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Eligard suspension

Generic Name: leuprolide (LOO-proe-lide)
Brand Name: Eligard

Eligard suspension is used for:

Treating symptoms of advanced prostate cancer. It may also be used for other conditions as determined by your doctor.

Eligard suspension is a gonadotropin-releasing hormone (GnRH) agonist. It works by decreasing levels of certain hormones produced by the testes and preventing the growth of certain tumors that need these hormones to grow.

Do NOT use Eligard suspension if:

  • you are allergic to any ingredient in Eligard suspension, GnRH, or another GnRH agonist (eg, histrelin)
  • you are pregnant, may become pregnant, or are breast-feeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Eligard suspension:

Some medical conditions may interact with Eligard suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of urinary problems (eg, blockage of the bladder or ureters), spinal cord problems, abnormal growths on or near the spine or spinal cord, nervous system problems (eg, tumors), seizures, a certain type of irregular heartbeat (congenital long QT syndrome) or other heart problems (eg, congestive heart failure), blood vessel problems (eg, in the brain), a stroke, or diabetes or high blood sugar
  • if you have bone problems (eg, weak bones, osteoporosis) or if a family member has had bone problems
  • if you have blood electrolyte problems (eg, low blood magnesium or potassium levels)
  • if you are taking medicines that can weaken the bones, such as anticonvulsants (eg, phenytoin) or corticosteroids (eg, prednisone)
  • if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval) or seizures. Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of these problems

Some MEDICINES MAY INTERACT with Eligard suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Bupropion or selective serotonin reuptake inhibitors (SSRIs) (eg, sertraline) because they may increase the risk of seizures

This may not be a complete list of all interactions that may occur. Ask your health care provider if Eligard suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Eligard suspension:

Use Eligard suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Eligard suspension is usually given every 6 months (24 weeks) as an injection at your doctor's office, hospital, or clinic. If you will be using Eligard suspension at home, a health care provider will teach you how to use it. Be sure you understand how to use Eligard suspension. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use Eligard suspension if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
  • Wear gloves when mixing and giving Eligard suspension.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of Eligard suspension, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Eligard suspension.

Important safety information:

  • Certain hormone levels may increase during the first few weeks of treatment with Eligard suspension. This may cause you to experience worsening symptoms or onset of new symptoms (eg, bone pain; blood in the urine; difficulty urinating; burning, numbness, or tingling) during the first few weeks of treatment. Patients with growths on or near the spine or spinal cord or with blockage of the bladder or ureters may be at greater risk of developing serious and sometimes fatal complications. Contact your doctor if any new or worsened symptoms occur while using Eligard suspension.
  • Eligard suspension lowers the amount of certain hormones in your body. This may cause certain expected side effects to occur, such as breast enlargement, soreness, or tenderness; testicular changes, pain, or soreness; decreased sexual ability; hot flashes; or night sweats. Contact your doctor if you have questions or concerns or if you experience any of these side effects.
  • Eligard suspension may cause your bones to weaken or become more prone to fractures, especially if you use Eligard suspension for long periods of time. Contact your doctor if you experience bone pain or if you have concerns regarding changes in bone density.
  • A slight increase in the risk of stroke or serious and sometimes fatal heart problems has been reported with the use of GnRH agonists in men. Although the risk appears to be low, seek immediate medical attention if you experience chest, jaw, or left arm pain; confusion; fainting; numbness of an arm or leg; one-sided weakness; slurred speech; sudden, severe headache or vomiting; or vision changes. Discuss any questions or concerns with your doctor.
  • Eligard suspension may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Rarely, a serious pituitary gland problem (pituitary apoplexy) may occur after you use Eligard suspension. This serious problem usually occurs shortly after you begin to use Eligard suspension. Contact your doctor immediately if you experience a sudden headache, vomiting, fainting, eye weakness, inability to move your eyes, mental status changes, or vision changes.
  • Lab tests, including blood testosterone levels, prostate-specific antigen (PSA) levels, hemoglobin A1c, blood glucose, and bone density, may be performed while you use Eligard suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Eligard suspension may interfere with certain lab tests, including certain hormone tests and pituitary gland function tests. Be sure your doctor and lab personnel know you are using Eligard suspension.
  • PREGNANCY and BREAST-FEEDING: Eligard suspension is not approved for use in women. Eligard suspension may cause birth defects or fetal death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if this medicine is found in breast milk. Do not breast-feed while using Eligard suspension.

Possible side effects of Eligard suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; hot flashes; increased sweating; mild burning, bruising, itching, pain, redness, stinging, or swelling at the injection site; muscle pain; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bone pain; burning, numbness, or tingling; fainting; fast or irregular heartbeat; mental or mood changes (eg, depression); seizures; severe dizziness or light-headedness; symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes); symptoms of high blood sugar (eg, drowsiness; fast breathing; flushing; fruit-like breath odor; increased thirst, hunger, or urination); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech, vision changes); unusual tiredness or weakness; urination problems (eg, inability to urinate, loss of bladder control, painful urination); vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Eligard suspension:

Store Eligard suspension in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Once mixed, Eligard suspension must be used within 30 minutes. Discard Eligard suspension if it is not used within 30 minutes. Keep Eligard suspension out of the reach of children and away from pets.

General information:

  • If you have any questions about Eligard suspension, please talk with your doctor, pharmacist, or other health care provider.
  • Eligard suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Eligard suspension or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Eligard suspension. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Eligard suspension. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Eligard suspension.

Issue Date: June 3, 2015