RESEARCH PRO00037880 INFUSION TREATMENT / HUANG		version 2/27/2025		

Appointment Requests 	

	
	Interval	Defer Until	Duration	
	☑	Referral to IV Infusion Room . Therapy Plan #1; Choose a treatment option: New Therapy Plan; Infusion Medication: tocilizumab; Urgency of Scheduling: Routine	Day 1 of every 1 month, at least 25 days apart	S	 treatments	
		Normal
	. Therapy Plan #1
	Choose a treatment option: New Therapy Plan
	Infusion Medication: tocilizumab
	Urgency of Scheduling: Routine		

Nursing Orders 	

	
	Interval	Defer Until	Duration	
	☐	Insert Peripheral IV or Access Portacath	Every visit	S	Until discont'd	
		No details available for preview		
	☐	Vital signs - T/P/R/BP Per Unit Protocol	Every visit	S	Until discont'd	
		No details available for preview		
	☐	Nursing communication: Monitor patient for any signs of MINOR INFUSION REACTION	Every visit	S	Until discont'd	
		Monitor patient for signs of minor infusion reaction; fever, chills, pruritis, uticaria, chest pain, mild hypotension, hypertension, or mild dyspnea. For *MINOR INFUSION REACTION* take the following steps: stop or slow infusion rate by 50%. If symptoms do not resolve within 5-10 minutes give Benadryl as ordered. Notify MD if symptoms do not resolve within 5-10 minutes. With MD approval, give Solu-medrol as ordered. When symptoms resolve, restart medication at 25% of the original rate. After 15-30 minutes gently increase rate and monitor patient closely until completion.		
	☐	Nursing communication: Monitor patient for signs of SEVERE INFUSION REACTION	Every visit	S	Until discont'd	
		Monitor patient for signs of severe infusion reaction: severe dyspnea, wheezing, stridor, angioedema, or marked hypotension. For *SEVERE INFUSION REACTION* take the following steps; STOP Infusion and start normal saline solution. Notify physician and administer Benadryl as ordered. Monitor vital signs. Administer  Epinephrine as ordered. Consult MD for further orders.		
	☐	Nursing communication: Check Triglyceride levels every 6 months and check counts	Every visit	S	Until discont'd	
		No details available for preview		
	☐	sodium chloride 0.9% flush 10 mL	Every visit	S	Until discont'd	
		10 mL, intravenous, PRN, line care, catheter care, Starting when released, for 10 doses		
	☐	sodium chloride 0.9% infusion 250 mL	Every visit	S	Until discont'd	
		250 mL, intravenous, at 30 mL/hr, PRN, Flush bag, Starting when released, Until Discontinued		
	☐	Discontinue IV	Every visit	S	Until discont'd	
		No details available for preview		

Research Labs 	

	
	Interval	Defer Until	Duration	
	☐	RESEARCH study specimen	Every visit	S	 treatments	
		Routine, Normal, Clinic Collect, EXTERNAL LAB NON-INTERFACED
	Research study number (H): CTOT-45 / Pro00037880 / Huang
	Study specimen type: Blood
	Collection tube types: Other
	Other: 6mL Red-top Vacutainer Tubes
	Study will provide tube/kit: Yes
	Number of tubes to collect: 2
	Volume per tube (mL): 6
	Contact name and number: Lindsay Barter (346-554-5429) or Elsie Rizk (832-946-0487) or Ahmed Uosef (832-491-3023)
	Specimen collection instructions: A paper requisition will print when this order is completed. The printout must accompany the specimen to the lab.		
	☐	RESEARCH study specimen	Every visit	S	 treatments	
		Routine, Normal, Clinic Collect, EXTERNAL LAB NON-INTERFACED
	Research study number (H): CTOT-45 / Pro00037880 / Huang
	Study specimen type: Blood
	Collection tube types: Green NaHep 10ml
	Study will provide tube/kit: Yes
	Number of tubes to collect: 5
	Volume per tube (mL): 10
	Contact name and number: Lindsay Barter (346-554-5429) or Elsie Rizk (832-946-0487) or Ahmed Uosef (832-491-3023)
	Specimen collection instructions: A paper requisition will print when this order is completed. The printout must accompany the specimen to the lab.		
	☐	RESEARCH study specimen	Every visit	S	 treatments	
		Routine, Normal, Clinic Collect, EXTERNAL LAB NON-INTERFACED
	Research study number (H): CTOT-45 / Pro00037880 / Huang
	Study specimen type: Blood
	Collection tube types: Other
	Other: 2mL Lavender-top (EDTA)
	Study will provide tube/kit: Yes
	Number of tubes to collect: 1
	Volume per tube (mL): 2
	Contact name and number: Lindsay Barter (346-554-5429) or Elsie Rizk (832-946-0487) or Ahmed Uosef (832-491-3023)
	Specimen collection instructions: A paper requisition will print when this order is completed. The printout must accompany the specimen to the lab.		
	☐	RESEARCH study specimen	Every visit	S	 treatments	
		Routine, Normal, Clinic Collect, EXTERNAL LAB NON-INTERFACED
	Research study number (H): CTOT-45 / Pro00037880 / Huang
	Study specimen type: Blood
	Collection tube types: Other
	Other: 6mL Lavender-top (EDTA)
	Study will provide tube/kit: Yes
	Number of tubes to collect: 1
	Volume per tube (mL): 6
	Contact name and number: Lindsay Barter (346-554-5429) or Elsie Rizk (832-946-0487) or Ahmed Uosef (832-491-3023)
	Specimen collection instructions: A paper requisition will print when this order is completed. The printout must accompany the specimen to the lab.		

Labs 	

	
	Interval	Defer Until	Duration	
	☐	CBC with platelet and differential	Every visit	S	 treatments	
		STAT, Normal, Clinic Collect		
	☐	Comprehensive metabolic panel	Every visit	S	 treatments	
		STAT, Normal, Clinic Collect		
	☐	Cytomegalovirus by PCR	Every visit	S	 treatments	
		STAT, Normal, Clinic Collect		
	☐	hCG qualitative, serum screen	Every visit	S	 treatments	
		STAT, Normal, Clinic Collect		
	☐	FK506 Tacrolimus level, trough	Every visit	S	 treatments	
		STAT, Normal, Clinic Collect		
	☐	Immunoglobulin G	Every visit	S	 treatments	
		STAT, Normal, Clinic Collect		
	☐	Lipid panel	Every visit	S	 treatments	
		STAT, Normal, Clinic Collect
	Patient must be fasting		

Pre-Medications 	

	
	Interval	Defer Until	Duration	
	☐	OP RSH CTOT-45 PRO00037880 PRE-MED INV-APAP				
	◎	INV-ACETAMINOPHEN (CTOT-45/PRO00037880/HUANG) TABLET 650 mg	Every visit	S	 treatments	
		650 mg, oral, once, Starting when released
	Administer 30 minutes before INV-Tocilizumab infusion.Caution: New Drug-Limited by Federal Law to Investigational use.
	Maximum of 4 grams of acetaminophen per day from all sources. (Cirrhosis patients maximum: 2 grams per day from all sources).		
	◎	INV-ACETAMINOPHEN (CTOT-45/PRO00037880/HUANG) intravenous solution	Every visit	S	 treatments	
		intravenous, Administer over: 15 Minutes, once, Starting when released
	IV acetaminophen (Ofirmev) is restricted to use only in OR, PACU, or ICU areas, and for patients that cannot tolerate oral, per tube, or rectal routes of administration.  This order is only to be used for patients in the CTOT-45 ALL in LUNG study Pro00037880.
	Maximum of 3 grams of acetaminophen per day from all sources.  (Cirrhosis patients maximum: 2 grams per day from all sources).

	Caution: New Drug-Limited by Federal (USA) Law to Investigational use.		
	☐	OP RSH CTOT-45 PRO00037880 PRE-MED INV-DIPHENHYDRAMINE				
	◎	INV-DIPHENHYDRAMINE (CTOT-45/PRO00037880/HUANG) TABLET 25 mg	Every visit	S	 treatments	
		25 mg, oral, once, Starting when released
	Administer 30 minutes before INV-Tocilizumab infusion.
	Caution: New Drug-Limited by Federal (USA) Law to Investigational use.		
	◎	INV-DIPHENHYDRAMINE (CTOT-45/PRO00037880/HUANG) intravenous push	Every visit	S	 treatments	
		intravenous, once, Starting when released
	Administer 30 minutes before INV-Tocilizumab infusion.
	Caution: New Drug-Limited by Federal (USA) Law to Investigational use.		
	☐	INV-METHYLPREDNISOLONE (CTOT-45/PRO00037880/HUANG) INJECTION 40 mg	Every visit	S	 treatments	
		40 mg, intravenous, once, Starting when released
	Administer 30 minutes before INV-Tocilizumab infusion.
	Caution: New Drug-Limited by Federal (USA) Law to Investigational use.		

Medications 	

	
	Interval	Defer Until	Duration	
	☐	INV-TOCILIZUMAB (CTOT-45/PRO00037880/HUANG) 8 mg/kg in sodium chloride 0.9% 100 mL infusion	Day 1 of every 1 month, at least 25 days apart	S	 treatments	
		8 mg/kg, intravenous, Administer over: 60 Minutes, once, Starting 30 minutes after treatment start time
	Prepared IV bag (covered in brown bag for light protection) contains active Tocilizumab 8mg/kg (max of 800mg). Administer intravenously over 1 hour. Flush with 50mL of NS from the top of the IV set. Stability of prepared dose: 24 hours (room temperature or refrigerated).
	Caution: New Drug-Limited by Federal (USA) Law to Investigational use.		

Hypersensitivity 	

	
	Interval	Defer Until	Duration	
	☐	acetaminophen (TYLENOL) tablet 650 mg	PRN	S	Until discont'd	
		650 mg, oral, every 4 hours PRN, headaches, fever, myalgia, Starting when released, Until Discontinued
	Give 325-650 mg for headache, fever, myalgia
	Maximum of 4 grams of acetaminophen per day from all sources. (Cirrhosis patients maximum: 2 grams per day from all sources).		
	☐	diphenhydrAMINE (BENADRYL) tablet 25 mg	PRN	S	Until discont'd	
		25 mg, oral, every 6 hours PRN, for allergic reaction symptoms, Starting when released, Until Discontinued		
	☐	diphenhydrAMINE (BENADRYL) injection 50 mg	PRN	S	Until discont'd	
		50 mg, intravenous, once PRN, for anaphylactic reaction, Starting when released, Until Discontinued		
	☐	epINEPHrine (ADRENALIN) injection 1 mg/mL 1 mg	PRN	S	Until discont'd	
		1 mg, intravenous, once PRN, anaphylaxis, for anaphylactic reaction, Starting when released, Until Discontinued		
	☐	promethazine (PHENERGAN) tablet 50 mg	PRN	S	Until discont'd	
		50 mg, oral, every 4 hours PRN, nausea, vomiting, Starting when released, Until Discontinued
	Give 25-50 mg every 4-6 hours for nausea/vomiting		
	☐	sodium chloride 0.9% infusion 250 mL	PRN	S	Until discont'd	
		250 mL, intravenous, once PRN, Hydration, Starting when released, Until Discontinued		
	☐	methylPREDNISolone sodium succinate (Solu-MEDROL) injection 40 mg	PRN	S	 treatments	
		40 mg, intravenous, Administer over: 5 Minutes, once PRN, chills/infusion reaction, Starting when released, for 1 dose