Summary of BAVENCIO warnings and precautions
Summary of INLYTA warnings and precautions
Adverse reactions (≥20%) in patients receiving BAVENCIO in combination with INLYTA (JAVELIN Renal 101 Trial)*
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Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events. Version 4.03 (NCI CTCAE v4).
*The trial was not designed to demonstrate a statistically significance differences in the incidence of adverse reactions between BAVENCIO in combination with INLYTA and sunitinib.
1Diarrhea is a composite term that includes diarrhea, autoimmune colitis, and colitis.
2Mucositis is a composite term that includes mucosal inflammation and stomatitis.
3Hepatotoxicity is a composite term that includes ALT increased, AST increased, autoimmune hepatitis, bilirubin conjugated, bilirubin conjugated increased, blood bilirubin increased, drug-induced liver injury, hepatic enzyme increased, hepatic function abnormal, hepatitis, hepatitis fulminant, hepatocellular injury, hepatotoxicity, hyperbilirubinemia, immune-mediated hepatitis, liver function test increased, liver disorder, liver injury, and transaminases increased.
4Abdominal pain is a composite term that includes abdominal pain, flank pain, abdominal pain upper, and abdominal pain lower.
5Fatigue is a composite term that includes fatigue and asthenia.
6Hypertension is a composite term that includes hypertension and hypertensive crisis.
7Musculoskeletal pain is a composite term that includes musculoskeletal pain, musculoskeletal chest pain, myalgia, back pain, bone pain, musculoskeletal discomfort, neck pain, spinal pain, and pain in extremity.
8Rash is a composite term that includes rash, rash generalized, rash macular, rash maculo-papular, rash pruritic, rash erythematous, rash papular, and rash pustular.
9Dyspnea is a composite term that includes dyspnea, dyspnea exertional, and dyspnea at rest.
Selected laboratory abnormalities worsening from baseline occurring in ≥20% of patients receiving BAVENCIO in combination with INLYTA (JAVELIN Renal 101 Trial)*
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*The trial was not designed to demonstrate a statistically significant difference in the incidence of laboratory abnormalities between BAVENCIO in combination with INLYTA and sunitinib.
1Each test incidence is based on the number of patients who had both baseline and at least 1 on-study laboratory measurement available:
the BAVENCIO-in-combination-with-INLYTA group (range: 413 to 428 patients) and the sunitinib group (range: 405 to 433 patients).
Reference: 1. Motzer RJ, Penkov K, Haanen J, et al. Avelumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med.
Discontinuations, dose interruptions, and dose reductions due to adverse reactions from the JAVELIN Renal 101 Trial