Shortage of CHEMET (succimer) capsules 100 mg

IMPORTANT PRESCRIBING INFORMATION

January 15, 2021

Dear Health Care Provider,

There has been an unexpected disruption in the manufacturing of CHEMET (succimer) capsule 100 mg approved for use and distribution in the United States (“CHEMET”), which has resulted in an interim shortage of this product in the US market.

U.S. FDA-approved Indication

CHEMET (succimer) is an orally active, heavy metal chelating agent. CHEMET is indicated for the treatment of lead poisoning in pediatric patients with blood lead levels above 45mcg/dL. CHEMET is not indicated for prophylaxis of lead poisoning in a lead-containing environment; the use of CHEMET should always be accompanied by identification and removal of the source of the lead exposure.

For reporting of adverse events and more information

Any adverse effects or medication issues resulting from the use of this drug or quality issues should be reported to Recordati Rare Diseases Inc. at 1-888-575-8344 or to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Important Safety Information

CHEMET should not be administered to patients with a history of allergy to the drug.

Keep out of reach of pediatric patients. CHEMET is not a substitute for effective abatement of lead exposure.

Mild to moderate neutropenia has been observed in some patients receiving CHEMET. While a causal relationship to CHEMET has not been definitely established, neutropenia has been reported with other drugs in the same chemical class. A complete blood count with white blood cell differential and direct platelet counts should be obtained prior to and weekly during treatment with CHEMET. Therapy should either be withheld or discontinued if the absolute neutrophil count (ANC) is below 1200/mcL and the patient followed closely to document recovery of the ANC to above 1500/mcL or to the patient’s baseline neutrophil count. There is limited experience with reexposure in patients who have developed neutropenia. Therefore, such patients should be rechallenged only if the benefit of CHEMET therapy clearly outweighs the potential risk of another episode of neutropenia and then only with careful patient monitoring.

Patients treated with CHEMET should be instructed to promptly report any signs of infection. If infection is suspected, the above laboratory tests should be conducted immediately.

All patients undergoing treatment should be adequately hydrated. Caution should be exercised in using CHEMET therapy in patients with compromised renal function.

Transient mild elevations of serum transaminases have been observed in 6-10% of patients during the course of CHEMET therapy. Serum transaminases should be monitored before the start of therapy and at least weekly during therapy. Patients with a history of liver disease should be monitored closely. No data are available regarding the metabolism of CHEMET in patients with liver disease.

The possibility of allergic or other mucocutaneous reactions to the drug must be borne in mind on readministration (as well as during initial courses). Patients requiring repeated courses of CHEMET should be monitored during each treatment course.

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 CHEMET, i.e., gastrointestinal symptoms or increases in serum transaminases, have been observed in about 10% of patients. 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 CHEMET. Rechallenge with CHEMET may be considered if lead levels are high enough to warrant retreatment. Allergic reactions including urticaria and angioedema have been reported on repeated administration of the drug. Mild to moderate neutropenia has been observed in some patients receiving CHEMET.

Patients should be instructed to maintain adequate fluid intake. If rash occurs, patients should consult their physician. Patients should be instructed to promptly report any indication of infection, which may be a sign of neutropenia.

We are committed to helping address patients’ unmet needs through our corporate mission. If you have questions or concerns regarding this product, please call Recordati Rare Diseases Medical Information at 1-888-575-8344.

Sandy S. Suh, Pharm.D.

Vice President, Regulatory Affairs & Chief Compliance Officer

Recordati Rare Diseases, Inc.