Arthritis/rheumatic disorders:

Indications for: XELJANZ ORAL SOLUTION

Active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients ≥2yrs.

Adult Dosage:

Not applicable.

Children Dosage:

<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.

Boxed Warning:

Serious infections. Mortality. Malignancy. 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 10mg twice daily dose: increased rate of all-cause mortality or thrombosis. Avoid in those with increased risk for thombosis. Known malignancy: consider risks/benefits prior to initiation. 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 immunization based on current guidelines prior to initiating therapy. 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).

See Also:

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.

Adverse Reactions:

Upper respiratory tract infections, headache, diarrhea, nasopharyngitis, elevated cholesterol, increased blood CPK, rash, herpes zoster; serious or opportunistic infections, TB, malignancies (eg, lymphoma), thrombosis (evaluate and discontinue if occurs), cytopenias, liver enzyme or lipid elevations, non-melanoma skin cancer, hypersensitivity reactions.

Generic Drug Availability:

NO

How Supplied:

Tabs 5mg—28, 60; 10mg—28, 60, 180; XR tabs 11mg—14, 30; 22mg—30; Oral soln—240mL (w. dosing syringe)