Lupron Depot 45mg Inj/6 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 luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to a temporary increase in testosterone (known as a 'flare'). However, chronic administration of leuprolide leads to downregulation of GnRH receptors in the pituitary, resulting in desensitization and a profound decrease in LH and FSH secretion. This, in turn, leads to a significant reduction in testicular testosterone production to 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 you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Allergic Reaction: 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, or swelling of the mouth, face, lips, tongue, or throat.
High Blood Sugar: Confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased sputum production or change in sputum color, painful urination, mouth sores, or a wound that won't heal.
High Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Dehydration: Dry skin, mouth, or eyes, thirst, rapid heartbeat, dizziness, rapid breathing, or confusion.
Liver Problems: Dark urine, fatigue, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin and eyes.
Other Severe Side Effects:
+ New or worsening bone pain
+ Difficulty urinating or changes in urine output
+ Severe back pain
+ Seizures
+ Blood in the urine
+ Abnormal sensations (burning, numbness, or tingling)
+ Severe dizziness or fainting
+ Abnormal heartbeat (fast, slow, or irregular)
+ Shortness of breath, significant weight gain, or swelling in the arms or legs
+ Inability to move
Behavior and Mood Changes: Aggression, crying, depression, mood swings, restlessness, and irritability (especially in children). If you or your child experience any new or worsening behavioral or mood changes, contact your doctor immediately.
Pituitary Gland Problem (Pituitary Apoplexy): Sudden headache, vomiting, fainting, mood changes, eye weakness, inability to move the eyes, or changes in vision. This rare condition usually occurs within 2 weeks of the first dose.
Severe Skin Reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek medical help immediately if you experience:
+ 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, or swollen glands

Other Side Effects

Most people taking this medication will not experience severe side effects, but some may encounter mild or moderate side effects. If you experience any of the following, contact your doctor if they bother you or persist:

Headache
Dizziness, fatigue, or weakness
Decreased appetite
Constipation
Upset stomach or vomiting
Difficulty sleeping
Irritation at the injection site
Back, muscle, or joint pain
Flu-like symptoms
Common cold symptoms

This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms.
Your gender, as this medication is not approved for use in females. If you are female, discuss the potential risks with your doctor, particularly if you are pregnant, planning to become pregnant, or are breastfeeding, as this medication may harm an unborn baby.
Any other medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or worsen certain health conditions.
All your health problems, as they may affect the safety and efficacy of this medication.

To ensure your safety, always consult with your doctor before starting, stopping, or changing the dose of any medication. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug can alter certain hormone levels in your body, which may lead to various effects such as changes in breast size, breast tenderness, testicle changes, erectile dysfunction, decreased libido, hot flashes, or excessive sweating. If you experience any of these symptoms, discuss them with your doctor.

Regular blood tests and bone density checks are crucial, as directed by your doctor. Additionally, this medication may interfere with certain laboratory tests, so it is vital to notify all your healthcare providers and lab personnel that you are taking this drug.

There is a risk of developing high blood sugar, including new-onset or worsening diabetes, associated with this medication. Monitor your blood sugar levels as advised by your doctor. If you smoke, consult with your doctor, as this medication may also increase cholesterol levels.

Long-term use of this drug may lead to weakened bones, increasing the risk of fractures. If you experience bone pain, contact your doctor immediately. Certain products containing this medication are not approved for use in individuals aged 65 or older or in children, so discuss any concerns with your doctor.

People with bladder blockage or spinal cord compression may be at a higher risk of severe and potentially life-threatening complications. Furthermore, lowering male hormone levels in the body may increase the risk of abnormal heart rhythms, known as prolonged QT interval. If you have any questions or concerns, consult with your doctor.

During the initial few weeks of treatment, you may experience a worsening of symptoms, known as a tumor flare reaction. In rare cases, this can lead to paralysis or even death, particularly in individuals with advanced prostate cancer. If you have urinary blockage or cancer in the spine, inform your doctor, and seek immediate medical attention if you experience difficulty urinating or moving your legs. Report any persistent or bothersome side effects, such as bone pain, numbness, tingling, blood in the urine, or urinary difficulties, to your doctor.

Males taking this medication may have a slightly increased risk of heart attack, stroke, or sudden cardiac death. Although this risk is low, seek immediate medical help if you experience chest pain, weakness on one side of the body, speech or cognitive difficulties, balance problems, facial drooping, or vision changes.

This medication may also affect fertility, so discuss any concerns about fathering a child with your doctor.

• Drugs that prolong the QT interval (e.g., Class IA antiarrhythmics, Class III antiarrhythmics, some antipsychotics, macrolide antibiotics, quinolone antibiotics): Although leuprolide itself is not a strong QT prolonger, androgen deprivation therapy may prolong the QT interval. Caution is advised.

• Hot flashes
• Fatigue
• Bone pain (especially new or worsening)
• Urinary symptoms (for prostate cancer progression)
• Cardiovascular symptoms (chest pain, shortness of breath, palpitations)
• Mood changes, depression
• Muscle weakness or loss
• Weight gain
• Injection site reactions (pain, swelling, redness)

Contraindicated in pregnant women. Leuprolide can cause fetal harm when administered to a pregnant woman. It is expected to cause abortion based on its pharmacologic action.

Not recommended 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.

This specific formulation (45mg/6 months) is not indicated for pediatric use. Leuprolide acetate is used in pediatric patients for central precocious puberty, but at different doses and formulations.

No specific dose adjustment is required based on age. However, geriatric patients may have increased risk of comorbidities (e.g., cardiovascular disease, diabetes, osteoporosis) that are also associated with androgen deprivation therapy. Close monitoring for these conditions is warranted.

• Patients should be informed about the initial 'flare' phenomenon (transient increase in testosterone and potential worsening of symptoms) during the first few weeks of therapy. Antiandrogens may be co-administered to mitigate this effect.
• Long-term use of GnRH agonists is associated with increased risk of bone loss, cardiovascular events, and diabetes. Comprehensive monitoring and management of these risks are crucial.
• Ensure proper subcutaneous injection technique for the 6-month depot formulation to ensure sustained release.
• Patients should be advised to report any new or worsening neurological symptoms (e.g., weakness, numbness) as spinal cord compression can occur in patients with vertebral metastases.
• Lupron Depot 45mg/6 month is a long-acting formulation, which can improve patient adherence compared to more frequent injections.

• Other GnRH agonists (e.g., goserelin, triptorelin)
• GnRH antagonists (e.g., degarelix, relugolix)
• Androgen receptor inhibitors (e.g., enzalutamide, apalutamide, darolutamide)
• Androgen synthesis inhibitors (e.g., abiraterone)
• Bilateral orchiectomy (surgical castration)
• Chemotherapy (e.g., docetaxel, cabazitaxel) for metastatic castration-resistant prostate cancer

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred.