Safety

Herceptin (trastuzumab)

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

March 2016

Summary View

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity
  • Verify the pregnancy status of females of reproductive potential prior to the initiation of Herceptin. Advise pregnant women and females of reproductive potential that exposure to  Herceptin during pregnancy or within 7 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of Herceptin.

ADVERSE REACTIONS

Post-Marketing Experience
  • Immune thrombocytopenia

 

April 2015

Summary View

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity
  • If the patient becomes pregnant while taking Herceptin or within 7 months following the last dose of Herceptin, apprise the patient of the potential hazard to a fetus [see Use in Specific Populations (8.1)].
  • Advise females of reproductive potential to avoid becoming pregnant while taking Herceptin. If contraceptive methods are being considered, use effective contraception during treatment and for at least 7 months after receiving the last dose of Herceptin

 

June 2014

Summary View

WARNINGS AND PRECAUTIONS
Cardiomyopathy

  • In Study 3 (one-year Herceptin treatment), at a median follow-up duration of 8 years, the incidence of severe CHF (NYHA III & IV) was 0.8%, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6%.


ADVERSE REACTION

Clinical Trials Experience
  • In Study 3, a comparison of 3-weekly Herceptin treatment for two years 277 versus one year was also performed. The rate of asymptomatic cardiac dysfunction was increased in the 2-year Herceptin treatment arm (8.1% versus 4.6% in the one-year Herceptin treatment arm). More patients experienced at least one adverse reaction of grade 3 or higher in the 2-year Herceptin treatment arm (20.4%) compared with the one-year Herceptin treatment arm (16.3%). The safety data from Studies 1 and 2 were obtained from 3655 patients, of whom 2000 received Herceptin; the median treatment duration was 51 weeks. The median age was 49 years (range: 24−80); 84% of patients were White, 7% Black, 4% Hispanic, and 3% Asian.

March 2014

Summary View

WARNINGS AND PRECAUTIONS

Cardiomyopathy
  • In Study 1, 15% (158/1031) of patients discontinued Herceptin due to clinical evidence of myocardial dysfunction or significant decline in LVEF after a median follow-up duration of 8.7 years in the AC-TH arm. In Study 3, the number of patients who discontinued Herceptin due to cardiac toxicity was 2.6% (44/1678). In Study 4, a total of 2.9% (31/1056) patients in the TCH arm (1.5% during the chemotherapy phase and 1.4% during the monotherapy phase) and 5.7% (61/1068) patients in the AC-TH arm (1.5% during the chemotherapy phase and 4.2% during the monotherapy phase) discontinued Herceptin due to cardiac toxicity.
  • Among 64 patients receiving adjuvant chemotherapy (Studies 1 and 2) who developed congestive heart failure, one patient died of cardiomyopathy, one patient died suddenly without documented etiology and 33 patients were receiving cardiac medication at last follow-up. Approximately 24% of the surviving patients had recovery to a normal LVEF (defined as ≥ 50%) and no symptoms on continuing medical management at the time of last follow-up. Incidence of congestive heart failure is presented in Table 1.

 

Page Last Updated: 04/15/2016
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