Quote:
Olumiant (Baricitinib)
WARNINGS AND PRECAUTIONS
The prescribing information for baricitinib contains a boxed warning about the increased risk for serious infections, malignancy, and thrombosis. Some cases of serious infection have led to hospitalization and death. The majority of patients who had infections were taking concomitant immunosuppressant drugs (ie, methotrexate or corticosteroids). These infections include active tuberculosis; invasive fungal infections, including candidiasis and pneumocystosis; and bacterial, viral, and other infections because of opportunistic pathogens.
Lymphoma and other malignancies have been reported in patients who received baricitinib; nonmelanoma skin cancers have also been reported. Increased incidences of thrombosis, some fatal, have been reported, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis.9
Baricitinib should not be used in patients with active and serious infections, including localized infections. Baricitinib should be used with caution in patients who are at increased risk for thrombosis or gastrointestinal perforations. Baricitinib should not be used with live vaccines.9
Starting baricitinib therapy should be avoided or interrupted if a patient has anemia (hemoglobin <8 g/dL), lymphopenia (absolute lymphocyte count <500 cells/mm3), or neutropenia (absolute neutrophil count <1000 cells/mm3).9
ADVERSE REACTIONS
The most common (occurring in ≥1% of patients) adverse reactions associated with baricitinib 2 mg and baricitinib 4 mg were upper respiratory tract infection (16.3% and 14.7%, respectively), nausea (2.7% and 2.8%, respectively), herpes simplex (0.8% and 1.8%, respectively), and herpes zoster (1.0% and 1.4%, respectively).9
At 16 weeks, adverse events led to treatment discontinuation in 17 patients who received baricitinib 2 mg versus 35 patients who received placebo.9 At 52 weeks, adverse events led to treatment discontinuation in 31 patients who received baricitinib 2 mg.9
At 16 weeks, serious infections were reported in 5 patients who received baricitinib 2 mg versus 13 patients who received placebo; no cases of venous thrombosis were reported with baricitinib 2 mg daily or with placebo, and arterial thrombosis was reported in 2 patients who received baricitinib 2 mg daily versus 1 patient who received placebo. At 52 weeks, baricitinib 2 mg was associated with serious infections in 14 patients, 2 cases of venous thrombosis, and 3 cases of arterial thromboses; no tuberculosis events were reported.
Worse than remdesivir.. Of course it's FDA
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