Parenteral Manual

CycloSPORINE

Disclaimer: Official controlled document is the CHEO online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
CYCLOSPORIN A, SANDIMMUNE
Classification: 
Immunosuppressive agent - NON-CYTOTOXIC HAZARDOUS
Original Date: 
August 2005
Revised Date: 
June 2015
Indications: 
  • Prevention of rejection of transplanted organs (kidney, liver, bone marrow)
  • Potentially useful for refractory inflammatory bowel disease and conditions that have an immunologic basis
Reconstitution and Stability: 
  • Available as 50 mg/mL solution
  • Protect from light and freezing
  • Stable in glass bottle at room temperature for 48 hours
  • Diluted solutions stable in NS at room temperature for 12 hrs in glass and 6 hrs in PVC
  • Diluted solutions stable in D5W at room temperature for 24 hrs in glass or PVC
  • Storage for 24 hours in PVC bags can cause significant leaching of diethylhexyl phthalate (DEHP) plasticizer. Use of  non-PVC container and DEHP-free tubing is recommended.
Compatibility: 

- Solutions Compatible: D5W, NS

- Additives/Above Cassette Compatible: no information

- Y-site Compatible: no information

- Incompatible: TPN; cyclosporine may be administered at Y-site only after TPN is stopped, the line clamped immediately above the Y and the line adequately flushed

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.  Don't use a minibag smaller than 50 mL
Usual dilution: 0.5-2.5 mg/mL
Infusion time: 2-6 hours
IV Continuous Infusion YES
Usual dilution: 2.5 mg/mL
Dosage: 

(For neonatal dosages, refer to Neonatal IV Drug Manual.)

  • 1.5 mg/kg/dose IV Q12H

** Dosage may vary according to protocol

Dosage adjustment in renal/hepatic impairement

  • Renal dysfunction: monitor levels; may need to decrease dose
  • Hepatic dysfunction: may need to decrease IV dose
Potential hazards of parenteral administration: 
  • Anaphylaxis; most likely related to the IV vehicle (polyoxyl 35 castor oil) rather than the drug itself, since oral administration does not carry the same risk
  • Other side effects such as nephrotoxicity, tremor, hirsutism, hepatotoxicity, various CNS effects, nausea, vomiting, diarrhea, anorexia, infectious complications and various hematologic effects which occur on oral therapy also occur with IV

- treatment for unsual side effects are available through the study chair identified on the front page of the protocol and/or pharmacy

Notes: 
  • For the first dose: monitor vital signs Q5 min for the first 15 min of the infusion, then Q15 min X 1, then Q30 min X 1, then Q1H thereafter
  • Since the IV vehicle may cause stripping from PVC, cyclosporine for continuous IV administration should be prepared freshly before use every 24 hours
  • Oral administration is the preferred route due to the risk of anaphylaxis from the IV vehicle
  • For patients unable to take the oral formulation, the IV dose is one-third the PO dose for solid organ transplant
  • Additive nephrotoxicity when administered with other nephrotoxic drugs (eg: amphotericin B, aminoglycoside antibiotics, acyclovir)

Therapeutic Drug Monitoring

If the patient has a double lumen central venous catheter, the sample for plasma levels should be drawn from the lumen other than the one through which cyclosporine is administered If the patient has a single lumen central venous catheter, the sample should be drawn peripherally For continuous infusion, the infusion should be shut off for 5 minutes before drawing the sample, draw morning levels. For intermittent dosing, draw levels prior to a.m. dose (trough levels) Plasma levels of cyclosporine may be altered by drugs which increase or decrease hepatic microsomal enzyme activity (eg: phenytoin, phenobarbital, clarithromycin, rifampin, fluconazole, erythromycin)

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