Supprelin LA implant

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

Irritation at the implant site (such as bruising, pain, redness), mood swings, or headache may occur. In men using this medication for prostate cancer, hot flashes (flushing), increased sweating, night sweats, tiredness, swelling of the ankles/feet, or constipation may occur. In girls using this medication for early puberty, breast tenderness or abnormal vaginal bleeding may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Infrequently, breast tenderness/swelling may occur in men and boys as a result of lowered testosterone levels. Shrinking of the testicles and reduced sexual interest/ability may also occur in men. Talk to your doctor if these effects occur.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

If you are a man using this medication for prostate cancer, tell your doctor right away if you have any serious side effects, including: new/worsening bone pain, easily broken bones, increased thirst/urination.

Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, fast/irregular heartbeat, severe dizziness, fainting, weakness on one side of the body, slurred speech, seizures.

Rarely, a very serious problem with the pituitary gland (pituitary apoplexy) has been reported with similar drugs, usually in the first 2 weeks after starting treatment. Get medical help right away if any of these very serious side effects occur: sudden severe headache, sudden severe mental/mood changes (e.g., severe confusion, difficulty concentrating), vision changes, severe vomiting, fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Supprelin LA (histrelin) is a man-made form of a hormone that regulates many processes in the body. Histrelin overstimulates the body's own production of certain hormones, which causes that production to shut down temporarily.

Supprelin LA implants are used to treat precocious puberty in both male and female children who are at least 2 years old.

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

Supprelin LA can cause a miscarriage or birth defects. Do not use if you are pregnant.

Supprelin LA 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.

Before you receive Supprelin LA, tell your doctor if you have painful or difficult urination, diabetes, heart disease, coronary artery disease, liver disease, a history of heart attack or stroke, osteoporosis, or a condition affecting your spine.

Call your doctor at once if you have a serious side effect such as severe numbness or tingling in your legs or feet, muscle weakness, problems with balance or coordination, loss of bladder or bowel control, urinating more or less than usual, sudden numbness or severe headache, problems with speech or vision, increased thirst or urination, excessive hunger, or chest pain spreading to the arm or shoulder.

A Supprelin LA implant is usually left in place for 12 months and then removed. Your doctor will determine at that time whether you need to receive another implant for treatment of your symptoms.

You should not receive Supprelin LA if you are allergic to histrelin or to similar hormone medications such as leuprolide (Lupron, Eligard, Viadur), nafarelin (Synarel), or ganirelix (Antagon).

Do not use Supprelin LA 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.

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).

It is not known whether histrelin passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Supprelin LA should not be used in a child younger than 2 years old.

Usual Pediatric Dose for Precocious Puberty:

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.

Comments:
-To continue therapy, another implant may be inserted at the time an implant is removed.
-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:
Treatment of children with central precocious puberty

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

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

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; or

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

Common Supprelin LA side effects may include:

• hot flashes;

• urination problems;

• constipation;

• breast swelling or tenderness (in males or females);

• feeling tired;

• decreased testicle size, trouble getting an erection; or

• redness, bruising, 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.