Lupron Depot Pediatric
The most common adverse reactions with GnRH agonists including LUPRON DEPOT-PED are injection site reactions/pain including abscess, general pain, headache, emotional lability and hot flushes/sweating.
During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the natural initial stimulatory effect of the drug (hormonal flare effect). Therefore, an increase in clinical signs and symptoms may be observed [see WARNINGS AND PRECAUTIONS].
LUPRON DEPOT-PED–1 Month (7.5 mg, 11.25 mg, and 15 mg Injection) - Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
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 which are not considered drug-related are excluded.
Table 2: Percentage of Patients with Treatment-Emergent Adverse
Reactions Occurring in ≥ 2% of Pediatric Patients Receiving LUPRON DEPOT-PED–1
|Number of Patients (N = 421)|
|Body as a Whole|
|Injection Site Reactions Including Abscess*||37||(9)|
|Integumentary System (Skin and Appendages)|
|Rash Including Erythema Multiforme||12||(3)|
|Vaginitis/Vaginal Bleeding/Vaginal Discharge||13||(3)|
|*Most events were mild or moderate in severity.|
Less Common Adverse Reactions
The following treatment-emergent adverse reactions were reported in less than 2% of the patients and are listed below by body system.
Body as a Whole – aggravation of preexisting tumor and decreased vision, allergic reaction, body odor, fever, flu syndrome, hypertrophy, infection; Cardiovascular System – bradycardia, hypertension, peripheral vascular disorder, syncope; Digestive System – constipation, dyspepsia, dysphagia, gingivitis, increased appetite, nausea/vomiting; Endocrine System – accelerated sexual maturity, feminization, goiter; Hemic and Lymphatic System – purpura; Metabolic and Nutritional Disorders – growth retarded, peripheral edema, weight gain; Musculoskeletal System – arthralgia, joint disorder, myalgia, myopathy; Nervous System – depression, hyperkinesia, nervousness, somnolence; Respiratory System – asthma, epistaxis, pharyngitis, rhinitis, sinusitis; Integumentary System (Skin and Appendages) – alopecia, hair disorder, hirsutism, leukoderma, nail disorder, skin hypertrophy; Urogenital System – cervix disorder/neoplasm, dysmenorrhea, gynecomastia/breast disorders, menstrual disorder, urinary incontinence.
The following adverse events have been observed with this or other formulations of leuprolide acetate injection. As leuprolide has multiple indications, and therefore patient populations, some of these adverse events may not be applicable to every patient.
General Disorders and Administration Site Conditions: chest pain, injection site reactions including induration and abscess have been reported;
Investigations: decreased WBC, weight increased;
Metabolism and Nutrition Disorders: diabetes mellitus;
Musculoskeletal and Connective Tissue Disorders: tenosynovitis-like symptoms;
Nervous System Disorders: neuropathy peripheral, convulsion, spinal fracture/paralysis;
Skin and Subcutaneous Tissue Disorders: hot flush, flushing, hyperhidrosis;
Reproductive System and Breast Disorders: prostate pain;
Vascular Disorders: hypertension, hypotension.
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 and LUPRON Injection package inserts for other events reported in different patient populations.
Read the Lupron Depot Pediatric (leuprolide acetate injection) Side Effects Center for a complete guide to possible side effects
No pharmacokinetic-based drug-drug interaction studies have been conducted; however, drug interactions are not expected to occur [see CLINICAL PHARMACOLOGY].
Drug/Laboratory Test Interactions
Administration of LUPRON DEPOT-PED in therapeutic doses results in suppression of the pituitary-gonadal system. Therefore, diagnostic tests of pituitary gonadotropic and gonadal functions conducted during treatment and up to six months after discontinuation of LUPRON DEPOT-PED may be affected. Normal pituitary-gonadal function is usually restored within six months after treatment with LUPRON DEPOT-PED is discontinued.
Read the Lupron Depot Pediatric Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 10/21/2011
Additional Lupron Depot Pediatric Information
Report Problems to the Food and Drug Administration
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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