Drug Safety-related Labeling Changes (SrLC)

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VASOTEC (NDA-018998)

(ENALAPRIL MALEATE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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07/21/2017 (SUPPL-82)

Approved Drug Label (PDF)

4 Contraindications

Addition of the following:

… VASOTEC is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer VASOTEC within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor …

5 Warnings and Precautions

PRECAUTIONS

Drug Interactions

Addition of the following:

Neprilysin Inhibitors

Patients taking concomitant neprilysin inhibitors may be at increased risk for angioedema.

WARNINGS

Head and Neck Angioedema:

Additions and/or revisions underlined:

Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema.

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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