Zuellig Pharma
Concise Prescribing Info
In combination w/ methotrexate (MTX) for the reduction of signs & symptoms as well as the improvement in physical function in patients w/ active disease when response to disease-modifying antirheumatic drugs (DMARDs) including MTX has been inadequate; patients w/ severe, active & progressive disease not previously treated w/ MTX or other DMARDs. Moderately to severely active Crohn's disease in patients not responsive of full & adequate course of therapy w/ a corticosteroid & an immunosuppressant, or who are intolerant to or have medical CI for such therapies. Fistulizing Crohn's disease in patients not responsive of a full & adequate course of conventional treatment. Severe, active Crohn's disease in ped patients (6-17 yr) who have not responded to conventional therapy including corticosteroid; or who are intolerant to or have CI for such therapies. Moderately to severely active ulcerative colitis (UC) in patients who have had an inadequate response to conventional therapy including corticosteroids & 6-mercaptopurine or azathioprine, or who are intolerant to or have medical CI for such therapies. Reducing signs & symptoms & inducing & maintaining clinical remission in ped patients (≥6 yr) w/ moderately to severely active UC who have had an inadequate response to conventional therapy. Ankylosing spondylitis in patients who have severe axial symptoms, elevated serological markers of inflammatory activity & who have responded inadequately to conventional therapy. In combination w/ MTX for active & progressive psoriatic arthritis in patients who have responded inadequately to DMARDs. Moderate to severe plaque psoriasis in adults, who failed to respond to, or who have a CI, or are intolerant to other systemic therapy including cyclosporine, MTX or PUVA.
Dosage/Direction for Use
IV Adult ≥18 yr RA 3 mg/kg over a 2-hr period followed by additional 3 mg/kg infusion doses at 2 & 6 wk after the 1st infusion, then every 8 wk thereafter. To be given concomitantly w/ MTX. Moderately to severely, active Crohn's disease 5 mg/kg over a 2-hr period of infusion. Maintenance: Additional 5 mg/kg infusions at 2 & 6 wk after the initial dose, followed by infusions every 8 wk. Fistulizing Crohn's disease Initially 5 mg/kg infusion over a 2-hr period followed w/ additional 5 mg/kg infusion doses at 2 & 6 wk after the 1st infusion. Responding patient: Additional 5 mg/kg infusions every 8 wk or re-administration if signs & symptoms of the disease recur followed by 5 mg/kg infusions every 8 wk. UC, psoriatic arthritis & psoriasis 5 mg/kg infusion over a 2-hr period followed by additional 5 mg/kg infusion doses at 2 & 6 wk after the 1st infusion, then every 8 wk thereafter. Ankylosing spondylitis 5 mg/kg over a 2-hr period followed by additional 5 mg/kg infusion doses at 2 & 6 wk after the 1st infusion, then every 6-8 wk. Re-administration for Crohn's disease & RA Re-administer w/in 16 wk following the last infusion, if signs & symptoms recur. Ped 6-17 yr Crohn's disease & UC 5 mg/kg infusion over a 2-hr period followed by additional 5 mg/kg infusion doses at 2 & 6 wk after the 1st infusion, then every 8 wk thereafter.
Hypersensitivity to infliximab or other murine proteins. Re-administration to patients who experienced severe hypersensitivity to infliximab products. Patients w/ moderate to severe heart failure (NYHA functional class III/IV); TB or other severe infections (eg, sepsis, abscesses & opportunistic infections).
Special Precautions
Evaluate for active & inactive (latent) TB prior to initiation of treatment. Active TB including miliary TB & TB w/ extrapulmonary location. Patients w/ mild heart failure (NYHA class I/II); closely monitor & discontinue use in patients who develop new or worsening heart failure symptoms. Interrupt infusion immediately if acute infusion reactions occur; may be pre-treated w/ antihistamine, hydrocortisone &/or paracetamol to prevent mild & transient effects. Greater risk of developing Abs in patients who discontinue immunosuppressants prior to or during Ixifi treatment. Closely monitor signs & symptoms of delayed hypersensitivity if re-treated after a prolonged period. Carefully consider the benefit-risk of re-administration of Ixifi after a period of no-treatment, especially as a re-induction regimen given at wk 0, 2 & 6. Closely monitor for infections (including TB) before, during & after treatment; do not give further treatment if patient develops a serious infection or sepsis. Should not be given in patient w/ a clinically important, active infection. Patients w/ chronic infection or history of recurrent infections, including use of concomitant immunosuppressive medications. Suppression of tumour necrosis factor-α (TNF-α) may mask symptoms of infection eg, fever. Patients taking TNF-blockers are more susceptible to serious infections. Patients who have resided in or traveled to regions where invasive fungal infections eg, histoplasmosis, coccidioidomycosis, or blastomycosis are endemic. Must not initiate therapy in patients w/ fistulizing Crohn's disease w/ acute suppurative fistulas until a source for possible infection, specifically abscess, has been excluded. Discontinue if HBV reactivation develops. Evaluate patients at risk for HBV infection prior to initiating therapy. Evaluate for evidence of liver injury. Discontinue use if jaundice &/or ALT elevations ≥5 times the upper limit of normal develops. Not recommended to be used concurrently w/ etanercept, anakinra; abatacept; other biological therapeutics; live vaccines. Monitor patients when switching from one biological DMARD to another. Not to be used concurrently w/ therapeutic infectious agents eg, live attenuated bacteria (eg, BCG bladder instillation for cancer treatment). Further treatment must not be given if patient develops symptoms suggestive of lupus-like syndrome & positive for Ab against double-stranded DNA. Patients w/ seizure & new onset or exacerbation of clinical symptoms &/or radiographic evidence of CNS demyelinating disorders; consider discontinuation if these disorders develop. Risk of malignancies & lymphoproliferative disorders. Patients w/ increased risk of malignancy due to heavy smoking; w/ psoriasis & a medical history of extensive immunosuppressant therapy or prolonged PUVA treatment. Monitor psoriasis patients for non-melanoma skin cancers, particularly those who have had prior prolonged phototherapy treatment. Potential ped malignancy. Risk of developing of hepatosplenic T-cell lymphoma. Patients w/ UC who are at increased risk or who had a prior history of dysplasia or colon carcinoma should be screened at regular intervals prior to therapy & throughout disease course. Potential acute & chronic leukemia. Melanoma & Merkel cell carcinoma. Increased incidence of cervical cancer in women w/ RA. Consider discontinuation in patients who develop significant hematologic abnormalities. Patients who have undergone arthroplasty; w/ intestinal strictures due to Crohn's disease. Re-administration for UC & psoriatic arthritis other than every 8 wk. Re-administration for ankylosing spondylitis other than every 6 to 8 wk. Re-administration for psoriasis. May affect ability to drive & use machines. Patients w/ renal & hepatic impairment. Women of childbearing potential should use adequate contraception & continue its use for at least 6 mth after the last infliximab treatment. Potentially fatal outcome in infant who received BCG vaccine after in utero exposure to infliximab; at least 6-mth waiting period is recommended prior to live vaccine administration in infant exposed in utero to infliximab. Women should not breasfeed during & for at least 6 mth after treatment. Childn <6 yr w/ Crohn's disease or UC. Elderly ≥65 yr.
Adverse Reactions
Viral infection (eg, flu, herpes infections); serum sickness-like reactions; headache, vertigo/dizziness; flushing; upper & lower resp tract infections (eg, bronchitis, pneumonia), dyspnea, sinusitis; nausea, diarrhea, abdominal pain, dyspepsia, vomiting; abnormal hepatic function, cholecystitis; rash, pruritus, urticaria, increased sweating, dry skin; fatigue, chest pain, infusion-related reactions, fever; elevated hepatic transaminases. Lupus-like syndrome. Infusion-related reactions.
Drug Interactions
Potential increased plasma conc w/ MTX & other immunomodulators. Not recommended in combination w/ other biological therapeutics used to treat the same conditions, including anakinra & abatacept. Not to be given concurrently w/ live vaccines; therapeutic infectious agents.
ATC Classification
L04AB02 - infliximab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Ixifi powd for conc for soln for infusion 100 mg
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