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Lupron Depot 22.5

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Lupron Depot 22.5

Lupron Depot 22.5 Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Lupron Depot 22.5 mg (leuprolide acetate for depot suspension) is a synthetic form of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The 3-Month Formulation is used in men to treat the symptoms of prostate cancer. It 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 include acne, increased growth of facial hair, breakthrough bleeding in a female child during the first 2 months of treatment, dizziness, weakness, tiredness, 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, insomnia, memory problems, or redness, burning, stinging, or pain where the shot was given.

The recommended dose of Lupron Depot 3 Month 22.5 mg to be administered is one injection every three months (84 days). 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 (e.g., condoms, diaphragm with spermicide) are recommended during treatment. It is unknown if this drug passes into breast milk. Because the effects of Lupron Depot on a nursing infant are unknown, breastfeeding is not recommended.

Our Lupron Depot 22.5 mg 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 22.5 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.

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.

Read the entire detailed patient monograph for Lupron Depot 22.5 (Leuprolide Acetate for Depot Suspension Injection) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lupron Depot 22.5 FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials

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 section).

In two clinical trials of LUPRON DEPOT (leuprolide acetate for depot suspension injection) -3 Month 22.5 mg, 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.

  LUPRON DEPOT-3 Month 22.5 mg
  N=94 (%)
Body As A Whole
  Asthenia 7 (7.4)
  General Pain 25 (26.6)
  Headache 6 (6.4)
  Injection Site Reaction 13 (13.8)
Cardiovascular System
  Hot flashes/Sweats* 55 (58.5)
  Digestive System    
  GI Disorders 15 (16.0)
Musculoskeletal System
  Joint Disorders 11 (11.7)
Central/Peripheral Nervous System
  Dizziness/Vertigo 6 (6.4)
  Insomnia/Sleep Disorders 8 (8.5)
  Neuromuscular Disorders 9 (9.6)
Respiratory System
  Respiratory Disorders 6 (6.4)
Skin and Appendages
  Skin Reaction 8 (8.5)
Urogenital System
  Testicular Atrophy* 19 (20.2)
  Urinary Disorders 14 (14.9)
*Physiologic effect of decreased testosterone.

In these same studies, the following adverse reactions were reported in less than 5% of the patients on LUPRON DEPOT (leuprolide acetate for depot suspension injection) -3 Month 22.5 mg.

Body As A Whole - Enlarged abdomen, Fever; Cardiovascular System - Arrhythmia, Bradycardia, Heart failure, Hypertension, Hypotension, Varicose vein; Digestive System - Anorexia, Duodenal ulcer, Increased appetite, Thirst/dry mouth; Hemic and Lymphatic System - Anemia, Lymphedema; Metabolic and Nutritional Disorders - Dehydration, Edema; Central/Peripheral Nervous System - Anxiety, Convulsion, Delusions, Depression, Hypesthesia, Libido decreased*, Nervousness, Paresthesia; Respiratory System - Epistaxis, Pharyngitis, Pleural effusion, Pneumonia; Special Senses - Abnormal vision, Amblyopia, Dry eyes, Tinnitus; Urogenital System - Gynecomastia, Impotence*, Penis disorders, Testis disorders.

Laboratory: 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.

Postmarketing

During postmarketing surveillance, which includes other dosage forms and other patient populations, the following adverse events were reported.

Symptoms consistent with an anaphylactoid or asthmatic process have been rarely (incidence rate of about 0.002%) reported. Rash, urticaria, and photosensitivity reactions have also been reported.

Localized reactions including induration and abscess have been reported at the site of injection.

Symptoms consistent with fibromyalgia (eg, 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; Hemic and Lymphatic System - Decreased WBC; Central/Peripheral Nervous System - Peripheral neuropathy, Spinal fracture/paralysis; Endocrine System - Diabetes; Musculoskeletal System - Tenosynovitis-like symptoms; Urogenital System - Prostate pain.

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 an LH-RH 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.

Pituitary apoplexy: 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.

See other LUPRON DEPOT (leuprolide acetate for depot suspension injection) and LUPRON Injection package inserts for other events reported in women and pediatric populations.

Read the entire FDA prescribing information for Lupron Depot 22.5 (Leuprolide Acetate for Depot Suspension Injection) »

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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