leuprolide

Generic Name: leuprolide (LOO proe lide)Brand names: Eligard, Lupron, Lupron Depot, Lupron Depot-Gyn, Lupron Depot-Ped, Viadur

What is leuprolide?

Leuprolide is a man-made form of a hormone that regulates many processes in the body. Leuprolide overstimulates the body's own production of certain hormones, which causes that production to shut down temporarily. Leuprolide reduces the amount of testosterone in men or estrogen in women.

Leuprolide is used in men to treat the symptoms of prostate cancer. Leuprolide treats only the symptoms of prostate cancer and does not treat the cancer itself. Use any other medications your doctor has prescribed to best treat your condition.

Leuprolide is used in women to treat symptoms of endometriosis (overgrowth of uterine lining outside of the uterus) or uterine fibroids.

Leuprolide is also used to treat precocious (early-onset) puberty in both male and female children.

Leuprolide may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about leuprolide?

This medication can cause birth defects. Do not use if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment. You should not use this medication if you are allergic to leuprolide or similar medications such as buserelin (Suprefact, Suprecor), goserelin (Zoladex), histrelin (Supprelin), nafarelin (Synarel), or if you have abnormal vaginal bleeding that has not been diagnosed by a doctor; or if you are breast-feeding a baby.

Before using leuprolide, tell your doctor if you have epilepsy, asthma, migraines, heart or kidney disease, a history of depression, bone cancer affecting your spine, blood in your urine, or if you are unable to urinate.

Tell your doctor if you have a personal or family history of osteoporosis, or if you have any risk factors for bone loss such as smoking, alcohol use, or taking steroid or seizure medications long term. Long-term use of this medication may decrease bone density, possibly leading to osteoporosis.

Certain brands or strengths of leuprolide are used to treat only men and should not be used in women or children. Always check your medication to make sure you have received the correct brand and strength prescribed by your doctor.

What should I discuss with my healthcare provider before using leuprolide?

Certain brands or strengths of leuprolide are used to treat only men and should not be used in women or children. Always check your medication to make sure you have received the correct brand and strength prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy. You should not use this medication if you are allergic to leuprolide or similar medications such as buserelin (Suprefact, Suprecor), goserelin (Zoladex), histrelin (Supprelin), nafarelin (Synarel), or if you have:

• abnormal vaginal bleeding that has not been diagnosed by a doctor; or

• if you are pregnant or breast-feeding.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use leuprolide:

• a personal or family history of osteoporosis;

• risk factors for bone loss such as smoking, alcohol use, or taking steroid or seizure medications long term;

• epilepsy;

• asthma;

• migraines;

• heart disease;

• kidney disease;

• a history of depression;

• bone cancer affecting your spine;

• blood in your urine; or

• if you are unable to urinate.

FDA pregnancy category X. This medication can cause birth defects. Do not use leuprolide if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Leuprolide usually causes women to stop ovulating or having menstrual periods. However, you may still be able to get pregnant. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective in preventing pregnancy while you are using leuprolide. Because leuprolide is expected to cause your menstrual periods to stop, contact your doctor if your periods continue while you are being treated with this medication. Do not breast-feed a baby while using leuprolide.

Long-term use of this medication may decrease bone density, possibly leading to osteoporosis. Talk with your doctor about your possible risk for osteoporosis. You may need to receive a bone scan if you ever need to be re-treated with leuprolide in the future.

How should I use leuprolide?

Leuprolide is given as an injection under the skin or into a muscle. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Leuprolide may be given once every month or once every 3 to 6 months. How often you receive this medication will depend on the condition being treated. Follow your doctor's instructions.

Because different brands or strengths of leuprolide are used to treat different conditions, it is very important that you receive exactly the brand and strength your doctor has prescribed. If you self-inject this medication at home, always check your medication to make sure you have received the correct brand and type prescribed by your doctor.

Your symptoms may become temporarily worse as your hormones adjust when you first start using this medication. For best results, keep using the medication as instructed by your doctor. Your condition should eventually improve with continued use of leuprolide.

To be sure this medication is helping your condition, your blood may need to be tested often. This will help your doctor determine how long to treat you with leuprolide. You may still need blood tests for up to 3 months after you stop using leuprolide to check your hormone levels and pituitary gland function. Do not miss any scheduled appointments.

Store Lupron in the original carton at room temperature, away from moisture and heat. Store Eligard in the refrigerator. Do not freeze. You may take the medicine out and allow it to reach room temperature before mixing and injecting your dose. After the dose is mixed, you must use the injection within 30 minutes.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

Women who miss more than one leuprolide dose may have breakthrough bleeding. Children who miss more than one dose may have a return of pubertal symptoms such as breast development, growth in the testicles, or menstrual periods.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include weakness, or irritation where the leuprolide shot was given.

What should I avoid while using leuprolide?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Leuprolide side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• bone pain;

• swelling, rapid weight gain;

• pain, burning, stinging, bruising, or redness where the medication was injected;

• feeling like you might pass out;

• painful or difficult urination;

• urinating more often than usual; or

• sudden headache with vision problems, vomiting, confusion, slow heart rate, weak pulse, fainting, or slow breathing.

Rare but serious side effects may include:

• pain or unusual sensations in your back;

• numbness, weakness, or tingly feeling in your legs or feet;

• muscle weakness or loss of use; and

• loss of bowel or bladder control.

Less serious side effects may include:

• acne, increased growth of facial hair;

• breakthrough bleeding in a female child during the first 2 months of leuprolide treatment;

• dizziness, weakness, tired feeling;

• hot flashes, night sweats, chills, clammy skin;

• nausea, diarrhea, constipation, stomach pain;

• skin redness, itching, or scaling;

• joint or muscle pain;

• vaginal itching or discharge

• breast swelling or tenderness;

• testicle pain;

• impotence, loss of interest in sex;

• depression, sleep problems (insomnia), memory problems; or

• redness, burning, itching, or swelling where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Leuprolide Dosing Information

Usual Adult Dose for Prostate Cancer:

1 mg injection subcutaneously once a day or7.5 mg depot IM or depot subcutaneously once a month or 22.5 mg depot IM once every 3 months or30 mg depot IM once every 4 months or45 mg subcutaneous injection every 6 months or65 mg subcutaneous implant once every 12 months

Usual Adult Dose for Endometriosis:

3.75 mg IM once a month for up to 6 months or 11.25 mg depot every 3 months.

Usual Adult Dose for Hirsutism:

3.75 mg IM once a month for up to 6 months or 11.25 mg depot every 3 months.

Usual Adult Dose for Uterine Leiomyomata:

3.75 mg IM once a month for up to 6 months or 11.25 mg depot every 3 months.

What other drugs will affect leuprolide?

There may be other drugs that can interact with leuprolide. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about leuprolide.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 7.01. Revision Date: 07/01/2009 8:09:19 PM.