Histrelin (implant)

Histrelin causes the body to produce certain hormones too much, which leads to a temporary shutdown of that production.

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

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

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

Histrelin is provided in a small implant that is placed under the skin on the inside of your upper arm. You will receive this implant during a minor surgical procedure at a clinic or doctor's office.

It is recommended to place the implant in your non-dominant arm (your left arm if you are right-handed). Make sure to inform your doctor which arm you use more.

The skin on your upper arm will be treated with a numbing medicine to prevent pain during the insertion. Your doctor will use a scalpel to make a small cut where the implant will be inserted.

The histrelin implant is inserted using a special tool that pushes the implant into position through the cut in your skin. After placing the implant and removing the insertion tool, your doctor will check your arm to ensure the implant is correctly positioned.

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

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

Contact your doctor if you experience any pain, swelling, tenderness, itching, tingling, bruising, or redness at the site of the implant, or if the implant comes through the skin or falls out.

A histrelin implant is typically left in place for 12 months and then needs to be removed through a surgical cut. Do not attempt to remove the implant on your own. Your doctor will decide if you need another implant for ongoing treatment.

You may notice a temporary increase in symptoms of precocious puberty for about a week after receiving the Supprelin LA implant.

You may need medical tests to assist your doctor in determining how long you should be treated with histrelin.

Histrelin can lead to unusual results in certain medical tests. Inform any doctor who treats you that you are using histrelin.

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.

You should not receive histrelin if you are allergic to histrelin or to similar hormone medications like 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 inform your doctor immediately if you become pregnant.

Vantas should not be used in women or children.

To ensure Supprelin LA is safe for you, inform 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 ensure Vantas is safe for you, inform 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 risks.

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.

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 right away 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.

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

Since histrelin is given as an implant, you do not need to take it every day.

The implant should not stay in your arm for more than 12 months. Call your doctor when it is time to remove your implant.

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, do not do strenuous exercise or heavy lifting.

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