triptorelin pamoate 11.25 mg IM suspension

Generic name:
Triptorelin 3 month (11.25 mg) - injection

Pronunciation
(trip-toe-REL-in)

Brand name(s)
Trelstar

Triptorelin is used to treat advanced prostate cancer. It is not a cure. Most types of prostate cancer need the 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.

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 drug may also be used for a certain disorder of the uterus (endometriosis). Triptorelin may also be used to stop early puberty in children.

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

Follow the dosing schedule carefully to get the most benefit from this drug. To help you remember, mark your calendar with a reminder.

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 right away 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 get better or if it gets worse.

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 this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including:

• bone/joint/unusual pain
• easily broken bones
• swelling of the ankles/feet
• unusual weakness
• inability to move (paralysis)
• increased thirst
• increased urination
• mental/mood changes (such as depression)
• signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)

Get medical help right away if you have any very serious side effects, including:

• chest/jaw/left arm pain
• fast/irregular heartbeat
• severe dizziness
• fainting
• weakness on one side of the body
• trouble speaking
• seizures

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 or at www.fda.gov/medwatch.

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

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
• mental/mood problems (such as depression)
• seizures

Triptorelin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause 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. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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 right away. Breastfeeding is also not recommended during triptorelin treatment. Consult your doctor for more details and before breastfeeding, and to discuss reliable forms of birth control.

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.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as testosterone blood levels, PSA blood tests, blood glucose, cholesterol/triglyceride levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

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

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.