Infliximab administration protocol

Protocol for Infliximab Infusion (Adults)


Indications and Dosage:
Rheumatoid arthritis, used in combination with methotrexate, where response to at least two DMARDS has been inadequate (NICE guidance).
• 3mg/kg IV infusion, followed by additional 3mg/kg at weeks 0, 2 and 6 weeks, then every 8 weeks depending on response/need. Clinical response is usually achieved within 12 weeks. Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this time.

Severe, active Crohn’s disease – treatment of severe, active disease in patients who have not responded despite a full and adequate course of therapy with a corticosteroid or immunosuppressant; or who are intolerant or have medical contraindications for such therapies.
• 5mg/kg IV infusion at 0, 2 and 6 weeks. In patients who respond alternative strategies for continued treatment are: • Maintenance: repeat infusions of 5mg/kg every 8 weeks depending on response/need or • Readministration: 5mg/kg infusion if signs and symptoms recur within 16 weeks of last infusion

Fistulising, active Crohn’s disease - treatment of fistulising, active Crohn’s disease, in patients who have not responded, despite full and adequate course of conventional treatment.
• initial 5mg/kg IV infusion, followed with additional 5mg/kg infusion doses at 2 and 6 weeks after the first infusion. If a patient does not respond after 3 doses, no additional treatment with infliximab should be given. In patients who respond alternative strategies for continued treatment are: • Additional infusions of 5mg/kg every 8 weeks or • Readministration if signs and symptoms of the disease recur within 16 weeks of last infusion followed by infusions of 5mg/kg every 8 weeks.

Ulcerative colitis - treatment of moderately to severely active ulcerative colitis in patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies.
• 5 mg/kg given as an intravenous infusion over a 2 hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. • Clinical response is usually achieved within 14 weeks of treatment, i.e. three doses. • Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.

Ankylosing spondylitis – in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.
• 5mg/kg IV infusion followed by additional 5mg/kg infusion at 2 and 6 weeks after the first infusion, then every 6-8 weeks depending on response/need thereafter. If a patient does not respond by 6 weeks (ie after 2 doses), no additional treatment with infliximab should be given.

Psoriatic arthritis, in combination with methotrexate, for treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to DMARDs. • 5mg/kg IV infusion followed by 5mg/kg infusion at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter depending on response/need.


Pretreatment:

Patients should be supplied with the package leaflet and special Alert card.

Contraindications:

• patients with TB or other severe infections such as sepsis, abcesses and opportunistic infections
• patients with moderate of severe heart failure
• hypersensitivity to infliximab, other murine proteins or any of the excipients




Special Warnings and Precautions for Use:
Infusion reactions • Associated with acute infusion-related reactions (eg wheezing, hypotension, pallor, nausea, anaphylactic shock and delayed hypersensitivity) which may develop within seconds or within a few hours following infusion. If this occurs then stop infusion immediately and refer to doctor.
• For severe reactions patients may require treatment with IV hydrocortisone, nebulised salbutamol and chlorphenamine.
• For mild reactions (including: drop in systolic BP < 40mmHg normal blood pressure) the infusion should be temporarily stopped until symptoms subside. Following discussion with a doctor the infusion may be restarted at a slower rate. Some patients may be rechallenged after several weeks.
• Hydrocortisone and/or paracetamol 30 mins before infliximab can prevent mild and transient effects. Infections
• Monitor closely for infections, including TB, before, during and up to 6 months after treatment



When to Withold Treatment

• Presentation of signs and symptoms of intercurrent infection. This includes upper respiratory tract infection and skin ulcer.
• Worsening of coexisting illness such as CCF or diabetes
• Suspected malignancy
• Persistent hypotension (systolic < 100mmHg)
• Impending Surgery (4 week gap for standard procedures; 8 week gap for high sepsis- risk surgery) – restart after wound healing



Exclude Infection Prior to Each Administration:

• Take a complete history and examination
• Monitor: • temperature, • urinalysis – refer to doctor if positive for blood or protein
• Send for the following bloodtests: FBC, ESR, U&Es, LFTs, CRP
• Additional tests for RA patients: Rheumatoid factor, ANA-dsDNA


Administration and Monitoring:

• Infliximab is obtained from the Aseptic Dispensing Unit (ADU), Pharmacy.
24 hour notice is required.
• IV Hydrocortisone 100-200mg stat prior to infliximab - not always necessary, there is evidence to suggest that this reduces the incidence of infliximab antibodies. Check with the prescriber.
• Insert venflon and flush with normal saline.
Monitor blood pressure, pulse and temperature every 30 minutes during the infusion and observation periods.
Patients should be observed for at least 1-2 hours post infusion for acute infusion related reactions.
• Infliximab is given in 250ml of sodium chloride 0.9%, and should be infused over a 2 hour period.
Occasionally there are patient specific deviations from this regimen.
The drug can be given through a normal giving set, via a 1.2-micron low-protein binding filter.
Filters can be ordered from supplies: "1.2micron filter lipid solutions priming volume 0.2cc male/female connectors" Medex code MX1483 Supplier = NHS Logistics, code FTC192 Rheumatoid arthritis patients – for carefully selected patients who have received 3 initial infusions over a 2 hour period, subsequent infusions can be infused over a period of not less than 1 hour, and patients observed for 1 hour afterwards.


Side Effects and Toxicity:

Recognised side effects of treatment include flu-like symptoms, headache, transient fever, gastrointestinal upset and skin rashes. Please consult the infliximab data sheet available on-line at www.medicines.org.uk for a complete list. Rarely patients have become ANA positive and developed lupus-like syndromes while receiving treatment. Adverse reactions should be reported to the CSM using the “Yellow Cards” in the usual manner.