Lupron Depot-Ped 15mg Inj/1 Mth 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 the levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) from the pituitary gland, leading to a temporary increase in gonadal steroid production (known as a 'flare' effect). However, continuous administration of leuprolide desensitizes and downregulates GnRH receptors in the pituitary, 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
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 rare but serious condition called pituitary apoplexy, which can occur 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:
+ 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 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
Pimples (acne)
Weight gain
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Common cold symptoms
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 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 allergy 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 drugs, natural products, and vitamins.
Any health problems your child has.

It is crucial to verify that it is safe to give this medication alongside your child's other medications and health conditions. Never start, stop, or change 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, 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.

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 can 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, it is essential to use a non-hormone form of birth control, such as condoms, to prevent pregnancy while taking this medication.

If your child becomes pregnant or is already pregnant, this medication may pose a risk to the unborn baby. If your child is pregnant or becomes pregnant while taking this medication, contact the doctor immediately.

If your child is breastfeeding, inform the doctor, as they will need to discuss the potential risks to the baby and determine the best course of action.

• Signs of continued pubertal progression (e.g., breast development, testicular enlargement, pubic hair growth, menstrual bleeding)
• Headache
• Hot flashes/flushing
• Mood changes
• Injection site pain, swelling, or redness
• Vaginal bleeding or discharge (especially in the first few weeks of treatment due to flare effect)
• 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 or fetal abnormalities based on its pharmacologic action.

Contraindicated during lactation. It is not known whether leuprolide is excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant, breastfeeding should be discontinued during treatment.

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 progression and hormone levels is crucial.

Not indicated for geriatric patients for central precocious puberty. Leuprolide formulations for other indications (e.g., prostate cancer) are used in geriatric populations.

• Ensure proper mixing of the lyophilized powder with the diluent immediately prior to intramuscular injection. Do not use if the solution appears clumpy or settled.
• Administer the injection deep intramuscularly, rotating injection sites to minimize local reactions.
• A transient 'flare' effect (temporary increase in pubertal signs, including vaginal bleeding in girls) may occur during the first few weeks of treatment. This is expected and usually resolves.
• Regular monitoring of clinical signs of puberty, bone age, and hormone levels (LH, FSH, sex steroids) is essential to ensure adequate suppression and guide treatment duration.
• Treatment is typically continued until the appropriate chronological age for the onset of puberty, or until growth plate fusion is complete, as determined by the treating endocrinologist.
• Educate patients and caregivers about the importance of adherence to the monthly injection schedule to maintain therapeutic suppression.

• Other GnRH agonists (e.g., triptorelin, histrelin implant)
• Observation (for very mild or slowly progressing cases, or when the child is close to the normal age of puberty)
• Treatment of underlying cause if CPP is secondary to a treatable condition (e.g., tumor)

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 by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult with your pharmacist, as they can provide guidance on available drug take-back programs in your area.

This medication is accompanied by a Medication Guide, which is a comprehensive patient fact sheet. It is crucial to read this guide carefully and review it again whenever 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 detailed information about the overdose, including the medication taken, the quantity, and the time it occurred, to ensure prompt and effective treatment.