Tavneos Side Effects

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Hepatotoxicity [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Hepatitis B Virus (HBV) Reactivation [see Warnings and Precautions (5.3) ] Serious Infections [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥5%) are: nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia.

To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc.

at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 Clinical Trials Experience Because the clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The identification of potential adverse drug reactions was based on safety data from the phase 3 clinical trial in which 330 patients with ANCA-associated vasculitis were randomized 1:1 to either TAVNEOS or prednisone [see Clinical Studies (14) ] .

The mean age of patients was 60.9 years (range of 13 to 88 years), with a predominance of men (56.4%) and Caucasians (84.2%).

The cumulative exposure to TAVNEOS was 138.7 patient-years.

Additionally, two phase 2 trials were conducted in ANCA-associated vasculitis.

The cumulative clinical trial exposure from the phase 2 and 3 trials equals 212.3 patient-years.

The most frequent serious adverse reactions reported more frequently in patients treated with TAVNEOS than with prednisone were pneumonia (4.8% TAVNEOS vs.