Lupron Depot 11.25mg Inj/3 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) (a 'flare' effect), leading to a transient increase in ovarian steroidogenesis. 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, suppresses ovarian steroidogenesis, resulting in hypoestrogenism (in women) and hypogonadism (in men), which is therapeutically beneficial for estrogen-dependent conditions like endometriosis and uterine fibroids.

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 or seek medical attention immediately:

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, drowsiness, excessive 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
Urination problems (inability to urinate 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
Menstrual irregularities (continued menstrual periods)
Vaginal itching or discharge
Vaginal irritation
Behavioral and mood changes (especially 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 starting the medication, 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

Most people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

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 or excitability

This is not an exhaustive list of possible side effects. If you have concerns or questions, 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 allergic reaction you experienced, including any symptoms that occurred.
Unexplained vaginal bleeding, as this may be a significant health concern.
If you are pregnant or think you might be pregnant. Do not take this medication if you are pregnant, as it may pose risks to your unborn baby.

Additionally, this medication may interact with other health conditions or medications you are taking. To ensure your safety, it is crucial to:

Provide your doctor and pharmacist with a comprehensive list of all your medications, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor, as some conditions may affect the safety or efficacy of this medication.
Never start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so. This will help prevent potential interactions or adverse effects.

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 existing symptoms persist or 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 tenderness or soreness, decreased libido, hot flashes, or excessive sweating. Discuss these potential effects with your doctor.

Regular blood tests and bone density assessments should be performed as directed by your doctor. Be aware that this medication may interfere with certain laboratory tests, so it is crucial to 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 instructed by your doctor. If you smoke, consult with your doctor, as smoking may exacerbate certain risks.

Additionally, this medication has been linked to increased cholesterol levels. If you have concerns or questions, discuss them with your doctor. Long-term use of this drug may cause bone weakening, potentially leading to an increased risk 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 determine the best course of treatment. This drug may affect fertility, but this effect is typically reversible upon discontinuation of the medication. If you have questions or concerns, discuss them with your doctor.

It is essential to note that this medication usually causes amenorrhea (cessation of menstrual bleeding), but this does not serve as a method of birth control. To prevent pregnancy, use a non-hormonal contraceptive method, such as condoms, while taking this medication. If you miss doses, you may experience intermenstrual bleeding; consult with your doctor if this occurs.

This medication can cause harm to the 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, contact 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)
• Androgens (may counteract effects in some conditions)

• Hot flashes
• Vaginal dryness
• Headache
• Mood changes (depression, emotional lability)
• Joint pain
• Decreased libido
• Injection site reactions (pain, swelling, redness)
• Signs of allergic reaction (rash, itching, difficulty breathing)
• Symptoms of ovarian cyst formation (pelvic pain, abdominal distension)

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

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.

The 11.25mg/3 month formulation is not indicated for pediatric use in women for endometriosis or fibroids. Other leuprolide formulations are used for Central Precocious Puberty in pediatric patients.

Safety and efficacy have not been established in geriatric patients for endometriosis or uterine fibroids, as these conditions are primarily premenopausal. No specific dosage adjustments are generally needed based on age alone, but age-related decline in renal function should be considered if present.

• Patients may experience a transient 'flare' of symptoms (e.g., increased pain, vaginal bleeding) during the first few weeks of treatment due to the initial surge in hormone levels. This is expected and usually resolves.
• Long-term use (beyond 6 months) of leuprolide without 'add-back' therapy is generally not recommended due to the risk of significant bone mineral density loss.
• Ensure the patient understands the importance of using non-hormonal contraception during treatment, as leuprolide is not a contraceptive and is teratogenic.
• Injection technique is crucial for depot formulations; ensure it is administered intramuscularly and not subcutaneously or intravenously.
• Monitor for mood changes, including depression, as these can occur with GnRH agonists.

• GnRH antagonists (e.g., elagolix, relugolix for endometriosis/fibroids)
• Progestins (e.g., medroxyprogesterone acetate, norethindrone acetate)
• Oral contraceptives
• NSAIDs (for symptom management)
• Surgical interventions (e.g., hysterectomy, myomectomy, endometrial ablation)

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 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 details about the medication taken, the amount, and the time it occurred.