Chemet Drug Information
Generic name: SUCCIMER
Lead Chelator [EPC]
Uses of Chemet
CHEMET is indicated for the treatment of lead poisoning in pediatric patients aged 1 year and older with blood lead levels above 45 mcg/dL. Limitations of Use CHEMET is not indicated for prophylaxis of lead poisoning in a lead-containing environment. CHEMET does not cross the blood-brain barrier and is not indicated to treat encephalopathy associated with lead toxicity.
Dosage & Administration of Chemet
Preparation and Administration Instructions Administer
CHEMET capsules whole. In pediatric patients who cannot swallow the capsules whole, separate the capsule and sprinkle the medicated beads on a small amount of soft food or put them in a spoon and follow with a fruit drink. Ensure that all patients receiving CHEMET are adequately hydrated.
| Weight in Kilograms (kg) | Dose (mg) | Number of Capsules |
|---|---|---|
| 8 to15 kg | 100 mg | 1 |
| 16 to 23 kg | 200 mg | 2 |
| 24 to 34 kg | 300 mg | 3 |
| 35 to 44 kg | 400 mg | 4 |
| >45 kg | 500 mg | 5 |
Side Effects of Chemet
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% |
Warnings & Cautions for Chemet
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. 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.
Neutropenia
Iron chelators, including CHEMET, can cause neutropenia. Monitoring of complete blood counts is recommended. 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.
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.
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.
Laboratory Test Interference CHEMET may interfere with serum and urinary laboratory tests.
Drug Interactions with Chemet
Laboratory Test Interference CHEMET may interfere with serum and urinary laboratory tests. In vitro studies have shown CHEMET to cause false positive results for ketones in urine using nitroprusside reagents and falsely decreased measurements of serum uric acid and creatinine phosphokinase (CPK).
Use with Other Chelation Therapies
Concomitant administration of CHEMET with other chelation therapy, such as CaNa 2 EDTA is not recommended.
Pregnancy Safety for Chemet
Pregnancy Risk Summary There are no studies with the use of CHEMET in pregnant women to inform drug-associated risks. Administration of CHEMET to pregnant mice during organogenesis at dose exposure of 11-times the human exposure at the maximum recommended human dose (MRHD) of 700 mg based on body surface area (BSA) resulted in maternal toxicity and mortality and impaired reflex development in offspring (see Animal Data ). There are adverse effects on maternal and fetal outcomes associated with lead poisoning in pregnancy (see Clinical Considerations ).
CHEMET should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Lead exposure in pregnancy may increase the risk of gestational hypertension. Lead crosses the placenta in amounts related to maternal plasma levels. Prenatal lead exposure may be associated with spontaneous abortion, preterm delivery, decreased birth weight, and impaired neurodevelopment.
Data Animal Data In embryo-fetal developmental studies, pregnant mice received subcutaneous succimer during the period of organogenesis at doses up to 1640 mg/kg/day (11-times the MRHD based on BSA) which resulted in both maternal and fetal toxicity. In a developmental study in rats, dosing with succimer during the period of organogenesis resulted in maternal toxicity and deaths at the dose of 720 mg/kg/day (10-times the MRHD based on BSA) or more. The dose of 510 mg/kg/day (7-times the MRHD based on BSA) was the highest tolerable dose in pregnant rats.
Impaired development of reflexes was noted in pups of dams receiving 720 mg/kg/day (10-times the MRHD based on BSA).
Pediatric Use of Chemet
Pediatric Use The safety and effectiveness of CHEMET for the treatment of lead poisoning in patients with blood levels above 45 mcg/mL have been established in pediatric patients aged 1 year and older. The safety and effectiveness of CHEMET have not been established in pediatric patients younger than 1 year of age.
Contraindications for Chemet
CHEMET is contraindicated in patients with a history of hypersensitivity reaction to succimer. Reactions have included mucocutaneous vesicular eruptions, urticaria, and angioedema.
Overdosage Information for Chemet
Doses of 2300 mg/kg in the rat and 2400 mg/kg in the mouse produced ataxia, convulsions, labored respiration and frequently death. Limited data indicate that CHEMET is dialyzable. In case of acute overdosage, consider use of induction of vomiting or gastric lavage followed by administration of an activated charcoal slurry and appropriate supportive therapy.
Clinical Studies of Chemet
The efficacy of CHEMET in the treatment of lead poisoning in pediatric patients was established in a dose-ranging, actively controlled study of 15 pediatric patients aged 2 to 7 years with blood lead levels of 30-49 mcg/dL and positive CaNa 2 EDTA lead mobilization tests. Following therapy, the mean blood lead levels decreased 78, 63, and 42% respectively in the three CHEMET treatment groups. Patients experienced a rebound in blood lead levels after discontinuation of CHEMET.
After the initial 5 days of therapy, the mean blood lead level in all subjects declined 61%. While the untreated group and the group treated with 350 mg/m 2 daily experienced rebound during the ensuing two weeks, the group who received the 350 mg/m 2 every 12 hours experienced no such rebound during the treatment period and less rebound following cessation of therapy. The mean blood lead levels decreased and remained stable at under 15 mcg/dL during the extended dosing period.
In addition to the controlled studies, approximately 250 patients with lead poisoning have been treated with CHEMET either orally or parenterally in open U.S. and foreign studies.
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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