Indications for: XELJANZ ORAL SOLUTION
Active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients ≥2yrs who have had an inadequate response or intolerance to 1 or more TNF blockers.
Limitations of Use:
Not recommended in combination with other biologic DMARDs, or potent immunosuppressants (eg, azathioprine, cyclosporine).
<2yrs: not established. 2–17yrs (10–<20kg): 3.2mg (3.2mL) twice daily; (20–<40kg): 4mg (4mL) twice daily; (≥40kg): 5mg (5mL) twice daily. Moderate to severe renal impairment (hemodialysis: give after session) or moderate hepatic impairment; concomitant strong CYP3A4 inhibitors, or drugs that result in both moderate CYP3A4 and strong CYP2C19 inhibition: reduce dosing frequency to once daily. Other dose adjustments: see full labeling.
Serious infections. Mortality. Malignancy. Major adverse cardiovascular events (MACE). Thrombosis.
XELJANZ ORAL SOLUTION Warnings/Precautions:
XR tabs are not interchangeable or substitutable with oral soln. Increased risk of serious or fatal infections (eg, TB, bacterial, viral, invasive fungal, or other opportunistic pathogens) esp. with 10mg twice daily dose (in UC treatment). Avoid in active, serious, or localized infections. Chronic, recurrent, or history of serious or opportunistic infections. Travel to, or residence in, areas with endemic TB or mycoses. Conditions that predispose to infection. Test/treat latent TB infection prior to and per applicable guidelines during therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of herpes virus or hepatitis occurs; interrupt treatment if serious or opportunistic infection, or sepsis develops. Screen for viral hepatitis (eg, Hep B or C) prior to initiation. History of chronic lung disease or in those who develop interstitial lung disease. RA patients age ≥50yrs with ≥1 CV risk factor on 5mg or 10mg twice daily dose: increased rate of all-cause mortality (including sudden CV death), MACE (CV death, MI, stroke), or thrombosis. Discontinue in those with previous MI or stroke, or with symptoms of thrombosis. Avoid in those with increased risk for thrombosis. RA patients on 5mg or 10mg twice daily: increased rate of malignancies (esp. lymphomas, lung cancers). Consider benefits/risks prior to or continuing therapy (esp. smokers, with other CV risk factors, or with a known malignancy). GI perforation risk (eg, history of diverticulitis). Discontinue and evaluate if serious hypersensitivity reaction occurs. Monitor lymphocytes at baseline, then every 3 months; neutrophils and hemoglobin at baseline, after 4–8 weeks, then every 3 months thereafter. Do not initiate therapy if lymphocytes <500cells/mm3, ANC <1000cells/mm3, or hemoglobin <9g/dL. Severe hepatic impairment: not recommended. Routinely monitor liver enzymes; interrupt therapy if drug-induced liver injury suspected. Monitor lipids 4–8 weeks following initiation. Perform periodic skin exam in those with skin cancer risk. Update immunizations based on current guidelines prior to initiation. XR tabs: pre-existing severe GI narrowing. Diabetes. Elderly. Pregnancy: females of reproductive potential should consider prevention. Nursing mothers: not recommended (during and for ≥18hrs [tabs/oral soln] or ≥36hrs [XR tabs] after last dose).
XELJANZ ORAL SOLUTION Classification:
Janus kinase (JAK) inhibitor.
XELJANZ ORAL SOLUTION Interactions:
Concomitant live vaccines, biologic DMARDs, biologics for UC, or potent immunosuppressants (eg, azathioprine, cyclosporine, tacrolimus): not recommended. Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole), or drugs that result in both moderate CYP3A4 and strong CYP2C19 (eg, fluconazole) inhibition; adjust dose. Antagonized by strong CYP3A4 inducers (eg, rifampin); avoid concomitant use. Caution with NSAIDs.
Upper respiratory tract infections, headache, diarrhea, nasopharyngitis, elevated cholesterol, increased blood CPK, rash, herpes zoster; serious or opportunistic infections, TB, malignancies, thrombosis, cytopenias, liver enzyme or lipid elevations, non-melanoma skin cancer, hypersensitivity reactions.
Generic Drug Availability:
Tabs 5mg—28, 60; 10mg—28, 60, 180; XR tabs 11mg—14, 30; 22mg—30; Oral soln—240mL (w. dosing syringe)