Lupron Depot 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 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 a 'flare'). However, chronic administration of leuprolide results in downregulation of GnRH receptors in the pituitary, leading to 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, 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:

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
+ Irregular heartbeat (fast, slow, or abnormal)
+ 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 experiences 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 sudden headache, vomiting, fainting, mood changes, eye weakness, inability to move your eyes, or changes in vision.
Severe Skin Reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions that can be life-threatening. 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 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 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.
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 of taking this medication.

To ensure your safety, always consult with your doctor before starting, stopping, or changing the dose of any medication. It is your responsibility 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 advised by your doctor. This medication may interfere with certain laboratory tests, so it is vital to notify all your healthcare providers and laboratory 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 directed by your doctor. If you smoke, consult your doctor, as this medication may also increase cholesterol levels.

Long-term use of this drug may cause bone weakness, increasing the risk of fractures. If you experience bone pain, contact your doctor immediately. Certain products 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 tumors may be at a higher risk of severe and potentially life-threatening complications. Additionally, 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, discuss them 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 spinal cancer, inform your doctor, and seek immediate medical attention if you experience difficulty urinating or leg weakness. Report any persistent or bothersome side effects, such as bone pain, numbness, tingling, hematuria, urinary retention, or other symptoms that last for more than a few weeks after starting this medication.

There is a low but increased risk of heart attack, stroke, or sudden cardiac death associated with the use of this type of medication in males. 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., antiarrhythmics, antipsychotics, macrolide antibiotics, fluoroquinolones): Leuprolide may cause QT prolongation, increasing risk of arrhythmias when co-administered with other QT-prolonging drugs.
• Androgen receptor inhibitors (e.g., bicalutamide, enzalutamide): While often used in combination therapy, careful monitoring is needed to manage potential additive adverse effects.

• Hot flashes
• Fatigue
• Decreased libido
• Erectile dysfunction
• Injection site reactions (pain, swelling, redness)
• Bone pain or fractures
• Urinary symptoms (especially during initial flare)
• Neurological symptoms (e.g., weakness, paresthesia, seizures - rare)
• Cardiovascular symptoms (e.g., chest pain, shortness of breath, palpitations)
• Symptoms of diabetes (e.g., increased thirst, urination)

Contraindicated in pregnancy. Leuprolide can cause fetal harm when administered to a pregnant woman. It is a GnRH agonist and can cause abortion or fetal abnormalities.

Not recommended 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, 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.

Not indicated for prostate cancer in pediatric patients. Leuprolide is used in pediatric patients for central precocious puberty, but with different formulations and dosing.

No specific dosage adjustment is required based solely on age. Elderly patients may be more susceptible to some adverse effects (e.g., cardiovascular events, bone loss, diabetes) due to comorbidities and polypharmacy. Monitor closely for these effects.

• Patients may experience a 'testosterone flare' during the first few weeks of treatment, which can temporarily worsen symptoms of prostate cancer (e.g., bone pain, urinary obstruction). Antiandrogens (e.g., bicalutamide) are often co-administered for the first few weeks to mitigate this flare.
• Ensure proper injection technique (IM or SC) as specified for the particular Lupron Depot formulation to ensure sustained release.
• Long-term use of GnRH agonists is associated with decreased bone mineral density and increased risk of fractures. Consider bone health management strategies (e.g., calcium/vitamin D supplementation, bisphosphonates).
• Monitor for metabolic changes, including increased risk of diabetes and cardiovascular events, especially in patients with pre-existing risk factors.
• Patients should be advised that hot flashes are a very common side effect and strategies for managing them can be discussed.
• The 7.5 mg formulation is for monthly administration. Other formulations (e.g., 3-month, 4-month, 6-month) are available for different dosing frequencies.

• Other GnRH agonists: Goserelin (Zoladex), Triptorelin (Trelstar), Histrelin (Vantas)
• GnRH antagonists: Degarelix (Firmagon), Relugolix (Orgovyx) - these do not cause a flare effect.
• Androgen receptor pathway inhibitors: Abiraterone (Zytiga), Enzalutamide (Xtandi), Apalutamide (Erleada), Darolutamide (Nubeqa)
• Bilateral orchiectomy (surgical castration)
• Estrogens (historically used, less common now due to side effects)

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 information. If you have any questions or concerns about this 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 details about the medication taken, the amount, and the time it happened.