Lead Chelator

Chemet

Approved 30 Jan 1991OralCapsule

Indications

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. CHEMET is a lead chelator indicated for the treatment of lead poisoning in pediatric patients aged 1 year and older with blood lead levels above 45 mcg/dL. ( 1 ) Limitations of Use CHEMET is not indicated for prophylaxis of lead poisoning in a lead-containing environment. ( 1 ) CHEMET does not cross the blood-brain barrier and is not indicated to treat encephalopathy associated with lead toxicity.

( 1 ) 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.

Contraindications

CHEMET is contraindicated in patients with a history of hypersensitivity reaction to succimer. Reactions have included mucocutaneous vesicular eruptions, urticaria, and angioedema [see Warnings and Precautions (5.1) ] . Patients with a history of hypersensitivity reaction to succimer. ( 4 )

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 )

5.1Hypersensitivity 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.

At a glance

Brand name: Chemet
Active substance: succimer
Pharmacologic class: Lead Chelator
Route: Oral
Dosage form: Capsule
Applicant: Recordati Rare
Status: Prescription
FDA approval: 30 Jan 1991
Application: NDA019998-002
RxCUI: 215984

Indications

Warnings and precautions

( 5.5 )

5.1Hypersensitivity and Dermatologic Reactions

Pregnancy and breastfeeding

8.1Pregnancy 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. However, the background risk in the U.S general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.

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).

Chemet

Indications

Contraindications

Warnings and precautions

5.1Hypersensitivity and Dermatologic Reactions

At a glance

Two medicines in one question?

Chemet

Indications

Contraindications

Warnings and precautions

5.1Hypersensitivity and Dermatologic Reactions

At a glance

Two medicines in one question?

5.2Neutropenia

5.3Hepatic Toxicity

5.4Embryo-Fetal Toxicity Based

5.5Laboratory Test Interference

Interactions

7.1Laboratory Test Interference

7.2Use with Other Chelation Therapies

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

Composition

Official product information