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Administration of infliximab: Guidelines for drug administration and the recognition and initial approach to infusion reactions

Administration of infliximab: Guidelines for drug administration and the recognition and initial approach to infusion reactions
Description
Intravenous (IV) administration of infliximab, a tumor necrosis factor-alpha antagonist biologic therapy. Infliximab, a chimeric antibody, is administered in the form of periodic infusions (zero, two, and six weeks and, depending on the subsequent course of the disease, every six to eight weeks thereafter).
Contraindications to treatment
Known hypersensitivity to the drug or murine proteins
Active systemic or localized infections
History of infection related to a prosthesis that remains in place
Infection with human immunodeficiency virus
Active infection with hepatitis B virus
Congestive heart failure classified on the New York Heart Association scale as functional class III/IV
History of demyelinating disease
History of cancer (except when there has been no recurrence in the preceding five years and in the case of patients with basal cell carcinoma)
Patients with a history of systemic lupus erythematosus
Live vaccines should not be administered during treatment: yellow fever, German measles, measles, polio, or bacillus Calmette-Guérin (BCG)
Patient care during IV administration of infliximab
Objectives
To prepare patients physically and psychologically so that they undergo treatment in the best possible conditions
To ensure the patient's safety throughout the infusion process
To prevent treatment-related problems and ensure prompt detection of any such problems
Preparation of the patient before the procedure
Ascertain what the patient knows about the treatment they are about to receive
Patients may eat breakfast or lunch and take their usual medication unless they have a history of moderate to severe infusion reactions (risk of vomiting)
Make the patient comfortable in a seat or bed, depending on the preference and physical state of each individual
Check whether the patient's chart includes an order for laboratory testing before the procedure, and whether premedication has been prescribed
Personnel: nursing staff
Procedure
Personnel: nursing staff
Materials:
  • Esmarch bandage
  • Cotton
  • Antiseptic
  • 20 G catheter
  • Catheter securement dressings
  • Pump
  • Filter (pore size ≤1.2 microns)
  • Infusion pump
  • 10 mL syringe
  • 21 G needle
  • 10 mL of double-distilled water for each vial of infliximab
  • Infliximab (store in refrigerator at between 2 and 8°C)
  • 250 mL of 0.9% saline solution
Implement laboratory testing order, if any, prior to infusion. Administer prescribed premedication, if any. This can only be diphenhydramine or hydrocortisone.
Check arterial blood pressure, heart rate, respiratory rate, and temperature at the start and after completion of infusion and whenever required by the patient's physical condition
Preparation of the drug
Aseptic technique
Reconstitute each 100 mg vial of infliximab with 10 mm of double-distilled water
Aim the double-distilled water against the side of the vial to prevent foaming
Ensure that the contents of the vial have dissolved completely, but avoid prolonged and energetic movements
Allow the solution to stand for five minutes
The solution should be colorless to slightly yellowish and may contain translucent particles (protein)
  • The solution should not be administered if it is inappropriately colored or contains visible opaque particles
From the bottle of saline solution, withdraw a volume of saline equal to the volume of infliximab solution to be used in order to obtain a final volume of 250 mL and a concentration of between 0.4 and 4 mg/ml
The solution must be infused within three hours of reconstitution
Never dissolve infliximab in dextrose solution
Cannulate the venous line
Administer the drug using a volumetric infusion pump
  • The first, second, third, and fourth infusions should be administered over two hours (125 mL/hour)
  • Starting with the fifth infusion, the dose can be infused in one hour (250 mL/hour)
Assess response to treatment; if the patient does not present any anomalous symptoms, he or she can be discharged and return to normal daily activity
Patients must be instructed to telephone their clinician or the nursing staff if they experience any reaction symptoms after the infusion
Observations
Infusion time can be modified by the clinician responsible for the patient
Description of problems related to the procedure and remedial action
Acute infusion reactions
Mild in the presence of Moderate in the presence of Severe in the presence of
  • Headache
  • Diaphoresis
  • Throat irritation
  • Lumbar pain
  • Hyperemia
  • Nausea
  • Palpitations
  • Itching
  • Cutaneous eruption
  • Flushing
  • Vertigo
  • Vomiting
The same symptoms as mild reactions and
  • Dysphagia
  • Hypotension or hypertension (± 20 mmHg with respect to baseline)
  • Chest pain or tightness
  • Edema of the face, hands, or lips
  • Suffocating sensation
  • Hyperemia (accompanied by a sensation of heat or fever)
  • Hyperthermia (<39°C)
  • Palpitations, tachycardia
  • Urticaria
The same symptoms as moderate reactions and
  • Severe hypotension or hypertension (± 40 mmHg with respect to baseline)
  • Hyperthermia and chills (≥39°C)
  • Swelling of the larynx or pharynx with stridor
  • Dyspnea
  • Severe bronchospasm
  • Convulsive seizure
  • Clinically significant chest pain
Action to be taken:
  • Stop the infusion
  • Monitor blood pressure, heart rate, respiratory rate, and temperature
  • Notify the treating clinician
  • If the reaction does not resolve, follow appropriate procedures for management of an acute reaction to infusion of infliximab
  • If extravasation occurs, stop the infusion immediately, notify the treating clinician, attempt to aspirate the extravasated fluid with a 10 to 20 mL syringe, withdraw the IV line, mark the affected area, and follow the hospital's treatment protocol covering such events
Important points
To ensure early detection of infusion reactions, monitor the patient's response to treatment
Ensure that the intravenous line is open
Assessment indicators
The nursing record should include details of the results of vital signs monitoring before and after treatment
The nursing record should provide details of the assessment of tolerance to treatment, that is, the occurrence or absence of incidents
Records
The following information should be recorded:
  • Vital signs
  • The assessment and preparation of the patient prior to treatment
  • Incidents (presence or absence) related to the procedure
  • Assessment of the patient's condition after treatment
Original figure modified for this publication. Puig Sanz L, Sáez E, Lozano MJ, et al. [Reactions to infliximab infusions in dermatologic patients: consensus statement and treatment protocol. Working Group of the Grupo Español de Psoriasis de la Academia Española de Dermatología y Venereología.] Actas Dermosifiliogr 2009; 100:103. Table used with the permission of Elsevier Inc. All rights reserved.
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