

The implant should not be left in your arm for longer than 12 months. Call your doctor when it is time for your implant to be removed.

Since the histrelin implant contains a specific amount of the medicine, you are not likely to receive an overdose.

For at least 7 days after your implant is inserted, avoid strenuous exercise or heavy lifting.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Histrelin may cause serious side effects. Call your doctor at once if you have:

• bone pain, numbness or weakness in your legs or feet;

• painful or difficult urination, blood in your urine;

• a seizure;

• increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or

• mental problems--crying spells, anger, aggression, feeling restless or irritable.

Common side effects of histrelin may include:

• constipation;

• urination problems;

• breast swelling;

• hot flashes;

• feeling tired;

• erectile dysfunction (impotence), decreased testicle size; or

• pain, redness, bruising, swelling, or skin irritation where the implant was inserted.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect histrelin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.