Leuprolide Suspension for Injection (Precocious Puberty)

What is this medication?

LEUPROLIDE (loo PROE lide) treats a condition that causes early puberty. It works by decreasing levels of the hormones estrogen and testosterone in the body. This slows or stops signs of puberty while you are taking this medication.

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

COMMON BRAND NAME(S): Fensolvi, Lupron Depot-Ped

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

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

• Brain tumor
• Mental health conditions
• Seizures
• An unusual or allergic reaction to leuprolide, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected into a muscle. 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. While it may be prescribed for children as young as 1 year for selected conditions, precautions do apply.

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 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. During the first weeks of therapy, your symptoms may get worse, then should improve as you continue treatment.

You may experience a menstrual cycle or spotting during the first month of therapy. If this continues, contact your care team.

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
• Increased pressure around the brain—severe headache, blurry vision, change in vision, nausea, vomiting
• Mood swings, irritability, hostility
• New or worsening seizures
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth

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

• Acne
• Bone pain
• Headache
• Muscle pain
• Pain, redness, or irritation at injection site
• Vaginal discharge
• Weight gain

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.