Lupron Depot 3.75mg Inj/1mth 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 in therapeutic doses. Initially, it causes a transient increase in luteinizing hormone (LH) and follicle-stimulating hormone (FSH) from the pituitary gland, leading to a temporary surge in ovarian steroidogenesis (estrogen). However, continuous administration of leuprolide results in desensitization and downregulation of GnRH receptors in the pituitary, leading to a profound suppression of gonadotropin release. This, in turn, causes a significant reduction in ovarian estrogen production in women, achieving a 'medical menopause' state. This reduction in estrogen is therapeutic for conditions like endometriosis and uterine fibroids, which are estrogen-dependent.

Urgent Side Effects: Seek Medical Attention Immediately

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 or seek medical help right away:

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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit
Signs of infection: fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal
Signs of high blood pressure: very bad headache or dizziness, passing out, or change in eyesight
Signs of dehydration: dry skin, mouth, or eyes; thirst; fast heartbeat; dizziness; fast breathing; or confusion
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, 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
Abnormal heartbeat (fast, slow, or irregular)
Shortness of breath, significant weight gain, or swelling in the arms or legs
Inability to move
Menstrual period despite expected cessation
Vaginal itching or discharge
Vaginal irritation
Behavioral and mood changes, particularly in children, including aggression, crying, depression, emotional instability, restlessness, and irritability
Sudden and severe pituitary gland problems (pituitary apoplexy), which may occur within 2 weeks of the first dose, characterized by sudden headache, vomiting, fainting, mood changes, eye weakness, inability to move the eyes, or changes in vision
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which may be life-threatening and affect internal organs, with symptoms such as 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 Possible Side Effects

While many people may not experience side effects or may only have mild side effects, it is essential to be aware of the following potential side effects. If you experience any of these symptoms or if they bother you or persist, contact your doctor or seek medical help:

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
Acne
Mood changes
Unintentional weight changes
Nervousness and excitability

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have 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, such as foods or drugs. Be sure to describe the symptoms you experienced.
Unexplained vaginal bleeding.
If you are pregnant or think you might be pregnant. Do not take this medication if you are pregnant.

This medication may interact with other medications or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking.
Any natural products or vitamins you are using.
Your health problems, including any medical conditions or concerns.

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. 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. During the initial few weeks of treatment, this drug may cause an increase in certain hormone levels, which can lead to a temporary worsening of disease symptoms before they improve. If you experience new symptoms or if your disease symptoms worsen for more than a few weeks after starting this medication, notify your doctor promptly.

As this drug lowers certain hormone levels in your body, you may experience side effects such as changes in breast size, breast soreness or tenderness, decreased interest in sex, hot flashes, or sweating. Discuss these potential effects with your doctor.

Regular blood tests and bone density checks are crucial, as directed by your doctor. Be aware that this medication may interfere with certain laboratory tests, so inform 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 advised by your doctor. If you smoke, consult with your doctor, as smoking may exacerbate certain risks.

Additionally, this medication has been linked to high cholesterol. If you have concerns or questions, discuss them with your doctor. Long-term use of this drug may increase the risk of weak bones, which can lead to a higher chance of fractures. If you experience bone pain, contact your doctor immediately.

Certain formulations of this medication are not approved for use in individuals aged 65 or older or in children. Consult with your doctor to discuss any specific concerns. This drug may affect fertility, but this effect is reversible once the medication is discontinued. If you have questions, discuss them with your doctor.

While taking this medication, you may experience a cessation of menstrual bleeding (amenorrhea), but this is not a reliable method of birth control. Use a non-hormone-based contraceptive, such as condoms, to prevent pregnancy. If you miss doses of this medication, you may experience bleeding between cycles; consult with your doctor if this occurs.

This medication can cause harm to an unborn baby if taken during pregnancy. A pregnancy test will be performed to confirm that you are not pregnant before initiating treatment. If you become pregnant while taking this medication, notify your doctor immediately. If you are breastfeeding, discuss the potential risks to your baby with your doctor.

• Drugs that prolong QT interval (theoretical risk, monitor ECG if co-administered with other QT-prolonging agents)
• Androgens (may antagonize effects in prostate cancer, but not relevant for 3.75mg women's indications)

• Hot flashes
• Vaginal dryness
• Headaches
• Mood changes (depression, anxiety)
• Joint pain
• Sleep disturbances
• Changes in libido
• Injection site reactions

Contraindicated. Leuprolide can cause fetal harm when administered to a pregnant woman. Pregnancy must be excluded before starting treatment.

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

Lupron Depot 3.75mg is not indicated for pediatric use. Higher doses (e.g., 7.5mg, 11.25mg, 15mg) are used for Central Precocious Puberty (CPP) in pediatric patients. The safety and efficacy of leuprolide for endometriosis or fibroids have not been established in pediatric patients.

The 3.75mg formulation is primarily used in premenopausal women. No specific dose adjustments are generally needed for elderly patients, but the indications (endometriosis, fibroids) are less common in this population. Higher doses of leuprolide are used in elderly men for prostate cancer, where age-related considerations for bone health and cardiovascular risk are more pertinent.

• Ensure a negative pregnancy test before each course of therapy.
• Patients should be advised that menstruation will cease during treatment. If menstruation persists, the patient should notify their physician.
• Initial transient flare of symptoms (e.g., pain, bleeding) may occur during the first few weeks of treatment due to the initial surge in hormones.
• Bone mineral density loss is a significant concern with long-term use (beyond 6 months) and should be discussed with patients. Add-back therapy (low-dose estrogen/progestin) can mitigate this and other menopausal symptoms.
• Lupron Depot 3.75mg is for women's health indications (endometriosis, fibroids). Different formulations and doses are used for prostate cancer or central precocious puberty.
• Injection site should be rotated. Administer IM or SC only.

• GnRH antagonists (e.g., elagolix, relugolix) for endometriosis/fibroids
• Progestins (e.g., medroxyprogesterone acetate, norethindrone acetate) for endometriosis/fibroids
• Danazol (for endometriosis)
• Aromatase inhibitors (off-label for severe endometriosis)
• NSAIDs (for pain management)
• Surgical interventions (e.g., hysterectomy, myomectomy, laparoscopy for endometriosis)

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 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.