Leuprolide Prefilled Syringe (LEUPROLIDE 6 MONTH (42 or 45 MG) - SUBCUTANEOUS INJECTION)

Instructions

This medicine is used by injecting it into the skin. Please ask your doctor, nurse or pharmacist for the correct places on your body where this medicine can be injected.

Read and make sure you understand the instructions for measuring dose and using syringe. If you have any questions, talk to your doctor, nurse, or pharmacist.

The medicine needs to be mixed before being injected.

Always inspect the medicine before using.

The liquid should be clear or light yellow.

Do not use the medicine if it contains any particles or if it has changed color.

Keep medicine in refrigerator. Do not freeze. Protect from light.

If your medicine is stored in the refrigerator, take it out of the refrigerator before use to warm to room temperature.

Inject the medicine immediately after mixing.

Speak with your nurse or pharmacist about how long the medicine can be stored safely at room temperature or in the refrigerator before it needs to be discarded.

Never use any medicine that has expired.

Discard any unused, mixed medicine after 30 minutes.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

Do not inject into skin that is red, swollen or itchy.

Change the location of the injection each time. Choose a location at least 1 inch from the last injection.

Do not rub or massage the area where the injection was given.

Tell your doctor if you have severe or persistent sweating, diarrhea or vomiting. These can increase your risk of a serious side effect.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

This medicine may affect the strength of your bones. If you have or are at increased risk for osteoporosis (weakening of the bones), your doctor may recommend foods with calcium and vitamin D.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

Do not use the medication any more than instructed.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Please check with your doctor before drinking alcohol while on this medicine.

Do not breastfeed while on this medicine.

Do not use this medicine if you are pregnant. If you become pregnant, contact your doctor immediately.

This medicine may reduce sperm count.

Ask your pharmacist how to properly throw away used needles or syringes.

Do not share this medicine with anyone who has not been prescribed this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• agitated feeling or trouble sleeping
• breast pain or swelling
• dizziness
• swelling of the legs, feet, and hands
• lack of energy and tiredness
• feeling of heat or flushing
• headaches
• pain, redness, swelling near injection
• pain in the joints
• problems with sexual functions or desire
• increased urinary frequency

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• severe or persistent bone, joint or jaw pain
• chest pain
• difficulty concentrating
• confusion
• fainting
• severe or persistent headache
• fast or irregular heart beats
• sudden leg pain, swelling, warmth or redness
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• mood changes
• seizures
• shortness of breath
• symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
• suicidal thoughts
• sweating
• excessive thirst
• difficulty or discomfort urinating
• blood in urine
• blurring or changes of vision

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.