Lupron Depot 22.5mg Inj Kit (3mth)

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 in therapeutic doses. Initially, it causes a transient increase in luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to a transient increase in testosterone (known as 'tumor flare'). However, continuous administration of leuprolide results in desensitization and downregulation of GnRH receptors in the pituitary, leading to a profound decrease in LH and FSH secretion. This, in turn, significantly reduces testicular testosterone production to castrate levels, which is the primary therapeutic effect in 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:

Signs of an 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.
Signs of high blood sugar: confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Signs of 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.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of dehydration: dry skin, mouth, or eyes, thirst, rapid heartbeat, dizziness, rapid breathing, or confusion.
Signs of liver problems: dark urine, fatigue, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
New or worsening bone pain.
Difficulty urinating or changes in urine output.
Severe back pain.
Seizures.
Blood in the urine.
Abnormal sensations such as burning, numbness, or tingling.
Severe dizziness or fainting.
Irregular heartbeat (fast, slow, or abnormal).
Shortness of breath, significant weight gain, or swelling in the arms or legs.
Inability to move.
Behavioral and mood changes, particularly in children, including aggression, crying, depression, mood swings, restlessness, and irritability. If you notice any new or worsening behavioral or mood changes, contact your doctor immediately.
A rare but serious pituitary gland problem (pituitary apoplexy) can occur, usually within 2 weeks of the first dose. Seek medical help right away if you experience a sudden headache, vomiting, fainting, mood changes, eye weakness, inability to move your eyes, or changes in vision.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, can occur. These reactions can be life-threatening and may affect other organs. Seek medical help immediately if you notice signs such as 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

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

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 possible side effects. If you have questions or concerns about side effects, contact 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 that occurred.
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.
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 exacerbate existing health problems.
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. Verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to determine the best course of treatment for you.

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 symptoms, discuss them with your doctor.

Regular blood tests and bone density checks are crucial while taking this medication, as directed by your doctor. Additionally, inform all your healthcare providers and laboratory personnel that you are taking this drug, as it may affect the results of certain lab tests.

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. Discuss any concerns 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 with your doctor if you are planning to father a child.

• Drugs that prolong QT interval (e.g., Class IA antiarrhythmics, Class III antiarrhythmics, some antipsychotics, macrolide antibiotics, fluoroquinolones): Potential for additive QT prolongation. Use with caution.
• Androgen receptor pathway inhibitors (e.g., enzalutamide, abiraterone): While often used sequentially or in combination in advanced prostate cancer, careful monitoring for additive adverse effects (e.g., cardiovascular, metabolic) is warranted.

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

Contraindicated in pregnant women. Leuprolide can cause fetal harm when administered to a pregnant woman. It is a GnRH agonist and can cause abortion, fetal harm, or birth defects.

Not applicable. Leuprolide is not indicated for use in women, and specifically not in lactating women. It is unknown if leuprolide is excreted in human milk.

Safety and effectiveness in pediatric patients have not been established for the treatment of advanced prostate cancer. Lupron Depot is approved for central precocious puberty in pediatric patients, but the 22.5mg 3-month formulation is not typically used for this indication.

No overall differences in safety or effectiveness were observed between older and younger patients. However, the greater sensitivity of some older individuals cannot be ruled out. Given that prostate cancer primarily affects older men, the majority of patients treated with leuprolide are geriatric.

• Patients should be warned about the initial 'tumor flare' (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) are often co-administered for the first few weeks to mitigate this effect.
• Long-term use of GnRH agonists is associated with decreased bone mineral density, increasing the risk of osteoporosis and fractures. Consider baseline and periodic bone density scans and discuss bone health strategies.
• Monitor for metabolic changes, including hyperglycemia and dyslipidemia, as GnRH agonists can increase the risk of diabetes and cardiovascular events.
• Ensure proper injection technique (subcutaneous or intramuscular) as per manufacturer instructions to ensure sustained release and efficacy.
• Patients should be advised that sexual function and libido will likely be significantly reduced due to testosterone suppression.

• Other GnRH agonists (e.g., goserelin, triptorelin, histrelin)
• GnRH antagonists (e.g., degarelix, relugolix)
• Androgen receptor pathway inhibitors (e.g., enzalutamide, apalutamide, darolutamide)
• Androgen synthesis inhibitors (e.g., abiraterone acetate)
• Bilateral orchiectomy (surgical castration)
• Chemotherapy (e.g., docetaxel, cabazitaxel)
• Radium-223 dichloride (for symptomatic bone metastases)

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more details. If you have any questions or concerns about your medication, don't hesitate to reach out to 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 information about the medication taken, the amount, and the time it happened.