Xeljanz

Tofacitinib

Adult patients w/ moderately to severely active RA who had inadequate response or intolerant to MTX, as monotherapy or in combination w/ MTX or other nonbiologic DMARDs. Adult patients w/ active psoriatic arthritis (PsA) who had inadequate response or intolerant to MTX or other DMARDs. Adult patients w/ moderately to severely active ulcerative colitis (UC) who had inadequate response or intolerant to TNF blockers. Not recommended to be used in combination w/ biologic DMARDs or potent immunosuppressants eg, azathioprine & cyclosporine.

RA & PsA 5 mg bd. UC Induction: 10 mg bd for at least 8 wk, may be continued for max: 16 wk. Maintenance: 5 mg bd. Moderate or severe renal impairment & moderate hepatic impairment 5 mg once daily.

May be taken with or without food.

Hypersensitivity.

Hypersensitivity reactions eg, angioedema & urticaria. Discontinue use in patients w/ thrombosis & avoid use in patients at increased risk of thrombosis. Not to be initiated in active infection. Serious & sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral or other opportunistic pathogens. Pneumonia, cellulitis, herpes zoster, UTI, diverticulitis & appendicitis. TB & other mycobacterial infections, cryptococcus, histoplasmosis, esophageal candidiasis, multidermatomal herpes zoster, cytomegalovirus & BK virus infections & listeriosis. ILD; malignancies; viral, hepatitis B & herpes virus reactivation (eg, herpes zoster appears to be higher in Japanese & Korean patients), viral hepatitis screening. Lymphomas, non-melanoma skin cancers; GI perforation. History of chronic lung disease; diabetes. Evaluate & test patients for latent or active TB prior to treatment. Monitor signs & symptoms of infection & TB. Assess for VTE risk factors prior to & periodically during treatment. Periodic skin exam in patients at increased risk of skin cancer. Monitor lab parameters eg, lymphocyte, neutrophil, Hb, lipids. Not recommended to be given concurrently w/ live vaccines. Concomitant use w/ MTX or corticosteroids. Dose should be given after dialysis session for patients undergoing hemodialysis; supplemental doses are not recommended in patients after dialysis if dose is taken prior to procedure. Not recommended in severe hepatic impairment. Moderate or severe renal & moderate hepatic impairment. May reduce female fertility. Women of reproductive potential should use effective contraception during treatment & at least 4 wk after last dose. Pregnancy. Not recommended during lactation. Ped. Elderly.

Nasopharyngitis, elevated cholesterol levels, headache, URTI, increased blood creatine phosphokinase, rash, diarrhea, herpes zoster, gastroenteritis, anemia, nausea.

Increased exposure w/ strong CYP3A4 inhibitors (eg, ketoconazole), moderate CYP3A4 inhibitors co-administered w/ strong CYP2C19 inhibitors (eg, fluconazole). Decreased exposure & loss or reduced clinical response w/ strong CYP3A4 inducers (eg, rifampin). Risk of added immunosuppression w/ immunosuppressive drugs (eg, azathioprine, tacrolimus, cyclosporine).

Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants

L04AF01 - tofacitinib ; Belongs to the class of Janus-associated kinase (JAK) inhibitors. Used as immunosuppressants.

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