Ruxolitinib 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 were current or past smokers had an 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, deuruxolitinib, and pacritinib. Consider the benefits and risks for each individual patient prior and during treatment with JAK inhibitors, especially in patients with other cardiovascular risk factors, history of cardiovascular events, 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.

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Malignancies (including lymphomas and solid tumors) have been reported in patients treated with tofacitinib, baricitinib, upadacitinib, deuruxolitinib and other Janus kinase (JAK) inhibitors used to treat inflammatory conditions. 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.

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Thrombosis (including deep venous thrombosis, pulmonary embolism, cerebral venous sinus thrombosis, and arterial thrombosis) has occurred in patients treated for inflammatory conditions with Janus kinase (JAK) inhibitors, including baricitinib, tofacitinib, deuruxolitinib and upadacitinib. Many of these adverse events were serious and some resulted in death. Based on a shared mechanism of action, this risk should be considered for other JAK inhibitors, including ruxolitinib, fedratinib, and pacritinib. In general, JAK inhibitors should be avoided in patients who may be at increased risk of thrombosis. Tofacitinib should be used at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response when treating ulcerative colitis. If symptoms of thrombosis occur in any patients receiving JAK inhibitors, treatment should be discontinued and patients should be evaluated promptly and treated appropriately.

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The use of certain multikinase inhibitors has been associated with pulmonary toxicity. Serious cases of interstitial lung disease (ILD), including fatal cases and interstitial pneumonitis or pulmonary fibrosis have been reported. Caution is recommended when using these agents in patients with a history of interstitial pneumonitis or pulmonary fibrosis or those patients presenting with acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever pending diagnostic evaluation. If ILD is confirmed, these agents should be permanently discontinued and appropriate measures should be instituted. Treatment should be immediately withheld in patients diagnosed with ILD/pneumonitis and permanently discontinued if no other potential causes of ILD/pneumonitis have been identified.

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The use of ruxolitinib can cause thrombocytopenia, anemia, and neutropenia. It is recommended to manage thrombocytopenia by reducing the dose, temporarily interrupting treatment with ruxolitinib, or as clinically appropriate. Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated. Close monitoring is recommended.

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A dose reduction of ruxolitinib is recommended for patients with hepatic impairment, particularly those patients with myelofibrosis with a platelet count between 50 X 109/L and 150 X 109/L. Close monitoring is recommended.

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Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking ruxolitinib. The effect of ruxolitinib on viral replication in patients with chronic HBV infection is unknown. Care and close monitoring is recommended and patients with chronic HBV infection should be treated and monitored according to clinical guidelines.

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Serious bacterial, mycobacterial, fungal and viral infections have been reported in patients receiving ruxolitinib. It is recommended to delay starting therapy with ruxolitinib until serious active infections have resolved. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment. Treatment should be interrupted if a patient develops a serious infection, an opportunistic infection, or sepsis and appropriate therapy should be instituted according to clinical guidelines. Prompt management of signs and symptoms of infection is advisable.

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The use of ruxolitinib may increase total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. It is recommended to assess lipid parameters approximately 8-12 weeks following initiation of therapy and to monitor and treat per clinical guidelines for the management of hyperlipidemia. Care should be exercised when using this agent in patients with lipids disorders.

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The use of ruxolitinib may increase the risk of progressive multifocal leukoencephalopathy (PML). Healthcare professionals should monitor patients for any new sign or symptom suggestive of PML. Withhold therapy dosing immediately and perform an appropriate diagnostic evaluation at the first sign or symptom suggestive of PML.

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A dose reduction of ruxolitinib is recommended for patients with moderate or severe renal impairment, particularly those patients with myelofibrosis with a platelet count between 50 X 10^9/L and 150 X 10^9/L; and in patients presenting with end stage renal disease on dialysis. Ruxolitinib is not removed by dialysis; however, the removal of some active metabolites by dialysis cannot be ruled out.

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Before initiating ruxolitinib, patients should be screened for latent or active tuberculosis infection. Prior to initiating therapy with ruxolitinib patients should be evaluated for tuberculosis risk factors, and those at higher risk should be tested for latent infection. Patients should be closely monitored for any signs and symptoms of tuberculosis, including those patients who tested negative for latent tuberculosis infection before initiating therapy. Patients with latent tuberculosis should be treated with standard therapy before initiation of treatment and should be closely screened for whether initiating anti-tuberculosis therapy is appropriate.

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