DARATUMUMAB INJ,SOLN
Clinical Criteria Summary
Exclusion Criteria
- Known hypersensitivity to daratumumab
- Unable to be observed in clinic for an extended period following the first dose
- Absolute Neutrophil Count (ANC) < 1000/mm3
- Hemoglobin < 8 g/dL; must transfuse to hemoglobin > 8 g/dL prior to therapy initiation
- Platelet count < 50,000/mm3 (< 30,000/mm3 if myeloma involvement in bone marrow > 50%)
- Estimated creatinine clearance (CrCl) < 15 ml/min
- New York Heart Association (NYHA) Class III or IV heart failure
- Ongoing or active systemic infection including active hepatitis B or C or known HIV infection
- Patient has not been screened for Hepatitis B Virus (HBV)
- Pregnancy (e.g. known or positive pregnancy test)
- Breastfeeding
Indications
- Multiple myeloma
- Light chain amyloidosis
Pre-treatment & Clinical Management Requirements
- Care is provided by a VA/VA Community Care hematology/oncology provider
- Goals of care and role of Palliative Care consult have been discussed and documented
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Type and screen patients for Red Blood Cell antibodies PRIOR to starting therapy
- Provider has informed Blood Bank that patient will be starting daratumumab
- Antiviral prophylaxis to prevent herpes zoster reactivation to start within 1 week after starting daratumumab and continue for 3 months following the end of treatment
- Female patients of child-bearing potential and male patients with female partners of child-bearing potential: counseling provided on contraception (use during treatment and 3 months after) and risks vs. benefits of treatment