"The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for"...
Lupron Depot Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Lupron Depot (leuprolide acetate for depot suspension) is a man-made form of gonadotropin-releasing hormone (GnRH) used in men to treat the symptoms of prostate cancer. Lupron Depot is used in women to treat symptoms of endometriosis (overgrowth of uterine lining outside of the uterus) or uterine fibroids, and is also used to treat precocious (early-onset) puberty in both male and female children. Common side effects of Lupron Depot include hot flashes (flushing), increased sweating, night sweats, chills, clammy skin, tiredness, swelling of the ankles/feet, increased urination at night, mental/mood changes (e.g., depression, mood swings), dizziness, injection site reactions (burning, redness, stinging, pain, bruising), acne, increased growth of facial hair, breakthrough bleeding in a female child during the first 2 months of Lupron Depot treatment, weakness, nausea, diarrhea, constipation, stomach pain, skin redness/itching/scaling, joint or muscle pain, vaginal itching or discharge, breast swelling or tenderness, testicle pain, impotence, loss of interest in sex, sleep problems (insomnia), or memory problems.
The recommended dose of Lupron Depot 22.5 mg for 3-month administration is one injection every 12 weeks. The recommended dose of Lupron Depot 30 mg for 4-month administration is one injection every 16 weeks. It is administered under physician supervision. Other drugs may interact with Lupron Depot. Tell your doctor all medications and supplements you use. Lupron Depot must not be used during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, inform your doctor. Consult your doctor to discuss birth control. Non-hormonal birth control methods are recommended. It is unknown if this drug passes into breast milk. Because the effects on a nursing infant are unknown, breastfeeding is not recommended.
Our Lupron Depot (leuprolide acetate for depot suspension) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Lupron Depot in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- bone pain, loss of movement in any part of your body;
- swelling, rapid weight gain;
- pain, burning, stinging, bruising, or redness where the medication was injected;
- feeling like you might pass out;
- sudden chest pain or discomfort, wheezing, dry cough or hack;
- painful or difficult urination;
- urinating more often than usual;
- high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);
- sudden numbness or weakness (especially on one side of the body), problems with speech or balance;
- sudden headache with vision problems, vomiting, confusion, slow heart rate, weak pulse, fainting, or slow breathing; or
- chest pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.
Rare but serious side effects may include:
- pain or unusual sensations in your back;
- numbness, weakness, or tingly feeling in your legs or feet;
- muscle weakness or loss of use;
- loss of bowel or bladder control; or
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
- acne, increased growth of facial hair;
- breakthrough bleeding in a female child during the first 2 months of leuprolide treatment;
- dizziness, weakness, tired feeling;
- hot flashes, night sweats, chills, clammy skin;
- nausea, diarrhea, constipation, stomach pain;
- skin redness, itching, or scaling;
- joint or muscle pain;
- vaginal itching or discharge;
- breast swelling or tenderness;
- testicle pain;
- impotence, loss of interest in sex;
- depression, sleep problems (insomnia), memory problems; or
- redness, burning, stinging, or pain where the shot was given.
Read the entire detailed patient monograph for Lupron Depot (Leuprolide Acetate for Depot Suspension)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Lupron Depot Overview - Patient Information: Side Effects
Infrequently, shrinking of the testicles, breast tenderness/swelling, and reduced sexual interest/ability may also occur as a result of lowered testosterone levels. Talk to your doctor if these effects occur.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
During the first few weeks of treatment, your level of testosterone will actually increase before it decreases. This is a normal response by your body to this drug. This may sometimes result in new or worsening symptoms for a few weeks. If you have prostate cancer that has spread to the spine or caused urinary blockage, you may require closer monitoring by your doctor, especially when you first start treatment. Tell your doctor immediately if you experience any of the following serious side effects: bone pain, numbness/tingling/weakness of the arms/legs, blood in the urine, painful/difficult urination, unusual weakness, inability to move.
Tell your doctor immediately if any of these unlikely but serious side effects occur: new/worsening bone pain, easily broken bones, increased thirst/urination, mental/mood changes (such as depression, thoughts of suicide, mood swings, aggression in children).
Get medical help right away if any of these rare but serious side effects occur: chest/jaw/left arm pain, weakness on one side of the body, slurred speech, seizures, fast/irregular heartbeat, severe dizziness, fainting.
Rarely, a very serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after your first injection. Seek immediate medical attention if any of these very serious side effects occur: sudden severe headache, sudden severe mental/mood changes (e.g., severe confusion, difficulty concentrating), vision changes, severe vomiting.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Lupron Depot (Leuprolide Acetate for Depot Suspension)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Lupron Depot FDA Prescribing Information: Side Effects
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
LUPRON DEPOT 7.5 mg For 1-Month Administration
In the majority of patients testosterone levels increased above baseline during the first week, declining thereafter to baseline levels or below by the end of the second week of treatment.
Potential exacerbations of signs and symptoms during the first few weeks of treatment is a concern in patients with vertebral metastases and/or urinary obstruction or hematuria which, if aggravated, may lead to neurological problems such as temporary weakness and/or paresthesia of the lower limbs or worsening of urinary symptoms [see WARNINGS AND PRECAUTIONS].
In a clinical trial of LUPRON DEPOT 7.5 mg for 1-month administration, the following adverse reactions were reported in 5% or more of the patients during the initial 24-week treatment period.
Table 2: Adverse Reactions Reported in ≥ 5% of
|LUPRON DEPOT 7.5 mg for 1-Month Administration (N=56)|
|Body As A Whole|
|Metabolic and Nutritional Disorders|
|* Due to the expected physiologic effect of decreased testosterone levels.|
In this same study, the following adverse reactions were reported in less than 5% of the patients on LUPRON DEPOT 7.5 mg for 1-month administration.
Hemic and Lymphatic System - Ecchymosis
Musculoskeletal System - Myalgia
Nervous System - Agitation, Insomnia/sleep disorders, Neuromuscular disorders
Skin and Appendages - Hair disorder, Skin reaction
Abnormalities of certain parameters were observed, but their relationship to drug treatment are difficult to assess in this population. The following were recorded in ≥ 5% of patients at final visit: Decreased albumin, decreased hemoglobin/hematocrit, decreased prostatic acid phosphatase, decreased total protein, decreased urine specific gravity, hyperglycemia, hyperuricemia, increased BUN, increased creatinine, increased liver function tests (AST, LDH), increased phosphorus, increased platelets, increased prostatic acid phosphatase, increased total cholesterol, increased urine specific gravity, leukopenia.
LUPRON DEPOT 22.5 mg For 3-Month Administration
In two clinical trials of LUPRON DEPOT 22.5 mg for 3-month administration, the following adverse reactions were reported to have a possible or probable relationship to drug as ascribed by the treating physician in 5% or more of the patients receiving the drug. Often, causality is difficult to assess in patients with metastatic prostate cancer. Reactions considered not drug-related are excluded.
Table 3: Adverse Reactions Reported in ≥ 5% of
|LUPRON DEPOT 22.5 mg for 3-Month Administration|
|Body As A Whole|
|Injection Site Reaction||13||(13.8)|
|Central/Peripheral Nervous System|
|Skin and Appendages|
In these same studies, the following adverse reactions were reported in less than 5% of the patients on LUPRON DEPOT 22.5 mg for 3-month administration.
Body As A Whole - Enlarged abdomen, Fever
Digestive System - Anorexia, Duodenal ulcer, Increased appetite, Thirst/dry mouth
Metabolic and Nutritional Disorders - Dehydration, Edema Central/Peripheral
Nervous System - Anxiety, Delusions, Depression, Hypesthesia, Libido decreased*, Nervousness, Paresthesia
* Physiologic effect of decreased testosterone.
Abnormalities of certain parameters were observed, but are difficult to assess in this population. The following were recorded in ≥ 5% of patients: Increased BUN, Hyperglycemia, Hyperlipidemia (total cholesterol, LDL-cholesterol, triglycerides), Hyperphosphatemia, Abnormal liver function tests, Increased PT, Increased PTT. Additional laboratory abnormalities reported were: Decreased platelets, Decreased potassium and Increased WBC.
LUPRON DEPOT 30 mg For 4-Month Administration
The 4-month formulation of LUPRON DEPOT 30 mg was utilized in clinical trials that studied the drug in 49 nonorchiectomized prostate cancer patients for 32 weeks or longer and in 24 orchiectomized prostate cancer patients for 20 weeks.
In the above described clinical trials, the following adverse reactions were reported in ≥ 5% of the patients during the treatment period.
Table 4: Adverse Reactions Reported in ≥ 5% of
|LUPRON DEPOT 30 mg for 4-Month Administration|
|Body System/Events||Non orchiectomized Study 013||Orchiectomized Study 012|
|Body As A Whole|
|Injection Site Reaction||4||(8.2)||9||(37.5)|
|Metabolic and Nutritional Disorders|
|Skin and Appendages|
In these same studies, the following adverse reactions were reported in less than 5% of the patients on LUPRON DEPOT 30 mg for 4-month administration.
Hemic and Lymphatic System - Lymphadenopathy
Metabolic and Nutritional Disorders - Healing abnormal, Hypoxia, Weight loss
Skin and Appendages - Herpes zoster, Melanosis
* Physiologic effect of decreased testosterone.
Abnormalities of certain parameters were observed, but their relationship to drug treatment is difficult to assess in this population. The following were recorded in ≥ 5% of patients: Decreased bicarbonate, Decreased hemoglobin/hematocrit/RBC, Hyperlipidemia (total cholesterol, LDL-cholesterol, triglycerides), Decreased HDL-cholesterol, Eosinophilia, Increased glucose, Increased liver function tests (ALT, AST, GGTP, LDH), Increased phosphorus. Additional laboratory abnormalities were reported: Increased BUN and PT, Leukopenia, Thrombocytopenia, Uricaciduria.
LUPRON DEPOT 45 mg For 6-Month Administration
One open label, multicenter study was conducted with LUPRON DEPOT 45 mg for 6-month administration in 151 prostate cancer patients. Patients were treated for 48 weeks, with 139/151 receiving two injections 24 weeks apart.
In the above described clinical trial, the following adverse events were reported in ≥ 5% of the patients during the treatment period. The Table 5 includes all adverse events reported in ≥ 5% of patients as well as the incidences of these adverse events that were considered, by the treating physician, to have a definite or possible relationship to LUPRON.
Table 5: Adverse Events in ≥ 5% of Patients
|LUPRON DEPOT 45 mg for 6-Month Administration|
|Adverse Event||Treatment Emergent||Treatment Related|
|N = 151||(%)||N = 151||(%)|
|Injection Site Pain/Discomfort||29||19.2||16||10.6|
|Upper Respiratory Tract Infection/Influenza-like Illness1||32||21.2||0||0|
|Musculoskeletal Pain/ Myalgia||12||7.9||3||2.0|
|Second Primary Neoplasm2||11||7.3||0||0|
|Urinary Tract Infection/Cystitis||9||6.0||0||0|
|Dyspnea/Dyspnea on Exertion||8||5.3||2||1.3|
|Coronary Artery Disease/Angina||8||5.3||1||0.7|
|1Includes influenza, nasal congestion,
nasopharyngitis, rhinorrhea, upper respiratory tract infection, and viral upper
respiratory tract infection
2Includes basal cell carcinoma, bladder transitional cell carcinoma, lung neoplasm, malignant melanoma, non-Hodgkin's lymphoma, and squamous cell carcinoma
The following adverse events led to discontinuation; fatigue, hot flush, second primary neoplasm, asthenia, coronary artery disease, constipation, hyperkalemia, and sleep disorder. Serious adverse events in ≥ 2% of patients, regardless of causality, included chronic obstructive pulmonary disease, coronary artery disease/angina, cerebrovascular accident/transient ischemic attack, pneumonia, and second primary neoplasms.
At baseline, 13.9% of patients had a CTCAE v4.0 grade 1 or 2 decreased hemoglobin. During the study, 42.4% of subjects had grade 1 decreased hemoglobin (10 - < 12-5 g/dL), 2.0% had grade 2 ( 8 - < 10 g/dL) and 1.3% of subjects had grade 3 or 4 ( < 8 g/dL). Likewise, 28.5% of patients had a grade 1 or 2 increased cholesterol at baseline while 55.0% had grade 1 increased cholesterol ( > 199- 300 mg/dL), 3.3% had a grade 2 increase ( > 300-400 mg/dL), and 0.7% of subjects had grade 3 ( > 400 mg/dL) during the study.
The following adverse reactions have been identified during post-approval use of LUPRON DEPOT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
During postmarketing surveillance, which includes other dosage forms and other patient populations, the following adverse reactions were reported.
Like other drugs in this class, mood swings, including depression, have been reported. There have been very rare reports of suicidal ideation and attempt. Many, but not all, of these patients had a history of depression or other psychiatric illness. Patients should be counseled on the possibility of development or worsening of depression during treatment with LUPRON.
Changes In Bone Density
Decreased bone density has been reported in the medical literature in men who have had orchiectomy or who have been treated with a GnRH agonist analog. In a clinical trial, 25 men with prostate cancer, 12 of whom had been treated previously with leuprolide acetate for at least six months, underwent bone density studies as a result of pain. The leuprolide-treated group had lower bone density scores than the nontreated control group. It can be anticipated that long periods of medical castration in men will have effects on bone density.
During post-marketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing hormone agonists. In a majority of these cases, a pituitary adenoma was diagnosed, with a majority of pituitary apoplexy cases occurring within 2 weeks of the first dose, and some within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.
Localized reactions including induration and abscess have been reported at the site of injection.
Symptoms consistent with fibromyalgia (e.g., joint and muscle pain, headaches, sleep disorders, gastrointestinal distress, and shortness of breath) have been reported individually and collectively.
Cardiovascular System - Hypotension, Myocardial infarction, Pulmonary embolism
Respiratory, thoracic and mediastinal disorder - Interstitial lung disease
Hepato-biliary disorder - Serious drug-induced liver injury
Hemic and Lymphatic System - Decreased WBC
Central/Peripheral Nervous System - Convulsion, Peripheral neuropathy, Spinal fracture/paralysis
Endocrine System - Diabetes
Musculoskeletal System - Tenosynovitis-like symptoms
Urogenital System - Prostate pain
See other LUPRON DEPOT and LUPRON Injection package inserts for other reactions reported in women and pediatric populations.
Read the entire FDA prescribing information for Lupron Depot (Leuprolide Acetate for Depot Suspension)
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