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Example of 12-step desensitization protocol for intravenous infliximab (600 mg dose, 250 mL per solution)

Example of 12-step desensitization protocol for intravenous infliximab (600 mg dose, 250 mL per solution)
Solution Total volume Concentration Dose
Solution 1 250 mL 0.024 mg/mL 6 mg
Solution 2 250 mL 0.24 mg/mL 60 mg
Solution 3 250 mL 2.38 mg/mL 600 mg
 
Step Solution Rate (mL/hour) Time (minutes) Volume infused per step (mL) Dose administered with this step (mg) Cumulative dose (mg)
1 1 2.0 15 0.50 0.012 0.012
2 1 5.0 15 1.25 0.030 0.042
3 1 10.0 15 2.50 0.060 0.102
4 1 20.0 15 5.00 0.120 0.222
5 2 5.0 15 1.25 0.300 0.522
6 2 10.0 15 2.50 0.600 1.122
7 2 20.0 15 5.00 1.200 2.322
8 2 40.0 15 10.00 2.400 4.722
9 3 10.0 15 2.50 5.953 10.675
10 3 20.0 15 5.00 11.906 22.580
11 3 40.0 15 10.00 23.811 46.392
12 3 80.0 174.38 232.50 553.609 600.000
NOTE: Each step is administered over 15 minutes. At conclusion of protocol, observe patient for 30 minutes, and then give full therapeutic dose by the desired route.
Total time = 339 minutes (5.7 hours).
Standard premedications included diphenhydramine, 25 mg administered intravenously and famotidine, 20 mg administered intravenously, 20 minutes before desensitization. Medications at the bedside included intramuscular epinephrine (1:1000, 0.3 mg); diphenhydramine, 25 to 50 mg administered intravenously; famotidine, 20 mg administered intravenously; methylprednisolone, 50 mg administered intravenously; aspirin, 325 mg administered orally; montelukast, 10 mg administered orally; albuterol, two puffs; and lorazepam, 0.5 mg administered intravenously.
Desensitization protocol instructions:
1. Confirm written consent is in medical record.
2. Ensure preceding dose of beta-blockers was held, unless otherwise advised by supervising clinician.
3. Obtain IV access and vital signs (temperature, HR, BP, RR, oxygen saturation, peak flow).
4. Have at bedside: Epinephrine 0.3 mg (for adults) for IM injection, oxygen, normal saline, peak flow meter, and BP cuff, albulterol, injectable preparation of diphenhydramine, and methylprednisolone.
5. A nurse must closely observe the patient throughout the protocol (one-to-one).
Administration: Hang each solution successively. Each step is administered over 15 minutes per protocol. There is no reason to wait between bags. Vital signs should be taken and recorded every 15 minutes and every 30 minutes during the last step.
Monitoring and charting during desensitization:
Clearly document any reaction, including:
a. Patient's symptoms, vital signs, and physical findings.
b. Exactly when the reaction occurred (ie, what step, how many minutes into that step).
c. Treatment administered, how and when the reaction resolved, and when the protocol was restarted.
Treatment of allergic reactions:
For mild reactions: In case of isolated itching, flushing, hives, mild chest tightness, nausea, abdominal pain, or back pain with normal vital signs, stop the infusion and treat with IV diphenhydramine. Observe patient until the reaction subsides, and then resume the protocol by repeating the step at which the reaction occurred.
For severe reactions: In case of hypotension, throat swelling, wheezing/respiratory distress, or decreased oxygen saturation, stop the infusion and treat with epinephrine 0.3 mg IM x 1, diphenhydramine and methylprednisolone IV, oxygen, inhaled albuterol for bronchospasm, and IV fluids (normal saline). Place patient in a recumbent position if hypotensive. Consider glucagon 1 to 2 mg IV bolus if patient has taken beta-blockers, followed by infusion at 1 to 5 mg/hour. Immediately alert the housestaff and supervising clinician. When the patient is stable, the protocol will be resumed as instructed by the supervising clinician.
Contact the supervising clinician for ANY severe or prolonged reaction or any questions regarding the protocol, reactions, and appropriate management.
IV: intravenous; HR: heart rate; BP: blood pressure; RR: respiratory rate; IM: intramuscular.
Reproduced with permission from: Brennan PJ, Bouza TR, Hsu FI, et al. Hypersensitivity reactions to mAbs: 105 desensitizations in 23 patients, from evaluation to treatment. J Allerg Clin Immunol 2009; 124:1259. Illustration used with the permission of Elsevier Inc. All rights reserved.
Instructions courtesy of Mariana Castells, MD, PhD.
Graphic 75979 Version 6.0

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