Leuprolide for Pediatric Use, Injection

________________________________________________________________________

KEY POINTS

• This medicine is given by injection to treat central precocious puberty.
• Keep all appointments for tests to see how this medicine affects your child.
• This medicine may cause unwanted side effects. Tell your healthcare provider if your child has any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat your child about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that your child takes.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: gonadotropin-releasing hormone analog

Generic and brand names: leuprolide for pediatric use, injection

What is this medicine used for?

This medicine is given by injection (shots) to treat central precocious puberty (when a child starts to mature too early in life).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before my child takes this medicine?

Before taking this medicine, tell your healthcare provider if your child has ever had:

• An allergic reaction to any medicine or hormone, or to benzyl alcohol
• A stroke or transient ischemic attack (TIA)
• Abnormal vaginal bleeding
• Blood clots or a bleeding disorder such as anemia
• Cancer in the spine
• Depression
• Diabetes
• Heart problems
• Bone thinning
• Seizures
• Trouble urinating

Females of childbearing age: Do not use this medicine if you are pregnant because it may cause a miscarriage or may seriously harm the baby. Do not breast-feed while receiving this medicine.

How do I use it?

The shots are given just under the skin every day by a parent or healthcare provider. Be sure the shots are given exactly on schedule.

Your healthcare provider will adjust the dosage based on the child's response. Check the label on the medicine for directions about your specific dose. Your healthcare provider may teach you how to give this medicine to your child at home. Wash your hands before and after giving the shot. Be sure you know when to use the medicine and how much medicine you should use. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

This medicine is usually discontinued before age 11 years in females and 12 years in males. Talk with your healthcare provider about this.

What if I miss a dose?

Do not miss a dose. If you miss giving a dose to your child, contact your healthcare provider for instructions.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If your child passes out, has seizures, weakness or confusion, or has trouble breathing, call 911. If you think that your child may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: decreased activity, trouble breathing.

What should I watch out for?

During the first 2 months of treatment, females may experience vaginal bleeding or spotting. If this continues beyond 2 months, contact your healthcare provider.

Your healthcare provider will monitor your child regularly to see how this medicine is working. Keep all appointments.

During the early stages of treatment with this medicine, there may be more symptoms of puberty. These symptoms should go away with time.

Contact your healthcare provider right away if there is any irritation at the spots where shots are given. Also report any unusual signs or symptoms.

If your child needs emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist your child has received this medicine.

Your child may develop diabetes when taking this medicine. If your child already has diabetes, it may get worse. Talk with your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, the medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your child’s body adjusts to the medicine. Tell your healthcare provider if your child has any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in the chest; swelling of lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of the body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Vaginal bleeding or spotting that continues beyond 2 months of treatment; pain, swelling, or rash at the spot where a shot has been given; severe mood or behavior changes; sudden vomiting; confusion; chest pain; trouble breathing; fainting; seizures.

Other: General pain, acne, rash, body odor, fever, headache, nausea, hot flushes, sweating, weight gain.

What products might interact with this medicine?

When your child takes this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if your child is taking:

• Diabetes medicines such as acarbose (Precose), glipizide (Glucotrol), glyburide (Glynase), metformin (Fortamet, Glucophage, Riomet), miglitol (Glyset), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)

If you are not sure if your child’s medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your child’s medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that your child takes. Be sure that you tell all healthcare providers who treat your child about all the products your child is taking.

How should I store this medicine?

Store this medicine at room temperature. Do not let it freeze. Keep the vial in the box until you use it. Protect it from heat, high humidity, and bright light. Do not use this medicine after the expiration date on the bottle.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.