Label Changes for:

CombiPatch (estradiol/norethindrone acetate transdermal system)

September 2013

Changes have been made to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

September 2013

BOXED WARNING

  • Revised general heading and two specific subheadings: Estrogen Plus Progestin Therapy and  Estrogen-Alone Therapy
  • Updated the text in the Boxed Warning to reflect the current recommended estrogen-class labeling

CONTRAINDICATIONS

  • Known anaphylactic reaction or angioedema or hypersensitivity to CombiPatch.
  • Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

WARNINGS

Cardiovascular Disorders
  • added the following Sub-Headings: a. Stroke, b. Coronary heart disease, and c. Venous thromboembolism;
  • modified the accompanying text to reflect the current recommended estrogen-class labeling.
Malignant Neoplasms
  • changed to reflect current recommended estrogen-class labeling
  • Ovarian cancer and: 
    • The WHI estrogen plus progestin substudy reported a statistically non-significant increased risk of ovarian cancer. After an average follow-up of 5.6 years, the relative risk for ovarian cancer for CE plus MPA versus placebo was 1.58 (95 percent CI, 0.77-3.24). The absolute risk for CE plus MPA versus placebo was 4 versus 3 cases per 10,000 women-years. In some epidemiologic studies, the use of estrogen plus progestin and estrogen-only products, in particular for 5 or more years, has been associated with an increased risk of ovarian cancer. However, the duration of exposure associated with increased risk is  not consistent across all epidemiologic studies and some report no association
 Probable Dementia
  •  to reflect current recommended estrogen-class labeling
 Hereditary Angioedema
  •  Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema

PRECAUTIONS 

  • removed Ovarian cancer and removed the accompanying text.
Geriatric Use
  • to reflect the findings in The Women’s Health Initiative Studies and The Women’s Health Initiative Memory Study;
  • accompanying text was modified to reflect current recommended estrogen-class labeling

ADVERSE REACTIONS

  • added Postmarketing Experience sub-section and updated the accompanying text as appropriate.

PATIENT INFORMATION LEAFLET

  • Updated the Boxed Warning to include current recommended estrogen-class labeling.
  • “Who should not use CombiPatch?”
    • “Have been diagnosed with a bleeding disorder”
  • Modified “What are the possible side effects of CombiPatch?” to reflect current recommended estrogen-class labeling

PATIENT INFORMATION AND INSTRUCTION FOR USE

What should I tell my healthcare provider before I use CombiPatch?

  • Before you use CombiPatch, tell your healthcare provider if you: 
    •  “are going to have surgery or will be on bed rest"
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