November 25, 2015
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"The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.




  • Hemorrhage:
    Advise patients that CYRAMZA can cause severe bleeding. Advise patients to contact their health care provider for bleeding or symptoms of bleeding including lightheadedness [see WARNINGS AND PRECAUTIONS].
  • Arterial thromboembolic events:
    Advise patients of an increased risk of an arterial thromboembolic event [see WARNINGS AND PRECAUTIONS].
  • Hypertension:
    Advise patients to undergo routine blood pressure monitoring and to contact their health care provider if blood pressure is elevated or if symptoms from hypertension occur including severe headache, lightheadedness, or neurologic symptoms [see WARNINGS AND PRECAUTIONS].
  • Gastrointestinal perforations:
    Advise patients to notify their health care provider for severe diarrhea, vomiting, or severe abdominal pain [see WARNINGS AND PRECAUTIONS].
  • Impaired wound healing:
    Advise patients that CYRAMZA has the potential to impair wound healing. Instruct patients not to undergo surgery without first discussing this potential risk with their health care provider [see WARNINGS AND PRECAUTIONS].
  • Pregnancy and fetal harm:
    Advise females of reproductive potential of the potential risk for maintaining pregnancy, risk to the fetus, and risk to newborn and infant development and to use effective contraception during CYRAMZA therapy and for at least 3 months following the last dose of CYRAMZA [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].
  • Lactation:
    Advise patients not to breastfeed during CYRAMZA treatment [see Use In Specific Populations].
  • Infertility:
    Advise females of reproductive potential regarding potential infertility effects of CYRAMZA [see Use in Specific Populations].

Last reviewed on RxList: 9/14/2015
This monograph has been modified to include the generic and brand name in many instances.

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