Gazyva 1000mg Injection

Obinutuzumab is a CD20-directed cytolytic antibody indicated: in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). in combination with bendamustine followed by Obinutuzumab monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are refractory to, a rituximab-containing regimen. in combination with chemotherapy followed by Obinutuzumab monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma. for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy Chronic Lymphocytic Leukemia (CLL) Obinutuzumab, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia. Follicular Lymphoma (FL) Obinutuzumab, in combination with bendamustine followed by Obinutuzumab monotherapy, is indicated for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab-containing regimen. Obinutuzumab, in combination with chemotherapy followed by Obinutuzumab monotherapy in patients achieving at least a partial remission, is indicated for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma. Lupus Nephritis (LN) Obinutuzumab is indicated for the treatment of adult patients with active lupus nephritis who are receiving standard therapy.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Boxed warning. HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including Obinutuzumab. Screen all patients for HBV infection before treatment initiation. Monitor HBV-positive patients during and after treatment with Obinutuzumab. Discontinue Obinutuzumab and concomitant medications in the event of HBV reactivation. Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving Obinutuzumab. WARNING: HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning. Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Progressive Multifocal Leukoencephalopathy (PML) resulting in death. Infusion-Related Reactions: Premedicate patients with glucocorticoid, acetaminophen, and anti-histamine. Monitor patients closely during infusions. Interrupt, reduce rate, or discontinue for infusion-related reactions based on severity. Hypersensitivity Reactions Including Serum Sickness: Discontinue Obinutuzumab permanently. Tumor Lysis Syndrome: In CLL and FL, premedicate with anti-hyperuricemics and adequate hydration, especially for patients with high tumor burden, high circulating lymphocyte count or renal impairment. Correct electrolyte abnormalities, provide supportive care, and monitor renal function and fluid balance. Serious, Including Fatal, Infections: Do not administer Obinutuzumab to patients with an active infection. Patients with a history of recurring or chronic infections may be at increased risk of infection. Neutropenia: In patients with Grade 3 to 4 neutropenia, monitor laboratory tests until resolution and for infection. Consider dose delays and infection prophylaxis, as appropriate. Thrombocytopenia: Monitor for decreased platelet counts and bleeding. Transfusion may be necessary. Disseminated Intravascular Coagulation: Evaluate cause and monitor for bleeding, thrombosis, and need for supportive care. Immunization: Avoid administration of live virus vaccines during Obinutuzumab treatment and until B-cell recovery. Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use effective contraception. Hepatitis B Virus Reactivation Obinutuzumab can cause Hepatitis B virus (HBV) reactivation. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with anti-CD20 antibodies such as Obinutuzumab. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hepatitis B virus reactivation Progressive multifocal leukoencephalopathy Infusion-related reactions Hypersensitivity reactions including serum sickness Tumor lysis syndrome Infections Neutropenia Thrombocytopenia Disseminated intravascular coagulation The most common adverse reactions (incidence ≥ 20% and ≥ 2% greater in the Obinutuzumab treated arm in CLL and NHL, and incidence ≥ 5% in the Obinutuzumab treated arm in LN) were: Previously untreated CLL: infusion-related reactions and neutropenia. Relapsed or refractory non-Hodgkin lymphoma (NHL): infusion-related reactions, fatigue, neutropenia, cough, upper respiratory tract infections, and musculoskeletal pain. Previously untreated NHL: infusion-related reactions, neutropenia, upper respiratory tract infections, cough, constipation, and diarrhea. Lupus Nephritis: upper respiratory tract infection, COVID-19, urinary tract infection, bronchitis, pneumonia, infusion-related reactions, and neutropenia. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Chronic Lymphocytic Leukemia The data below are based on a safety population of 773 previously untreated patients with CLL in the CLL11 study. Patients were treated with chlorambucil alone, Obinutuzumab in combination with chlorambucil, or rituximab product in combination with chlorambucil. The Stage 1 analysis compared Obinutuzumab in combination with chlorambucil vs. chlorambucil alone and Stage 2 compared Obinutuzumab in combination with chlorambucil vs. rituximab product in combination with chlorambucil. Adverse reactions rates and laboratory abnormalities from the Stage 2 phase are presented below and are consistent with the rates in Stage 1. In addition to the adverse reactions observed in Stage 2, in Stage 1, back pain (5% vs. 2%), anemia (12% vs. 10%) and cough (10% vs. 7%) were observed at a higher incidence in the Obinutuzumab treated patients. The incidence of Grade 3 to 4 back pain (< 1% vs. 0%), cough (0% vs. < 1%) and anemia (5% vs. 4%) was similar in both treatment arms. With regard to laboratory abnormalities, in Stage 1 hyperkalemia (33% vs. 18%), creatinine increased (30% vs. 20%) and alkaline phosphatase increased (18% vs. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.