Trelstar Depot

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

Triptorelin is used to treat the symptoms of prostate cancer. Triptorelin treats only the symptoms of prostate cancer and does not treat the cancer itself. Use any other medications your doctor has prescribed to best treat your condition.

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

Although triptorelin is not for use by women, this medication can cause birth defects and should not be used by a woman who is pregnant or who may become pregnant.

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

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

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

• any type of cancer that has spread to your spine;
• a bladder obstruction or problems with urination;
• diabetes, recent weight gain, high cholesterol (especially in men);
• heart disease, high blood pressure, high cholesterol;
• personal or family history of long QT syndrome;
• a history of heart attack or stroke; or
• if you smoke.

Although triptorelin is not for use by women, this medication can harm an unborn baby or cause birth defects. Triptorelin should not be used by a woman who is pregnant or who may become pregnant.

It is not known whether triptorelin passes into breast milk or if it could harm a nursing baby. Although triptorelin is not for use by women, this medication should not be used while breast-feeding a baby.

Included as part of the PRECAUTIONS section.

In the U.S.

• Trelstar
• Trelstar Depot
• Trelstar LA
• Triptodur

Available Dosage Forms:

• Powder for Suspension, 6 Month
• Powder for Suspension

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Luteinizing Hormone Releasing Hormone Agonist

Trelstar Depot Must Be Administered Under the Supervision of a Physician.

The recommended dose of Trelstar Depot is 3.75 mg incorporated in a depot formulation and is administered monthly as a single intramuscular injection. The lyophilized microgranules are to be reconstituted in sterile water. No other diluent should be used.

Reconstitute in accord with the following:

For Trelstar Depot:

1. Using a syringe fitted with a sterile 20-gauge needle, withdraw 2 mL sterile water for injection, USP, and after removing the flip-off seal from the vial, inject into the vial.

2. Shake well to thoroughly disperse particles to obtain a uniform suspension. The suspension will appear milky.

3. Withdraw the entire content of the reconstituted suspension into the syringe and inject it immediately.

For the Trelstar Depot Clip'n'Ject® single-dose delivery system, see adjacent INSTRUCTIONS FOR CLIP'N'JECT® USE section.

The suspension should be discarded if not used immediately after reconstitution.

As with other drugs administered by intramuscular injection, the injection site should be altered periodically.

Dosage Adjustments: Patients with renal or hepatic impairment showed 2- to 4-fold higher exposure than young healthy males. The clinical consequences of this increase, as well as the potential need for dose adjustment, is unknown.

Applies to triptorelin: intramuscular powder for suspension

Along with its needed effects, triptorelin (the active ingredient contained in Trelstar Depot) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking triptorelin:

• Diarrhea
• loss of appetite
• nausea
• stomach pain
• weakness

• Anxiety
• body aches or pain
• chills
• cough
• cough producing mucus
• difficulty with breathing
• ear congestion
• fever
• general feeling of discomfort or illness
• headache
• joint pain
• loss of voice
• mood or mental changes, including abnormal crying, aggression, agitation, delusions, irritability, nervousness, or restlessness
• muscle aches and pains
• nasal congestion
• runny nose
• shivering
• sneezing
• sore throat
• sweating
• tightness in the chest
• trouble sleeping
• unusual tiredness or weakness
• vomiting

• Bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• blurred vision
• chest pain
• cough producing mucus
• decrease in urine volume or frequency of urination
• difficult or labored breathing
• difficult, burning, or painful urination
• difficulty in passing urine
• dizziness
• dry mouth
• flushed, dry skin
• frequent urge to urinate
• fruit-like breath odor
• headache
• increased hunger
• increased thirst
• increased urination
• loss of consciousness
• lower back or side pain
• nausea
• nervousness
• pale skin
• pounding in the ears
• rapid weight gain
• slow or fast heartbeat
• stomach ache
• sweating
• tightness in the chest
• tingling of the hands or feet
• troubled breathing
• troubled breathing with exertion
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting

• Blurred or loss of vision
• depression
• difficulty with swallowing
• disturbed color perception
• dizziness
• double vision
• halos around lights
• hives, itching, skin rash
• nervousness
• night blindness
• overbright appearance of lights
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• slow or fast heartbeat
• thoughts of killing oneself

• Anxiety
• changes in skin color
• changes in vision
• chest discomfort
• cold, clammy, or pale skin
• confusion
• dizziness or lightheadedness
• fainting
• inability to speak
• irregular heartbeat
• numbness or tingling in the face, arms, or legs
• pain
• pain or discomfort in the arms, jaw, back, or neck
• pain, redness, or swelling in the arm or leg
• seizures
• severe or sudden headache
• slow heart rate
• slurred speech
• sudden shortness of breath or troubled breathing
• temporary blindness
• tenderness
• trouble speaking, thinking, or walking
• weakness in the arm or leg on one side of the body, sudden and severe

Some side effects of triptorelin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• stuffy or runny nose

• Bone pain
• chills
• decrease in testicle size
• decreased interest in sexual intercourse
• diarrhea
• feeling of warmth or redness of the face, neck, arms, and occasionally, upper chest
• fever
• general feeling of discomfort or illness
• inability to have or keep an erection
• joint pain
• leg pain
• loss in sexual ability, desire, drive, or performance
• loss of appetite
• muscle aches and pains
• redness of the face, neck, arms, and occasionally, upper chest
• runny nose
• shivering
• sore throat
• sudden sweating
• trouble sleeping

• Change in hearing
• dryness or soreness of the throat
• ear drainage
• earache
• hoarseness
• itching of the ears
• pain or tenderness around the eyes and cheekbones
• tender, swollen glands in the neck
• voice changes

• Back pain
• belching
• body aches or pain
• breast pain
• burning, dry, or itching eyes
• congestion
• crying
• depersonalization
• difficulty having a bowel movement
• difficulty with moving
• discharge or excessive tearing
• dysphoria
• euphoria
• eye pain
• heartburn
• hoarseness
• indigestion
• injection site pain
• itching or rash
• lack or loss of strength
• leg cramps
• loss of appetite
• muscle aching or cramping
• muscle pains or stiffness
• paranoia
• quick to react or overreact emotionally
• rapidly changing moods
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• runny nose
• stomach discomfort, upset, or pain
• swelling of the breasts or breast soreness in both females and males
• swollen joints
• tender, swollen glands in the neck
• trouble swallowing
• voice changes
• weight loss