Leuprolide for Pediatric Use, Injection LOO-proh-lyd

What are other names for this medicine?

Type of medicine: gonadotropin-releasing hormone analog

leuprolide for pediatric use, injection; Lupron for Pediatric Use

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).

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

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

• an allergic reaction to any medicine or hormone, or to benzyl alcohol
• a stroke
• abnormal vaginal bleeding
• blood clots or a bleeding disorder such as anemia
• cancer in the spine
• depression
• heart problems
• bone thinning
• problems with drug or alcohol abuse
• 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. Be sure to withdraw the right amount of medicine from the vial, keeping it sterile. Use sterile, disposable syringes and needles. Use them only once, and dispose of them safely.

Carefully read and follow the directions that come in the package of medicine for preparing the shots.

Wash your hands before using this medicine. Follow these steps to give yourself the shots:

1. Choose a site on your child’s abdomen (around the belly button but not in the belly button), thigh, upper arm, or other sites. Each day, choose a different spot for the shot to lessen irritation.
2. Before each injection, look carefully at the medicine to check for any particles or a change in color. Do not use medicine that has changed color or has particles in it. Use an alcohol swab to clean the skin where you will give yourself the shot.
3. Gently pinch up the skin and insert the needle into the skin at a 45° angle. After you insert the needle completely, release your grasp of the skin.
4. After you have given the shot, withdraw the needle and syringe and press the alcohol swab at the spot where the shot was given.
5. Discard the syringe, needle, and drug vial. Use the syringes and needles ONLY ONCE. Throw them away after use. Put used needles in rigid puncture-resistant containers with lids or caps, such as heavy plastic bleach bottles with screw caps. DO NOT throw needles directly into garbage cans or dumpsters.
6. When you repeat the procedure, use a new pack.

If you do not clearly understand how to get the right amount or give the shots, ask your healthcare provider or pharmacist to explain.

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 you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else 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 health care 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 you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you have 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, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have 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 your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Vaginal bleeding or spotting that continues beyond 2 months of treatment, irritation or rash at the spot where a shot has been given, seizures.

Other: General pain, acne, rash, body odor, fever, headache, stomach upset, feeling faint

What products might interact with this medicine?

When you take 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 you are taking:

• medicines to treat diabetes such as acarbose (Precose), glipizide (Glucotrol), glyburide (DiaBeta, Glynase), metformin (Glucophage), miglitol (Glyset), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)

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

How should I store this medicine?

Store this medicine in the refrigerator. 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.