Zuellig Pharma
Concise Prescribing Info
In combination w/ methotrexate (MTX) for reducing the signs & symptoms of RA in adult patients w/ moderately to severely active RA who have had inadequate response to MTX. Monotherapy in cases of intolerance to MTX.
Dosage/Direction for Use
5 mg bd in combination w/ MTX. Monotherapy may be considered in cases of intolerance to MTX. Moderate or severe renal impairment Reduce to 5 mg once daily. Moderate hepatic impairment Reduce to 5 mg once daily. Patient receiving potent CYP3A4 inhibitors (eg, ketoconazole); or receiving ≥1 medication resulting to both moderate CYP3A4 inhibition & potent CYP2C19 inhibition (eg, fluconazole) Reduce to 5 mg once daily.
May be taken with or without food.
Special Precautions
Promptly discontinue if serious hypersensitivity reaction occurs. Risk of serious or opportunistic infections; events of interstitial lung disease. Do not initiate in patients w/ an active infection including localized infections. Patients w/ chronic or recurrent infections, or those who have been exposed to TB, history of a serious or an opportunistic infection, resided or travelled in areas of endemic TB or endemic mycoses; underlying conditions that may predispose to infection; diabetes, history of chronic lung disease. Monitor for development of signs & symptoms of infection (during & after treatment) & TB. Evaluate & test patients for latent or active infection prior to & during administration. Perform screening for viral hepatitis before therapy. Higher risk of herpes zoster in Japanese & Korean patients. Assess patients for risk factors & urgently evaluate patients w/ signs & symptoms of venous thromboembolism. Malignancy & lymphoproliferative disorder (excluding nonmelanoma skin cancer). Perform periodic skin exam in patients at increased risk of skin cancer. Patients who may be at increased risk for GI perforation (eg, history of diverticulitis). Not recommended to initiate in patients w/ lymphocyte count <500 cells/mm3, or those w/ absolute neutrophil count <1,000 cells/mm3, or in patients w/ Hb <9 g/dL. Monitor lymphocyte at baseline & every 3 mth thereafter; neutrophils & Hb at baseline & after 4-8 wk of treatment & every 3 mth thereafter. Routinely monitor liver enzymes. Assess lipid parameters approx 4-8 wk following initiation of therapy. Do not concurrently give w/ live vaccines. Avoid use in combination w/ biological DMARDs. Reduce dose in moderate or severe renal impairment & moderate hepatic impairment. Do not use in severe hepatic impairment. Women of reproductive potential should use effective contraception during treatment & for at least 4 wk after the last dose. Pregnancy. Do not breastfeed. Childn <18 yr.
Adverse Reactions
Pneumonia, flu, herpes zoster, UTI, sinusitis, bronchitis, nasopharyngitis, pharyngitis; anaemia; hyperlipidaemia; headache; HTN; cough; abdominal pain, vomiting, diarrhoea, nausea, gastritis, dyspepsia; rash; arthralgia; pyrexia, peripheral oedema, fatigue; increased γ-glutamyltransferase, blood cholesterol, wt & blood creatine phosphokinase.
Drug Interactions
Increased exposure w/ potent (eg, ketoconazole) & moderate CYP3A4 inhibitors; potent CYP2C19 inhibitors (eg, fluconazole). Decreased exposure w/ potent CYP inducers (eg, rifampin). Increased AUC & decreased Cmax w/ tacrolimus & cyclosporine. Decreased AUC & Cmax of MTX.
ATC Classification
L04AA29 - tofacitinib ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Xeljanz FC tab 5 mg
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Sign up for free
Already a member? Sign in