Gazyva 1000 mg/40mL
obinutuzumab · INJECTION, SOLUTION, CONCENTRATE · Genentech, Inc.
Gazyva is a injection, solution, concentrate containing obinutuzumab at 1000 mg/40mL, taken intravenous. Manufactured by Genentech, Inc..
Key Facts
- Brand Name
- Gazyva
- Generic Name
- obinutuzumab
- NDC Code (Product)
50242-070- Manufacturer
- Genentech, Inc.
- Strength
- 1000 mg/40mL
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA125486
- Drug Class
- CD20-directed Cytolytic Antibody [EPC]
- Marketing Start
- 11/01/2013
Recall History
Infusion Options, Inc.
Lack of Assurance of Sterility
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE GAZYVA is a CD20-directed cytolytic antibody indicated: in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). ( 1.1 , 14 ) in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of patients with follicular lymphoma (FL)who relapsed after, or are refractory to, a rituximab-containing regimen. ( 1.2 , 14 ) in combination with chemotherapy followed by GAZYVA 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. ( 1.2 , 14 ) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy ( 1.3 , 14 ) 1.1 Chronic Lymphocytic Leukemia (CLL) GAZYVA, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia. 1.2 Follicular Lymphoma (FL) GAZYVA, in combination with bendamustine followed by GAZYVA monotherapy, is indicated for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab-containing …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Premedicate for infusion-related reactions and tumor lysis syndrome. ( 2.1 , 5.3 , 5.4 ) Administer only as intravenous infusion. Do not administer as an intravenous push or bolus. ( 2.1 ) The recommended dosage for chronic lymphocytic leukemia is 100 mg on day 1 and 900 mg on day 2 of Cycle 1, 1,000 mg on day 8 and 15 of Cycle 1, and 1,000 mg on day 1 of Cycles 2–6. ( 2.2 ) The recommended dosage for follicular lymphoma is 1,000 mg on day 1, 8 and 15 of Cycle 1, 1,000 mg on day 1 of Cycles 2-6 or Cycles 2-8, and then 1,000 mg every 2 months for up to 2 years. ( 2.3 ) The recommended dosage for active lupus nephritis is 1,000 mg at the initial infusion, on Week 2, 24, 26, and every 6 months thereafter. ( 2.4 ) 2.1 Important Dosing Information Premedicate before each infusion [see Dosage and Administration (2.4) ] . Provide prophylactic hydration and anti-hyperuricemics to patients at high risk of tumor lysis syndrome [see Dosage and Administration (2.4) and Warnings and Precautions (5.4) ]. Administer only as an intravenous infusion through a dedicated line [see Dosage and Administration (2.6) ] . Do not administer as an intravenous push or bolus. Monito…
Contraindications
4 CONTRAINDICATIONS GAZYVA is contraindicated in patients with known hypersensitivity reactions (e.g., anaphylaxis) to obinutuzumab or to any of the excipients, or serum sickness with prior obinutuzumab use [see Warnings and Precautions (5.4) ]. GAZYVA is contraindicated in patients with known hypersensitivity reactions (e.g., anaphylaxis) to obinutuzumab or any of the excipients, including serum sickness with prior obinutuzumab use. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hepatitis B virus reactivation [see Warnings and Precautions (5.1) ] Progressive multifocal leukoencephalopathy [see Warnings and Precautions (5.2) ] Infusion-related reactions [see Warnings and Precautions (5.3) ] Hypersensitivity reactions including serum sickness [see Warnings and Precautions (5.4) ] Tumor lysis syndrome [see Warnings and Precautions (5.5) ] Infections [see Warnings and Precautions (5.6) ] Neutropenia [see Warnings and Precautions (5.7) ] Thrombocytopenia [see Warnings and Precautions (5.8) ] Disseminated intravascular coagulation [see Warnings and Precautions (5.9) ] The most common adverse reactions (incidence ≥ 20% and ≥ 2% greater in the GAZYVA treated arm in CLL and NHL, and incidence ≥ 5% in the GAZYVA treated arm in LN) were: Previously untreated CLL : infusion-related reactions and neutropenia. ( 6 ) Relapsed or refractory non-Hodgkin lymphoma (NHL) : infusion-related reactions, fatigue, neutropenia, cough, upper respiratory tract infections, and musculoskeletal pain. ( 6 ) Previously untreated NHL : infusion-related reactions, neutropenia,…
Frequently Asked Questions
What is Gazyva used for?
Gazyva contains obinutuzumab. It is a injection, solution, concentrate taken intravenous. Consult your doctor for specific uses.
Is Gazyva a controlled substance?
Gazyva is not classified as a controlled substance by the DEA.
What is the generic name for Gazyva?
The generic name for Gazyva is obinutuzumab. There are no other listed brand versions of obinutuzumab.
What is the NDC code for Gazyva 1000 mg/40mL?
The NDC (National Drug Code) for Gazyva 1000 mg/40mL is 50242-070, listed by Genentech, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)