Triptorelin 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.

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

Some people using triptorelin 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).

Triptorelin 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.

Before taking this medicine

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

Do not use triptorelin 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 triptorelin is safe for you, 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.

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

Take triptorelin exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

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

Triptorelin 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.

Triptorelin 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 triptorelin.

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

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

Usual Pediatric Dose for Precocious Puberty:

2 years and older:
22.5 mg IM every 24 weeks

Duration of therapy: Therapy should be discontinued at the onset of puberty at the discretion of the physician.

Comments:
-This drug should only be administered by a healthcare provider.
-Monitor response to this drug with LH levels after a GnRH or GnRH agonist stimulation test, basal LH, or serum concentration of sex steroid levels beginning 1 to 2 months following initiation of therapy, during therapy as necessary to confirm maintenance of efficacy, and with each subsequent dose.
-Measure height (for calculation of growth rate) every 3 to 6 months and monitor bone age periodically.
-Noncompliance with drug regimen or inadequate dosing may result in inadequate control of the pubertal process with gonadotropins and/or sex steroids increasing above prepubertal levels.
-If the dose of this drug is not adequate switching to an alternative GnRH agonist for the treatment of CPP with the ability for dose adjustment may be necessary.

Use: For the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP)

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

Do not use triptorelin 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 triptorelin is safe for you, 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.

Triptorelin 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 triptorelin injection.

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 triptorelin: 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 triptorelin 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).

Triptorelin 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;

• (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;

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

• loss of movement in any part of your body;

• 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 triptorelin 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 interact with triptorelin, 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.