Lupron Depot-Ped 7.5mg Inj/1mth Kit

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) (a 'flare' effect), leading to a temporary increase in gonadal steroid levels. However, continuous administration of leuprolide results in desensitization and downregulation of GnRH receptors in the pituitary gland, leading to a profound suppression of LH and FSH secretion. This, in turn, reduces gonadal steroidogenesis (estradiol in females, testosterone in males) 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 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
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
Pituitary apoplexy, a rare but serious condition that can occur, especially within 2 weeks of the first dose. Watch for:
+ Sudden headache
+ Vomiting
+ Fainting
+ Mood changes
+ Eye weakness
+ Inability to move eyes
+ Changes in eyesight
Behavior and mood changes, including:
+ Aggression
+ Crying
+ Depression
+ Emotional ups and downs
+ Restlessness
+ Irritability
+ 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 that can affect body organs and be life-threatening. Seek medical help if your child experiences:
- 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 mild 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, its components, or other substances, including foods or drugs. Please 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, tell your doctor and pharmacist about:

All prescription and over-the-counter (OTC) medications your child is taking
Any natural products or vitamins your child is using
* Your child's existing health problems

It is crucial to verify that this medication can be safely given with all your child's other medications and health conditions. Do not initiate, stop, or adjust the dosage 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 lab 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:

This medication may harm the unborn baby if taken during pregnancy. If your child becomes pregnant while taking this medication, contact the doctor immediately.
* 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 growth, testicular enlargement)
• Cessation of menses (in girls)
• Changes in growth velocity
• Headaches
• Hot flashes
• Mood changes
• Injection site pain, redness, swelling, or induration

Contraindicated in pregnancy. Leuprolide can cause fetal harm when administered to a pregnant woman. Pregnancy must be excluded before starting therapy.

Not recommended 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.

This formulation (Lupron Depot-Ped) is specifically indicated and dosed for pediatric patients with Central Precocious Puberty. Safety and efficacy have been established in this population. Treatment should be initiated and monitored by a pediatric endocrinologist or a physician experienced in the management of CPP.

Not indicated for geriatric use in this specific formulation. No specific dose adjustments or considerations for geriatric patients are relevant for Lupron Depot-Ped.

• Lupron Depot-Ped is a lyophilized powder that must be reconstituted with the supplied diluent immediately prior to intramuscular injection. Ensure proper mixing to form a uniform suspension.
• The injection must be administered intramuscularly, not intravenously or subcutaneously. Rotate injection sites to minimize local reactions.
• An initial 'flare' effect (transient increase in pubertal signs, including vaginal bleeding in girls) may occur during the first few weeks of treatment. This is expected and usually resolves with continued therapy.
• Treatment duration is individualized; therapy is typically continued until the appropriate chronological age for the onset of puberty, or until the child is ready to discontinue treatment, usually around 11-12 years of age.
• Upon discontinuation of therapy, pubertal development will resume. Fertility may be impaired in some patients, though long-term data on fertility after CPP treatment are limited.
• Regular monitoring of growth, bone age, and hormonal levels is crucial to assess treatment efficacy and guide management.

• Triptorelin (Trelstar, Triptodur)
• Histrelin (Supprelin LA)
• Nafarelin (Synarel - nasal spray, less common for CPP)
• GnRH agonist implants (e.g., histrelin implant)

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, as many communities have 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 you refill the prescription. 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.