first-rate [30:28 days), or delayed-onset ( 28 days following completion of therapy) neutropenia. 1 Risk of severe or acute-onset ( 24 hours after completion of therapy) thrombocytopenia. 1 Monitor CBCs and platelet counts at regular intervals; more frequent monitoring recommended in patients with grade 3 or 4 cytopenia. 1 Transfusion of blood products (i.e., platelets) may be necessary. 1 If neutropenia occurs, anti-infective, antiviral, or antifungal prophylaxis may be necessary. 1 (See Anti-infective Prophylaxis under Dosage and Administration.) Monitor for signs or symptoms of infection; if infection develops, institute appropriate treatment. 1 Immunization Safety and efficacy of immunization with live or attenuated virus vaccines during or following obinutuzumab therapy not established. 1 Avoid immunization with live virus vaccines during obinutuzumab therapy and until recovery of B-cell counts. 1 Immunogenicity Antibodies to obinutuzumab reported. 1 Clinical relevance is not known. 1 Neutralizing antibodies have not been assessed. 1 Specific Populations Pregnancy Category C. 1 Teratogenicity not demonstrated in animals; however, presence of obinutuzumab and depletion of B cells were observed in offspring on day 28 postpartum. 1 B-cell count and immune function normalized within 6 months of birth. 1 Avoid pregnancy during and for 12 months after therapy. 1 Lactation Not known whether obinutuzumab is distributed into milk. 1 Discontinue nursing or the drug. 1 Pediatric Use Safety and efficacy not established. 1 Geriatric Use Most (82%) patients in the phase 3 clinical trial in CLL were 65 years of age. 1 No overall differences in efficacy relative to younger adults. 1 Serious or fatal adverse events occurred at a higher incidence among patients 75 years of age. 1 Hepatic Impairment Not studied in patients with hepatic impairment. 1 Renal Impairment Pharmacokinetics not affected by baseline Cl cr >30 mL/minute. 1 Not studied in patients with baseline Cl cr] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class CD20 monoclonal antibodies Related Drugs Chronic Lymphocytic Leukemia Rituxan , rituximab , cyclophosphamide , Imbruvica , Cytoxan , ibrutinib , bendamustine , Venclexta , Octagam , Leukeran , chlorambucil , Gazyva , More... Follicular Lymphoma Rituxan , rituximab , copanlisib , Gazyva , Zydelig , Intron A , idelalisib , Aliqopa , Rituxan Hycela , interferon alfa-2b , hyaluronidase / rituximab , More... Obinutuzumab Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! without borders
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