pharmacopeia
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/api/v1/drug/succimer

Mechanism of action

Sourced from openFDA

Succimer is a lead chelator; it forms water soluble chelates and, consequently, increases the urinary excretion of lead.

Indications

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  • 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.

Contraindications

Sourced from openFDA
  • 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) ] .contraindicated

Dosage & administration

Sourced from openFDA

See Full Prescribing Information for important pretreatment evaluations. ( 2.1 ) Ensure patients receiving CHEMET are adequately hydrated. ( 2.3 ) Administer CHEMET capsules whole when possible. ( 2.3 ) Pediatric patients who cannot swallow whole capsules: Sprinkle contents of capsule in food (or on a spoon followed by a drink). ( 2.3 ) Recommended Dosage: 10 mg/kg or 350 mg/m 2 orally every 8 hours for five days followed by 10 mg/kg or 350 mg/m 2 orally every 12 hours for an additional 14 days. ( 2.2 ) 2.1 Important Pretreatment Evaluations Identify the source of lead in the pediatric patient's environment and eliminate the source prior to beginning treatment with CHEMET. Assess the following before initiating treatment with CHEMET: Blood lead concentration Complete blood count (CBC) with differential and platelets [see Dosage and Administration (2.2) , Warnings and Precautions (5.2) ] Ensure absolute neutrophil count (ANC) > 1500/mcL [see Dosage and Administration (2.2) ] Transaminases (AST/ALT) [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6) ] Renal function with blood urea nitrogen (BUN), creatinine, urinary protein [see Use in Specific Populations (8.5) ] . Patients who have previously received Edetate calcium disodium (CaNa 2 EDTA) with or without dimercaprol may receive CHEMET for subsequent treatment after an interval of four weeks.

Warnings & precautions

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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).

Adverse reactions

Sourced from openFDA

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.

Use in specific populations

Sourced from openFDA

Pregnancy: May cause fetal harm. ( 8.1 ) Renal Impairment: Assess renal function. ( 8.6 ) Hepatic Impairment: Assess hepatic function. (8.7) 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.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption Succimer achieved peak plasma concentrations at 1–2 hours. Elimination Metabolism Approximately 90% of absorbed dose is metabolized to mixed succimer-cysteine disulfides.

Overdosage

Sourced from openFDA

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.

Approval history

Sourced from openFDA
  • Jan 30, 1991NDANDA019998Recordati Rare
  • Feb 18, 2022NDANDA214993Theragnostics

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
69 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use2333%
  2. 2Product Availability Issue913%
  3. 3Arthralgia710%
  4. 4Dizziness57.2%
  5. 5Hypertension57.2%
  6. 6No Adverse Event57.2%
  7. 7Weight Increased57.2%
  8. 8Asthenia45.8%
  9. 9Condition Aggravated45.8%
  10. 10Fatigue45.8%
  11. 11Pain In Extremity45.8%
  12. 12Skin Striae45.8%
  13. 13Abdominal Pain Upper34.3%
  14. 14Aortic Arteriosclerosis34.3%
  15. 15Arrhythmia34.3%

Literature

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Recent PubMed references pinned to Succimer as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 9 most recently updated of 9 ClinicalTrials.gov registrations naming Succimer as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Succimer work?
Succimer is a lead chelator; it forms water soluble chelates and, consequently, increases the urinary excretion of lead.
What is Succimer used for?
According to FDA labeling, Succimer carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Succimer?
Succimer is classified as Lead Chelator, Lead Chelating Activity, Unknown Physiological Effect.
What are the brand names for Succimer?
Succimer is marketed under brand names including Chemet.
What are the contraindications for Succimer?
Succimer labeling lists contraindications including: 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) ] .. Always consult the full prescribing information and a clinician.
Note. Data for succimer is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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