obinutuzumab (Rx)

Brand and Other Names:Gazyva
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IV solution

  • 25mg/mL (1000mg/40mL single-use vial)

Chronic Lymphocytic Leukemia

Indicated for previously untreated chronic lymphocytic leukemia in combination with chlorambucil

Administer for 6 treatment cycles (28-day cycles)

Cycle 1

  • Day 1: 100 mg IV infused at 25 mg/hr over 4 hr; do not increase infusion rate
  • Day 2
    • 900 mg IV
    • No infusion reaction with previous infusion: Infuse at 50 mg/hr; may increase rate of infusion in 50 mg/hr increments q30min, not to exceed 400 mg/hr
    • Infusion reaction with previous infusion: Infuse at 25 mg/hr; may increase rate in 50 mg/hr increments q30min, not to exceed 400 mg/hr
  • Days 8 and 15
    • 1000 mg IV
    • No infusion reaction with previous infusion: Infuse at 100 mg/hr or faster; may increase rate of infusion in 100 mg/hr increments q30min, not to exceed 400 mg/hr
    • Infusion reaction with previous infusion: Infuse at 50 mg/hr; may increase rate in 50 mg/hr increments q30min, not to exceed 400 mg/hr

Cycles 2-6

  • Day 1: 1000 mg IV
  • No infusion reaction with previous infusion: Infuse at 100 mg/hr or faster; may increase rate of infusion in 100 mg/hr increments q30min, not to exceed 400 mg/hr
  • Infusion reaction with previous infusion: Infuse at 50 mg/hr; may increase rate in 50 mg/hr increments q30min, not to exceed 400 mg/hr

Follicular Lymphoma

Indications

  • For patients with follicular lymphoma (FL) who relapsed after, or are refractory to a rituximab-containing regimen; administer in combination with bendamustine (six 28-day cycles) followed by obinutuzumab monotherapy for up to 2 years
  • In addition, for patients with untreated stage II bulky, III or IV follicular lymphoma; administer in combination with chemotherapy followed by obinutuzumab monotherapy
  • Previously untreated FL chemotherapy regimens
    • Six 28-day cycles in combination with bendamustine
    • Six 21-day cycles in combination with CHOP, followed by 2 additional 21-day cycles of obinutuzumab alone
    • Eight 21-day cycles in combination with CVP
    • Patients with previously untreated FL who achieve a complete response or partial response to initial 6 or 8 cycles should continue on obinutuzumab 1000 mg as monotherapy for up to 2 years

Cycle 1

  • Day 1: 1000 mg IV infuse at 50 mg/hr; may increase rate of infusion in 50 mg/hr increments q30 min, not to exceed 400 mg/hr
  • Day 8 and 15
    • 1000 mg IV
    • No infusion reaction or Grade 1 infusion reaction with previous infusion and final infusion rate was ≥100 mg/hr: Infuse at 100 mg/hr and may increase by 100 mg/hr increments q30min, not to exceed 400 mg/hr
    • Infusion reaction of ≥Grade 2 occurred with previous infusion: Infuse at 50 mg/hr; may increase rate in 50 mg/hr increments q30min, not to exceed 400 mg/hr

Cycles 2-6

  • Day 1: 1000 mg IV
  • No infusion reaction or Grade 1 infusion reaction with previous infusion and final infusion rate was ≥100 mg/hr: Infuse at 100 mg/hr and may increase by 100 mg/hr increments q30min, not to exceed 400 mg/hr
  • Infusion reaction of ≥Grade 2 occurred with previous infusion: Infuse at 50 mg/hr; may increase rate in 50 mg/hr increments q30min, not to exceed 400 mg/hr

Monotherapy

  • 1000 mg IV q2months for up to 2 years
  • No infusion reaction or a Grade 1 infusion reaction with previous infusion and final infusion rate was ≥100 mg/hr, infuse at 100 mg/hr and may increase by 100 mg/hr increments q30min, not to exceed 400 mg/hr
  • Infusion reaction of ≥Grade 2 with previous infusion, infuse at 50 mg/hr; may increase rate in 50 mg/hr increments q30min, not to exceed 400 mg/hr

Premedication

Premedicate before each infusion

For patients at high risk of tumor lysis syndrome, provide prophylactic hydration and antihyperuricemics (eg, allopurinol)

When glucocorticoids are indicated, use dexamethasone or methylprednisolone; hydrocortisone is not recommended as it has not been effective in reducing the rate of infusion reactions

Hypotension may occur during IV infusions; consider withholding antihypertensive agents for 12 hr prior to and throughout each obinutuzumab infusion and for the first hr after administration

For patients with high tumor burden and/or high circulating absolute lymphocyte counts, premedicate with antihyperuricemics (eg, allopurinol) beginning 12-24 hr before initiating therapy and ensure adequate hydration for prophylaxis of tumor lysis syndrome

Patients with neutropenia are strongly recommended to receive antimicrobial prophylaxis throughout the treatment period; antiviral and antifungal prophylaxis should be considered

Cycle 1

  • CLL Days 1 and 2 or FL Day 1
  • Dexamethasone 20 mg IV or methylprednisolone 80 mg IV; complete administration at least 1 hr prior to obinutuzumab infusion
  • Acetaminophen 650-1000 mg PO; at least 30 min prior to obinutuzumab infusion
  • Diphenhydramine 50 mg IV/PO; at least 30 min prior to obinutuzumab infusion

All subsequent infusions

  • All patients: Acetaminophen 650-1000 mg PO; at least 30 min prior to obinutuzumab infusion
  • Infusion-related reaction (≥Grade 1) with previous infusion: Add diphenhydramine 50 mg IV/PO; cat least 30 min prior to obinutuzumab infusion
  • Infusion-related reaction (Grade 3) with previous infusion OR with a lymphocyte count >25 x 10^9/L prior to next treatment: Dexamethasone 20 mg IV or methylprednisolone 80 mg IV; complete administration at least 1 hr prior to obinutuzumab infusion

Dosage Modifications

Consider treatment interruption, if patients experience an infection, Grade 3 or 4 cytopenia, or a ≥Grade 2 nonhematologic toxicity

Infusion-related reactions

  • Grade 1-2 (mild-to-moderate): Reduce infusion rate or interrupt infusion and treat symptoms; upon resolution, continue/resume infusion and, if patient does not experience any further infusion reaction symptoms, infusion rate escalation may resume at the increments and intervals as appropriate for the treatment cycle dose
  • Grade 1-2 for CLL patients only: Day 1 infusion rate may be increased back up to 25 mg/hr after 1 hr, but not increased further
  • Grade 3 (severe): Interrupt infusion and manage symptoms; upon resolution of symptoms, consider restarting infusion at ≤50% of the previous rate and, if patient does not experience any further infusion reaction symptoms, infusion rate escalation may resume at the increments and intervals as appropriate for the treatment cycle dose
  • Permanently discontinue treatment if patients experience a Grade 3 infusion related symptom upon rechallenge
  • Grade 3 for CLL patients only
    • Day 1 infusion rate may be increased back up to 25 mg/hr after 1 hr, but not increased further
  • Grade 4 (life threatening): Stop infusion immediately and permanently discontinue

Marginal Zone Lymphoma (Orphan)

Orphan designation for treatment of splenic marginal zone lymphoma

Sponsor

  • Genentech, Inc; 1 DNA Way, MS# 214A; South San Francisco, CA 94080-4990

Safety and efficacy not established

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Interactions

Interaction Checker

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      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (2)

              • deferiprone

                deferiprone, obinutuzumab. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.

              • palifermin

                palifermin increases toxicity of obinutuzumab by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              Monitor Closely (28)

              • adenovirus types 4 and 7 live, oral

                obinutuzumab decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunization with live virus vaccines is not recommended during obinutuzumab treatment and until after B-cell recovery.

              • amifostine

                amifostine, obinutuzumab. Either decreases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Hypotension may occur during administration. Consider withholding antihypertensive treatments for 12 hr before and during each obinutuzumab infusion and for the first hour after administration.

              • BCG vaccine live

                obinutuzumab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunization with live virus vaccines is not recommended during obinutuzumab treatment and until after B-cell recovery.

              • benazepril

                obinutuzumab increases effects of benazepril by pharmacodynamic synergism. Use Caution/Monitor. Obinutuzumab may enhance the hypotensive effect of blood pressure lowering agents.

              • captopril

                obinutuzumab, captopril. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs lower blood pressure. Monitor blood pressure.

              • chlorambucil

                chlorambucil increases toxicity of obinutuzumab by Other (see comment). Modify Therapy/Monitor Closely. Comment: Reported to cause thrombocytopenia and subsequent hemorrhage that may require blood product support.

              • cholera vaccine

                obinutuzumab, cholera vaccine. immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

              • dengue vaccine

                obinutuzumab decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • dichlorphenamide

                dichlorphenamide and obinutuzumab both decrease serum potassium. Use Caution/Monitor.

              • haemophilus influenzae type b vaccine

                obinutuzumab decreases effects of haemophilus influenzae type b vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response may be suboptimal. Patients on chemotherapy with anti-B cell antibodies should wait =6 months after therapy before being vaccinated with inactivated vaccines.

              • influenza virus vaccine quadrivalent, intranasal

                obinutuzumab decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunization with live virus vaccines is not recommended during obinutuzumab treatment and until after B-cell recovery.

              • measles (rubeola) vaccine

                obinutuzumab decreases effects of measles (rubeola) vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunization with live virus vaccines is not recommended during obinutuzumab treatment and until after B-cell recovery.

              • measles mumps and rubella vaccine, live

                obinutuzumab decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunization with live virus vaccines is not recommended during obinutuzumab treatment and until after B-cell recovery.

              • measles, mumps, rubella and varicella vaccine, live

                obinutuzumab decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunization with live virus vaccines is not recommended during obinutuzumab treatment and until after B-cell recovery.

              • ofatumumab SC

                ofatumumab SC, obinutuzumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • poliovirus vaccine inactivated

                obinutuzumab decreases effects of poliovirus vaccine inactivated by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response may be suboptimal. Patients on chemotherapy with anti-B cell antibodies should wait =6 months after therapy before being vaccinated with inactivated vaccines.

              • rotavirus oral vaccine, live

                obinutuzumab decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunization with live virus vaccines is not recommended during obinutuzumab treatment and until after B-cell recovery.

              • rubella vaccine

                obinutuzumab decreases effects of rubella vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunization with live virus vaccines is not recommended during obinutuzumab treatment and until after B-cell recovery.

              • siponimod

                siponimod and obinutuzumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • smallpox (vaccinia) vaccine, live

                obinutuzumab decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunization with live virus vaccines is not recommended during obinutuzumab treatment and until after B-cell recovery.

              • trastuzumab

                trastuzumab, obinutuzumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, obinutuzumab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • typhoid polysaccharide vaccine

                obinutuzumab decreases effects of typhoid polysaccharide vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunization with live virus vaccines is not recommended during obinutuzumab treatment and until after B-cell recovery.

              • typhoid vaccine live

                obinutuzumab decreases effects of typhoid vaccine live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunization with live virus vaccines is not recommended during obinutuzumab treatment and until after B-cell recovery.

              • varicella virus vaccine live

                obinutuzumab decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunization with live virus vaccines is not recommended during obinutuzumab treatment and until after B-cell recovery.

              • yellow fever vaccine

                obinutuzumab decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunization with live virus vaccines is not recommended during obinutuzumab treatment and until after B-cell recovery.

              • zoster vaccine live

                obinutuzumab decreases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunization with live virus vaccines is not recommended during obinutuzumab treatment and until after B-cell recovery.

              • zoster vaccine recombinant

                obinutuzumab decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.

              Minor (0)

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                Adverse Effects

                >10%

                Infusion related reactions (69%)

                Neutropenia (33%)

                Hypocalcemia (32%)

                Hyperkalemia (31%)

                Hyponatremia (29%)

                Creatinine increased (28%)

                AST/SGOT increased (28%)

                AST/SGPT increased (25%)

                Hypoalbuminemia (16%)

                Alkaline phosphatase increased (16%)

                Thrombocytopenia (15%)

                Hypokalemia (13%)

                Anemia (12%)

                1-10%

                Pyrexia (10%)

                Cough (10%)

                Leukopenia (7%)

                Tumor lysis syndrome (2%)

                Postmarketing Reports

                Hypophosphatemia

                Diarrhea

                Headache

                Insomnia

                Pruritus

                Serum sickness

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                Warnings

                Black Box Warnings

                Progressive multifocal leukoencephalopathy (PML) including fatal PML, can occur in patients receiving obinutuzumab

                Hepatitis B virus reactivation

                • 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
                • Screen all patients for HBV infection before treatment initiation
                • Monitor HBV positive patients during and after treatment
                • Discontinue obinutuzumab and concomitant medications in the event of HBV reactivation

                Contraindications

                None

                Cautions

                Anticipate tumor lysis syndrome; premedicate with anti-hyperuricemics and adequate hydration especially for patients with high tumor burden and/or high circulating lymphocyte count; correct electrolyte abnormalities, provide supportive care, and monitor renal function and fluid balance

                May reactivate hepatitis B virus (see Black Box Warnings)

                Progressive multifocal leukoencephalopathy (PML) reported (see Black Box Warnings)

                Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, and/or hyperphosphatemia from tumor lysis syndrome (TLS) can occur within 12-24 hr after the first infusion (see Premedication)

                Serious bacterial, fungal, and new or reactivated viral infections can occur; do not give obinutuzumab with an active infection

                Neutropenia may occur (in combination with chlorambucil, Grade 3 or 4 neutropenia reported in 34% of patients); patients with neutropenia are strongly recommended to receive antimicrobial prophylaxis throughout the treatment period; antiviral and antifungal prophylaxis should be considered

                Thrombocytopenia may occur (in combination with chlorambucil, Grade 3 or 4 neutropenia reported in 12% of patients); monitor all patients frequently for thrombocytopenia and hemorrhagic events, especially during the first cycle; management of hemorrhage may require blood product support

                Safety and efficacy of immunization with live or attenuated viral vaccines during or following obinutuzumab therapy has not been studied; immunization with live virus vaccines is not recommended during treatment and until B-cell recovery

                Hypersensitivity reactions have been reported; signs of immediate onset hypersensitivity (eg, dyspnea, bronchospasm, hypotension, urticaria and tachycardia); late onset hypersensitivity diagnosed as serum sickness has also been reported, symptoms (eg, chest pain, diffuse arthralgia and fever)

                Infusion-related reactions

                • May cause severe and life-threatening infusion reactions (see Dosage Modification and Premedication sections)
                • Patients with pre-existing cardiac or pulmonary conditions are at greater risk of severe reactions
                • Monitor closely throughout the infusion and the post-infusion period; interrupt or discontinue infusion for reactions
                • Due to the risk of infusion induced hypotension, consider withholding antihypertensive treatments for 12 hr prior to, during , and for the first hour after administration until blood pressure is stable
                • Consider the benefits versus the risks of withholding their antihypertensive medication in patients who are at increased of hypertensive crisis
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                Pregnancy & Lactation

                Pregnancy

                There are no data with obinutuzumab use in pregnant women to inform a drug-associated risk

                Based on findings from animal studies and the drug’s mechanism of action, obinutuzumab may cause fetal B-cell depletion

                Avoid administering live vaccines to neonates and infants exposed to obinutuzumab in utero until B-cell recovery occurs

                In animal reproduction studies, weekly IV administration of obinutuzumab to pregnant cynomolgus monkeys from day 20 of pregnancy until parturition which includes the period of organogenesis at doses with exposures up to 2.4 times the exposure at the clinical dose of 1000 mg monthly produced opportunistic infections and immune complex mediated hypersensitivity reactions

                Drug can cause fetal harm when administered to a pregnant woman; advise females of reproductive potential to use effective contraception during treatment and for 6 months after last dose

                Lactation

                Unknown if distributed in human breast milk; because of potential of serious adverse reactions in breastfed child, advise women not to breastfeed during treatment and for 6 months after last dose

                Excreted in the milk of lactating cynomolgus monkeys and human IgG is known to be excreted in human milk; consider developmental and health benefits along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                CD20-directed cytolytic antibody; upon binding to CD20, obinutuzumab mediates B-cell lysis through 1) engagement of immune effector cells, 2) by directly activating intracellular death signaling pathways and/or, 3) activation of the complement cascade

                CD20 antigen is expressed on the surface of pre B- and mature B-lymphocytes; the immune effector cell mechanisms include antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis

                Distribution

                Vd: 3.8 L

                Elimination

                Half-life: 28.4 days

                Clearance: 0.09 L/day

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                Administration

                IV Compatibility

                0.9% NaCl

                IV Preparation

                Inspect visually for any particulate matter and discoloration prior to administration

                Dilute into 0.9% NaCl PVC or non-PVC polyolefin infusion bag

                Do not use other diluents (eg, dextrose 5%)

                Dilute under appropriate aseptic conditions

                100 mg and 900 mg doses

                • Withdraw 40 mL of solution from the vial
                • Dilute 4 mL (100 mg) into 100 mL 0.9% NaCl infusion bag for immediate administration
                • Dilute the remaining 36 mL (900 mg) into a 250 mL 0.9% sodium chloride infusion bag at the same time for use on Day 2
                • After allowing the diluted bag to come to room temperature, use immediately
                • Clearly label each infusion bag

                1000 mg dose

                • Withdraw 40 mL of solution from the vial
                • Dilute 40 mL (1000 mg) into a 250 mL 0.9% NaCl infusion bag
                • Mix diluted solution by gentle inversion; do not shake
                • For microbiological stability, the diluted infusion solution should be used immediately
                • The product can be administered at a final concentration of 0.4 mg/mL to 4 mg/mL
                • If not used immediately, diluted solution may be refrigerated at 2-8°C (36-46°F) for up to 24 hours prior to use

                IV Administration

                Administer as IV infusion only

                Do not administer as IV push or bolus

                Do not mix with other drugs

                Missed dose

                • Chronic lymphocytic leukemia
                  • If a planned dose is missed, administer the missed dose as soon as possible and adjust dosing schedule accordingly
                  • If appropriate, patients who do not complete the Day 1 Cycle 1 dose may proceed to the Day 2 Cycle 1 dose
                • Follicular lymphoma
                  • Obinutuzumab and chemotherapy treatment: Adjust dosing schedule accordingly to maintain time interval between chemotherapy cycles
                  • Obinutuzumab monotherapy: Maintain original dosing schedule for subsequent doses; monotherapy should be initiated ~2 months after the last dose of obinutuzumab administered during the induction phase

                Storage

                Do not freeze or shake either unopened vials or diluted solution

                Unopened vials: Store between 2-8°C [36-46°F]) in original carton and protect from light

                Reconstituted vials and diluted solutions: Store in a refrigerator at 2-8°C (36-46°F) for up to 24 hr

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                Images

                No images available for this drug.
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                Patient Handout

                Patient Education
                obinutuzumab intravenous

                OBINUTUZUMAB - INJECTION

                (OH-bi-nue-TOOZ-ue-mab)

                COMMON BRAND NAME(S): Gazyva

                WARNING: Obinutuzumab may cause serious (possibly fatal) liver disease in people who have a current or past infection with hepatitis B. Before starting treatment with this medication, your doctor should order a test to see if you have hepatitis B. Your doctor may also order blood tests and watch for symptoms of liver disease during treatment and for several months after your last dose of medication. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellowing eyes/skin.Obinutuzumab may increase your risk of getting a rare but very serious (sometimes fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if any of these rare but very serious side effects occur: confusion, dizziness, loss of balance, difficulty talking/walking, vision changes.

                USES: Obinutuzumab is used to treat certain types of blood cancer (such as chronic lymphocytic leukemia, follicular lymphoma). Obinutuzumab belongs to a class of drugs known as monoclonal antibodies. It works by stopping the growth of cancer cells.

                HOW TO USE: This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor. Your doctor may direct you to receive this medication in a treatment cycle (for example, only on certain days each month). Carefully follow your doctor's instructions.The dosage is based on your medical condition and response to treatment.Obinutuzumab may cause very serious infusion-related reactions during or up to 24 hours after treatment. These reactions occur more often with the first and second treatments. Your doctor will monitor you closely and increase your dose slowly to reduce the chance of these serious side effects. Your doctor may also prescribe other medications before each treatment, including acetaminophen, an antihistamine (such as diphenhydramine), and a corticosteroid (such as methylprednisolone) to prevent these side effects. If you have a reaction, your treatment may be temporarily stopped. Tell your doctor or nurse right away if any of these side effects occur: dizziness, fainting, fast heartbeat, chest pain, trouble breathing, wheezing, itching/swelling of the throat, nausea, vomiting, diarrhea, flushing, headache, fever, or chills.If you take drugs for high blood pressure, ask your doctor ahead of time if you should change the way you take your blood pressure medication right before and after your dose of obinutuzumab. Some people have had reactions (such as dizziness/fainting) due to taking blood pressure medication too close to the time of their obinutuzumab infusion.

                SIDE EFFECTS: See also Warning and How to Use sections.Cough or joint/muscle pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: unusual tiredness, pale skin, signs of infection (such as sore throat that doesn't go away, fever, chills), easy bruising/bleeding.Obinutuzumab sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before using obinutuzumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (such as hepatitis B), active/current infection, heart disease, kidney disease, lung disease.Obinutuzumab can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using obinutuzumab. Obinutuzumab may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 6 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Do not share this medication with others.Lab tests (such as kidney function, complete blood count) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

                MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

                STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

                MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

                Information last revised September 2020. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
                Additional Offers
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.