CLINICAL TRIALS

Potential exacerbation of signs and symptoms during the first few weeks of treatment (see PRECAUTIONS section) is a concern in patients with rapidly advancing central precocious puberty.

In two studies of children with central precocious puberty, in 2% or more of the patients receiving the drug, the following adverse reactions were reported to have a possible or probable relationship to drug as ascribed by the treating physician. Reactions considered not drug related are excluded.

In those same studies, the following adverse reactions were reported in less than 2% of the patients.

Body as a Whole - Body Odor, Fever, Headache, Infection; Cardiovascular System - Syncope, Vasodilation; Digestive System - Dysphagia, Gingivitis, Nausea/Vomiting; Endocrine System - Accelerated Sexual Maturity; Metabolic and Nutritional Disorders - Peripheral Edema, Weight Gain; Nervous System - Nervousness, Personality Disorder, Somnolence, Emotional Lability; Respiratory System - Epistaxis; Integumentary System - Alopecia, Skin Striae; Urogenital System - Cervix Disorder, Gynecomastia/Breast Disorders, Urinary Incontinence.

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 (e.g., joint and muscle pain, headaches, sleep disorders, gastrointestinal distress, and shortness of breath) have been reported individually and collectively.

Cardiovascular System ¾ Hypotension, Pulmonary embolism; Gastrointestinal System ¾ Hepatic dysfunction; Hemic and Lymphatic System ¾ Decreased WBC; Integumentary System ¾ Hair growth; Central/Peripheral Nervous System ¾ Peripheral neuropathy, Spinal fracture/paralysis, Hearing disorder; Miscellaneous ¾ Hard nodule in throat, Weight gain, Increased uric acid; Musculoskeletal System ¾ Tenosynovitis-like symptoms; Respiratory System ¾ Respiratory disorders; Urogenital System ¾ 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. The effects on bone density in children are unknown.

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 INJECTION and LUPRON DEPOT package inserts for adverse events reported in other patient populations.

See CLINICAL PHARMACOLOGY, Pharmacokinetics section.

Drug/Laboratory Test Interactions: Administration of leuprolide acetate in therapeutic doses results in suppression of the pituitary-gonadal system. Normal function is usually restored within 4 to 12 weeks after treatment is discontinued.

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