Uses

Buserelin 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. This medication 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. Talk to your doctor about the risks and benefits of treatment.

Buserelin is a man-made hormone that is similar to a natural hormone made by the body (gonadotropin-releasing hormone-GnRH).

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using buserelin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Your doctor will inject the medicated rods (implants) under the skin of your abdomen. The implants release buserelin into your blood slowly and continuously over several months. Buserelin works best when the amount of medicine in your body is kept at a constant level. Keep regularly scheduled appointments with your doctor to have the implants replaced every few months.

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

Side Effects

Hot flashes (flushing), decreased sexual interest/ability, change in the amount of scalp/body hair, upset stomach, joint pain, dizziness, mood swings, breast pain/swelling, or pain/redness/swelling at the injection site may occur. If any of these effects last or get worse, 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.

During the first few weeks of treatment, your hormone levels will actually increase before they decrease. This is your body's normal response to this drug. Your symptoms may get worse for a few weeks when you first start treatment. If your symptoms do not improve after this time, consult your doctor promptly.

If you have prostate cancer that has spread to the spine or caused urinary blockage, your doctor may need to monitor your condition more closely, especially during the first few weeks of treatment. Tell your doctor right away if any of the following serious symptoms occur or worsen:

• bone pain
• numbness/tingling/weakness of the arms/legs
• blood in the urine
• painful/difficult urination
• unusual weakness
• inability to move

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as depression)
• new/worsening bone pain
• broken bones
• signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

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

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

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.

Precautions

Before using buserelin, tell your doctor or pharmacist if you are allergic to it; 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:

• heart disease (such as heart attack)
• stroke
• high cholesterol
• high blood pressure
• diabetes
• mental/mood problems (such as depression)

If buserelin is used for a long time, it may weaken your bones and increase your risk for bone loss (osteoporosis). Before using this medication, tell your doctor or pharmacist if you have osteoporosis or if you have any of the following risk factors:

• long-term alcohol use
• smoking
• family history of osteoporosis and broken bones
• use of certain medications (including corticosteroids such as prednisone, certain anti-seizure drugs such as phenytoin)

Buserelin 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 buserelin, 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 buserelin safely.

If you have diabetes, this drug may make it harder to control your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar (see Side Effects section). Your doctor may need to adjust your diabetes medication, exercise program, or diet.

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).

Use of this medication for a long time may make the testicles unable to produce testosterone or sperm. It is not known if these effects go away in all men after the medication is stopped. However, these effects alone should not be considered a reliable form of birth control. Men using this medication should use reliable birth control methods (such as condoms) to prevent pregnancy. Ask your doctor for more details and to discuss reliable forms of birth control.

This product is not approved for use in women or children. Buserelin must not be used during pregnancy. It may harm an unborn baby. Consult your doctor for details.

Drug 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

This implant may be harmful if swallowed. If someone has swallowed it 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 their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

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

If you have radiology tests (such as X-rays, MRI), make sure radiology personnel and all your doctors know you use this product.

Missed Dose

To help prevent a missed dose, mark your calendar with your next scheduled implant appointment. Keep all medical and lab appointments.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Before this product is placed in the body, store it at room temperature away from heat. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.