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 provided by your pharmacist before you start using this drug and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

This medication is given as an injection under the skin, usually every 8 hours for the first week of treatment, and then once a day thereafter, or as directed by your doctor.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Change the location of the injection site each time to avoid problem areas under the skin.

Buserelin works best when the amount of medicine in your body is kept at a constant level. Use this drug regularly at evenly spaced intervals. To help you remember, use it at the same time(s) each day.

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

Side Effects

Hot flashes (flushing), decreased sexual interest/ability, swelling ankles/feet, 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

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.

Buserelin has been used in women for other conditions. This medication must not be used during pregnancy. It may harm an unborn baby. Women should consult their doctor for more details and to discuss reliable forms of non-hormonal birth control.

When buserelin is used in women for other conditions, small amounts of this medication pass into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug. Women should consult their doctor before breast-feeding.

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

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 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

Do not share this medication with others.

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

Missed Dose

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. Do not double the dose to catch up.

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

Storage

Store at room temperature away from light and moisture. Do not freeze. Do not store in the bathroom. 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.