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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity and dermatologic reactions: Interrupt treatment if rash or mucocutaneous vesicular eruptions occur. ( 5.1 ) Neutropenia: Monitor complete blood counts, interrupt treatment for ANC below 1200/mcL, and monitor for infection. ( 5.2 ) Hepatic Toxicity: Monitor hepatic transaminases (ALT/AST); interrupt treatment if above 5 times ULN. ( 5.3 ) Embryo-Fetal Toxicity: May cause fetal harm when administered to a pregnant woman. ( 5.5 ) 5.1 Hypersensitivity and Dermatologic Reactions CHEMET can cause hypersensitivity reactions and dermatologic reactions. Rash Rash occurs in approximately 4% of patients treated with CHEMET. Interrupt treatment if rash occurs. Consider rechallenge if lead levels are high enough to warrant retreatment. Hypersensitivity reactions including urticaria and angioedema have been reported on repeated administration of CHEMET [see Contraindications (4) ]. Mucocutaneous Reactions Mucocutaneous vesicular eruptions can occur with CHEMET use and may increase with each treatment course. Monitor patients requiring repeated CHEMET courses for the occurrence of mucocutaneous eruptions, including oral, urethral, and perianal. Interrupt treatment if mucocutaneous vesicular eruptions occur. 5.2 Neutropenia Iron chelators, including CHEMET, can cause neutropenia. Monitoring of complete blood counts is recommended [see Dosage and Administration (2.2) ] . Interrupt treatment if absolute neutrophil count (ANC) is <1200/mcL and interrupt treatment until recovery to above 1500/mcL (or the patient's baseline count). Only rechallenge patients who developed neutropenia with CHEMET therapy if the benefit clearly outweighs the potential risk. If rechallenge is attempted, monitor CBC more frequently. Monitor for signs and symptoms of infection and immediately discontinue CHEMET if they develop. 5.3 Hepatic Toxicity Elevated transaminases (ALT/AST) occurred in 6-10% of patients treated with CHEMET. Monitor serum AST and ALT at baseline and at least weekly during treatment. Monitor patients with a history of liver disease more frequently. Serum aminotransferase elevations above 5 times the upper limit of normal (if confirmed) should lead to dose reduction or temporary cessation. 5.4 Embryo-Fetal Toxicity Based on findings from animal reproduction studies, CHEMET may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use an effective method of contraception during treatment with CHEMET and for 14 days after the final dose [see Use in Specific Populations (8.1 , 8.3) ] . 5.5 Laboratory Test Interference CHEMET may interfere with serum and urinary laboratory tests [see Drug Interactions (7.1) ] .
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity and Dermatologic Reactions [see Warnings and Precautions (5.1) ] Neutropenia [see Warnings and Precautions (5.2) ] Hepatic Toxicity [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence ≥ 10%) in Pediatric patients: Digestive (nausea, vomiting, diarrhea, appetite loss, hemorrhoidal symptoms, metallic taste in mouth). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Table 2 presents the adverse reactions associated with Chemet in pediatric patients. Table 2 Incidence of Adverse Reactions Associated with Chemet in Pediatric Patients Body System: Adverse Reactions Pediatric Patients (n=191) Digestive Nausea, vomiting, diarrhea, appetite loss, hemorrhoidal symptoms, metallic taste in mouth 12% Body as a Whole Back pain, abdominal cramps, stomach pains, head pain, rib pain, chills, flank pain, fever, flu-like symptoms, heavy head/tired, head cold, headache, moniliasis. 5% Metabolic Elevated ALT or AST, alkaline phosphatase, serum cholesterol. 4% Respiratory Sore throat, rhinorrhea, nasal congestion, cough. 4% Skin Papular rash, herpetic rash, rash, mucocutaneous eruptions, pruritis. 3% Nervous Drowsiness, dizziness, sensorimotor neuropathy, sleepiness, paresthesia. 1% Special Senses Cloudy film in eye, ears plugged, otitis media, eyes watery. 1% Heme/Lymphatic Neutropenia, increased platelet count, eosinophilia 1%