Ojjaara Disease Interactions

In a major safety study of a Janus kinase (JAK) inhibitor, tofacitinib, in rheumatoid arthritis patients 50 years and older with at least 1 cardiovascular risk factor, higher rates of all-cause mortality (including sudden cardiovascular death) and major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke) were observed with the JAK inhibitor when compared with tumor necrosis factor (TNF) blockers; patients who are current or past smokers are at additional increased risk. Based on a shared mechanism of action, this risk should be considered for other JAK inhibitors, including baricitinib, upadacitinib, ruxolitinib, fedratinib, ritlecitinib, and pacritinib. Before starting or continuing therapy, the benefits and risks for the individual patient should be considered, especially in patients with other cardiovascular risk factors and patients who are current or past smokers. Patients should be informed about the symptoms of serious cardiovascular events and what to do if they occur. Tofacitinib, baricitinib, and upadacitinib are indicated for patients with inadequate response or intolerance to 1 or more TNF blockers, but should be discontinued in patients who have experienced a myocardial infarction or stroke. The dosage recommended for tofacitinib should not be exceeded; for the treatment of ulcerative colitis, tofacitinib should be used at the lowest effective dose and for the shortest duration needed to achieve and/or maintain therapeutic response.

Malignancies (including lymphomas and solid tumors) have been reported in patients treated with tofacitinib and other Janus kinase (JAK) inhibitors used to treat inflammatory conditions; lymphomas and other malignancies have been seen in patients treated with baricitinib or upadacitinib. Patients who are current or past smokers are at additional increased risk of malignancies. Based on a shared mechanism of action, this risk should be considered for other JAK inhibitors, including ruxolitinib, pacritinib, and fedratinib. Before starting or continuing therapy, the benefits and risks for the individual patient should be considered, especially in patients with a known malignancy (other than successfully treated nonmelanoma skin cancer), patients who develop a malignancy during therapy, and patients who are current or past smokers. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

Momelotinib increases the risk of serious and fatal infections. Patients should be evaluated for active infection before and during treatment with momelotinib, and administration should be avoided if infection is detected.

Janus kinase (JAK) inhibitors, including momelotinib, have been shown to increase hepatitis B viral load with or without elevations in ALT and AST levels in chronic hepatitis B virus (HBV) infections. Obtain hepatitis B serologies in patients with HBV infections prior to initiating therapy. Consider consulting a hepatologist regarding monitoring or prophylactic hepatitis B therapy if a positive HBsAg and/or total anti-HBc is positive. Patients with chronic HBV infection taking momelotinib should be treated and monitored according to guidelines.

Momelotinib has been reported to cause worsening elevations of ALT, AST, and bilirubin in patients. The AUC and Cmax of momelotinib are increased in patients with severe hepatic impairment (Child-Pugh C). The patient's liver enzyme levels should be monitored prior to initiation and during treatment with momelotinib. Patients with acute and chronic liver disease should be treated before initiating treatment and the hepatic impairment dosing regimen should be followed during treatment.