Zuellig Pharma
Concise Prescribing Info
Adult patients w/ moderately to severely active RA who had an inadequate response or intolerance to MTX, as monotherapy or in combination w/ MTX or other nonbiologic DMARDs. Adult patients w/ active psoriatic arthritis (PsA) who had an inadequate response or intolerance to MTX or other DMARDs. Not recommended to be used in combination w/ biologic DMARDs or potent immunosuppressants eg, azathioprine & cyclosporine.
Dosage/Direction for Use
5 mg bd. Moderate or severe renal impairment & moderate hepatic impairment 5 mg once daily.
May be taken with or without food.
Special Precautions
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. Periodic skin exam for those at increased risk of skin cancer. Monitor lab parameters eg, lymphocyte, neutrophil, Hb, lipids. Not recommended to be given concurrently w/ live vaccines. 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. Women of reproductive potential should use effective contraception during treatment & at least 4 wk after last dose. Not to be used during pregnancy. Not recommended during lactation. Elderly.
Adverse Reactions
Pneumonia, cellulitis, herpes zoster, UTI, diarrhea, nasopharyngitis, URTI, headache, HTN, liver enzymes, lipid & serum creatinine elevations, anemia, diverticulitis, dehydration, insomnia, paresthesia, dyspnea, cough, sinus congestion, ILD, abdominal pain, dyspepsia, vomiting, gastritis, nausea, hepatic steatosis, rash, erythema, pruritus, musculoskeletal pain, arthralgia, tendonitis, joint swelling, non-melanoma skin cancer, thrombosis, pyrexia, fatigue, peripheral edema. Malignancy eg, lung, breast, gastric, colorectal, renal cell, prostate & pancreatic cancer, lymphoma, malignant melanoma.
Drug Interactions
Potent CYP3A4 inhibitors (eg, ketoconazole) & inducers (eg, rifampin), moderate CYP3A4 & potent CYP2C19 inhibitors (eg, fluconazole), immunosuppressive drugs (eg, azathioprine, tacrolimus, cyclosporine).
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants
ATC Classification
L04AA29 - tofacitinib ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Xeljanz FC tab 5 mg
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