Lupron Depot 30mg Inj/4 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 luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to a temporary increase in testosterone (in males) or estrogen (in females). However, continuous administration of leuprolide results in desensitization and downregulation of GnRH receptors in the pituitary gland, leading to a profound decrease in LH and FSH secretion. This, in turn, suppresses gonadal steroidogenesis, resulting in castrate levels of testosterone in males and estrogen in females. This reduction in sex hormones is the basis for its therapeutic effect in hormone-dependent conditions like prostate cancer.

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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
High Blood Sugar: Confusion, feeling sleepy, unusual 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 or eyes.
Other Severe Side Effects:
+ New or worsening bone pain
+ Urination problems 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
+ Mobility problems
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): A rare but potentially life-threatening condition that may occur within 2 weeks of starting this medication. Seek medical help right away if you experience a sudden headache, vomiting, fainting, mood changes, eye weakness, or vision changes.
Severe Skin Reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions that can affect the skin and other organs. Get medical help immediately if you notice red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Other Possible Side Effects

Most people taking this medication do 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 do not go away:

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

This is not an exhaustive list of possible 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 drug, its components, or other medications, foods, or substances. Be sure to describe the symptoms you experienced.
Your gender, as this medication is not approved for use in females. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential risks with your doctor, as this medication may harm an unborn baby.
Potential interactions with other medications or health conditions. Provide your doctor and pharmacist with a comprehensive list of all your medications, including prescription and over-the-counter drugs, natural products, and vitamins. Also, share any health problems you have.
Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure it is safe to do so in conjunction with this medication.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug works by reducing 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 effects, discuss them with your doctor.

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

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 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, reducing male hormones in the body may increase the risk of abnormal heart rhythms, known as prolonged QT interval. If you have any questions or concerns, consult 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 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 medical help immediately if you experience chest pain, weakness on one side of the body, speech or cognitive difficulties, balance problems, facial drooping, or changes in vision.

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, methadone, moxifloxacin, antipsychotics): Increased risk of Torsade de Pointes due to potential for QT prolongation with GnRH agonists.

• Androgen receptor inhibitors (e.g., enzalutamide, apalutamide, darolutamide): May be used in combination, but monitor for additive adverse effects.
• Corticosteroids: May be used to manage tumor flare, but monitor for corticosteroid-related side effects.

• Hot flashes
• Fatigue
• Bone pain (especially initial tumor flare)
• Urinary symptoms (initial worsening during flare)
• Erectile dysfunction
• Decreased libido
• Gynecomastia
• Injection site reactions (pain, swelling, redness)
• Signs of cardiovascular events (chest pain, shortness of breath, leg swelling)
• Signs of diabetes (increased thirst, urination, unexplained weight loss)
• Mood changes, depression

Contraindicated in pregnancy. Leuprolide can cause fetal harm when administered to a pregnant woman. It is expected to cause abortion or teratogenic effects based on its hormonal 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 from leuprolide, 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 30mg/4 Mth is not indicated for pediatric use. Different formulations (e.g., Lupron Depot-PED) are used for central precocious puberty in children, with specific dosing and monitoring.

No specific dose adjustment is required for elderly patients. However, elderly patients may be more susceptible to some adverse effects (e.g., cardiovascular events, bone loss, diabetes). Monitor closely for these effects.

• Patients should be warned about the initial 'tumor flare' phenomenon (transient worsening of symptoms like bone pain, urinary obstruction) during the first few weeks of treatment due to the initial surge in testosterone. Anti-androgens (e.g., bicalutamide) may be co-administered for the first few weeks to mitigate this effect.
• Long-term use of GnRH agonists is associated with a risk of decreased bone mineral density, increased risk of fractures, and increased risk of cardiovascular events (e.g., myocardial infarction, stroke, sudden cardiac death) and diabetes. Monitor patients for these risks.
• Ensure proper mixing and administration technique for the depot formulation to ensure sustained release and efficacy.
• Patients should be advised to report any new or worsening symptoms, especially neurological symptoms (e.g., weakness, numbness) or severe pain, which could indicate spinal cord compression or other serious complications.
• Leuprolide is a peptide and must be administered by injection (subcutaneous or intramuscular); it is not orally bioavailable.

• Orchiectomy (surgical castration)
• Androgen receptor pathway inhibitors (e.g., enzalutamide, apalutamide, darolutamide)
• Androgen synthesis inhibitors (e.g., abiraterone acetate)
• Chemotherapy (e.g., docetaxel, cabazitaxel)
• Radium-223 dichloride (for symptomatic bone metastases)
• Immunotherapy (e.g., sipuleucel-T)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 medication taken, the amount, and the time it occurred.