Drug Safety-related Labeling Changes (SrLC)

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EXFORGE HCT (NDA-022314)

(AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN)

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

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06/12/2019 (SUPPL-27)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Fetal Toxicity

Additions and/or revisions underlined:

Valsartan

Exforge HCT can cause fetal harm when administered to a pregnant woman.  Use of drugs that act …

Hydrochlorothiazide

Thiazides cross the placenta and use of thiazides during pregnancy is associated with fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

6 Adverse Reactions

6.2 Postmarketing Experience

Valsartan

Newly added information:

Musculoskeletal: Rhabdomyolysis

7 Drug Interactions

Additions and/or revisions underlined:

Amlodipine

Impact of Other Drugs on Amlodipine

CYP3A Inducers

… when amlodipine is co-administered with CYP3A inducers (e.g. rifampicin, St. John’s Wort).

8 Use in Specific Populations

PLLR conversion for subsections below; please refer to label for complete information

8.1 Pregnancy

8.2 Lactation

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Newly added information:

Lactation: Advise women not to breastfeed during treatment with Exforge HCT.

PATIENT INFORMATION

What should I tell my doctor before taking EXFORGE HCT?

Tell your doctor about all of your medical conditions, including if you:

  • are breastfeeding or plan to breastfeed. EXFORGE HCT is present in human milk. It is not known whether EXFORGE HCT effects your breastfed baby or milk production. Do not breastfeed …

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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