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

Trelstar injections are 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.

Trelstar is supplied in a Mixject single-dose delivery system consisting of a vial of sterile powder and a pre-filled syringe containing sterile water for injection.

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

Some people using Trelstar 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 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.

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

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

Triptorelin can increase the levels of certain hormones when you first start using Trelstar or after each new injection. This may cause symptoms of prostate cancer 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.

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

Store at room temperature away from moisture and heat. Do not freeze.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose for Prostate Cancer:

3.75 mg IM every 4 weeks
OR
11.25 mg IM every 12 weeks
OR
22.5 mg IM every 24 weeks

Comments:
-Administered as a single IM injection in either buttock; the injection site should be alternated periodically.
-Due to different release characteristics, the dosage strengths are not additive and must be selected based upon the desired dosing schedule.

Use: For the palliative treatment of advanced prostate cancer

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

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

To make sure Trelstar is safe for you, tell your doctor if you have:

• 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.

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 to Trelstar: 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 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 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. Call your doctor at once if you have:

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

• bone pain;

• 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 Trelstar side effects 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, 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.