Lupron Depot-Ped 11.25mginj/1 Mth

Leuprolide 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 (flare effect). However, continuous administration of leuprolide leads to desensitization and downregulation of GnRH receptors in the pituitary, resulting in a profound decrease in LH and FSH secretion. This, in turn, leads to a significant reduction in ovarian and testicular steroidogenesis, suppressing the production of sex hormones (estradiol and testosterone) to prepubertal levels, thereby arresting the progression of central precocious 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 immediate 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
+ Trouble 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 (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 internal organs and be life-threatening
+ Signs of severe skin 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 potential 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: Inform Your Doctor If:
- Your child has an allergy to this medication, any of its components, or any other medications, foods, or substances. Be sure to discuss the specifics of the allergy and the symptoms your child experienced.

Pregnancy Considerations:
- This medication should not be given to your child if they are pregnant, as it may pose risks to the unborn baby.

Potential Interactions and Precautions:
- This medication can interact with other medications or exacerbate existing health conditions. Therefore, it is crucial to inform your doctor and pharmacist about all the medications your child is taking, including prescription and over-the-counter drugs, natural products, and vitamins.
- Ensure that you discuss all of your child's health problems with the doctor to verify the safety of this medication in conjunction with their other treatments and conditions.
- Do not initiate, discontinue, or adjust the dosage of any medication your child is taking without first consulting with the doctor to confirm it is safe to do so.

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 this 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.

• Drugs that prolong the QT interval (theoretical risk, though leuprolide itself is not known to prolong QT significantly, caution with other QT-prolonging agents is prudent).

• Progression of pubertal signs (breast development, pubic hair, testicular enlargement, menstrual bleeding)
• Headache
• Mood changes (emotional lability, depression)
• Hot flashes
• Vaginal bleeding/spotting (especially in first few weeks of treatment)
• Injection site reactions (pain, redness, swelling, induration)
• Signs of allergic reaction (rash, itching, difficulty breathing)

Contraindicated in pregnancy (Category X). Leuprolide can cause fetal harm when administered to a pregnant woman. Pregnancy must be excluded before starting treatment.

Contraindicated during lactation (L5 - contraindicated). It is not known whether leuprolide is excreted in human milk. Due to the potential for serious adverse reactions in the nursing 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.

This formulation (Lupron Depot-Ped) is specifically indicated and dosed for pediatric patients with Central Precocious Puberty (CPP). Safety and efficacy have been established in this population.

Not indicated for geriatric use in this specific formulation. Leuprolide is used in older adults for prostate cancer, but different formulations and dosing apply.

• Lupron Depot-Ped is a long-acting formulation; strict adherence to the monthly (28-31 day) injection schedule is crucial for optimal suppression of puberty.
• An initial 'flare effect' (transient increase in pubertal signs, including vaginal bleeding/spotting in girls) may occur during the first 1-2 weeks of treatment. This is expected and usually resolves.
• Regular monitoring of LH, FSH, sex steroids, bone age, and clinical pubertal staging is essential to confirm adequate suppression and guide treatment duration.
• Treatment should be individualized and continued until the appropriate age for onset of puberty or when the child reaches the desired pubertal stage, as determined by the treating endocrinologist.
• The injection site should be rotated to prevent lipohypertrophy or other local reactions. The product must be reconstituted immediately before administration and administered subcutaneously.

• Other GnRH agonists for CPP: Triptorelin (e.g., Trelstar, Decapeptyl), Histrelin implant (Supprelin LA), Leuprolide acetate (other depot formulations like Lupron Depot 3.75 mg, 7.5 mg, 15 mg, 30 mg, or daily subcutaneous injections).
• For specific cases, other approaches might be considered, but GnRH agonists are the standard of care for true central precocious puberty.

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. For guidance on the proper disposal method, consult with your pharmacist, and consider participating in local drug take-back programs.

This medication is accompanied by a Medication Guide, which provides crucial information for safe use. Read this guide carefully and review it each time the medication is refilled to ensure you understand the necessary precautions and potential side effects. If you have any questions or concerns about this medication, consult 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 detailed information about the overdose, including the medication taken, the quantity, and the time it occurred, to facilitate prompt and effective treatment.