Remsima 120 mg

In combination w/ MTX for reduction of signs & symptoms of RA in adults w/ active disease when response to DMARDs including MTX is inadequate; severe, active & progressive disease not previously treated w/ MTX or other DMARDs.

SC Adult ≥18 yr 120 mg inj once every 2 wk, in combination w/ MTX. Initial as maintenance therapy: Administer 4 wk after last 2 infliximab 3 mg/kg IV infusion given 2 wk apart. Switch from the maintenance therapy of infliximab IV: Administered 8 wk after the last administration of the IV infusion of infliximab.

Hypersensitivity to infliximab & other murine proteins. Patients w/ TB or other severe infections eg, sepsis, abscesses & opportunistic infections; moderate to severe heart failure (NYHA class III/IV).

Not intended for IV administration. Systemic inj reactions, anaphylactic shock & delayed hypersensitivity reactions. Discontinue treatment if patient develops new serious infection or sepsis; HBV reactivation; jaundice &/or ALT elevations ≥5x ULN. Consider discontinuation if new onset or exacerbation of CNS (including multiple sclerosis) & peripheral (including Guillain-Barre syndrome) demyelinating disorders develop; in patients w/ confirmed significant haematologic abnormalities. Not to initiate treatment if active TB is diagnosed; in patients w/ fistulising Crohn's disease w/ acute suppurative fistulas. Not to give further treatment if patient develops symptoms suggestive of lupus-like syndrome; serious infection or sepsis following treatment. TB, bacterial infections including sepsis & pneumonia, invasive fungal, viral, & other opportunistic infections eg, pneumocytosis, candidiasis, listeriosis & aspergillosis. Not to be continued in patients who develop new or worsening symptoms of heart failure. Reactivation of hepatitis B. Jaundice & non-infectious hepatitis w/ features of autoimmune hepatitis; liver failure. Hepatosplenic T-cell lymphoma; melanoma and Merkel cell carcinoma; pancytopenia, leukopenia, neutropenia & thrombocytopenia; leukemia. Increased risk of cancer development in patients w/ newly diagnosed dysplasia treated w/ infliximab. Switching between biological DMARDs. Patients w/ chronic infection or history of recurrent infections including concomitant immunosuppressive therapy; travel history to regions where invasive fungal infections eg, histoplasmosis, coccidioidomycosis, or blastomycosis are endemic; pre-existing or recent onset of demyelinating disorders; moderate to severe COPD; history of malignancy or increased risk for malignancy due to heavy smoking; psoriasis & medical history of extensive immunosuppressant therapy or prolonged PUVA treatment; mild heart failure (NYHA class I/II); who have undergone surgical procedures eg, arthroplasty. Pretreat w/ antihistamine, hydrocortisone &/or paracetamol to prevent mild & transient anaphylactic effects. Closely monitor patients for signs & symptoms of delayed hypersensitivity; infections including TB before, during & after treatment; development of new infection while undergoing treatment; signs & symptoms of active HBV infection throughout therapy & for several mth following termination of therapy; for infections in those who require surgery. Evaluate for both active & inactive TB before starting treatment; evidence of liver injury in patients w/ signs & symptoms of liver dysfunction. Consider anti-TB therapy in patients w/ history of latent or active TB before initiation of infliximab treatment; antifungal therapy in patients w/ risk of severe fungal infection. Test for HBV infection before initiating treatment. Perform periodic skin exam in patients w/ risk factors for skin cancer; periodic screening in treated women & those >60 yr. Screen all patients w/ ulcerative colitis at increased risk for dysplasia or colon carcinoma, or who had history of dysplasia or colon carcinoma for dysplasia at regular intervals before therapy & throughout disease course. Increased susceptibility to infections in patients taking TNF-blockers. Not recommended to use concomitantly w/ anakinra; abatacept; other biological therapeutics; live vaccines. Concomitant use w/ azathioprine or mercaptopurine. Minor influence on ability to drive & use machines. Women of childbearing potential must use adequate contraception during & at least 6 mth after treatment. Pregnancy. Not to breastfeed until at least 6 mth after treatment. Malignancies in childn, adolescents & young adults up to 22 yr. Childn <18 yr. Elderly ≥65 yr.

Viral infection eg, flu, herpes virus infection; headache; URTI, sinusitis; abdominal pain, nausea; infusion-related reaction, pain. Bacterial infections eg, sepsis, cellulitis, abscess; neutropenia, leukopenia, anaemia, lymphadenopathy; allergic resp symptom; depression, insomnia; vertigo, dizziness, hypoaesthesia, paraesthesia; conjunctivitis; tachycardia, palpitation; hypotension, HTN, ecchymosis, hot flush, flushing; lower resp tract infection (eg, bronchitis, pneumonia), dyspnoea, epistaxis; GI haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation; abnormal hepatic function, increased transaminases; new onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis, dry skin, fungal dermatitis, eczema, alopecia; arthralgia, myalgia, back pain; UTI; chest pain, fatigue, fever, inj site reaction, chills, oedema.

Not to be given concomitantly w/ other biological therapeutics; live vaccines; therapeutic infectious agents.

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

L04AB02 - infliximab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.

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