"Today, the U.S. Food and Drug Administration approved Kanuma (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency.
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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
|Pediatric Patients (191)||Adults (134)|
|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.|
|Elevated SGPT, SGOT, alkaline phosphatase, elevated serum cholesterol.|
|Drowsiness, dizziness, sensorimotor neuropathy, sleepiness, paresthesia.|
|Skin and Appendages:||2.6||5||11.2||15|
|Papular rash, herpetic rash, rash, mucocutaneous eruptions, pruritus.|
|Cloudy film in eye, ears plugged, otitis media, eyes watery.|
|Throat sore, rhinorrhea, nasal congestion, cough.|
|Decreased urination, voiding difficulty, proteinuria increased.|
|Mild to moderate neutropenia, increased platelet count, intermittent eosinophilia.|
|Kneecap pain, leg pains.|
|*Does not include neutropenia - see WARNINGS.|
To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-755-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Read the Chemet (succimer) Side Effects Center for a complete guide to possible side effects
CHEMET is not known to interact with other drugs including iron supplements; interactions have not been systematically studied. Concomitant administration of CHEMET with other chelation therapy, such as CaNa2EDTA is not recommended.
Drug/Laboratory Tests Interaction
Succimer may interfere with serum and urinary laboratory tests. In vitro studies have shown succimer to cause false positive results for ketones in urine using nitroprusside reagents such as Ketostix and falsely decreased measurements of serum uric acid and CPK.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/18/2013
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