Ixifi

Ixifi

infliximab

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Infliximab
Indications/Uses
Chronic severe (extensive &/or disabling) plaque psoriasis who are candidates for systemic therapy & when other systemic therapies are medically less appropriate. Reduction of signs & symptoms, inducing & maintaining clinical remission in adults & ped patients ≥6 yr w/ moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. Reducing the number of draining enterocutaneous & rectovaginal fistulas & maintaining fistula closure in adults w/ fistulizing Crohn's disease. Reduction of signs & symptoms, inducing & maintaining clinical remission & mucosal healing & eliminating corticosteroid use in adults w/ moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy. Reduction of signs & symptoms, inducing & maintaining clinical remission in ped patients ≥6 yr w/ moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy. In combination w/ methotrexate, for reducing signs & symptoms, inhibiting the progression of structural damage & improving physical function in patients w/ moderately to severely active RA. Reducing signs & symptoms of active ankylosing spondylitis. Reducing signs & symptoms of active arthritis, inhibition of progression of structural damage, & improvement of physical function in psoriatic arthritis.
Dosage/Direction for Use
Moderately to severely active or fistulizing Crohn's disease Adult 5 mg/kg as IV induction regimen at 0, 2, & 6 wk followed by a maintenance regimen of 5 mg/kg every 8 wk, thereafter. Consider 10 mg/kg in adults who respond & then lose their response. Moderately to severely Crohn's disease Ped patients ≥6 yr 5 mg/kg as IV induction regimen at 0, 2, & 6 wk followed by a maintenance regimen of 5 mg/kg every 8 wk. Moderate to severe active ulcerative colitis Adult & ped patients ≥6 yr 5 mg/kg as IV induction regimen at 0, 2, & 6 wk followed by a maintenance regimen of 5 mg/kg every 8 wk. Moderate to severe active RA In combination w/ methotrexate: 3 mg/kg as an IV induction regimen at 0, 2, & 6 wk followed by a maintenance regimen of 3 mg/kg every 8 wk thereafter. Patients w/ incomplete response Dose may be adjusted up to 10 mg/kg or treating as often every 4 wk. Active ankylosing spondylitis 5 mg/kg as an IV induction regimen at 0, 2, & 6 wk followed by a maintenance regimen of 5 mg/kg every 6 wk thereafter. Psoriatic arthritis 5 mg/kg as IV induction regimen at 0, 2 & 6 wk followed by a maintenance regimen of 5 mg/kg every 8 wk, as monotherapy or in combination w/ methotrexate. Chronic severe (extensive &/or disabling) plaque psoriasis 5 mg/kg as IV induction regimen at 0, 2 & 6 wk followed by a maintenance regimen of 5 mg/kg every 8 wk thereafter.
Contraindications
Hypersensitivity to infliximab or other murine proteins. TB or other severe infections eg, sepsis, abscesses, & opportunistic infections. Moderate or severe heart failure (NYHA class III/IV).
Special Precautions
Active infusion-related reactions, including anaphylactic shock, & delayed hypersensitivity reactions. May premedicate patients w/ an antihistamine, hydrocortisone &/or paracetamol. Patients who discontinue immunosuppressants prior to or during treatment are at greater risk of developing Ab to infliximab. Closely monitor for infections (eg, TB) before, during & 6 mth after treatment. Patients w/ chronic infection or history of recurrent infections including concomitant immunosuppressive therapy; receiving TNF-blockers; increased risk for malignancy due to heavy smoking, or w/ history of or who develop malignancy; psoriasis & history of extensive immunosuppressant therapy or prolonged PUVA treatment; mild heart failure (NYHA class I/II); controlled Na diet. Evaluate for active & latent TB prior to start of therapy; do not initiate if active TB is diagnosed; consider anti-TB therapy in patients w/ history of latent or active TB in whom adequate course of treatment cannot be confirmed. Invasive fungal infections. Do not initiate therapy in patients w/ fistulizing Crohn's disease w/ acute suppurative fistulas. HBV reactivation; test for HBV infection before initiating treatment; discontinue use if HBV reactivation develops. Evaluate for evidence of liver injury; discontinue use if jaundice &/or ALT-elevations ≥5 x ULN develops. Discontinue use if symptoms suggestive of a lupus-like syndrome following treatment & is positive for Ab against double-stranded DNA develops. Carefully consider preexisting or recent onset of demyelinating disorders prior to initiating therapy. Periodic skin exam is recommended particularly for patients w/ risk factors for skin cancer. Screen all patients w/ ulcerative colitis who are at increased risk for or had prior history of dysplasia or colon carcinoma at regular intervals before therapy & during treatment. Consider discontinuing in patients w/ confirmed significant hematologic abnormalities. Monitor patient who requires surgery for infections during therapy. Concomitant use w/ anakinra, abatacept, other biological therapeutics used to treat the same conditions, live vaccines is not recommended; therapeutic infectious agents eg, live attenuated bacteria; AZA or 6-MP. Switching between biological DMARDs. May have a minor influence on the ability to drive & use machines. Women of childbearing potential should consider use of adequate contraception for at least 6 mth after the last treatment. Pregnancy. Women must not breastfeed for at least 6 mth after treatment. Administration of live vaccines to infants exposed to infliximab in utero is not recommended for at least 6 mth after birth. Childn w/ Crohn's disease &/or ulcerative colitis <6 yr; childn & adolescents w/ juvenile RA <18 yr. Elderly.
Adverse Reactions
Viral infection (eg, flu, herpes virus infection); headache; upper resp tract infection, sinusitis; abdominal pain, nausea; infusion-related reaction, pain. Bacterial infections (eg, sepsis, cellulitis, abscess); neutropenia, leukopenia, anemia, lymphadenopathy; allergic resp symptom; depression, insomnia; vertigo, dizziness, hypoesthesia, paresthesia; conjunctivitis; tachycardia, palpitation; hypotension, HTN, ecchymosis, hot flush, flushing; lower resp tract infection (eg, bronchitis, pneumonia), dyspnea, epistaxis; GI hemorrhage, diarrhea, 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, edema.
Drug Interactions
Other biological therapeutics used to treat the same conditions eg, anakinra & abatacept. Live vaccines & therapeutic infectious agents.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants
ATC Classification
L04AB02 - infliximab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Ixifi infusion 100 mg
Packing/Price
1's
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