Parenteral Manual

Rivipansel (STUDY DRUG)

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): 
GMI-1070
Classification: 
Pan-selectin antagonist
Original Date: 
November 2016
Revised Date: 
March 2017
Indications: 
  • Treatment of Vaso-occlusive crisis (VOC) of sickle cell disease (SCD)

    THIS MEDICATION IS TO BE ADMINISTERED BY A STUDY-TRAINED NURSE on 4N

Reconstitution and Stability: 
  • Supplied as 30 mg/mL solution
  • Store in refrigerator
  • Administration must be completed within 24 hours of initiation of dose preparation - with a maximum of 6 hours of the storage period at room temperature (15 - 25˚C) and the remainder must be under refrigeration (2 – 8 ˚C).
  • The 6 hours at room temperature must account for preparation, transfer time to the inpatient unit and infusion time
Compatibility: 

-  Solution Compatibility :  D5W, 0.9% NaCl, dextrose-saline combinations

-  Additive/Above Cassette Compatible:  No information

-  Y- site Compatible:  up to 20 mEq/L KCl

Administration: 

(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)

SC NO
IM NO
IV Push NO
IV Intermittent Infusion

YES
Usual dilution:  undiluted (30 mg/mL)
Infusion time: drug and flush over 30 minutes

- using a  0.22 micron inline filter and line supplied by pharmacy
IV Continuous Infusion NO

 

Dosage: 

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

Subject Age and Weight Loading Dose Maintenance Dose
  •  6 - 11 years and any weight or
  • 12 years and older and weight less than or equal to 40 kg
 40 mg/kg
MAX: 1680 mg		 20 mg/kg
MAX: 840 mg Q12H
 ± 2 hours
  • 12 years and older and weight greater than 40 kg
 1680 mg 840 mg Q12H
 ± 2 hours

 

Potential hazards of parenteral administration: 
  • Upper abdominal pain
  • Infusion site irritation
  • Dizziness
  • Headache
  • Dysmenorrhoea
     
References: 
  • Protocol Number:  B5201002, Amendment 1, 20 March 2015
    A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Rivipansel (GMI-1070)  in the treatment of vaso-occlusive crisis in hospitalized subjects with sickle cell disease

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