<unk>  was initially not approved by European regulatory agencies because of concerns over efficacy and safety, although by 2018, the European Commission had approved it. Animal studies with<unk>  conducted prior to human trials showed some carcinogenesis, mutagenesis, and impairment of fertility. The most commonly reported adverse reactions during the first three months in controlled clinical trials (occurring in 2% or more of patients treated with<unk>  citrate monotherapy or in combination with DMARDs) were upper respiratory tract infections, headache, diarrhea, and nasopharyngitis (the "common cold").<unk>  is required by the FDA to have a boxed warning on its label about possible injury and death due to problems such as infections, lymphoma, and other malignancies, which can arise from use of this drug. Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving<unk> . Epstein Barr virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with<unk>  while on immunosuppressive medications. Patients are warned to avoid use of<unk>  citrate during an "active serious infection, including localized infections." Doctors are advised to use it with caution in patients who may be at increased risk of gastrointestinal perforations. Laboratory monitoring is recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids.<unk>  claims to have no contraindications, but doctors are advised to reduce the patient's dosage when combined with "potent inhibitors of cytochrome P450 3A4 (CYP3A4)," such as ketoconazole, or one or more combined medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 such as fluconazole. Furthermore, immunizations with live vaccines should be avoided by<unk>  users. According to postmarketing research,<unk>  may also increase the risk for pulmonary embolism. Prescribers should consider risk factors for pulmonary embolism, including age, obesity, smoking, and immobilization before prescribing this medication. Patients taking this medication, irrespective of indication or risk factors, should be monitored for signs and symptoms of pulmonary embolism.
Tofacitinib
Ocrelizumab
Belatacept
Etanercept
Ibalizumab
Sarilumab
Theralizumab
Atezolizumab