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U.S. Department of Health and Human Services

Safety

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Insulin Product Labeling Changes March 2013

*Use of TZDs in combination with insulin

March 2013 Summary View

 

Novolin N (NPH, human insulin isophane suspension [rDNA origin]) Injection

Novolin 70/30 (70% NPH, human insulin isophane suspension and 30% regular human insulin [rDNA origin]) Injection

Humulin 70/30 (70% human insulin isophane suspension/30% insulin human injection, rDNA origin)

Humulin N NPH (human insulin isophane suspension [rNDA origin])

Humulin R (insulin human injection, USP [rDNA origin])

 

PATIENT PACKAGE INSERT

What should I tell my healthcare provider before using this medicine?

Tell your healthcare provider if you:

  • take any other medicines, especially ones commonly called TZDs (thiazolidinediones).
What are the possible side effects?

This medicine can cause serious side effects, including:

Heart Failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with this medicine may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs.

Your healthcare provider should monitor you closely while you are taking TZDs with this medicine. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:

  • shortness of breath
  • swelling of your ankles or feet
  • sudden weight gain

Treatment with TZDs and this medicine may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

 


 

NovoLog (insulin aspart [rDNA origin] injection)

Levemir (insulin detemir [rDNA origin] injection)

NovoLog Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart [rDNA origin] injection)

NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart [rDNA origin] injection)

Humalog (insulin lispro [rDNA origin] injection)

Humalog Mix 50/50 (50% insulin lispro protamine suspension/50% insulin lispro [rDNA origin] injection)

Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% insulin lispro [rDNA origin] injection)

 

WARNINGS AND PRECAUTIONS

Fluid retention and heart failure with concomitant use of PPAR-gamma agonists:
  • Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.

PATIENT PACKAGE INSERT

What should I tell my healthcare provider before using this medicine?

Tell your healthcare provider if you:

  • take any other medicines, especially ones commonly called TZDs (thiazolidinediones).
What are the possible side effects?

This medicine can cause serious side effects, including:

Heart Failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with this medicine may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs. Your healthcare provider should monitor you closely while you are taking TZDs with this medicine. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:

  • shortness of breath
  • swelling of your ankles or feet
  • sudden weight gain

Treatment with TZDs and this medicine may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.