Interactions between ProFeno and Tofacitinib

The fenoprofen in ProFeno has a major potential interaction with Alcoholism.

Nonsteroidal anti-inflammatory drugs (NSAIDs) can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can develop at any time, with or without warning symptoms. NSAIDs should be used with caution in patients with history of peptic ulcer disease and/or GI bleeding, as these patients had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors. Caution is also advised if NSAIDs are prescribed to patients with other factors that increase risk of GI bleeding, such as: prolonged NSAID therapy; concomitant use of oral corticosteroids, antiplatelet agents (e.g., aspirin), anticoagulants, selective serotonin reuptake inhibitors; alcohol use; smoking; history of gastrointestinal surgery or anastomosis, older age; poor general health status; and advanced liver disease and/or coagulopathy. Particular vigilance is necessary when treating older adult or debilitated patients since most postmarketing reports of fatal GI events occurred in these patients.

The fenoprofen in ProFeno has a moderate potential interaction with Anemia.

Anemia has been reported in patients treated with nonsteroidal anti-inflammatory drugs (NSAIDs). This may be due to fluid retention, occult/gross blood loss, or an incompletely described effect on erythropoiesis. Hemoglobin or hematocrit should be monitored in patients with any signs/symptoms of anemia or blood loss, especially during long-term therapy. NSAIDs may increase risk of bleeding events; comorbid conditions (e.g., coagulation disorders; concomitant use of warfarin/other anticoagulants, antiplatelet agents, serotonin/serotonin norepinephrine reuptake inhibitors) may increase this risk, and patients with these conditions should be monitored for signs of bleeding. Therapy with NSAIDs should be administered cautiously in patients with or predisposed to anemia. Clinical monitoring of hematopoietic function may be appropriate, particularly during chronic therapy.

The fenoprofen in ProFeno has a major potential interaction with Asthma.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are contraindicated in patients with history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients. A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps, severe potentially fatal bronchospasm, and/or intolerance to aspirin and other NSAIDs. Since cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, therapy with any NSAID should be avoided in patients with this form of aspirin sensitivity. NSAIDs should be used with caution in patients with preexisting asthma (without known aspirin sensitivity), and these patients should be monitored for changes in the signs and symptoms of asthma.

The fenoprofen in ProFeno has a moderate potential interaction with Bleeding Disorder.

Nonsteroidal anti-inflammatory drugs (NSAIDs) reversibly inhibit platelet adhesion and aggregation and may prolong bleeding time in some patients. With the exception of aspirin, the platelet effects seen with most NSAIDs at usual recommended dosages are generally slight and of relatively short duration but may be more pronounced in patients with underlying hemostatic abnormalities. Thrombocytopenia has also been reported rarely during NSAID use. Therapy with NSAIDs should be administered cautiously in patients with significant active bleeding or a hemorrhagic diathesis, including hemostatic and/or coagulation defects associated with hemophilia, vitamin K deficiency, hypoprothrombinemia, thrombocytopenia, thrombocytopathy, or severe hepatic impairment. NSAIDs that selectively inhibit cyclooxygenase-2 (i.e., COX-2 inhibitors) do not appear to affect platelet function or bleeding time at indicated dosages and may be preferable if risk of bleeding is a concern.

The fenoprofen in ProFeno has a moderate potential interaction with Bleeding Disorder.

Anemia has been reported in patients treated with nonsteroidal anti-inflammatory drugs (NSAIDs). This may be due to fluid retention, occult/gross blood loss, or an incompletely described effect on erythropoiesis. Hemoglobin or hematocrit should be monitored in patients with any signs/symptoms of anemia or blood loss, especially during long-term therapy. NSAIDs may increase risk of bleeding events; comorbid conditions (e.g., coagulation disorders; concomitant use of warfarin/other anticoagulants, antiplatelet agents, serotonin/serotonin norepinephrine reuptake inhibitors) may increase this risk, and patients with these conditions should be monitored for signs of bleeding. Therapy with NSAIDs should be administered cautiously in patients with or predisposed to anemia. Clinical monitoring of hematopoietic function may be appropriate, particularly during chronic therapy.

Tofacitinib has a major potential interaction with Cardiovascular Conditions and Disorders.

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.

The fenoprofen in ProFeno has a major potential interaction with Cerebrovascular Insufficiency.

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Clinical trials of several cyclooxygenase-2 (COX-2) selective and nonselective NSAIDs of up to 3 years duration have supported this increased risk. It is unclear from available data if the risk for cardiovascular thrombotic events is similar for all NSAIDs. Therapy with NSAIDs should be administered cautiously in patients with a history of cardiovascular or cerebrovascular disease. Patients should be treated with the lowest effective dosage for the shortest duration necessary. Appropriate antiplatelet therapy should be administered to patients requiring cardioprotection; however, there is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious cardiovascular thrombotic events associated with NSAID use, while the risk of serious gastrointestinal events is increased. Physicians and patients should remain alert for the development of adverse cardiovascular events throughout the entire duration of therapy, even without prior cardiovascular symptoms. Patients should be advised to promptly seek medical attention if they experience symptoms of cardiovascular thrombotic events (including chest pain, shortness of breath, weakness, or slurring of speech).

NSAIDs are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. Two large clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.

The use of NSAIDs should be avoided in patients with a recent myocardial infarction unless the benefits are expected to outweigh the risk of recurrent cardiovascular thrombotic events. If an NSAID is used in patients with a recent myocardial infarction, they should be monitored for signs of cardiac ischemia.

The fenoprofen in ProFeno has a moderate potential interaction with Coagulation Defects and Disorders.

Nonsteroidal anti-inflammatory drugs (NSAIDs) reversibly inhibit platelet adhesion and aggregation and may prolong bleeding time in some patients. With the exception of aspirin, the platelet effects seen with most NSAIDs at usual recommended dosages are generally slight and of relatively short duration but may be more pronounced in patients with underlying hemostatic abnormalities. Thrombocytopenia has also been reported rarely during NSAID use. Therapy with NSAIDs should be administered cautiously in patients with significant active bleeding or a hemorrhagic diathesis, including hemostatic and/or coagulation defects associated with hemophilia, vitamin K deficiency, hypoprothrombinemia, thrombocytopenia, thrombocytopathy, or severe hepatic impairment. NSAIDs that selectively inhibit cyclooxygenase-2 (i.e., COX-2 inhibitors) do not appear to affect platelet function or bleeding time at indicated dosages and may be preferable if risk of bleeding is a concern.

The fenoprofen in ProFeno has a major potential interaction with Colonic Ulceration.

Nonsteroidal anti-inflammatory drugs (NSAIDs) can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can develop at any time, with or without warning symptoms. NSAIDs should be used with caution in patients with history of peptic ulcer disease and/or GI bleeding, as these patients had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors. Caution is also advised if NSAIDs are prescribed to patients with other factors that increase risk of GI bleeding, such as: prolonged NSAID therapy; concomitant use of oral corticosteroids, antiplatelet agents (e.g., aspirin), anticoagulants, selective serotonin reuptake inhibitors; alcohol use; smoking; history of gastrointestinal surgery or anastomosis, older age; poor general health status; and advanced liver disease and/or coagulopathy. Particular vigilance is necessary when treating older adult or debilitated patients since most postmarketing reports of fatal GI events occurred in these patients.

The fenoprofen in ProFeno has a major potential interaction with Dehydration.

Long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) has resulted in renal papillary necrosis and other renal injury. Renal toxicity has been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion; in such patients, NSAIDs may cause a dose-dependent reduction in prostaglandin synthesis and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk for this reaction include those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction; those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers; and older adult patients. Discontinuation of NSAID therapy generally leads to recovery to the pretreatment state. No information is available regarding NSAID use in patients with advanced renal disease; the renal effects of NSAIDs may hasten the progression of renal dysfunction in patients with preexisting renal disease. Volume status should be corrected in dehydrated or hypovolemic patients prior to initiating treatment. Renal function should be monitored in patients with renal or liver dysfunction, heart failure, dehydration, or hypovolemia during therapy. NSAIDs should be avoided in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function; if an NSAID is used in such patients, they should be monitored for signs of worsening renal function.

The fenoprofen in ProFeno has a major potential interaction with Dermatitis, Drug-Induced.

Nonsteroidal anti-inflammatory drugs (NSAIDs) can cause serious skin adverse reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, and exfoliative dermatitis), which can be fatal. NSAIDs can also cause fixed drug eruption, and may present as generalized bullous fixed drug eruption, which can be life-threatening. These serious events may occur without warning. Patients should be advised to discontinue the NSAID and seek medical attention promptly at the first sign of skin rash or any other sign of hypersensitivity. NSAIDs are contraindicated in patients with previous serious skin reactions to these drugs.

Tofacitinib has a moderate potential interaction with Diabetes Mellitus.

The use of tofacitinib increases the risk of infections. As there is a higher incidence of infection in diabetic patients in general, caution is recommended when treating patients with diabetes.

The fenoprofen in ProFeno has a major potential interaction with Fluid Retention.

Fluid retention and edema have been reported in association with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including some topical formulations. NSAIDs (including topicals) can lead to new onset of hypertension or worsening of preexisting hypertension, either of which can contribute to the increased incidence of cardiovascular events. NSAIDs should be used with caution in patients with preexisting fluid retention, hypertension, or history of heart failure. NSAIDs should be avoided in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure; if an NSAID is used in such patients, they should be monitored for signs of worsening heart failure. Blood pressure and cardiovascular status should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

The fenoprofen in ProFeno has a major potential interaction with Gastritis/Duodenitis.

Nonsteroidal anti-inflammatory drugs (NSAIDs) can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can develop at any time, with or without warning symptoms. NSAIDs should be used with caution in patients with history of peptic ulcer disease and/or GI bleeding, as these patients had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors. Caution is also advised if NSAIDs are prescribed to patients with other factors that increase risk of GI bleeding, such as: prolonged NSAID therapy; concomitant use of oral corticosteroids, antiplatelet agents (e.g., aspirin), anticoagulants, selective serotonin reuptake inhibitors; alcohol use; smoking; history of gastrointestinal surgery or anastomosis, older age; poor general health status; and advanced liver disease and/or coagulopathy. Particular vigilance is necessary when treating older adult or debilitated patients since most postmarketing reports of fatal GI events occurred in these patients.

Tofacitinib has a moderate potential interaction with Gastrointestinal Diverticula.

Tofacitinib should be used with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with history of diverticulitis or taking NSAIDs). Patients presenting with new onset of abdominal symptoms should be evaluated promptly for early identification of gastrointestinal perforation.

The fenoprofen in ProFeno has a major potential interaction with Gastrointestinal Hemorrhage.

Nonsteroidal anti-inflammatory drugs (NSAIDs) can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can develop at any time, with or without warning symptoms. NSAIDs should be used with caution in patients with history of peptic ulcer disease and/or GI bleeding, as these patients had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors. Caution is also advised if NSAIDs are prescribed to patients with other factors that increase risk of GI bleeding, such as: prolonged NSAID therapy; concomitant use of oral corticosteroids, antiplatelet agents (e.g., aspirin), anticoagulants, selective serotonin reuptake inhibitors; alcohol use; smoking; history of gastrointestinal surgery or anastomosis, older age; poor general health status; and advanced liver disease and/or coagulopathy. Particular vigilance is necessary when treating older adult or debilitated patients since most postmarketing reports of fatal GI events occurred in these patients.

Tofacitinib has a moderate potential interaction with Gastrointestinal Obstruction.

As with any other nondeformable material, caution is recommended when administering tofacitinib extended-release tablets to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic). There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other drugs utilizing a nondeformable extended-release formulation.

The fenoprofen in ProFeno has a major potential interaction with Gastrointestinal Perforation.

Nonsteroidal anti-inflammatory drugs (NSAIDs) can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can develop at any time, with or without warning symptoms. NSAIDs should be used with caution in patients with history of peptic ulcer disease and/or GI bleeding, as these patients had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors. Caution is also advised if NSAIDs are prescribed to patients with other factors that increase risk of GI bleeding, such as: prolonged NSAID therapy; concomitant use of oral corticosteroids, antiplatelet agents (e.g., aspirin), anticoagulants, selective serotonin reuptake inhibitors; alcohol use; smoking; history of gastrointestinal surgery or anastomosis, older age; poor general health status; and advanced liver disease and/or coagulopathy. Particular vigilance is necessary when treating older adult or debilitated patients since most postmarketing reports of fatal GI events occurred in these patients.

Tofacitinib has a moderate potential interaction with Gastrointestinal Perforation.

Tofacitinib should be used with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with history of diverticulitis or taking NSAIDs). Patients presenting with new onset of abdominal symptoms should be evaluated promptly for early identification of gastrointestinal perforation.

The fenoprofen in ProFeno has a major potential interaction with Heart Failure.

Long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) has resulted in renal papillary necrosis and other renal injury. Renal toxicity has been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion; in such patients, NSAIDs may cause a dose-dependent reduction in prostaglandin synthesis and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk for this reaction include those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction; those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers; and older adult patients. Discontinuation of NSAID therapy generally leads to recovery to the pretreatment state. No information is available regarding NSAID use in patients with advanced renal disease; the renal effects of NSAIDs may hasten the progression of renal dysfunction in patients with preexisting renal disease. Volume status should be corrected in dehydrated or hypovolemic patients prior to initiating treatment. Renal function should be monitored in patients with renal or liver dysfunction, heart failure, dehydration, or hypovolemia during therapy. NSAIDs should be avoided in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function; if an NSAID is used in such patients, they should be monitored for signs of worsening renal function.

The fenoprofen in ProFeno has a major potential interaction with Heart Failure.

Fluid retention and edema have been reported in association with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including some topical formulations. NSAIDs (including topicals) can lead to new onset of hypertension or worsening of preexisting hypertension, either of which can contribute to the increased incidence of cardiovascular events. NSAIDs should be used with caution in patients with preexisting fluid retention, hypertension, or history of heart failure. NSAIDs should be avoided in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure; if an NSAID is used in such patients, they should be monitored for signs of worsening heart failure. Blood pressure and cardiovascular status should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

Tofacitinib has a moderate potential interaction with Hemoglobinopathy.

Adverse hematologic effects including neutropenia, lymphocytosis, and anemia have been associated with the use of tofacitinib. It is recommended to avoid starting therapy in patients with absolute lymphocyte counts (ALC) less than 500 cells/mm3, absolute neutrophil counts (ANC) less than 1000 cells/mm3, or hemoglobin levels less than 9 g/dL. For persistent ANC of 500 to 1000 cells/mm3, hemoglobin levels less than 8 g/dL, or a hemoglobin level drop greater than 2 g/dL, therapy should be interrupted until ANC is greater than 1000 cells/mm3 and hemoglobin values have normalized. Treatment with tofacitinib is not recommended in patients who develop a confirmed ALC less than 500 cells/mm3 or an ANC less than 500 cells/mm3. Lymphocyte counts should be monitored at baseline and every 3 months thereafter; neutrophil counts and hemoglobin should be monitored at baseline, after 4 to 8 weeks of therapy, and every 3 months thereafter. Treatment should be modified based on ALC, ANC, and/or hemoglobin levels. Caution is recommended in patients who may be at increased risk.

The fenoprofen in ProFeno has a major potential interaction with High Blood Pressure.

Fluid retention and edema have been reported in association with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including some topical formulations. NSAIDs (including topicals) can lead to new onset of hypertension or worsening of preexisting hypertension, either of which can contribute to the increased incidence of cardiovascular events. NSAIDs should be used with caution in patients with preexisting fluid retention, hypertension, or history of heart failure. NSAIDs should be avoided in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure; if an NSAID is used in such patients, they should be monitored for signs of worsening heart failure. Blood pressure and cardiovascular status should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

Tofacitinib has a moderate potential interaction with High Cholesterol.

Treatment with tofacitinib was associated with dose-dependent increases in lipid parameters (including total cholesterol, low-density lipoprotein [LDL] cholesterol, high-density lipoprotein [HDL] cholesterol); maximum effects generally occurred within 6 weeks. Lipid parameters should be assessed about 4 to 8 weeks after initiation of therapy. Patients should be managed according to clinical guidelines for the management of hyperlipidemia.

The fenoprofen in ProFeno has a major potential interaction with History, Peptic Ulcer.

Nonsteroidal anti-inflammatory drugs (NSAIDs) can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can develop at any time, with or without warning symptoms. NSAIDs should be used with caution in patients with history of peptic ulcer disease and/or GI bleeding, as these patients had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors. Caution is also advised if NSAIDs are prescribed to patients with other factors that increase risk of GI bleeding, such as: prolonged NSAID therapy; concomitant use of oral corticosteroids, antiplatelet agents (e.g., aspirin), anticoagulants, selective serotonin reuptake inhibitors; alcohol use; smoking; history of gastrointestinal surgery or anastomosis, older age; poor general health status; and advanced liver disease and/or coagulopathy. Particular vigilance is necessary when treating older adult or debilitated patients since most postmarketing reports of fatal GI events occurred in these patients.

Tofacitinib has a major potential interaction with History, Tuberculosis.

Use of tofacitinib should be avoided in patients with an active, serious infection. Patients should be evaluated and tested for latent or active tuberculosis (TB) infection before and per applicable guidelines during use of tofacitinib. Anti-TB therapy should also be considered before use of tofacitinib in patients with history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Consultation with a physician with expertise in the treatment of TB is recommended to aid in the decision about whether initiating anti-TB therapy is appropriate for an individual patient. Patients should be closely monitored for signs/symptoms of TB, including patients who tested negative for latent TB infection before initiating therapy. Patients with latent TB should be treated with standard antimycobacterial therapy before using tofacitinib.

The fenoprofen in ProFeno has a major potential interaction with History - Cerebrovascular Disease.

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Clinical trials of several cyclooxygenase-2 (COX-2) selective and nonselective NSAIDs of up to 3 years duration have supported this increased risk. It is unclear from available data if the risk for cardiovascular thrombotic events is similar for all NSAIDs. Therapy with NSAIDs should be administered cautiously in patients with a history of cardiovascular or cerebrovascular disease. Patients should be treated with the lowest effective dosage for the shortest duration necessary. Appropriate antiplatelet therapy should be administered to patients requiring cardioprotection; however, there is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious cardiovascular thrombotic events associated with NSAID use, while the risk of serious gastrointestinal events is increased. Physicians and patients should remain alert for the development of adverse cardiovascular events throughout the entire duration of therapy, even without prior cardiovascular symptoms. Patients should be advised to promptly seek medical attention if they experience symptoms of cardiovascular thrombotic events (including chest pain, shortness of breath, weakness, or slurring of speech).

NSAIDs are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. Two large clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.

The use of NSAIDs should be avoided in patients with a recent myocardial infarction unless the benefits are expected to outweigh the risk of recurrent cardiovascular thrombotic events. If an NSAID is used in patients with a recent myocardial infarction, they should be monitored for signs of cardiac ischemia.

The fenoprofen in ProFeno has a major potential interaction with History - Myocardial Infarction.

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Clinical trials of several cyclooxygenase-2 (COX-2) selective and nonselective NSAIDs of up to 3 years duration have supported this increased risk. It is unclear from available data if the risk for cardiovascular thrombotic events is similar for all NSAIDs. Therapy with NSAIDs should be administered cautiously in patients with a history of cardiovascular or cerebrovascular disease. Patients should be treated with the lowest effective dosage for the shortest duration necessary. Appropriate antiplatelet therapy should be administered to patients requiring cardioprotection; however, there is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious cardiovascular thrombotic events associated with NSAID use, while the risk of serious gastrointestinal events is increased. Physicians and patients should remain alert for the development of adverse cardiovascular events throughout the entire duration of therapy, even without prior cardiovascular symptoms. Patients should be advised to promptly seek medical attention if they experience symptoms of cardiovascular thrombotic events (including chest pain, shortness of breath, weakness, or slurring of speech).

NSAIDs are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. Two large clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.

The use of NSAIDs should be avoided in patients with a recent myocardial infarction unless the benefits are expected to outweigh the risk of recurrent cardiovascular thrombotic events. If an NSAID is used in patients with a recent myocardial infarction, they should be monitored for signs of cardiac ischemia.

The fenoprofen in ProFeno has a moderate potential interaction with Hyperkalemia.

Increases in serum potassium concentration (including hyperkalemia) have been reported with use of nonsteroidal anti-inflammatory drugs (NSAIDs), even in some patients without renal impairment. In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state. Caution is advised in patients with hyperkalemia.

The fenoprofen in ProFeno has a major potential interaction with Hyponatremia.

Long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) has resulted in renal papillary necrosis and other renal injury. Renal toxicity has been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion; in such patients, NSAIDs may cause a dose-dependent reduction in prostaglandin synthesis and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk for this reaction include those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction; those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers; and older adult patients. Discontinuation of NSAID therapy generally leads to recovery to the pretreatment state. No information is available regarding NSAID use in patients with advanced renal disease; the renal effects of NSAIDs may hasten the progression of renal dysfunction in patients with preexisting renal disease. Volume status should be corrected in dehydrated or hypovolemic patients prior to initiating treatment. Renal function should be monitored in patients with renal or liver dysfunction, heart failure, dehydration, or hypovolemia during therapy. NSAIDs should be avoided in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function; if an NSAID is used in such patients, they should be monitored for signs of worsening renal function.

Tofacitinib has a major potential interaction with Immunodeficiency.

Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving tofacitinib. Use of tofacitinib should be avoided in patients with an active, serious infection, including localized infections. The risks and benefits of treatment should be considered before starting tofacitinib in patients: with chronic/recurrent infection, who have been exposed to tuberculosis, with history of serious/opportunistic infection, who have resided/traveled in areas of endemic tuberculosis/mycoses, or with underlying conditions that may predispose them to infection. Patients should be closely monitored for signs/symptoms of infection during and after tofacitinib treatment. Tofacitinib should be interrupted if a patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with tofacitinib should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be started, and the patient should be monitored closely. Caution is also recommended in patients with history of chronic lung disease, or in those who develop interstitial lung disease, as they may be more prone to infections.

Tofacitinib has a major potential interaction with Infection.

Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving tofacitinib. Use of tofacitinib should be avoided in patients with an active, serious infection, including localized infections. The risks and benefits of treatment should be considered before starting tofacitinib in patients: with chronic/recurrent infection, who have been exposed to tuberculosis, with history of serious/opportunistic infection, who have resided/traveled in areas of endemic tuberculosis/mycoses, or with underlying conditions that may predispose them to infection. Patients should be closely monitored for signs/symptoms of infection during and after tofacitinib treatment. Tofacitinib should be interrupted if a patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with tofacitinib should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be started, and the patient should be monitored closely. Caution is also recommended in patients with history of chronic lung disease, or in those who develop interstitial lung disease, as they may be more prone to infections.

Tofacitinib has a moderate potential interaction with Infectious Hepatitis.

Viral reactivation (including cases of herpes virus reactivation [e.g., herpes zoster]) was observed in clinical trials with tofacitinib; postmarketing cases of hepatitis B reactivation have been reported with tofacitinib. Patients should be screened for viral hepatitis in accordance with clinical guidelines before starting therapy with tofacitinib. Close monitoring is recommended, and appropriate supportive treatment should be initiated if appropriate.

The fenoprofen in ProFeno has a major potential interaction with Intestinal Anastomoses.

Nonsteroidal anti-inflammatory drugs (NSAIDs) can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can develop at any time, with or without warning symptoms. NSAIDs should be used with caution in patients with history of peptic ulcer disease and/or GI bleeding, as these patients had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors. Caution is also advised if NSAIDs are prescribed to patients with other factors that increase risk of GI bleeding, such as: prolonged NSAID therapy; concomitant use of oral corticosteroids, antiplatelet agents (e.g., aspirin), anticoagulants, selective serotonin reuptake inhibitors; alcohol use; smoking; history of gastrointestinal surgery or anastomosis, older age; poor general health status; and advanced liver disease and/or coagulopathy. Particular vigilance is necessary when treating older adult or debilitated patients since most postmarketing reports of fatal GI events occurred in these patients.

The fenoprofen in ProFeno has a major potential interaction with Ischemic Heart Disease.

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Clinical trials of several cyclooxygenase-2 (COX-2) selective and nonselective NSAIDs of up to 3 years duration have supported this increased risk. It is unclear from available data if the risk for cardiovascular thrombotic events is similar for all NSAIDs. Therapy with NSAIDs should be administered cautiously in patients with a history of cardiovascular or cerebrovascular disease. Patients should be treated with the lowest effective dosage for the shortest duration necessary. Appropriate antiplatelet therapy should be administered to patients requiring cardioprotection; however, there is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious cardiovascular thrombotic events associated with NSAID use, while the risk of serious gastrointestinal events is increased. Physicians and patients should remain alert for the development of adverse cardiovascular events throughout the entire duration of therapy, even without prior cardiovascular symptoms. Patients should be advised to promptly seek medical attention if they experience symptoms of cardiovascular thrombotic events (including chest pain, shortness of breath, weakness, or slurring of speech).

NSAIDs are contraindicated in the setting of coronary artery bypass graft (CABG) surgery. Two large clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.

The use of NSAIDs should be avoided in patients with a recent myocardial infarction unless the benefits are expected to outweigh the risk of recurrent cardiovascular thrombotic events. If an NSAID is used in patients with a recent myocardial infarction, they should be monitored for signs of cardiac ischemia.

The fenoprofen in ProFeno has a major potential interaction with Liver Disease.

Long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) has resulted in renal papillary necrosis and other renal injury. Renal toxicity has been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion; in such patients, NSAIDs may cause a dose-dependent reduction in prostaglandin synthesis and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk for this reaction include those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction; those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers; and older adult patients. Discontinuation of NSAID therapy generally leads to recovery to the pretreatment state. No information is available regarding NSAID use in patients with advanced renal disease; the renal effects of NSAIDs may hasten the progression of renal dysfunction in patients with preexisting renal disease. Volume status should be corrected in dehydrated or hypovolemic patients prior to initiating treatment. Renal function should be monitored in patients with renal or liver dysfunction, heart failure, dehydration, or hypovolemia during therapy. NSAIDs should be avoided in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function; if an NSAID is used in such patients, they should be monitored for signs of worsening renal function.

The fenoprofen in ProFeno has a moderate potential interaction with Liver Disease.

Therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) should be administered cautiously in patients with preexisting liver disease. Periodic monitoring of liver function is recommended during prolonged therapy. NSAIDs are also highly protein-bound and some are extensively metabolized by the liver. Metabolic activity and/or plasma protein binding may be altered in patients with hepatic impairment. A dosage reduction may be required in some cases.

Tofacitinib has a moderate potential interaction with Liver Disease.

Treatment with tofacitinib was associated with an increased incidence of liver enzyme elevation compared to placebo. No dose adjustment of tofacitinib is needed in patients with mild liver dysfunction. Tofacitinib-treated patients with moderate liver dysfunction had greater tofacitinib blood levels than those with normal liver function; therefore, dose adjustment of tofacitinib is recommended in these patients. Tofacitinib has not been studied in patients with severe liver dysfunction, and its use is not recommended in these patients. The safety and efficacy of tofacitinib has not been studied in patients with positive hepatitis B virus or hepatitis C virus serology. Routine monitoring of liver tests and prompt investigation of the causes of liver enzyme elevations is recommended to identify potential cases of drug-induced liver injury; if drug-induced liver injury is suspected, therapy should be interrupted until this diagnosis has been excluded.

Tofacitinib has a moderate potential interaction with Lymphocytopenia.

Adverse hematologic effects including neutropenia, lymphocytosis, and anemia have been associated with the use of tofacitinib. It is recommended to avoid starting therapy in patients with absolute lymphocyte counts (ALC) less than 500 cells/mm3, absolute neutrophil counts (ANC) less than 1000 cells/mm3, or hemoglobin levels less than 9 g/dL. For persistent ANC of 500 to 1000 cells/mm3, hemoglobin levels less than 8 g/dL, or a hemoglobin level drop greater than 2 g/dL, therapy should be interrupted until ANC is greater than 1000 cells/mm3 and hemoglobin values have normalized. Treatment with tofacitinib is not recommended in patients who develop a confirmed ALC less than 500 cells/mm3 or an ANC less than 500 cells/mm3. Lymphocyte counts should be monitored at baseline and every 3 months thereafter; neutrophil counts and hemoglobin should be monitored at baseline, after 4 to 8 weeks of therapy, and every 3 months thereafter. Treatment should be modified based on ALC, ANC, and/or hemoglobin levels. Caution is recommended in patients who may be at increased risk.

Tofacitinib has a moderate potential interaction with Neutropenia.

Adverse hematologic effects including neutropenia, lymphocytosis, and anemia have been associated with the use of tofacitinib. It is recommended to avoid starting therapy in patients with absolute lymphocyte counts (ALC) less than 500 cells/mm3, absolute neutrophil counts (ANC) less than 1000 cells/mm3, or hemoglobin levels less than 9 g/dL. For persistent ANC of 500 to 1000 cells/mm3, hemoglobin levels less than 8 g/dL, or a hemoglobin level drop greater than 2 g/dL, therapy should be interrupted until ANC is greater than 1000 cells/mm3 and hemoglobin values have normalized. Treatment with tofacitinib is not recommended in patients who develop a confirmed ALC less than 500 cells/mm3 or an ANC less than 500 cells/mm3. Lymphocyte counts should be monitored at baseline and every 3 months thereafter; neutrophil counts and hemoglobin should be monitored at baseline, after 4 to 8 weeks of therapy, and every 3 months thereafter. Treatment should be modified based on ALC, ANC, and/or hemoglobin levels. Caution is recommended in patients who may be at increased risk.

The fenoprofen in ProFeno has a major potential interaction with Noninfectious Colitis.

Nonsteroidal anti-inflammatory drugs (NSAIDs) can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can develop at any time, with or without warning symptoms. NSAIDs should be used with caution in patients with history of peptic ulcer disease and/or GI bleeding, as these patients had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors. Caution is also advised if NSAIDs are prescribed to patients with other factors that increase risk of GI bleeding, such as: prolonged NSAID therapy; concomitant use of oral corticosteroids, antiplatelet agents (e.g., aspirin), anticoagulants, selective serotonin reuptake inhibitors; alcohol use; smoking; history of gastrointestinal surgery or anastomosis, older age; poor general health status; and advanced liver disease and/or coagulopathy. Particular vigilance is necessary when treating older adult or debilitated patients since most postmarketing reports of fatal GI events occurred in these patients.

The fenoprofen in ProFeno has a major potential interaction with Peptic Ulcer.

Nonsteroidal anti-inflammatory drugs (NSAIDs) can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can develop at any time, with or without warning symptoms. NSAIDs should be used with caution in patients with history of peptic ulcer disease and/or GI bleeding, as these patients had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors. Caution is also advised if NSAIDs are prescribed to patients with other factors that increase risk of GI bleeding, such as: prolonged NSAID therapy; concomitant use of oral corticosteroids, antiplatelet agents (e.g., aspirin), anticoagulants, selective serotonin reuptake inhibitors; alcohol use; smoking; history of gastrointestinal surgery or anastomosis, older age; poor general health status; and advanced liver disease and/or coagulopathy. Particular vigilance is necessary when treating older adult or debilitated patients since most postmarketing reports of fatal GI events occurred in these patients.

Tofacitinib has a major potential interaction with Pulmonary Impairment.

Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving tofacitinib. Use of tofacitinib should be avoided in patients with an active, serious infection, including localized infections. The risks and benefits of treatment should be considered before starting tofacitinib in patients: with chronic/recurrent infection, who have been exposed to tuberculosis, with history of serious/opportunistic infection, who have resided/traveled in areas of endemic tuberculosis/mycoses, or with underlying conditions that may predispose them to infection. Patients should be closely monitored for signs/symptoms of infection during and after tofacitinib treatment. Tofacitinib should be interrupted if a patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with tofacitinib should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be started, and the patient should be monitored closely. Caution is also recommended in patients with history of chronic lung disease, or in those who develop interstitial lung disease, as they may be more prone to infections.

The fenoprofen in ProFeno has a major potential interaction with Renal Dysfunction.

Long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) has resulted in renal papillary necrosis and other renal injury. Renal toxicity has been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion; in such patients, NSAIDs may cause a dose-dependent reduction in prostaglandin synthesis and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk for this reaction include those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction; those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers; and older adult patients. Discontinuation of NSAID therapy generally leads to recovery to the pretreatment state. No information is available regarding NSAID use in patients with advanced renal disease; the renal effects of NSAIDs may hasten the progression of renal dysfunction in patients with preexisting renal disease. Volume status should be corrected in dehydrated or hypovolemic patients prior to initiating treatment. Renal function should be monitored in patients with renal or liver dysfunction, heart failure, dehydration, or hypovolemia during therapy. NSAIDs should be avoided in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function; if an NSAID is used in such patients, they should be monitored for signs of worsening renal function.

The fenoprofen in ProFeno has a moderate potential interaction with Renal Dysfunction.

Increases in serum potassium concentration (including hyperkalemia) have been reported with use of nonsteroidal anti-inflammatory drugs (NSAIDs), even in some patients without renal impairment. In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state. Caution is advised in patients with hyperkalemia.

Tofacitinib has a moderate potential interaction with Renal Dysfunction.

No dose adjustment of tofacitinib is needed in patients with mild renal dysfunction. Tofacitinib-treated patients with moderate and severe renal dysfunction had greater tofacitinib blood levels than those with normal renal function; therefore, dose adjustment of tofacitinib is recommended in patients with moderate or severe renal dysfunction (including but not limited to those with severe dysfunction undergoing hemodialysis). Caution should be exercised when using tofacitinib in these patients.

The fenoprofen in ProFeno has a major potential interaction with Smoking.

Nonsteroidal anti-inflammatory drugs (NSAIDs) can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can develop at any time, with or without warning symptoms. NSAIDs should be used with caution in patients with history of peptic ulcer disease and/or GI bleeding, as these patients had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors. Caution is also advised if NSAIDs are prescribed to patients with other factors that increase risk of GI bleeding, such as: prolonged NSAID therapy; concomitant use of oral corticosteroids, antiplatelet agents (e.g., aspirin), anticoagulants, selective serotonin reuptake inhibitors; alcohol use; smoking; history of gastrointestinal surgery or anastomosis, older age; poor general health status; and advanced liver disease and/or coagulopathy. Particular vigilance is necessary when treating older adult or debilitated patients since most postmarketing reports of fatal GI events occurred in these patients.

Tofacitinib has a major potential interaction with Smoking.

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.

Tofacitinib has a major potential interaction with Smoking.

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.

The fenoprofen in ProFeno has a moderate potential interaction with Thrombocytopathy.

Nonsteroidal anti-inflammatory drugs (NSAIDs) reversibly inhibit platelet adhesion and aggregation and may prolong bleeding time in some patients. With the exception of aspirin, the platelet effects seen with most NSAIDs at usual recommended dosages are generally slight and of relatively short duration but may be more pronounced in patients with underlying hemostatic abnormalities. Thrombocytopenia has also been reported rarely during NSAID use. Therapy with NSAIDs should be administered cautiously in patients with significant active bleeding or a hemorrhagic diathesis, including hemostatic and/or coagulation defects associated with hemophilia, vitamin K deficiency, hypoprothrombinemia, thrombocytopenia, thrombocytopathy, or severe hepatic impairment. NSAIDs that selectively inhibit cyclooxygenase-2 (i.e., COX-2 inhibitors) do not appear to affect platelet function or bleeding time at indicated dosages and may be preferable if risk of bleeding is a concern.

The fenoprofen in ProFeno has a moderate potential interaction with Thrombocytopenia.

Nonsteroidal anti-inflammatory drugs (NSAIDs) reversibly inhibit platelet adhesion and aggregation and may prolong bleeding time in some patients. With the exception of aspirin, the platelet effects seen with most NSAIDs at usual recommended dosages are generally slight and of relatively short duration but may be more pronounced in patients with underlying hemostatic abnormalities. Thrombocytopenia has also been reported rarely during NSAID use. Therapy with NSAIDs should be administered cautiously in patients with significant active bleeding or a hemorrhagic diathesis, including hemostatic and/or coagulation defects associated with hemophilia, vitamin K deficiency, hypoprothrombinemia, thrombocytopenia, thrombocytopathy, or severe hepatic impairment. NSAIDs that selectively inhibit cyclooxygenase-2 (i.e., COX-2 inhibitors) do not appear to affect platelet function or bleeding time at indicated dosages and may be preferable if risk of bleeding is a concern.

Tofacitinib has a major potential interaction with Thrombotic/Thromboembolic Disorder.

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.

Tofacitinib has a major potential interaction with Tuberculosis, Active.

Use of tofacitinib should be avoided in patients with an active, serious infection. Patients should be evaluated and tested for latent or active tuberculosis (TB) infection before and per applicable guidelines during use of tofacitinib. Anti-TB therapy should also be considered before use of tofacitinib in patients with history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Consultation with a physician with expertise in the treatment of TB is recommended to aid in the decision about whether initiating anti-TB therapy is appropriate for an individual patient. Patients should be closely monitored for signs/symptoms of TB, including patients who tested negative for latent TB infection before initiating therapy. Patients with latent TB should be treated with standard antimycobacterial therapy before using tofacitinib.

Tofacitinib has a major potential interaction with Tuberculosis, Latent.

Use of tofacitinib should be avoided in patients with an active, serious infection. Patients should be evaluated and tested for latent or active tuberculosis (TB) infection before and per applicable guidelines during use of tofacitinib. Anti-TB therapy should also be considered before use of tofacitinib in patients with history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Consultation with a physician with expertise in the treatment of TB is recommended to aid in the decision about whether initiating anti-TB therapy is appropriate for an individual patient. Patients should be closely monitored for signs/symptoms of TB, including patients who tested negative for latent TB infection before initiating therapy. Patients with latent TB should be treated with standard antimycobacterial therapy before using tofacitinib.

Tofacitinib has a moderate potential interaction with Varicella-Zoster.

Viral reactivation (including cases of herpes virus reactivation [e.g., herpes zoster]) was observed in clinical trials with tofacitinib; postmarketing cases of hepatitis B reactivation have been reported with tofacitinib. Patients should be screened for viral hepatitis in accordance with clinical guidelines before starting therapy with tofacitinib. Close monitoring is recommended, and appropriate supportive treatment should be initiated if appropriate.

The fenoprofen in ProFeno has a moderate potential interaction with Vitamin K Deficiency.

Nonsteroidal anti-inflammatory drugs (NSAIDs) reversibly inhibit platelet adhesion and aggregation and may prolong bleeding time in some patients. With the exception of aspirin, the platelet effects seen with most NSAIDs at usual recommended dosages are generally slight and of relatively short duration but may be more pronounced in patients with underlying hemostatic abnormalities. Thrombocytopenia has also been reported rarely during NSAID use. Therapy with NSAIDs should be administered cautiously in patients with significant active bleeding or a hemorrhagic diathesis, including hemostatic and/or coagulation defects associated with hemophilia, vitamin K deficiency, hypoprothrombinemia, thrombocytopenia, thrombocytopathy, or severe hepatic impairment. NSAIDs that selectively inhibit cyclooxygenase-2 (i.e., COX-2 inhibitors) do not appear to affect platelet function or bleeding time at indicated dosages and may be preferable if risk of bleeding is a concern.