Lupron Depot-Ped 11.25mginj/3 Mth

Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). It acts as a potent inhibitor of gonadotropin secretion when given continuously. Initially, it causes a transient increase in luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion from the pituitary gland (a 'flare' effect). However, continuous administration leads to desensitization and downregulation of GnRH receptors in the pituitary, resulting in a profound decrease in LH and FSH secretion. This, in turn, suppresses ovarian and testicular steroidogenesis, leading to a reduction in circulating levels of sex hormones (estradiol and testosterone). In central precocious puberty, this suppression halts or reverses the progression of pubertal development.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If your child exhibits any of the following symptoms, contact their doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
A fast heartbeat
Fever
Seizures
Swelling or numbness in the arms or legs
Vaginal bleeding that is not normal
Vaginal itching or discharge
Severe bone pain
Chest pain
A rare but serious condition called pituitary apoplexy, which can occur within 2 weeks of the first dose. Symptoms may include:
+ Sudden headache
+ Vomiting
+ Passing out
+ Mood changes
+ Eye weakness
+ Inability to move eyes
+ Changes in eyesight
Behavior and mood changes, such as:
+ Acting aggressively
+ Crying
+ Depression
+ Emotional ups and downs
+ Restlessness
+ Feeling angry and irritable
+ Suicidal thoughts or actions
Raised pressure in the brain, which can cause:
+ Headache
+ Eyesight problems (e.g., blurred vision, double vision, loss of vision)
+ Pain behind the eye
+ Pain when moving the eye
+ Ringing in the ears
+ Dizziness
+ Severe stomach upset
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions that can affect body organs and be life-threatening. Symptoms may include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, eyes, genitals, or skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands

Other Possible Side Effects

Most people experience no side effects or only mild side effects when taking this medication. However, if your child experiences any of the following side effects, contact their doctor or seek medical attention if they are bothersome or do not go away:

Irritation at the injection site
Headache
Hot flashes
Excessive sweating
Acne
Weight gain
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Common cold symptoms
Nose or throat irritation
Cough
Arm or leg pain
* Back pain

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your child's doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Giving This Medication to Your Child: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

If your child has any allergies to this medication, any of its components, or other medications, foods, or substances. Please describe the allergic reaction and the symptoms your child experienced.
If your child is pregnant, as this medication should not be administered during pregnancy due to potential interactions with the pregnancy or other health issues.

To ensure safe use, tell your doctor and pharmacist about:

All medications your child is taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins.
Any health problems your child has, as this medication may interact with other medications or health conditions.

Before making any changes to your child's medication regimen, consult with your doctor to confirm it is safe to:

Start or stop taking any medication.
Change the dosage of any medication.
* Combine this medication with other medications or health conditions.

It is essential to inform all of your child's healthcare providers, including doctors, nurses, pharmacists, and dentists, that your child is taking this medication. Regular blood tests will be necessary, as directed by the doctor, to monitor your child's condition. Be sure to discuss any concerns or questions with the doctor.

This medication may interfere with certain laboratory tests, so it is crucial to notify all healthcare providers and laboratory personnel that your child is taking this drug.

During the initial few weeks of treatment, this medication may cause an increase in certain hormone levels in your child's body. As a result, signs of puberty, such as vaginal bleeding or spotting, may occur or worsen before improving. If your child experiences any new symptoms or if puberty signs persist after 2 months of treatment, notify the doctor.

In some cases, this medication may affect growth in children and teenagers. To monitor this potential effect, regular growth checks may be necessary. Discuss this with the doctor to determine the best course of action.

For children of childbearing age, a pregnancy test will be required before starting this medication to confirm that they are not pregnant.

This medication may temporarily affect fertility during treatment, which could lead to difficulty conceiving. However, fertility typically returns to normal once the medication is discontinued. If you have concerns about this potential effect, consult with the doctor.

If your child is sexually active or may become sexually active:

If your child is using birth control, it is recommended to use a non-hormonal method, such as condoms, to prevent pregnancy while taking this medication.

If your child is pregnant or breastfeeding:

If your child becomes pregnant or is already pregnant while taking this medication, contact the doctor immediately, as the medication may harm the unborn baby.
* If your child is breastfeeding, inform the doctor to discuss any potential risks to the baby and determine the best course of action.

• Regression or stabilization of secondary sexual characteristics (e.g., breast development, pubic hair, testicular enlargement)
• Absence of menses in girls
• Changes in mood or behavior
• Signs of allergic reaction (rash, itching, difficulty breathing)
• Injection site reactions (pain, swelling, redness, bruising)

Contraindicated in pregnancy. Leuprolide can cause fetal harm when administered to a pregnant woman. It is expected to cause abortion or fetal abnormalities based on its pharmacologic action.

Contraindicated during lactation. It is not known whether leuprolide is excreted in human milk. However, due to the potential for serious adverse reactions in a breastfed infant from leuprolide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Lupron Depot-Ped is specifically indicated and dosed for pediatric patients with central precocious puberty. Safety and efficacy have been established in this population. Close monitoring of pubertal suppression and growth is essential.

Not indicated for geriatric patients for this specific formulation and indication. Leuprolide acetate is used in geriatric males for prostate cancer, but at different doses and formulations.

• Ensure proper mixing and administration technique for the depot suspension to ensure full dose delivery and sustained release.
• The initial 'flare' effect (transient increase in sex hormones) may cause a temporary worsening of pubertal signs in the first few weeks of therapy. Reassure parents/patients that this is expected and temporary.
• Regular monitoring of height, weight, bone age, and hormone levels (LH, FSH, sex steroids) is crucial to assess treatment efficacy and adjust therapy if needed.
• Treatment is typically continued until the appropriate chronological age for the onset of puberty, or until growth potential is maximized, as determined by the treating endocrinologist.
• Patients and caregivers should be educated on the importance of adherence to the every 3-month injection schedule to maintain continuous suppression.

• Other GnRH agonists for CPP: Triptorelin (e.g., Trelstar, Triptodur), Histrelin implant (Supprelin LA).
• For specific cases, other approaches might be considered, but GnRH agonists are the mainstay for central precocious puberty.

If your child's symptoms or health issues persist or worsen, it is essential to contact their doctor promptly. To ensure safe use, never share your child's medication with others, and do not administer someone else's medication to your child. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist, as there may be drug take-back programs available in your area.

This medication is accompanied by a Medication Guide, which provides crucial information. Read this guide carefully and review it again each time the medication is refilled. If you have any questions or concerns about this medication, discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion to ensure prompt and effective treatment.