Succimer
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From MedlinePlus, U.S. National Library of Medicine
Lead Chelator
Dosing in kidney impairment
Renal Impairment Assess renal function prior to and periodically during prolonged therapy. Adequately hydrate patients during therapy. Limited data suggests that succimer is dialyzable, but the lead chelates are not. Monitor patients with a history of renal impairment more frequently.
Dosing in liver impairment
Hepatic Impairment Assess hepatic function prior to and periodically during therapy. Monitor patients with a history of liver disease more frequently [see Warnings and Precautions ] .
Preparation and administration
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 [see Use in Specific Populations , Pharmacokinetics ] .
Drug interactions
Check succimer against a medication listLabel text (3 paragraphs)
7 DRUG INTERACTIONS CHEMET may interfere with serum and urinary laboratory test. ( 7.1 )
7.1 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).
7.2 Use with Other Chelation Therapies Concomitant administration of CHEMET with other chelation therapy, such as CaNa 2 EDTA is not recommended.
Contraindications
4 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 )
Pregnancy and lactation
Pregnancy
8.1 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. 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).
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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