Alternate Name(s):
RENFLEXIS®
Classification:
Chimeric monoclonal antibody
Original Date:
August 2005
Revised Date:
September 2023
Indications:
- Severe Crohn's disease or fistulizing Crohn's disease
Reconstitution and Stability:
|
VIAL SIZE |
STERILE WATER for INJECTION REQUIRED |
FINAL CONCENTRATION |
|
100 mg |
10 mL |
10 mg/mL |
- Refrigerate unreconstituted vials
- Inject Sterile Water for Injection on vial wall; do not use if no vacuum; DO NOT SHAKE; swirl; let solution stand for 5 minutes and slowly add to NS and mix gently
- Reconstituted solution stable 24 hours at room temperature
- Diluted solution stable 24 hours when stored in fridge
- Infusion should begin within 3 hours of preparation
Compatibility:
- Solutions Compatible: NS
- Additives/Above Cassette Compatible: no information
- Y-site Compatible: no information
Incompatible: DO NOT infuse with any other medications
Administration:
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
| SC | NO |
| IM | NO |
| IV Direct | NO |
| IV Intermittent Infusion |
YES: Large Volume Pump ONLY |
| IV Continuous Infusion | NO |
Dosage:
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
Pediatric/Adult:
- Crohn's disease:
- 5 mg/kg given as a single IV infusion
- Fistulizing Crohn's disease:
- Three separate infusions of 5 mg/kg at weeks 0,2 and 6
- Doses of 10 mg/kg may be used as clinically indicated according to GI assessment
- Patients may be retreated within 14 weeks of last infusion
Potential hazards of parenteral administration:
- Hypersensitivity reactions (during or within 2 hours after infusion): urticaria, dyspnea, hypotension
- Headache, nausea, abdominal pain, vomiting, flu-like symptoms
- Susceptibility to infections: upper respiratory tract infection, urinary tract infection, invasive fungal infections, sepsis
Notes:
- Monitor vital signs pre-infusion, q30 minutes during infusion and 1 hour post-infusion
- Patient should be monitored for at least 1-2 hours following end of infusion
- Infusion must be administered through a 0.22 micron in-line filter
- Patients are required to have a tuberculin skin test prior to initiation of therapy. Contact prescriber for exceptions
- Infliximab should not be administered in the setting of active tuberculosis and should be used with caution if latent disease is present
- Patients who develop a new infection while receiving infliximab should be monitored closely
- If a patient develops a serious infection while on infliximab, discontinue treatment.
- Monitor CBC with differential, albumin, serum creatinine, BUN, LFTs, electrolytes and total protein, signs and symptoms of lupus
- DO NOT administer live vaccines concurrently with infliximab
INFUSION GUIDELINES:
- Step 1: 2.5 mL x 15 minutes
Step 2: 5 mL x 15 minutes
Step 3: 10 mL x 15 minutes
Step 4: 20 mL x 15 minutes
Step 5: 75 mL x 30 minutes ____
250 mL/h or _________ mL/h until completion. - Flush IV with 20 mL of 0.9% NaCl at same final infusion rate.
- Have Epinephrine Anaphylaxis kit at bedside and in portable kit for patient transport off unit