Infliximab


Generic Medicine Info
Indications and Dosage
Intravenous
Rheumatoid arthritis
Adult: In combination with methotrexate for the treatment of moderate to severe cases: 3 mg/kg at weeks 0, 2, and 6, followed by maintenance dose of 3 mg/kg every 8 weeks thereafter. If response is incomplete, may consider adjusting the dose up to 10 mg/kg every 8 weeks; alternatively, the 3 mg/kg dose may be given as often as every 4 weeks. Doses are given via IV infusion over at least 2 hours. If signs and symptoms recur, re-administer treatment within 16 weeks following the last infusion. Dosage and treatment recommendations may vary among countries (refer to specific product guidelines).

Intravenous
Crohn's disease
Adult: For the treatment of moderate to severe cases with inadequate response to conventional therapy: 5 mg/kg at weeks 0, 2, and 6, followed by maintenance dose of 5 mg/kg every 8 weeks thereafter. If response is incomplete during maintenance treatment, may consider adjusting the dose up to 10 mg/kg. Alternatively, an initial 5 mg/kg dose may be followed by repeat 5 mg/kg infusions when signs and symptoms of the disease recur. Re-administration of treatment when signs and symptoms recur may be done within 16 weeks following the last infusion. Doses are given via IV infusion over at least 2 hours. Dosage recommendations may vary among countries (refer to specific product guidelines).
Child: 6-17 years For the treatment of moderate to severe cases in patients who have an inadequate response to conventional therapy or for patients who are intolerant to or have contraindications for such therapy: In combination with immunosuppressive therapy: 5 mg/kg at weeks 0, 2, and 6, followed by maintenance dose of 5 mg/kg every 8 weeks thereafter. Doses are given via IV infusion over at least 2 hours. Dosage and treatment recommendations may vary among countries (refer to specific product guidelines).

Intravenous
Ulcerative colitis
Adult: For the treatment of moderate to severe cases with inadequate response to conventional therapy: 5 mg/kg at weeks 0, 2, and 6, followed by maintenance dose of 5 mg/kg every 8 weeks thereafter. Doses are given via IV infusion over at least 2 hours. Treatment recommendations may vary among countries (refer to specific product guidelines).
Child: 6-17 years For the treatment of moderate to severe cases with inadequate response to conventional therapy, or for severe cases who are intolerant to or have contraindications for conventional therapy: Same as adult dose.

Intravenous
Fistulising Crohn's disease
Adult: To reduce the number of draining enterocutaneous and rectovaginal fistulae and maintain fistula closure: 5 mg/kg at weeks 0, 2, and 6. If response is inadequate after the 3 doses, no additional treatment should be given. In responding patients, give a maintenance dose of 5 mg/kg every 8 weeks. If signs and symptoms recur, re-administer 5 mg/kg followed by 5 mg/kg every 8 weeks. Re-administration of treatment may be done within 16 weeks following the last infusion. Doses are given via IV infusion over at least 2 hours.

Intravenous
Ankylosing spondylitis
Adult: 5 mg/kg at weeks 0, 2, and 6, followed by maintenance dose of 5 mg/kg every 6-8 weeks thereafter. Doses are given via IV infusion over at least 2 hours. Treatment recommendations may vary among countries (refer to specific product guidelines).

Intravenous
Psoriatic arthritis
Adult: As monotherapy or in combination with methotrexate: 5 mg/kg at weeks 0, 2, and 6, followed by maintenance dose of 5 mg/kg every 8 weeks thereafter. Doses are given via IV infusion over at least 2 hours. Treatment recommendations may vary among countries (refer to specific product guidelines).

Intravenous
Plaque psoriasis
Adult: For the treatment of moderate to severe cases unresponsive to, or who are intolerant or have a contraindication to other systemic therapy: 5 mg/kg at weeks 0, 2, and 6, followed by maintenance dose of 5 mg/kg every 8 weeks thereafter. If there is no response after 14 weeks (4 doses), no additional treatment should be given. Doses are given via IV infusion over at least 2 hours. Treatment recommendations may vary among countries (refer to specific product guidelines).
Reconstitution
Reconstitute vial labelled as 100 mg with 10 mL of sterile water for inj to provide a concentration of 10 mg/mL; direct the stream of the diluent towards the wall of the vial. Gently swirl the vial to mix; do not shake. Allow the solution to stand for 5 minutes. Further dilute the reconstituted solution to 250 mL with NaCl 0.9% to a final concentration of 0.4-4 mg/mL. Add the reconstituted solution slowly; gently invert the bag to mix the solution. For volumes >250 mL, a larger infusion bag (e.g. 500 mL or 1,000 mL) or multiple 250 mL infusion bags may be used to ensure that the concentration of the infusion solution does not exceed 4 mg/mL. Refer to specific product guidelines for other detailed instructions.
Contraindications
Hypersensitivity. Moderate to severe heart failure (NYHA class III or IV); active TB or other severe infections (e.g. sepsis, abscesses, opportunistic infections).
Special Precautions
Patient with mild heart failure (NYHA class I or II); chronic infection or a history of recurrent infections; current or history of haematologic abnormalities; pre-existing or recent onset of CNS demyelinating disorders; underlying condition predisposing to infections (e.g. diabetes), history of malignancy or seizures; moderate to severe COPD. Psoriasis patient with a history of prolonged phototherapy or immunosuppressant therapy. Patient who resides in or has travelled in areas where TB or mycoses (e.g. blastomycoses, coccidioidomycosis, histoplasmosis) are endemic. Patient undergoing surgery. Concurrent administration of live vaccines is not recommended; for infants exposed in utero to infliximab, at least a 6-month waiting period after birth is recommended before giving live vaccines. Some products available are approved as biosimilars of reference biological infliximab (Remicade®); interchangeability and product availability may vary between countries, refer to local or specific product guidelines. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: New-onset and exacerbation of heart failure; cerebrovascular accidents, hypotension, hypertension, arrhythmias; antibody formation; acute infusion-related reactions (including anaphylactic shock), delayed hypersensitivity reactions (e.g. serum sickness-like reactions); increased serum transaminases, cutaneous eruptions (e.g. new-onset or exacerbation of psoriasiform eruption; hidradenitis suppurativa, eczematous rash, pustular rash, maculopapular rash, hypersensitivity angiitis). Rarely, autoimmune disorders (e.g. lupus-like syndrome); demyelinating disorders (e.g. multiple sclerosis, optic neuritis, systemic vasculitis, Guillain-Barre syndrome, acute transverse myelitis, chronic inflammatory demyelinating polyneuropathy).
Cardiac disorders: Tachycardia, palpitations.
Ear and labyrinth disorders: Vertigo.
Eye disorders: Conjunctivitis.
Gastrointestinal disorders: Nausea, abdominal pain, diarrhoea, dyspepsia, constipation, gastrointestinal haemorrhage, gastro-oesophageal reflux.
General disorders and administration site conditions: Pain, chest pain, fatigue, fever, chills, oedema.
Musculoskeletal and connective tissue disorders: Back pain, myalgia, arthralgia.
Nervous system disorders: Headache, dizziness, hypoaesthesia, paraesthesia.
Psychiatric disorders: Depression, insomnia.
Renal and urinary disorders: Urinary tract infection.
Respiratory, thoracic and mediastinal disorders: Sinusitis, upper respiratory tract infection, dyspnoea, epistaxis, bronchitis.
Skin and subcutaneous tissue disorders: Urticaria, pruritus, hyperhidrosis, dry skin, fungal dermatitis, alopecia.
Vascular disorders: Flushing, ecchymosis.
Potentially Fatal: Active TB or reactivation of latent TB, invasive fungal infections (e.g. aspergillosis, candidiasis, pneumocystosis, histoplasmosis, blastomycosis, coccidioidomycosis), bacterial infections (e.g. sepsis, pneumonia), viral infections, and other opportunistic infections; malignancies (including Hodgkin's and non-Hodgkin's lymphoma, nonmelanoma skin cancer, melanoma, Merkel cell carcinoma, and hepatosplenic T-cell lymphoma); MI; haematologic toxicities (e.g. leucopenia, neutropenia, thrombocytopenia, pancytopenia); reactivation of HBV; severe hepatic reactions (e.g. hepatic failure, jaundice, hepatitis, cholestasis).
Patient Counseling Information
This drug may cause dizziness, if affected, do not drive or operate machinery. Women of childbearing potential should consider using adequate birth control method during therapy and for at least 6 months after treatment.
Monitoring Parameters
Perform screening tests for TB (latent and active) before treatment initiation and during therapy; HBV or HCV before initiating treatment; and HIV at baseline. Monitor HBV carriers for clinical and laboratory signs of active HBV infection during and for several months after treatment. Monitor CBC with differential (at baseline), complete metabolic panel (at baseline), and LFT (at baseline and during treatment). Perform skin examinations periodically during treatment, particularly in patients with risk factors for skin cancer. Screen women periodically for cervical cancer. Observe for at least 1-2 hours after infusion for acute infusion-related reactions. Assess for signs and symptoms of infection (during and after treatment), heart failure, hypersensitivity reactions, lupus-like syndrome, and malignancy. In psoriasis patients with history of phototherapy, monitor for nonmelanoma skin cancer.
Drug Interactions
May increase the risk of serious infections and neutropenia with anakinra. Increased risk of infections with abatacept, live vaccines and other live therapeutic infectious agents (e.g. BCG for intravesical instillation).
Action
Description:
Mechanism of Action: Infliximab, a chimeric human-murine monoclonal antibody, binds with high affinity to both transmembrane and soluble forms of tumour necrosis factor alpha (TNFα), thus neutralising the biological activity of TNFα. TNFα is a pro-inflammatory cytokine that mediates chronic inflammation when overexpressed in diseases such as Crohn's disease and rheumatoid arthritis.
Onset: Rheumatoid arthritis: 3-7 days. Crohn's disease: 1-2 weeks. Psoriasis: 8-10 weeks.
Duration: Rheumatoid arthritis: 6-12 weeks. Crohn's disease: 8-48 weeks.
Pharmacokinetics:
Distribution: Distributed within the vascular compartment. Crosses the placenta; enters breast milk (small amounts). Volume of distribution: 3-6 L.
Excretion: Elimination half-life: 7-12 days.
Storage
Store intact vials between 2-8°C. May be stored at up to 30°C for a single period of up to 6 months (not exceeding the original expiration date). Do not return to refrigerated storage once removed. Storage recommendations may vary among countries. Refer to specific product guidelines.
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.
References
Anon. Infliximab, Infliximab-dyyb. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 19/09/2023.

Anon. Infliximab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 09/02/2023.

Buckingham R (ed). Infliximab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/02/2023.

Janssen-Cilag (New Zealand) Ltd. Remicade Powder for Injection data sheet 18 May 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 09/02/2023.

Joint Formulary Committee. Infliximab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/02/2023.

Remicade 100 mg Powder for Concentrate for Solution for Infusion (Janssen Biologics B.V.). MHRA. https://products.mhra.gov.uk. Accessed 09/02/2023.

Remicade 100 mg Powder for Concentrate for Solution for Infusion (Johnson & Johnson Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 09/02/2023.

Remicade Injection, Powder, Lyophilized, for Solution (Janssen Biotech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/02/2023.

Disclaimer: This information is independently developed by MIMS based on Infliximab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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