Leuprolide Emulsion for Injection

What is this medication?

LEUPROLIDE (loo PROE lide) reduces the symptoms of prostate cancer. It works by decreasing levels of the hormone testosterone in the body. This prevents prostate cancer cells from spreading or growing.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): CAMCEVI

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes
• Heart disease
• Heart failure
• High or low levels of electrolytes, such as magnesium, potassium, or sodium in your blood
• Irregular heartbeat or rhythm
• Seizures
• An unusual or allergic reaction to leuprolide, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is injected under the skin. It is given by your care team in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Ketoconazole
• Levoketoconazole
• Pimozide
• Thioridazine

This medication may also interact with the following:

• Other medications that cause heart rhythm changes

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower the risk of diabetes while taking this medication.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

Heart attacks and strokes have been reported with the use of this medication. Get emergency help if you develop signs or symptoms of a heart attack or stroke. Talk to your care team about the risks and benefits of this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• New or worsening seizures
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Swelling and pain of the tumor site or lymph nodes

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Change in sex drive or performance
• Hot flashes
• Joint pain
• Pain, redness, or irritation at injection site
• Swelling of the ankles, hands, or feet
• Unusual weakness or fatigue

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.