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Trelstar intramuscular

TRIPTORELIN 3 MONTH (11.25 MG) - INJECTION

GENERIC NAME(S): TRIPTORELIN PAMOATE

Uses

Triptorelin is used to treat advanced prostate cancer in men. It is not a cure. Most types of prostate cancer need the male hormone testosterone to grow and spread. Triptorelin works by reducing the amount of testosterone that the body makes. This effect helps slow or stop the growth of cancer cells and helps relieve symptoms such as painful/difficult urination. This medication is similar to a natural substance made by the body (luteinizing hormone releasing hormone-LHRH). Talk to your doctor about the risks and benefits of treatment.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat a certain disorder of the uterus (endometriosis). In women, triptorelin reduces the amount of estrogen that the body makes. Triptorelin may also be used to stop early puberty in children.

How to use Trelstar intramuscular

This medication is given as an injection into the muscle of your buttocks by a health care professional, usually once every 3 months (12 weeks) or as directed by your doctor.

Follow the dosing schedule carefully to get the most benefit from this drug. To help you remember, mark your calendar to keep track of your next dose.

During the first few weeks of treatment, your testosterone level will actually increase before it decreases. This is a normal response by your body to this drug. This effect may result in new or worsening symptoms for the first few weeks. If you have prostate cancer that has spread to the spine or that has caused urinary blockage, you may require closer monitoring by your doctor, especially when you first start treatment. Tell your doctor immediately if you experience any of the following serious side effects: bone pain, numbness/tingling/weakness of the arms/legs, blood in the urine, painful/difficult urination.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

See also the How to Use section.

Hot flashes (flushing), decreased sexual interest/ability, shrinking of the testicles, and breast tenderness/swelling may occur as a result of lowered testosterone levels. Dizziness and headache may also occur with this drug. If any of these effects bother you, tell your doctor or pharmacist promptly.

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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: bone/joint/unusual pain, easily broken bones, swelling of the ankles/feet, unusual weakness, inability to move (paralysis), increased thirst, unusual change in the amount of urine.

Get medical help right away if any of these rare but serious side effects occur: chest/jaw/left arm pain, fast/irregular heartbeat, severe dizziness, fainting, weakness on one side of the body, slurred speech.

Rarely, a serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after your first dose of this medication. Get medical help right away if any of these serious side effects occur: sudden severe headache, mental/mood changes (such as confusion), vision changes, vomiting.

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.

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

Precautions

Before using triptorelin, tell your doctor or pharmacist if you are allergic to it; or to other LHRH-type drugs (such as leuprolide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, personal or family history of weak/broken bones (osteoporosis), diabetes, heart disease (such as heart attack), stroke, high cholesterol.

Triptorelin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using triptorelin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using triptorelin safely.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

Females: Triptorelin is not usually used by women. It must not be used by pregnant women because it may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. Breast-feeding is also not recommended during triptorelin treatment. Consult your doctor for more details and before breast-feeding, and to discuss reliable forms of birth control.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Laboratory and/or medical tests (such as testosterone blood levels, PSA blood tests, blood glucose) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

It is very important that you do not miss any doses. However, if you do miss a dose, contact your doctor promptly to establish a new schedule.

Storage

Not applicable. This medication is given in a doctor's office and will not be stored at home.

Information last revised July 2014. Copyright(c) 2014 First Databank, Inc.

Images

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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