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Lupron Depot 22.5

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Lupron Depot 22.5

Side Effects
Interactions

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 Lupron Depot 22.5 (leuprolide acetate for depot suspension injection) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No pharmacokinetic-based drug-drug interaction studies have been conducted with LUPRON DEPOT (leuprolide acetate for depot suspension injection) . However, because leuprolide acetate is a peptide that is primarily degraded by peptidase and not by cytochrome P-450 enzymes as noted in specific studies, and the drug is only about 46% bound to plasma proteins, drug interactions would not be expected to occur.

Drug/Laboratory Test Interactions

Administration of LUPRON DEPOT (leuprolide acetate for depot suspension injection) 3.75 mg in women results in suppression of the pituitary-gonadal system. Normal function is usually restored within one to three months after treatment is discontinued. Therefore, diagnostic tests of pituitary gonadotropic and gonadal functions conducted during treatment and up to three months after discontinuation of LUPRON DEPOT 3.75 mg therapy may be misleading.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Last reviewed on RxList: 6/2/2010
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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