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warnings
WARNINGS Keep out of reach of pediatric patients. CHEMET is not a substitute for effective abatement of lead exposure. Mild to moderate neutropenia has been observed in some patients receiving succimer. While a causal relationship to succimer has not been definitely established, neutropenia has been reported with other drugs in the same chemical class. A complete blood count with white blood cell differential and direct platelet counts should be obtained prior to and weekly during treatment with succimer. Therapy should either be withheld or discontinued if the absolute neutrophil count (ANC) is below 1200/mcL and the patient followed closely to document recovery of the ANC to above 1500/mcL or to the patient's baseline neutrophil count. There is limited experience with reexposure in patients who have developed neutropenia. Therefore, such patients should be rechallenged only if the benefit of succimer therapy clearly outweighs the potential risk of another episode of neutropenia and then only with careful patient monitoring. Patients treated with succimer should be instructed to promptly report any signs of infection. If infection is suspected, the above laboratory tests should be conducted immediately.
ADVERSE REACTIONS Clinical experience with CHEMET has been limited. Consequently, the full spectrum and incidence of adverse reactions including the possibility of hypersensitivity or idiosyncratic reactions have not been determined. The most common events attributable to succimer, i.e., gastrointestinal symptoms or increases in serum transaminases, have been observed in about 10% of patients (see PRECAUTIONS ). Rashes, some necessitating discontinuation of therapy, have been reported in about 4% of patients. If rash occurs, other causes (e.g. measles) should be considered before ascribing the reaction to succimer. Rechallenge with succimer may be considered if lead levels are high enough to warrant retreatment. One allergic mucocutaneous reaction has been reported on repeated administration of the drug (see PRECAUTIONS ). Mild to moderate neutropenia has been observed in some patients receiving succimer (see WARNINGS ). Table I presents adverse events reported with the administration of succimer for the treatment of lead and other heavy metal intoxication. TABLE I INCIDENCE OF ADVERSE EVENTS IN DOMESTIC STUDIES REGARDLESS OF ATTRIBUTION OR SUCCIMER DOSAGE * Does not include neutropenia - see WARNINGS . Pediatric Patients (191) Adults (134) % (n) % (n) Digestive: 12.0 23 20.9 28 Nausea, vomiting, diarrhea, appetite loss, hemorrhoidal symptoms, loose stools, metallic taste in mouth. Body as a Whole: 5.2 10 15.7 21 Back pain, abdominal cramps, stomach pains, head pain, rib pain, chills, flank pain, fever, flu-like symptoms, heavy head/tired, head cold, headache, moniliasis. Metabolic: 4.2 8 10.4 14 Elevated SGPT, SGOT, alkaline phosphatase, elevated serum cholesterol. Nervous: 1.0 2 12.7 17 Drowsiness, dizziness, sensorimotor neuropathy, sleepiness, paresthesia. Skin and Appendages: 2.6 5 11.2 15 Papular rash, herpetic rash, rash, mucocutaneous eruptions, pruritus. Special Senses: 1.0 2 3.7 5 Cloudy film in eye, ears plugged, otitis media, eyes watery. Respiratory 3.7 7 0.7 1 Throat sore, rhinorrhea, nasal congestion, cough. Urogenital: 0.0 - 3.7 5 Decreased urination, voiding difficulty, proteinuria increased. Cardiovascular: 0.0 - 1.8 2 Arrhythmia Heme/Lymphatic: 0.5* 1 1.5* 2 Mild to moderate neutropenia, increased platelet count, intermittent eosinophilia. Musculoskeletal: 0.0 - 3.0 4 Kneecap pain, leg pains. To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.