SUCCIMER Drug Interactions: What You Need to Know

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.

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 )

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 )

5.1 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 <span class="opacity-50 text-xs">[see Dosage and Administration (2.2) ]</span> . Interrupt treatment if absolute neutrophil count (ANC) is &lt;1200/mcL and interrupt treatment until recovery to above 1500/mcL (or the patient&apos;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.

5.3 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.

5.4 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 <span class="opacity-50 text-xs">[see Use in Specific Populations (8.1 , 8.3) ]</span> .

5.5 Laboratory Test Interference CHEMET may interfere with serum and urinary laboratory tests <span class="opacity-50 text-xs">[see Drug Interactions (7.1) ]</span> .