Eligard

Eligard injection is used to treat the symptoms associated with advanced prostate cancer.

Eligard slows prostate cancer growth through androgen deprivation therapy.

Eligard belongs to a class of medications called gonadotropin-releasing hormone (GnRH) agonists. Leuprolide works by decreasing the amount of certain hormones in the body.

Your symptoms may become temporarily worse when you first start using Eligard, including new or worsening symptoms of sexual development in children. Tell your doctor if this continues for longer than 2 months.

Call your doctor at once if you have a seizure, unusual changes in mood or behavior, severe headaches, ringing in your ears, dizziness, nausea, vision problems, or pain behind your eyes.

Do not use if you are pregnant. Use effective birth control. Do not use if you have abnormal vaginal bleeding that has not been checked by a doctor.

You should not use Eligard if you are allergic to leuprolide or similar medicines such as buserelin, goserelin, histrelin, nafarelin, or if you have abnormal vaginal bleeding that has not been checked by a doctor.

To make sure Eligard is safe for you, tell your doctor if you have ever had:

• depression, mental illness, or psychosis;
• seizures or epilepsy;
• a blood vessel disorder;
• a brain tumor or spinal cord injury;
• heart disease, congestive heart failure, long QT syndrome;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or
• risk factors for bone loss (personal or family history of osteoporosis, smoking, alcohol use, taking steroid or seizure medicines long term).

Eligard usually causes women to stop ovulating or having menstrual periods. However, you may still be able to get pregnant. Use barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge.

Call your doctor if your periods continue while you are being treated with this medicine.

Leuprolide may cause birth defects. Do not use if you are pregnant. Tell your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction to Eligard (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have a seizure, unusual changes in mood or behavior (crying spells, irritability, restlessness, anger, aggression), severe headaches, ringing in your ears, dizziness, nausea, vision problems, or pain behind your eyes.

Your symptoms may become temporarily worse when you first start using Eligard. Tell your doctor if this continues for longer than 2 months.

Eligard may cause serious side effects. Call your doctor at once if you have:

• bone pain, loss of movement in any part of your body;
• swelling, rapid weight gain;
• a seizure;
• unusual changes in mood or behavior (crying spells, anger, feeling irritable);
• sudden chest pain or discomfort, wheezing, dry cough or hack;
• painful or difficult urination;
• pain or unusual sensations in your back, numbness, weakness, or tingly feeling in your legs or feet;
• muscle weakness or loss of muscle use, loss of bladder or bowel control;
• problems with your pituitary gland - sudden severe headache, vomiting, problems with your eyes or vision, changes in mood or behavior;
• high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor;
• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or
• signs of a stroke - sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance.

Common Eligard side effects may include:

• pituitary gland problems;
• acne, itching, rash, white scales (seborrhea);
• cold symptoms such as stuffy nose, sneezing, sore throat, cough with or without mucus;
• fractures, ligament sprain;
• fever, tiredness, not feeling well;
• stomach pain, nausea, vomiting, diarrhea, constipation;
• wheezing, chest tightness, trouble breathing;
• breast tenderness, hot flashes, sweating;
• dizziness, sleep problems, mood changes;
• headache, general pain;
• vaginal swelling, itching, or discharge;
• weight changes;
• decreased testicle size;
• irregular menstrual periods, decreased interest in sex; or
• redness, pain, swelling, or oozing where the medicine was injected.

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 the FDA at 1-800-FDA-1088.

Use Eligard as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

There are many brands, strengths, or forms of leuprolide used to treat different conditions. Avoid medication errors by using only the medicine your doctor prescribes.

Eligard is usually administered by a healthcare provider.

Eligard is injected under the skin or into a muscle, once every month or once every 3 to 6 months.

Your symptoms may become temporarily worse as your hormones adjust to Eligard.

You may need frequent medical tests while using Eligard.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Follow all storage instructions provided with Eligard. Your pharmacist can provide more information about how to store this medicine.

Usual Adult Dose for Prostate Cancer:

Eligard: administered by subcutaneous injection and provides continuous release of leuprolide acetate over a one, three, four, or six-month period:

• One 7.5 mg injection every month; or
• One 22.5 mg injection every 3 months; or
• One 30 mg injection every 4 months; or
• One 45 mg injection every 6 months,

Call your doctor for instructions if you miss a dose or miss an appointment for your injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Eligard can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other drugs may interact with leuprolide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Distributed by: Tolmar Pharmaceuticals, Inc., Fort Collins, CO 80526, USA.