Leuprolide (Injection)

Brand Name(s)

Lupron Depot, Lupron Depot-Ped, Eligard

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to leuprolide or similar medicines such as goserelin (Zoladex®), histrelin (Supprelin®), or triptorelin (Trelstar®). You should not use this medicine if you are pregnant, may become pregnant, are breastfeeding, or if you have any unusual vaginal bleeding that has not been checked by your doctor. Certain brands of this medicine (such as Eligard®, Viadur®) should not be given to children.

How to Use This Medicine

Injectable

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• Leuprolide injection is given by different methods depending on the condition being treated. Sometimes it is injected into the skin or into a muscle. For some conditions it is given every day, for others it is given once a month or every few months.
• A nurse or other trained health professional will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Use a new needle and syringe each time you inject your medicine.
• Before each injection, look carefully at the medicine to check for any particles or a change in color. You should not use medicine that has changed color or has particles in it.
• Avoid shaking the medicine bottle.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
• Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

If a dose is missed:

• This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

How to Store and Dispose of This Medicine

• If you store this medicine at home, keep it at room temperature, away from heat, moisture, and direct light.
• The mixed suspension should be discarded if not used right away. Eligard® must be used within 30 minutes after mixing, and Lupron Depot® must be used within 2 hours after mixing.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. You will also need to throw away old medicine after the expiration date has passed.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using medicine to treat heart rhythm problems such as amiodarone, disopyramide, procainamide, quinidine, sotalol, Betapace®, Cardioquin®, Cordarone®, Norpace®, Procanbid®, or Quinaglute®. Tell your doctor if you are also using medicine to treat depression such as bupropion, citalopram, escitalopram, fluoxetine, paroxetine, sertraline, Celexa®, Lexapro?, Paxil®, Prozac®, Sarafem®, Wellbutrin®, or Zoloft®).

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you have bone problems, diabetes, congestive heart failure, heart or blood vessel disease, heart rhythm problems (such as congenital long QT syndrome), mineral imbalance, spinal cord (back) problems, trouble urinating, pituitary gland problems, or a history of brain tumors, seizures or epilepsy, stroke, or other brain problems. Tell your doctor if you or your child have had an allergic reaction to benzyl alcohol if you are going to use Lupron® injection.
• When you first start using leuprolide for prostate cancer, your symptoms may increase for a few days. This should clear up as you continue to use the medicine. You might have bone pain, back pain, a tingling or numbness in the body, blood in the urine, or trouble urinating. Call your doctor if your symptoms do not improve or get worse.
• If you are a woman using leuprolide, your symptoms may increase for a few days. This should clear up as you continue to use the medicine. Your menstrual periods should stop while you are using leuprolide. You may have occasional bleeding or spotting. If you continue to have heavy bleeding or regular periods after 2 months of using this medicine, call your doctor.
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
• This medicine can cause decreases in bone mineral density, which may lead to osteoporosis or weakened bones. Talk with your doctor about how this risk will affect you.
• If you develop a rash or irritation at the injection site, check with your doctor right away.
• Do not stop using or changing the dose of Lupron® injection without checking first with your doctor.
• If you are using this medicine for prostate cancer:
  • This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.
  • This medicine may increase your risk of having a heart attack or stroke. Check with your doctor right away if you are having chest pain or discomfort; pain or discomfort in the arms, jaw, back, or neck; confusion; shortness of breath; nausea or vomiting, or sweating.
  • This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or uneven heartbeats.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood and urine tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Change in how much or how often you urinate, difficult or painful urination.
• Chest pain.
• Fast, pounding, or uneven heartbeat.
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches.
• Joint or muscle pain.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Pain, itching, burning, or swelling where the shot was given.
• Seizures.
• Shortness of breath or troubled breathing.
• Swelling or puffiness in your face, hands, ankles, or feet.
• Unusual bleeding, bruising, or weakness.
• Vaginal bleeding that is heavier than spotting.

If you notice these less serious side effects, talk with your doctor:

• Acne or pimples.
• Bone or back pain.
• Breast pain or swelling (in men or women).
• Decrease in the size of the testicles.
• Diarrhea, constipation, nausea or vomiting, indigestion, or stomach pain.
• Hair loss.
• Headache, mood changes, mild depression, or unusual tiredness.
• Loss of appetite.
• Mild skin rash.
• Sweating.
• Trouble having sex or loss of interest in sex.
• Trouble sleeping.
• Vaginal itching, swelling, or discharge.
• Warmth or redness in your face, neck, arms, or upper chest.
• Weight gain.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Introduction

Leuprolide Acetate (LOO-proe-lide AS-e-tate)

Treats advanced prostate cancer in men, endometriosis or fibroid tumors in women, and premature puberty in children.