leuprolide acetate 45 mg (6 month) subcutaneous syringe

Generic name:
Leuprolide 6 month (42 or 45 mg) - subcutaneous injection

Pronunciation
(LOO-proe-lide)

Brand name(s)
Camcevi , Eligard

Leuprolide 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. Leuprolide works by reducing the amount of testosterone that the body makes. This 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.

Some brands of this medication are also used to stop early puberty (precocious puberty) in children. It helps to delay sexual development (such as growth of the breasts/testicles) and the start of menstrual periods. It also helps slow down early bone growth to increase the likelihood of reaching normal adult height. Leuprolide works by decreasing the amount of sex hormones that a child's body makes (estrogen in girls, testosterone in boys).

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

This medication is given by injection under the skin by a health care professional as directed by the doctor, usually every 6 months. This product slowly releases the medication into the blood over a 6-month period.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

During the first few weeks of treatment, your hormone levels will actually go up before they go down. This is a normal response to this medication. Your symptoms may get worse for a few weeks.

If you have prostate cancer that has spread to the spine or caused urinary blockage, you may require closer monitoring by your doctor, especially when you first start treatment. Tell your doctor right away if you have any bone pain, numbness/tingling/weakness of the arms/legs, blood in the urine, painful/difficult urination, unusual weakness, or inability to move.

If you are using this medication to stop early puberty, you may notice worsening symptoms (such as menstrual periods) at the start of treatment. However, you should see an improvement in symptoms usually within 1 to 2 months. Tell the doctor promptly if new or worsened symptoms develop after starting treatment.

Hot flashes (flushing), increased sweating, night sweats, tiredness, swelling of the ankles/feet, increased urination at night, dizziness, or mild burning/pain/bruising at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Rarely in men, shrinking of the testicles, breast tenderness/swelling, or reduced sexual interest/ability may also occur as a result of lowered testosterone levels. Talk to your doctor if these effects occur.

In girls, when this medication is used regularly, it is expected that the menstrual period will stop or decrease to light bleeding/spotting during the first 2 months. Tell the doctor promptly if regular periods continue after 2 months of treatment with leuprolide.

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:

• new/worsening bone pain (in adults)
• easily broken bones (in adults)
• increased thirst/urination (in adults)
• mental/mood changes (such as depression, thoughts of suicide, mood swings, aggression)

In adults, leuprolide may rarely cause serious liver disease. Tell your doctor right away if you develop signs of liver disease, such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.

In adults, this medication may rarely cause heart problems and stroke. Get medical help right away if any of these very serious side effects occur:

• symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)
• signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion)
• fast/irregular heartbeat
• severe dizziness
• fainting

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

• seizures

Children using leuprolide may rarely be at risk for increased pressure around the brain (intracranial hypertension). Get medical help right away if any of these very serious side effects occur:

• nausea/vomiting that doesn't stop
• headache that is severe or doesn't go away
• eye pain
• vision changes (such as blurred/double vision, decreased vision)
• ringing in the ears

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:

• fever
• swollen lymph nodes
• 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 leuprolide, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as histrelin, triptorelin); 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:

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

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

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

In adults, leuprolide 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 leuprolide, 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 leuprolide 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).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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

This medication can affect fertility in males. Ask your doctor for more details.

This medication must not be used during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while using this medication. Consult your doctor for more details and to discuss using reliable forms of non-hormonal birth control (such as condoms, diaphragm with spermicide) while using this medication. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if leuprolide passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

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.

This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

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.

Do not share this medication with others.

Lab and/or medical tests (such as hormone levels, PSA blood test for men, blood glucose, cholesterol/triglyceride levels, height measurements and bone tests in children) 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 a dose is missed, ask the doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Not applicable. This medication is given in a clinic or 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.