Lupron Depot-Ped 30mg Inj/3 Mth Kit

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) levels (a 'flare' effect), leading to a temporary increase in gonadal steroid production. However, continuous administration of leuprolide results in desensitization and downregulation of pituitary GnRH receptors, leading to a profound suppression of LH and FSH secretion. This, in turn, suppresses ovarian and testicular steroidogenesis, effectively reducing sex hormone levels to prepubertal or castrate levels. In Central Precocious Puberty (CPP), this suppression prevents further progression of puberty.

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
Very bad bone pain
Chest pain
A severe pituitary gland problem (pituitary apoplexy), which can occur rarely, usually within 2 weeks of the first dose. Watch for:
+ Sudden headache
+ Vomiting
+ Passing out
+ Mood changes
+ Eye weakness
+ Inability to move eyes
+ Changes in eyesight
Behavior and mood changes, including:
+ Aggressive behavior
+ 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 (blurred vision, double vision, or 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, which can affect body organs and be life-threatening. Look for:
- 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
Pimples (acne)
Weight gain
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Signs of a common cold
Nose or throat irritation
Cough
Pain in the arms or legs
* 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: Inform Your Doctor About the Following

Any allergies your child has, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
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:

Provide your doctor and pharmacist with a comprehensive list of all medications your child is taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Inform them about any health problems your child has, as this medication may interact with other drugs or exacerbate certain health conditions.
Verify that it is safe to administer this medication alongside your child's other medications and health conditions.
Do not initiate, discontinue, or modify the dosage of any medication your child is taking without first consulting with the doctor to avoid potential interactions or adverse effects.

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 your child is 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 while taking this medication, it may harm the unborn baby. Immediately contact the doctor if your child is pregnant or suspects they may be pregnant.
* If your child is breastfeeding, inform the doctor, as they will need to discuss potential risks to the baby and determine the best course of action.

• Injection site reactions (pain, redness, swelling, abscess)
• Headache
• Hot flashes/flushing
• Mood changes/emotional lability
• Vaginal bleeding/spotting (especially during initial flare)
• Acne
• Weight gain
• Peripheral edema
• Hypersensitivity reactions (rare)

Contraindicated in pregnancy. Leuprolide may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Contraindicated during breastfeeding. It is not known whether leuprolide is excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant, 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 the treatment of Central Precocious Puberty (CPP) in pediatric patients. Safety and efficacy have been established in this population. Close monitoring of pubertal progression and hormone levels is crucial.

Not applicable for this specific pediatric formulation and indication. Leuprolide is used in geriatric populations for prostate cancer, but different formulations and dosing apply.

• The initial 'flare' effect (transient increase in sex hormones) may cause a temporary worsening of pubertal signs or vaginal bleeding/spotting in girls during the first few weeks of treatment. This is expected and usually resolves.
• Ensure proper injection technique (subcutaneous or intramuscular) to maximize efficacy and minimize injection site reactions. Rotate injection sites.
• Adherence to the every 3-month dosing schedule is critical for sustained suppression of puberty.
• Treatment is typically continued until the appropriate chronological age for puberty (e.g., 11-12 years for girls, 12-13 years for boys), at which point it is discontinued to allow natural pubertal progression.
• Monitor for psychological effects, including mood changes, as these have been reported with GnRH agonists, though causality is not fully established.

• Triptorelin (Trelstar, Triptodur)
• Histrelin implant (Supprelin LA)
• Goserelin (Zoladex)

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 important information about its use. 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 emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred, as this will aid in providing appropriate treatment.