Trelstar Mixject is a man-made form of a hormone that regulates many processes in the body.

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

The Triptodur brand of triptorelin is used to treat precocious puberty in boys and girls who are at least 2 years old.

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

Do not use if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Some people using Trelstar Mixject have had new or worsening mental problems or seizures (convulsions). Call your doctor right away if you have a seizure, or any unusual changes in mood or behavior (anger, aggression, crying, feeling restless or irritable).

Trelstar Mixject can cause a temporary increase in certain hormones, especially when you first start using this medicine. This may cause side effects that are similar to the condition being treated.

Follow all directions on your prescription label and read all medication guides or instruction sheets.

Trelstar Mixject is injected into a muscle. A healthcare provider will give you this injection.

Trelstar Mixject is usually given once every 4, 12, or 24 weeks. Your dose schedule will depend on the strength and brand of triptorelin you are using.

Trelstar Mixject can increase certain hormones when you first start using this medicine or after each new injection. This may cause symptoms of prostate cancer or precocious puberty to get worse for a short time. These side effects should get better within 1 to 2 months. Call your doctor if your symptoms do not improve, or if they get worse while using this medicine.

You may need frequent medical tests.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Trelstar Mixject.

You should not use this medication if you are allergic to Trelstar Mixject or similar drugs such as leuprolide (Lupron, Viadur, Eligard) or goserelin (Zoladex).

Do not use Trelstar Mixject if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using Trelstar Mixject.

Tell your doctor if you have ever had:

• heart disease, long QT syndrome or other heart rhythm disorder;

• a heart attack or stroke;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• diabetes;

• epilepsy or other seizure disorder;

• mental illness;

• a bladder obstruction or other urination problems;

• a condition affecting your spine;

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

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

Ask a doctor if it is safe to breastfeed while using this medicine.

This medicine may affect fertility (ability to have children) in men.

Call your doctor for instructions if you miss a dose, or if you miss an appointment for your Trelstar Mixject.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives, red skin rash, severe itching, sweating; dizziness, fast heartbeats; trouble breathing or swallowing; swelling of your face, lips, tongue, or throat.

Some people using Trelstar Mixject have had new or worsening mental problems or seizures (convulsions). Call your doctor right away if you have a seizure, or any unusual changes in mood or behavior (anger, aggression, crying, feeling restless or irritable).

Trelstar Mixject can cause a temporary increase in certain hormones, especially when you first start using Trelstar Mixject. This may cause side effects that are similar to the condition being treated. Call your doctor at once if you have:

• painful or difficult urination, burning when you urinate, blood in the urine;

• bone pain;

• (in children) new or worsening signs of puberty;

• a seizure;

• chest pain or pressure, pain spreading to your jaw or shoulder;

• sudden numbness or weakness, slurred speech;

• loss of movement in any part of your body;

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

• high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor; or

• nerve problems--back pain, muscle weakness, problems with balance or coordination, severe numbness or tingling in your legs or feet, loss of bladder or bowel control.

Common side effects of Trelstar Mixject may include:

• pain, swelling, itching, or redness where an injection was given;

• hot flashes;

• erectile dysfunction, loss of interest in sex, impotence, difficulty having an orgasm;

• headache, bone pain, pain or swelling in your legs;

• vaginal bleeding; or

• cold or flu symptoms (stuffy nose, sneezing, cough, sore throat, ear pain).

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 Trelstar Mixject, 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.