Version July 2025
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.
Dosage guidance
Safety: Premedicate with acetaminophen, an antihistamine, and a glucocorticoid (dexamethasone or methylprednisolone) to prevent infusion reactions. Administer appropriate tumor lysis syndrome (TLS) prophylaxis with antihyperuricemics and adequate hydration in patients at high risk for TLS prior to initiating obinutuzumab therapy (and prior to subsequent cycles if needed). Consider temporarily withholding antihypertensive therapies for 12 hours prior to, during, and for 1 hour after obinutuzumab administration (due to the risk for hypotension; consider risks/benefits of withholding antihypertensive therapy in patients at risk for hypertensive crisis). Consider withholding platelet inhibitors, anticoagulants, or other medications that may increase bleeding risk (especially during the first cycle).
Clinical considerations: Antimicrobial prophylaxis is recommended in patients with grade 3 or 4 neutropenia lasting >1 week (continue until neutropenia resolves to ≤ grade 2); consider antiviral and antifungal prophylaxis with severe neutropenia lasting >1 week. Do not administer obinutuzumab to patients with an active infection. Refer to the protocol or institutional guidance for additional details of off-label dosing.
Chronic lymphocytic leukemia, previously untreated:
In combination with chlorambucil:
Cycle 1: IV: 100 mg on day 1, followed by 900 mg on day 2, followed by 1,000 mg weekly for 2 doses (days 8 and 15) of a 28-day treatment cycle (Ref).
Cycles 2 through 6: IV: 1,000 mg on day 1 of a 28-day treatment cycle for 5 doses (Ref).
Off-label dosing/combinations:
Single-agent obinutuzumab:
Cycle 1: IV: 100 mg on day 1, followed by 900 mg on day 2, followed by 1,000 mg weekly for 2 doses (days 8 and 15) of a 21-day treatment cycle (Ref).
Cycles 2 through 8: IV: 1,000 mg on day 1 of a 21-day treatment cycle for 7 doses (Ref).
In combination with acalabrutinib:
Cycle 2: IV: 100 mg on day 1, followed by 900 mg on day 2, followed by 1,000 mg weekly for 2 doses (days 8 and 15) of a 28-day treatment cycle (cycle 1 is acalabrutinib only; obinutuzumab begins with cycle 2) (Ref).
Cycles 3 through 7: IV: 1,000 mg on day 1 of a 28-day treatment cycle for 5 doses (continue acalabrutinib until disease progression or unacceptable toxicity) (Ref).
In combination with ibrutinib:
Cycle 1: IV: 100 mg on day 1, followed by 900 mg on day 2, followed by 1,000 mg weekly for 2 doses (days 8 and 15) of a 28-day treatment cycle (Ref).
Cycles 2 through 6: IV: 1,000 mg on day 1 of a 28-day treatment cycle for 5 doses (continue ibrutinib until disease progression or unacceptable toxicity) (Ref).
In combination with venetoclax (in patients with coexisting conditions):
Cycle 1: IV: 100 mg on day 1, followed by 900 mg on day 2 (or 1,000 mg on day 1), followed by 1,000 mg weekly for 2 doses (days 8 and 15) of a 28-day treatment cycle (venetoclax is initiated on day 22 of cycle 1) (Ref).
Cycles 2 through 6: IV: 1,000 mg on day 1 of a 28-day treatment cycle for 5 doses (continue venetoclax until the end of cycle 12) (Ref).
Diffuse large B cell lymphoma, relapsed or refractory; glofitamab pretreatment (off-label combination): Note: For use as a pretreatment prior to glofitamab to mitigate potential cytokine release syndrome.
IV: 1,000 mg as a single dose 7 days prior to initiation of glofitamab (Ref); if glofitamab is delayed, obinutuzumab may need to be repeated.
Follicular lymphoma, previously untreated:
Note: Patients with complete response or partial response to the initial 6 or 8 cycles of combination therapy (with either bendamustine or cyclophosphamide, doxorubicin, vincristine, prednisone [CHOP] or cyclophosphamide, vincristine, and prednisone [CVP]) should continue on obinutuzumab as monotherapy for up to 2 years.
In combination with bendamustine (induction):
Cycle 1: IV: 1,000 mg weekly for 3 doses on days 1, 8, and 15 of a 28-day treatment cycle (Ref).
Cycles 2 through 6: IV: 1,000 mg on day 1 of a 28-day treatment cycle for 5 doses (Ref).
In combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) (induction):
Cycle 1: IV: 1,000 mg weekly for 3 doses on days 1, 8, and 15 of a 21-day treatment cycle (Ref).
Cycles 2 through 8: IV: 1,000 mg on day 1 of a 21-day treatment cycle for 5 combination therapy doses (in combination with CHOP in cycles 2 through 6), followed by 1,000 mg on day 1 of a 21-day treatment cycle for 2 doses (as a single agent) in cycles 7 and 8 (Ref).
In combination with CVP (cyclophosphamide, vincristine, and prednisone) (induction):
Cycle 1: IV: 1,000 mg weekly for 3 doses on days 1, 8, and 15 of a 21-day treatment cycle (Ref).
Cycles 2 through 8: IV: 1,000 mg on day 1 of a 21-day treatment cycle for 7 doses (Ref).
Obinutuzumab monotherapy continuation (in patients who achieve a complete or partial response following induction therapy in combination with bendamustine, CHOP, or CVP): 1,000 mg once every 2 months for up to 2 years beginning ~2 months after the last induction phase obinutuzumab dose (Ref).
Follicular lymphoma, relapsed or refractory:
Note: Patients with stable disease, complete response, or partial response after 6 cycles of combination therapy (with bendamustine) should continue on obinutuzumab as monotherapy for up to 2 years.
In combination with bendamustine:
Cycle 1: IV: 1,000 mg weekly for 3 doses on days 1, 8, and 15 of a 28-day treatment cycle (in combination with bendamustine) (Ref).
Cycles 2 through 6: IV: 1,000 mg on day 1 of a 28-day treatment cycle for 5 doses (in combination with bendamustine) (Ref).
Obinutuzumab monotherapy: IV: 1,000 mg once every 2 months for up to 2 years beginning ~2 months after the last induction phase obinutuzumab dose (Ref).
In combination with zanubrutinib ( off-label combination):
Cycle 1: IV: 1,000 mg weekly for 3 doses on days 1, 8, and 15 of a 28-day treatment cycle (in combination with zanubrutinib) (Ref).
Cycles 2 through 6: IV: 1,000 mg on day 1 of a 28-day treatment cycle for 5 doses (in combination with zanubrutinib) (Ref).
Maintenance therapy: IV: 1,000 mg once every 8 weeks (in combination with zanubrutinib); continue obinutuzumab for up to a total of 20 infusions; zanubrutinib is continued until disease progression or unacceptable toxicity (Ref).
Missed doses:
Chronic lymphocytic leukemia: Administer the missed dose as soon as possible; adjust dosing schedule to maintain the time interval between doses. In some cases, patients who do not complete the day 1 cycle 1 dose may proceed to the day 2 cycle 1 treatment (if appropriate).
Follicular lymphoma: Administer the missed dose as soon as possible; adjust dosing schedule accordingly to maintain the time interval between chemotherapy cycles. During obinutuzumab monotherapy, maintain the original dosing schedule for subsequent doses.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment is not necessary in patients with renal impairment and no need for dosage adjustment is expected in patients on hemodialysis (Ref).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). However, no need for dosage adjustment is expected (Ref).
|
Adverse reaction |
Severity |
Dosage modification |
|---|---|---|
|
a Appropriate symptom management may also include glucocorticoids, epinephrine, bronchodilators, and/or oxygen. | ||
|
Hematologic toxicity (concomitant chemotherapy may also require dose reduction or delay) | ||
|
Neutropenia |
Grade 3 or 4 |
Consider treatment interruption and use of granulocyte colony-stimulating factors. In patients with severe and long-lasting (>1 week) neutropenia, antimicrobial prophylaxis is recommended until neutropenia improves to grade 1 or 2. Consider antiviral and antifungal prophylaxis in patients with severe and long-lasting (>1 week) neutropenia. |
|
Thrombocytopenia |
Grade 3 or 4 |
Consider treatment interruption. Platelet transfusions may be necessary. |
|
Other cytopenia |
Grade 3 or 4 |
Consider treatment interruption. |
|
Nonhematologic toxicity | ||
|
Disseminated intravascular coagulation |
Any |
Manage according to standard guidelines for disseminated intravascular coagulation. May require supportive management, including blood product transfusion(s). |
|
Hypersensitivity |
Any |
If a hypersensitivity reaction is suspected during or after an infusion, stop the infusion and permanently discontinue treatment. |
|
Infusion reaction |
Mild or moderate (grade 1 and 2) |
Reduce infusion rate or interrupt infusion and manage symptoms as appropriatea. Upon symptom resolution, continue or resume infusion. If no further infusion reaction symptoms occur, may resume infusion rate escalation as appropriate for the treatment cycle dose. For chronic lymphocytic leukemia (CLL) only, day 1 (cycle 1) infusion rate may be increased back up to a maximum of 25 mg/hour after 1 hour (but not increased further). |
|
Severe (grade 3) |
Interrupt infusion; manage symptoms as appropriatea. Standard infusion rate: Upon symptom resolution, may reinitiate infusion at no more than 50% of the rate at which the reaction occurred. If no further infusion reaction symptoms occur, may resume infusion rate escalation as appropriate for the treatment cycle dose. For CLL only, day 1 (cycle 1) infusion rate may be increased back up to a maximum of 25 mg/hour after 1 hour. Permanently discontinue if ≥ grade 3 infusion-related symptoms occur upon rechallenge. 90-minute infusion rate (in follicular lymphoma): Upon symptom resolution, may reinitiate infusion at no more than 50% of the rate at which the reaction occurred and not greater than 400 mg/hour. Administer subsequent infusions at the standard infusion rate. Permanently discontinue if ≥ grade 3 infusion-related symptoms occur upon rechallenge. | |
|
Life-threatening (grade 4) |
Discontinue infusion immediately and manage symptoms as appropriatea; permanently discontinue therapy. | |
|
Infection |
Any |
Consider treatment interruption (do not administer to patients with active infection). |
|
Progressive multifocal leukoencephalopathy |
Suspected |
Discontinue obinutuzumab and consider discontinuation or dose reduction of any concomitant chemotherapy or immunosuppressive therapy. |
|
Tumor lysis syndrome |
Any |
Correct electrolyte abnormalities; administer supportive care, including dialysis as indicated. |
|
Viral hepatitis |
Any |
Discontinue obinutuzumab (and concomitant medications) and initiate appropriate antiviral therapy if viral hepatitis develops. |
|
Other toxicity |
≥ grade 2 |
Consider treatment interruption. |
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults with the standard infusion rate in combination with chlorambucil or bendamustine unless incidence is identified as having occurred during the monotherapy phase.
>10%:
Dermatologic: Pruritus (11%), skin rash (monotherapy: ≥10%; combination therapy: 17%)
Endocrine & metabolic: Hyperkalemia (20% to 33%), hypernatremia (16%), hyperuricemia (28%), hypoalbuminemia (23% to 33%), hypocalcemia (32% to 39%), hypokalemia (14%), hyponatremia (26%), hypophosphatemia (36% to 41%)
Gastrointestinal: Constipation (8% to 32%) decreased appetite (14%), diarrhea (monotherapy: ≥10%; combination therapy: 10% to 30%; grades 3/4: 2% to 3%)
Genitourinary: Urinary tract infection (monotherapy: ≥10%; combination therapy: 5% to 13%)
Hematologic & oncologic: Anemia (12% to 39%; grades 3/4: 5% to 10%), hemorrhage (12%; grades 3/4: 4%), hypoproteinemia (32%), leukopenia (84% to 92%; grades 3/4: 17% to 49%), lymphocytopenia (monotherapy: grades 3/4: 5% to 23%; combination therapy: 80% to 97%; grades 3/4: 33% to 92%), neutropenia (monotherapy: 13% to 20%; grades 3/4: 10% to 25%; combination therapy: 37% to 84%; grades 3/4: 33% to 59%; onset ≥28 days after completion of treatment: 4% to 16%; lasting ≥28 days: 1% to 3%), thrombocytopenia (14% to 68%; grades 3/4: 7% to 13%; onset within 24 hours of infusion: 4%)
Hepatic: Hyperbilirubinemia (21%), increased serum alanine aminotransferase (28% to 50%), increased serum alkaline phosphatase (18% to 27%), increased serum aspartate aminotransferase (27% to 44%)
Hypersensitivity: Infusion-related reaction (monotherapy: 8% to 9%; combination therapy: 66% to 72%, cycle 1: 37% to 65%, subsequent cycles: ≤23% [dependent on dose, cycle, and use of premedications]; can be severe infusion-related reaction)
Infection: Herpes virus infection (monotherapy: 13%; combination therapy: 18%), infection (38% to 82%)
Nervous system: Fatigue (monotherapy: ≥10%; combination therapy: 40%), headache (18%), insomnia (15%)
Neuromuscular & skeletal: Arthralgia (12% to 16%), musculoskeletal signs and symptoms (including musculoskeletal pain: monotherapy: 20%; combination therapy: 18% to 54%)
Renal: Increased serum creatinine (30%)
Respiratory: Cough (monotherapy: 23%; combination therapy: 10% to 35%), pneumonia (14%), respiratory tract infection (monotherapy: ≥10%; combination therapy: 14%), upper respiratory tract infection (monotherapy: 40%; combination therapy: 36% to 50%)
Miscellaneous: Fever (9% to 19%)
1% to 10%:
Hematologic & oncologic: Febrile neutropenia (6%), tumor lysis syndrome (grades 3/4: ≤2%)
Immunologic: Antibody development (≤7%)
Infection: Sepsis (7%)
Neuromuscular & skeletal: Back pain (5%)
Respiratory: Nasopharyngitis (6%)
<1%: Hematologic & oncologic: Disseminated intravascular coagulation
Frequency not defined:
Cardiovascular: Exacerbation of heart disease
Hepatic: Fulminant hepatitis, hepatic failure
Infection: JC virus infection, reactivation of HBV
Nervous system: Progressive multifocal leukoencephalopathy
Postmarketing:
Gastrointestinal: Gastrointestinal perforation
Hypersensitivity: Hypersensitivity reactions, serum sickness
Known hypersensitivity reactions (eg, anaphylaxis) to obinutuzumab or any component of the formulation; serum sickness with prior obinutuzumab use.
Concerns related to adverse effects:
• Bone marrow suppression: Severe and life-threatening (grade 3 and 4) neutropenia (including neutropenic fever) has been observed in clinical trials. Neutropenia may have a late onset (>28 days after therapy completion) and/or be prolonged (duration >28 days). Consider administration of granulocyte colony-stimulating factors in patients who develop grade 3 or 4 neutropenia. Severe and life-threatening thrombocytopenia has also been reported when used in combination with chemotherapy. In a small percentage of patients, thrombocytopenia occurred acutely (within 24 hours) after obinutuzumab administration. Fatal hemorrhagic events have been reported.
• Disseminated intravascular coagulation: Disseminated intravascular coagulation (DIC), which may be severe or fatal, has occurred. Most cases involved platelet and laboratory coagulation parameter changes following the first infusion and resolved by day 8; DIC was associated with infusion-related reactions and/or tumor lysis syndrome in some cases.
• Hepatitis B virus reactivation: Hepatitis B virus (HBV) reactivation may occur with use of CD20-directed cytolytic antibodies (including obinutuzumab) and may result in fulminant hepatitis, hepatic failure, and death. Reactivation has occurred in patients who are hepatitis B surface antigen (HBsAg) positive as well as in those who are HBsAg negative but are anti-HBc positive; HBV reactivation has also been observed in patients who had previously resolved HBV infection. HBV reactivation has been reported for other CD20-directed antibodies after therapy discontinuation. Reactivation of HBV replication is often followed by hepatitis. Use cautiously in patients who show evidence of prior HBV infection (eg, HBsAg positive [regardless of antibody status] or HBsAg negative but anti-HBc positive); consult with appropriate clinicians regarding monitoring and consideration of antiviral therapy before and/or during obinutuzumab treatment. The safety of resuming obinutuzumab treatment following HBV reactivation is not known; discuss reinitiation of therapy in patients with resolved HBV reactivation with health care providers experienced in HBV management.
• Hypersensitivity/serum sickness: Hypersensitivity reactions have been reported with obinutuzumab. Signs of immediate-onset hypersensitivity included dyspnea, bronchospasm, hypotension, urticaria, and tachycardia. Late-onset hypersensitivity (diagnosed as serum sickness) has also been reported with obinutuzumab; symptoms included chest pain, diffuse arthralgia, and fever. Hypersensitivity reactions may be difficult to clinically differentiate from infusion-related reactions. However, hypersensitivity very rarely occurs with the initial infusion and generally occurs after a prior exposure.
• Infection: Bacterial, fungal, and new or reactivated viral infections may occur during and/or following obinutuzumab therapy; serious and/or fatal infections have been reported. Grade 3 and higher infections have been observed (during and after treatment) when obinutuzumab was administered in combination with chemotherapy followed by obinutuzumab monotherapy. A higher incidence of grade 3 to 5 infections (including during monotherapy and after treatment) have been observed when obinutuzumab was administered in combination with bendamustine (compared to cyclophosphamide, doxorubicin, vincristine, prednisone [CHOP] or cyclophosphamide, vincristine, and prednisone [CVP]). Patients with a history of recurrent or chronic infections may be at increased risk.
• Infusion reaction: May cause severe and life-threatening infusion reactions; reactions may include bronchospasm, dyspnea, chest discomfort, tachycardia, larynx and throat irritation, wheezing, laryngeal edema, flushing, rash, hypertension, hypotension, fever, dizziness, nausea, vomiting, diarrhea, headache, fatigue, and/or chills. Infusion reactions occur more frequently with the first 1,000 mg infused or on day 1 of the infusion. Infusion reactions have occurred within 24 hours of receiving obinutuzumab; reactions with subsequent infusions have also occurred. Premedicate prior to infusion. Patients with preexisting cardiac or pulmonary conditions may be at higher risk for infusion reactions.
• Progressive multifocal leukoencephalopathy: Progressive multifocal leukoencephalopathy (PML) resulting in death may occur with obinutuzumab. PML is due to John Cunningham virus infection. Consider PML in any patient with new onset or worsening neurological symptoms and evaluate promptly if PML is suspected.
• Tumor lysis syndrome: Tumor lysis syndrome (TLS) has been reported with obinutuzumab (some cases fatal). Patients with high tumor burden, high circulating lymphocyte counts (>25,000/mm3), or renal impairment are at higher risk for TLS. Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, and/or hyperphosphatemia may occur.
Concurrent drug therapy issues:
• Immunizations: Administration of live virus vaccines during treatment (and until B-cell recovery) is not recommended; the safety and efficacy of immunization with live or attenuated viral vaccines during or after obinutuzumab therapy has not been determined. If obinutuzumab exposure occurs during pregnancy, the safety and timing of live virus vaccinations for the infant should be evaluated.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Gazyva: 1000 mg/40 mL (40 mL)
No
Solution (Gazyva Intravenous)
1000 mg/40 mL (per mL): $258.38
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Gazyva: 1000 mg/40 mL (40 mL)
IV: For IV infusion only. Do not administer IV push or as a bolus. Administer through a dedicated IV line; do not mix with or infuse with other medications. May use PVC or non-PVC administration sets. Premedication with acetaminophen, an antihistamine, and a glucocorticoid (dexamethasone or methylprednisolone) may be required to prevent infusion reactions (see below). In patients with severe (grade 3 or 4) neutropenia lasting more than 1 week, antimicrobial prophylaxis is strongly recommended (continue until neutropenia resolves to grade 1 or 2); antiviral and antifungal prophylaxis should be considered.
Premedication to prevent infusion reactions:
Chronic lymphocytic leukemia (CLL) (cycle 1 [days 1 and 2]) and follicular lymphoma (FL) (day 1): All patients should receive acetaminophen (650 to 1,000 mg) and an antihistamine (eg, diphenhydramine 50 mg) at least 30 minutes prior to obinutuzumab infusion. In addition, an IV glucocorticoid (dexamethasone 20 mg or methylprednisolone 80 mg [hydrocortisone has not been effective in reducing the rate of infusion reactions and is not recommended]) should be administered at least 1 hour prior to obinutuzumab infusion. If a glucocorticoid-containing chemotherapy regimen is administered on the same day as obinutuzumab, the glucocorticoid may be administered as an oral medication if administered at least 1 hour prior to obinutuzumab (an IV glucocorticoid is therefore not required).
All subsequent infusions: All patients should receive acetaminophen 650 to 1,000 mg at least 30 minutes prior to obinutuzumab infusion.
If patients experienced grade 1 or 2 infusion-related reaction with previous infusion: Administer an antihistamine (eg, diphenhydramine 50 mg) in addition to acetaminophen at least 30 minutes prior to obinutuzumab infusion.
If patients experienced a grade 3 infusion-related reaction with previous infusion or have a lymphocyte count >25,000 cells/mm3 prior to next treatment: Administer an IV glucocorticoid (dexamethasone 20 mg or methylprednisolone 80 mg [hydrocortisone has not been effective in reducing the rate of infusion reactions and is not recommended]) at least 1 hour prior to obinutuzumab infusion, in addition to acetaminophen and an antihistamine at least 30 minutes prior to obinutuzumab infusion.
Diffuse large B cell lymphoma, relapsed or refractory, glofitamab pretreatment (off-label use): Administer oral acetaminophen (500 to 1,000 mg) and an antihistamine (eg, diphenhydramine 50 to 100 mg) at least 30 minutes prior to obinutuzumab infusion. In addition, a glucocorticoid (dexamethasone 20 mg IV or methylprednisolone 80 mg IV should be administered at least 1 hour prior to obinutuzumab infusion [hydrocortisone has not been effective in reducing the rate of infusion reactions and is not recommended]) (Ref).
Infusion rate:
CLL:
Cycle 1 (day 1): Infuse at 25 mg/hour over 4 hours; do not increase the infusion rate.
Cycle 1 (day 2): If no reaction to previous infusion, initiate infusion at 50 mg/hour for 30 minutes; if tolerated, may escalate rate in increments of 50 mg/hour every 30 minutes to a maximum rate of 400 mg/hour. If an infusion reaction occurred during the previous infusion, initiate infusion at 25 mg/hour for 30 minutes; if tolerated, may escalate rate in increments of up to 50 mg/hour every 30 minutes to a maximum rate of 400 mg/hour.
Cycle 1 (days 8 and 15), and cycles 2 through 6 (day 1): If no reaction to previous infusion and the final infusion rate was 100 mg/hour or faster, initiate infusion at 100 mg/hour for 30 minutes; if tolerated, may escalate infusion rate in increments of 100 mg/hour every 30 minutes to a maximum rate of 400 mg/hour. If an infusion reaction occurred during the previous infusion, initiate infusion at 50 mg/hour for 30 minutes; if tolerated, may escalate rate in increments of 50 mg/hour every 30 minutes to a maximum rate of 400 mg/hour.
Diffuse large B-cell lymphoma, relapsed or refractory, glofitamab pretreatment (off-label use): Initiate infusion at 50 mg/hour for 30 minutes; if tolerated, may escalate rate in increments of 50 mg/hour every 30 minutes to a maximum rate of 400 mg/hour (Ref).
FL (previously untreated or relapsed/refractory): Standard infusion rate:
Cycle 1 (day 1): Initiate infusion at 50 mg/hour for 30 minutes; if tolerated, may escalate rate in increments of 50 mg/hour every 30 minutes to a maximum rate of 400 mg/hour.
All subsequent infusions: If no reaction or grade 1 reaction to previous infusion and the final infusion rate was 100 mg/hour or faster, initiate infusion at 100 mg/hour for 30 minutes; if tolerated, may escalate rate in increments of 100 mg/hour every 30 minutes to a maximum rate of 400 mg/hour. If a grade 2 or higher infusion reaction occurred during the previous infusion, initiate infusion at 50 mg/hour for 30 minutes; if tolerated, may escalate rate in increments of 50 mg/hour every 30 minutes to a maximum rate of 400 mg/hour.
FL (previously untreated or relapsed/refractory) : 90-minute infusion rate:
Note: Consider a 90-minute infusion rate for patients with FL who do NOT experience a ≥ grade 3 infusion reaction to obinutuzumab in cycle 1 and subsequent cycles.
Cycle 1 (day 1): Initiate infusion at 50 mg/hour for 30 minutes; if tolerated, may escalate rate in increments of 50 mg/hour every 30 minutes to a maximum rate of 400 mg/hour.
Cycle 1 (days 8 and 15): If no reaction or grade 1 reaction to previous infusion and the final infusion rate was 100 mg/hour or faster, initiate infusion at 100 mg/hour for 30 minutes; if tolerated, may escalate rate in increments of 100 mg/hour every 30 minutes to a maximum rate of 400 mg/hour. If a grade 2 or higher infusion reaction occurred during the previous infusion, initiate infusion at 50 mg/hour for 30 minutes; if tolerated, may escalate rate in increments of 50 mg/hour every 30 minutes to a maximum rate of 400 mg/hour.
All subsequent cycles/infusions (including monotherapy): If no ≥ grade 3 infusion reaction occurred during cycle 1, infuse at 100 mg/hour for 30 minutes, then infuse at 900 mg/hour for ~60 minutes. If a grade 1 or 2 infusion reaction with ongoing symptoms, or a ≥ grade 3 infusion reaction occurred during the previous ~90-minute infusion, administer all subsequent obinutuzumab infusions at the standard infusion rate.
Chronic lymphocytic leukemia, previously untreated: Treatment of previously untreated chronic lymphocytic leukemia (in combination with chlorambucil).
Follicular lymphoma:
Previously untreated: Treatment of previously untreated stage II bulky, stage III, or stage IV follicular lymphoma in combination with chemotherapy, followed by obinutuzumab monotherapy in patients achieving at least a partial remission.
Relapsed or refractory: Treatment of follicular lymphoma (in combination with bendamustine followed by obinutuzumab monotherapy) in patients who relapsed after, or are refractory to, a rituximab-containing regimen.
Diffuse large B cell lymphoma, relapsed or refractory; glofitamab pretreatment
Obinutuzumab may be confused with blinatumomab, dinutuximab, obiltoxaximab, ocrelizumab, ofatumumab, olaratumab, omalizumab, rituximab
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Agents with Antiplatelet Effects: May increase adverse/toxic effects of Obinutuzumab. Specifically, the risk of bleeding may be increased. Management: Consider avoiding coadministration of obinutuzumab and agents with antiplatelet effects, especially during the first cycle of obinutuzumab therapy. Risk D: Consider Therapy Modification
Alfuzosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Amifostine: Blood Pressure Lowering Agents may increase hypotensive effects of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider Therapy Modification
Amisulpride (Oral): May increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor
Anticoagulants: May increase adverse/toxic effects of Obinutuzumab. Specifically, the risk of serious bleeding-related events may be increased. Management: Consider avoiding coadministration of obinutuzumab and anticoagulants, especially during the first cycle of obinutuzumab therapy. Risk D: Consider Therapy Modification
Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may increase hypotensive effects of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor
Antithymocyte Globulin (Equine): Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of anti-CD20 B-cell depleting therapy is reduced. Anti-CD20 B-Cell Depleting Therapies may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor
Arginine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Barbiturates: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of BCG Products. Risk X: Avoid
Benperidol: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Blood Pressure Lowering Agents: Obinutuzumab may increase hypotensive effects of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider Therapy Modification
Brimonidine (Topical): May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Bromperidol: May decrease hypotensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase hypotensive effects of Bromperidol. Risk X: Avoid
Chikungunya Vaccine (Live): Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Chikungunya Vaccine (Live). Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor
Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Miscellaneous Oncologic Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
COVID-19 Vaccines: Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of COVID-19 Vaccines. Management: Administer COVID-19 vaccine 2 to 4 weeks prior to the next scheduled dose of anti-CD20 therapy, if used chronically for the treatment of autoimmune disease. Revaccinate 6 months after completion of anti-CD20 therapy if used over a limited period. Risk D: Consider Therapy Modification
Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification
Dengue Tetravalent Vaccine (Live): Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Risk X: Avoid
Denosumab: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Desmopressin: Hyponatremia-Associated Agents may increase hyponatremic effects of Desmopressin. Risk C: Monitor
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Diazoxide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Herbal Products with Blood Pressure Lowering Effects: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Iloperidone: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines 2 weeks prior to starting anti-CD20 B-cell depleting therapies. Vaccination of patients treated with these agents in the past 6 months is not recommended. Risk D: Consider Therapy Modification
Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification
Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Lormetazepam: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Metergoline: May decrease antihypertensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase orthostatic hypotensive effects of Metergoline. Risk C: Monitor
Molsidomine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Mumps- Rubella- or Varicella-Containing Live Vaccines: Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Naftopidil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Nicergoline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Nicorandil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor
Pentoxifylline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Pholcodine: Blood Pressure Lowering Agents may increase hypotensive effects of Pholcodine. Risk C: Monitor
Phosphodiesterase 5 Inhibitors: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid
Poliovirus Vaccine (Live/Trivalent/Oral): Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Prostacyclin Analogues: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Quinagolide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Rabies Vaccine: Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification
Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Silodosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Therapeutic Antiplatelets: May increase adverse/toxic effects of Obinutuzumab. Specifically, the risk of bleeding may be increased. Management: Consider avoiding coadministration of obinutuzumab and therapeutic antiplatelets, especially during the first cycle of obinutuzumab therapy. Risk D: Consider Therapy Modification
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid
Typhoid Vaccine: Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Typhoid Vaccine. Risk X: Avoid
Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Vaccines (Live). Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider Therapy Modification
Yellow Fever Vaccine: Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Yellow Fever Vaccine. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Anti-CD20 B-Cell Depleting Therapies may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Anti-CD20 B-Cell Depleting Therapies may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Patients who could become pregnant should use effective contraception during therapy and for 6 months after the last obinutuzumab dose.
Obinutuzumab is a humanized monoclonal antibody (IgG1). Potential placental transfer of human IgG is dependent upon the IgG subclass and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).
Based on the mechanism of action and on animal data, if exposure occurs during pregnancy, B-cell counts may be depleted and immunologic function may be affected in the neonate after birth. Administration of live vaccines to neonates and infants exposed in utero should be avoided until after B-cell recovery.
It is not known if obinutuzumab is present in breast milk.
However, endogenous human immunoglobulin can be detected in milk. Although antibodies in breast milk may not enter the breastfed infant's circulations in substantial amounts, the manufacturer recommends discontinuing breastfeeding during therapy and for 6 months after the last obinutuzumab dose.
CBC with differential (at regular intervals), renal function, electrolytes, uric acid (during initial treatment days if at risk for tumor lysis syndrome); hepatitis B screening in all patients (HBsAg and anti-HBc measurements) prior to therapy initiation. Monitor coagulation parameters and platelets (if disseminated intravascular coagulation is suspected).
The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Monitor for clinical and laboratory signs of hepatitis or active hepatitis B infection (during and for up to 12 months after therapy completion). Monitor for signs or symptoms of infusion reaction (eg, bronchospasm, dyspnea, chest discomfort, tachycardia, larynx and throat irritation, wheezing, laryngeal edema, flushing, rash, hypertension, hypotension, fever, dizziness, nausea, vomiting, diarrhea, headache, fatigue, and/or chills) during the entire infusion; monitor patients with preexisting cardiac or pulmonary conditions more frequently during infusion and in the postinfusion period. Monitor fluid status. Monitor for signs/symptoms of bleeding episodes due to thrombocytopenia (particularly during cycle 1), hypersensitivity, infection, and tumor lysis syndrome (assess fluid balance). Monitor for signs/symptoms of progressive multifocal leukoencephalopathy (PML; focal neurologic deficits, which may present as hemiparesis, visual field deficits, cognitive impairment, aphasia, ataxia, and/or cranial nerve deficits); evaluate for PML with brain MRI, lumbar puncture, and neurologist consultation. Monitor for signs and symptoms of bleeding and thrombosis in patients suspected of having disseminated intravascular coagulation.
Obinutuzumab is a glycoengineered type II anti-CD20 monoclonal antibody. The CD20 antigen is expressed on the surface of pre B- and mature B-lymphocytes; upon binding to CD20, obinutuzumab activates complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis, resulting in cell death (Sehn 2012).
Distribution: Vd: ~4.1 to 4.3 L.
Half-life elimination: 25.5 to 35.3 days.
Excretion: Clearance: 0.08 to 0.11 L/day.
