Drug Safety-related Labeling Changes (SrLC)

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EXFORGE (NDA-021990)

(AMLODIPINE BESYLATE; VALSARTAN)

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

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06/12/2019 (SUPPL-33)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Fetal Toxicity

Addition of the following:

Exforge can cause fetal harm when administered to a pregnant woman.

6 Adverse Reactions

6.2 Postmarketing Experience

Newly added information:

The following additional adverse reactions have been reported in postmarketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Musculoskeletal: Rhabdomyolysis

Blood and Lymphatic: Thrombocytopenia  

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).

Impact of Amlodipine on Other Drugs

Valsartan

Agents Increasing Serum Potassium: Concomitant use of valsartan with other agents that block the renin- angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine. If co-medication is considered necessary, monitoring of serum potassium is advisable.

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.

Symptomatic Hypotension: Advise patients that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to their healthcare provider. Tell patients that if syncope occurs to discontinue Exforge until the physician has been consulted. Caution all patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.

Hyperkalemia: Advise patients not to use salt substitutes without consulting their healthcare provider.

PATIENT INFORMATION

What should I tell my doctor before taking EXFORGE?

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

Additions and/or revisions underlined:

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

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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