Infliximab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Rheumatoid arthritis Initial: 3 mg/kg, repeat at 2 wk and 6 wk after 1st infusion then 8 wkly, in combination w/ methotrexate; may increase by 1.5 mg/kg to a max of 7.5 mg/kg 8 wkly if patient has inadequate response. Crohn's disease Initial: 5 mg/kg, repeat at 2 wk after 1st infusion; discontinue if there is no response after 2 doses. Maintenance: 5 mg/kg at 6 wk after initial dose then 8 wkly. Fistulising Crohn's disease; Ulcerative colitis Initial: 5 mg/kg, repeat at 2 wk and 6 wk after 1st infusion then 8 wkly; discontinue if there is no response after 3 doses. Ankylosing spondylitis Initial: 5 mg/kg, repeat at 2 wk and 6 wk, then 6-8 wkly; discontinue if there is no response after 2 doses. Psoriatic arthritis; Plaque psoriasis Initial: 5 mg/kg, repeat at 2 wk and 6 wk, then 8 wkly; discontinue if there is no response after 12 wk for psoriatic arthritis and after 14 wk for plaque psoriaris.
Dosage Details
Intravenous
Crohn's disease
Adult: Initially, 5 mg/kg by infusion over at least 2 hr, repeated at 2 wk after 1st infusion. No further doses should be given if there is no response after 2 doses. Responders: Maintenance: 5 mg/kg at 6 wk after initial dose then 8 wkly thereafter. May be re-administered w/in 16 wk after last infusion if signs/symptoms recur.
Child: 6-17 yr Initially, 5 mg/kg by infusion over at least 2 hr, repeated at 2 wk and 6 wk after 1st infusion then 8 wkly thereafter.

Intravenous
Rheumatoid arthritis
Adult: In combination w/ methotrexate: Initially, 3 mg/kg by infusion over at least 2 hr, repeated at 2 wk and 6 wk after 1st infusion then 8 wkly thereafter. May increase dose in increments of 1.5 mg/kg to a max of 7.5 mg/kg 8 wkly if patient has inadequate response or loses response over a period of 12 wk. Alternatively, 3 mg/kg 4 wkly. May be re-administered w/in 16 wk after last infusion if signs/symptoms recur.

Intravenous
Fistulising Crohn's disease
Adult: Initially, 5 mg/kg by infusion over at least 2 hr, repeated at 2 wk and 6 wk after 1st infusion. No further doses should be given if there is no response after 3 doses. Responders: Maintenance: 5 mg/kg 8 wkly. Re-admin: 5 mg/kg if signs/symptoms recur, followed by 5 mg/kg 8 wkly.

Intravenous
Ankylosing spondylitis
Adult: Initially, 5 mg/kg, repeated at 2 wk and 6 wk, then 6-8 wkly thereafter. Stop treatment if there is no response after 2 doses.

Intravenous
Plaque psoriasis, Psoriatic arthritis
Adult: Initially, 5 mg/kg by infusion over at least 2 hr, repeated at 2 wk and 6 wk, then 8 wkly thereafter. Stop treatment if there is no response after 12 wk for psoriatic arthritis and after 14 wk for plaque psoriaris.

Intravenous
Ulcerative colitis
Adult: Initially, 5 mg/kg by infusion over at least 2 hr, repeated at 2 wk and 6 wk after 1st infusion then 8 wkly thereafter. No further doses should be given if there is no response after 3 doses.
Child: 6-17 yr Initially, 5 mg/kg by infusion over 2 hr, repeated at 2 wk and 6 wk after 1st infusion then 8 wkly thereafter.
Reconstitution
Add 10 mL of sterile water for inj to the vial containing 100 mg to provide a 10 mg/mL soln. Dilute further w/ NaCl 0.9% inj to a total vol of 250 mL.
Contraindications
Patient w/ TB or other severe infections (e.g. sepsis, abscesses, opportunistic infections), moderate or severe heart failure (NYHA class III or IV).
Special Precautions
Patient w/ mild heart failure (NYHA class I or II), history of blood dyscrasias, chronic or recurrent infection. Childn. Pregnancy and lactation.
Adverse Reactions
Chills, fever, dyspnoea, chest pain, HTN or hypotension, urticaria, pruritus, nausea, vomiting, diarrhoea, abdominal pain, fatigue, dizziness, headache, back pain, hypersensitivity, upper resp tract infection, UTI, new-onset or exacerbation of heart failure; delayed reactions: myalgia, fever, arthralgia, rash. Rarely, lupus-like syndrome, sarcoidosis or sarcoid-like reaction, anaphylactic reactions, exacerbation of demyelinating disorders (e.g. multiple sclerosis, optic neuritis).
Potentially Fatal: Hepatitis B reactivation in chronic carriers. Rarely, serious opportunistic infections, bacterial sepsis, invasive fungal infections, pneumonia, onset or reactivation of TB, severe hepatic reactions (e.g. acute liver failure, jaundice, cholestasis, hepatitis, blood dyscrasias (e.g. leucopenia, thrombocytopenia, pancytopenia, aplastic anaemia), interstitial lung disease (e.g. pneumonitis, pulmonary fibrosis), lymphoma and other malignancies (e.g. hepatosplenic T-cell lymphoma, leukaemia).
Patient Counseling Information
This drug may cause dizziness, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor for signs and/or symptoms of infection, hypersensitivity reaction, lupus-like syndrome, heart failure, malignancy. Monitor vital signs every 2-10 min if reaction is noted during infusion. Perform hepatitis B virus screening prior to and hepatitis B virus carriers during and several mth after therapy; CBC w/ differential, LFTs.
Drug Interactions
Increased risk of serious infection and neutropenia w/ anakinra or abatacept. Risk of clinical infections, including disseminated infections w/ concurrent admin of live vaccines.
Action
Description: Infliximab is a chimeric monoclonal antibody which binds w/ high affinity to the soluble and transmembrane forms of tumour necrosis factor-α (TNF-α) thereby inhibiting binding of TNF-α to its receptors.
Onset: Crohn's disease: Approx 2 wk.
Pharmacokinetics:
Distribution: Distributed mainly in the vascular compartment; detected in serum for at least 8 wk after repeated doses; crosses the placenta. Volume of distribution: 3-6 L.
Excretion: Terminal elimination half-life: 8-9.5 days.
Storage
Store between 2-8°C. Avoid freezing.
ATC Classification
L04AB02 - infliximab ; Belongs to the class of tumor necrosis factor alpha (TNF-alpha) inhibitors. Used as immunosuppressants.
References
Anon. Infliximab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 21/12/2015.

Buckingham R (ed). Infliximab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 21/12/2015.

McEvoy GK, Snow EK, Miller J et al (eds). Infliximab . AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 21/12/2015.

Remicade for IV Injection. U.S. FDA. https://www.fda.gov/. Accessed 21/12/2015.

Remicade Injection, Powder, Lyophilized, for Solution (Janssen Biotech, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 21/12/2015.

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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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