Parenteral Manual

Risvutatug Rezetecan (Investigational)

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Alternate Name(s): 
RIS-REZ; GSK5764227
Classification: 
Antibody drug conjugate - fully human anti-B7-H3 IgG1 monoclonal antibody; immune checkpoint inhibitor – CYTOTOXIC/HAZARDOUS
Original Date: 
May 2026
Indications: 
  • Investigational use for previously treated relapsed/refractory osteosarcoma and advanced/metastatic soft tissue sarcomas in patients =>12 years old. 
Reconstitution and Stability: 
VIAL SIZE STERILE WATER FOR INJECTION REQUIRED FINAL CONCENTRATION
100 mg 5 mL 20 mg/mL
  • Available as 100 mg/vial dry powder for solution for injection. Single dose vials.  
  • Store vials refrigerated between 2C – 8C, protected from light.  
  • Diluted solutions of 0.4 - 12 mg/mL in NS or D5W are stable 24h refrigerated and protected from light.  
  • Reconstitution Instructions
    1. Allow the vial(s) to equilibrate to ambient room temperature, protected from light for 30 minutes before reconstitution. 

    2. Reconstitute by adding 5 mL of SWFI to each vial to yield a 20 mg/mL solution. Gently swirl the vial until the contents are fully dissolved and the product is uniform in appearance. Do not shake or agitate vigorously.

    3. After reconstitution, visually inspect the solution. The appearance should be colourless to pale yellow and clear. If visible particles, unusual discoloration or any appearance otherwise not matching the provided description is observed, then the product should not be used.  

    4. Withdraw the required total volume from the vial(s) and inject the dose into the appropriate-sized minibag of 0.9% NaCl. The final concentration should be 0.4 mg/mL to 12 mg/mL. 

    5. Gently invert the container 5 to 10 times to ensure complete mixing. Avoid shaking or excessive agitation. 

Compatibility: 
  • Solutions Compatible: 0.9% NaCl, D5W 
  • Additive/Above Cassette Compatible: do not mix with other drugs or IV solutions 
  • Y-site Compatible: no information 
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: 0.4 - 12 mg/mL 

Must be administered using a 0.2 micron in-line filter.  

Infusion time: First dose is infused over 90 minutes. If tolerated, subsequent doses may be infused over 60 minutes.  

Central line not required but may be used. 

IV Continuous Infusion NO

 

Dosage: 

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

Children and Adolescents =>12 years (investigational agent): 

  • Administered every 2-3 weeks. Dose range is typically between 4 - 12 mg/kg/dose. Refer to specific study protocol.  
Potential hazards of parenteral administration: 
  • Infusion-related hypersensitivity reactions are possible (characterized by pyrexia, chills, headache, rash, pruritus, arthralgia, hypotension/hypertension, or bronchospasm).  
  • Prophylaxis with a corticosteroid, antihistamine, and acetaminophen is STRONGLY recommended.  
  • If an infusion-related reaction occurs, the infusion should be slowed or interrupted, and clinical supportive care should be given (e.g. corticosteroids, epinephrine, oxygen, bronchodilators); preventive medicines should be given before subsequent infusions. 
  • It is recommended that patients be monitored for at least 1 hour after completion of the infusion.  
Notes: 

Possible adverse effects: hematological toxicity (anemia, neutropenia, thrombocytopenia), interstitial lung disease, pneumonitis, infusion-related reactions, elevation of liver enzymes and bilirubin.  

References: 
  • EMBOLD Sarcoma-202 Protocol. Version 1; 10 March 2026.  

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