Lupron Depot-Ped 45mg Inj 6/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 gonadotropins (LH and FSH) and sex steroids (testosterone, estrogen) due to receptor stimulation (flare effect). However, chronic, continuous administration leads to desensitization and downregulation of GnRH receptors in the pituitary, resulting in a profound suppression of gonadotropin release. This, in turn, leads to a significant reduction in ovarian and testicular steroidogenesis, effectively suppressing sex hormone levels to prepubertal or castrate levels.

Urgent Side Effects: Seek Medical Help Right Away

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

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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Fast heartbeat
Fever
Seizures
Swelling or numbness in the arms or legs
Abnormal vaginal bleeding
Vaginal itching or discharge
Severe bone pain
Chest pain
Pituitary apoplexy (a rare but serious condition that can occur within 2 weeks of the first dose), characterized by:
+ Sudden headache
+ Vomiting
+ Fainting
+ Mood changes
+ Eye weakness
+ Inability to move eyes
+ Changes in vision
Behavioral and mood changes, including:
+ Aggression
+ Crying
+ Depression
+ Emotional instability
+ Restlessness
+ Irritability
+ Suicidal thoughts or actions
Raised intracranial pressure, which may cause:
+ Headache
+ Vision 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 that can affect internal organs and be life-threatening
+ Signs of these reactions 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

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to monitor your child's condition and contact their doctor if any of the following side effects occur or persist:

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 concerns or questions, consult 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.

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

All medications your child is taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems your child has.

It is crucial to verify that this medication can be safely given with all of your child's other medications and health conditions. Never start, stop, or change the dose of any medication your child is taking without first consulting with your doctor.

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 weeks of treatment, this medication may cause an increase in certain hormone levels, which can lead to the onset or worsening of puberty symptoms, such as vaginal bleeding or spotting. If your child experiences any new symptoms or if these symptoms persist beyond 2 months of treatment, notify the doctor promptly.

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 possibility with the doctor.

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

This medication may temporarily affect fertility during treatment, potentially leading 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, it is essential to use a non-hormonal form of birth control, such as condoms, to prevent pregnancy while taking this medication.

If your child becomes pregnant or is already pregnant, notify the doctor immediately, as this medication may harm the unborn baby. Additionally, if your child is breastfeeding, consult with the doctor to discuss any potential risks to the baby and determine the best course of action.

• Drugs that prolong the QT interval (theoretical risk, monitor ECG if co-administered with other QT-prolonging agents)
• Androgen deprivation therapy (ADT) in combination with other agents affecting the QT interval or causing Torsade de Pointes (e.g., Class IA and III antiarrhythmics)

• Headaches
• Hot flashes
• Mood changes
• Injection site reactions (pain, swelling, redness)
• Vaginal bleeding/spotting (especially in girls during initial treatment or if suppression is inadequate)
• Signs of allergic reaction (rash, itching, difficulty breathing)

Contraindicated in pregnancy. Leuprolide can cause fetal harm when administered to a pregnant woman. It is expected to cause abortion.

Contraindicated during lactation. It is not known whether leuprolide is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, 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 for the treatment of Central Precocious Puberty (CPP) in pediatric patients. Safety and efficacy have been established in this population. Close monitoring of pubertal suppression and growth is essential. The dose must be individualized and adjusted based on clinical and biochemical response.

Not indicated for geriatric patients for CPP. For other indications (e.g., prostate cancer), dose adjustments are generally not required based on age alone, but renal/hepatic function should be considered.

• Lupron Depot-Ped is a long-acting depot formulation; ensure proper administration technique (subcutaneous or intramuscular) to ensure sustained release.
• A transient 'flare effect' (initial increase in sex hormones and pubertal signs) may occur during the first few weeks of treatment. This is expected and usually resolves with continued therapy.
• Regular monitoring of clinical signs of puberty, sex hormone levels, LH/FSH, bone age, and growth velocity is crucial to assess treatment efficacy and guide dose adjustments.
• Adherence to the prescribed dosing schedule is critical for effective suppression of puberty. Missed doses can lead to breakthrough puberty.
• Counsel patients and caregivers about potential side effects, including injection site reactions, headaches, and mood changes. Emphasize the importance of reporting any concerning symptoms.
• The 45mg dose mentioned in the prompt is NOT for pediatric use. Lupron Depot-Ped doses for CPP are typically 7.5mg, 11.25mg, or 15mg monthly or every 3 months.

• Other GnRH analogs (e.g., triptorelin, histrelin)
• Surgical options (e.g., for specific underlying causes of CPP like tumors, though not a direct alternative to GnRH agonists for idiopathic CPP)

If your child's symptoms or health issues persist or worsen, it is essential to contact their doctor promptly. To ensure safety and efficacy, 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 by a healthcare professional or pharmacist. If you are unsure about the proper disposal method, consult with your pharmacist, who can also inform you about potential drug take-back programs in your area.

This medication is accompanied by a Medication Guide, which provides crucial information for safe 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 quantity, and the time of ingestion to ensure prompt and effective treatment.