Discontinue if adequate therapeutic benefit is not achieved after 24 wk. Serious infections (eg, herpes simplex, herpes zoster & pneumonia). Not to be initiated in patients w/ active, serious systemic infection. Consider risks & benefits of treatment prior to initiating in patients w/ chronic or recurrent infection, history of a serious or an opportunistic infection, underlying conditions predisposing them to infection, exposed to TB, or have resided or traveled in areas of endemic TB or mycoses. Closely monitor for signs & symptoms of infection during & after treatment. Perform prompt & complete diagnostic testing & initiate appropriate antimicrobial therapy in patient who develops new infection during treatment. Screen for TB before starting therapy & consider yrly screening for patients in highly endemic areas for TB; not to be given to patients w/ active TB. Start preventive therapy for latent TB prior to treatment initiation in patients w/ a new diagnosis of or prior untreated latent TB. Viral reactivation. Consider temporary treatment interruption in patients who develops herpes zoster; discontinuation or interruption of therapy until resolution of eczema herpeticum. Perform viral hepatitis screening before starting & during therapy. Use of live, attenuated vaccines during or immediately prior to therapy is not recommended. Risk of DVT/pulmonary embolism (PE) in patients w/ older age, obesity, a medical history of DVT/PE, prothrombotic disorder, concomitantly using combined hormonal contraceptives or HRT & in those undergoing major surgery or prolonged immobilisation. Discontinue treatment & promptly evaluate patients if DVT/PE occurs. May increase risk of malignancies including lymphoma. Consider the risk & benefits of treatment prior to initiating in patients w/ a known malignancy other than a successfully treated non-melanoma skin cancer or cervical cancer in situ or when continuing therapy in patients who develop a malignancy. Periodic skin exam is recommended for patients who are at increased risk for skin cancer. Do not initiate in patients w/ platelet count <150 × 10
3/mm
3 (discontinue if platelet count <50 × 10
3/mm
3), ALC <0.5 × 10
3/mm
3, ANC <1 × 10
3/mm
3 or those who have a Hb value <8 g/dL. Monitor platelet count & ALC 4 wk after therapy initiation & thereafter according to routine patient management. Assess lipid parameters approx 4 wk following therapy initiation & thereafter according to their CV disease risk. Monitor & manage patients according to clinical guidelines due to the known CV risks associated w/ hyperlipidaemia. Not recommended in concomitant use w/ moderate or strong CYP2C19/CYP2C9 enzyme inducers (eg, rifampin, apalutamide, efavirenz, enzalutamide, phenytoin). Do not use in patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Contains <1 mmol Na (23 mg/tab). Possible dizziness during treatment; may affect ability to drive & use machines. Patients w/ ESRD on renal replacement therapy. Women of reproductive potential should use effective contraception during treatment & for 1 mth following the final dose. Not recommended for childn <12 yr. Elderly ≥65 yr.
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