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Obinutuzumab Dosage

Applies to the following strength(s): 25 mg/mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Chronic Lymphocytic Leukemia

INITIAL CYCLE (loading doses): 100 mg IV on Day 1, 900 mg IV on Day 2, then 1000 mg IV on Day 8 and Day 15
-If appropriate, patients who do not complete the Initial Cycle, Day 1 dose may proceed to the Initial Cycle, Day 2 dose.
SUBSEQUENT CYCLES: 1000 mg IV on Day 1 of each subsequent 28 day cycle
-If a planned dose is missed, administer the missed dose as soon as possible and adjust dosing schedule accordingly.
-DURATION OF THERAPY: This drug is administered for 6 treatment cycles of 28 days each

PREMEDICATION TO PREVENT INFUSION RELATED REACTIONS (IRR):
-CYCLE 1 (CLL Days 1 and 2): All patients should receive acetaminophen (650 to 1000 mg) AND an antihistamine (e.g., diphenhydramine 50 mg) at least 30 minutes prior to infusion AND an IV glucocorticoid (dexamethasone 20 mg or methylprednisolone 80 mg) at least 1 hour prior to infusion.
-ALL SUBSEQUENT INFUSIONS: All patients should receive acetaminophen (650 to 1000 mg) at least 30 minutes prior to infusion.
-If patients experienced Grade 1 or 2 IRR with the previous infusion: Administer an antihistamine (e.g., diphenhydramine 50 mg) in addition to acetaminophen (650 to 1000 mg) at least 30 minutes prior to infusion.
-If patients experienced Grade 3 IRR with the previous infusion OR have a lymphocyte count greater than 25 X 10(9)/L prior to next treatment: Administer an IV glucocorticoid (dexamethasone 20 mg or methylprednisolone 80 mg) at least 1 hour prior to infusion, in addition to acetaminophen (650 to 1000 mg) and an antihistamine (e.g., diphenhydramine 50 mg) at least 30 minutes prior to infusion.

RATE OF ADMINISTRATION:
-Cycle 1, Day 1 (100 mg): Infuse at 25 mg/hr IV over 4 hours; do not increase the rate
-Cycle 1, Day 2 (900 mg): Infuse at an initial rate of 50 mg/hr; the rate may be increased in increments of 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr
-Cycle 1, Day 8 (1000 mg) and Day 15 (1000 mg) and Cycles 2 through 6 (1000 mg each): If no infusion reaction occurred during the previous infusion and the final rate was 100 mg/hr or faster, infusions can be started at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum rate of 400 mg/hr

Comments:
-Administration should be by a healthcare professional with appropriate medical support to manage severe infusion reactions that can be fatal if they occur.
-Premedicate before each infusion to reduce infusion related reactions.
-Do not administer as an IV push or bolus.
-Patients with high tumor burden, high circulating absolute lymphocyte counts (greater than 25 x 10(9)/L) or renal impairment are considered at risk of tumor lysis syndrome and should receive prophylaxis. Premedicate with antihyperuricemics (e.g., allopurinol, rasburicase) and ensure adequate hydration prior to start of therapy. Continue prophylaxis prior to each subsequent infusion, as needed.
-Hypotension may occur during the IV infusion. The clinician may consider withholding antihypertensive treatments for 12 hours prior to and throughout each infusion and for the first hour after administration.
-Monitor blood counts at regular intervals.
-Patients with Grade 3 to 4 neutropenia lasting more than one week should receive antimicrobial prophylaxis until resolution of neutropenia to Grade 1 or 2. -Antiviral and antifungal prophylaxis should be considered.
-Treatment interruption should be considered if patients experience an infection, Grade 3 or 4 cytopenia, or a Grade 2 or greater nonhematologic toxicity.

Use: The treatment of patients with previously untreated chronic lymphocytic leukemia, in combination with chlorambucil

Usual Adult Dose for Follicular Lymphoma

RECOMMENDED DOSE: 1000 mg IV for Cycle 1 Days 1, 8, and 15 AND Cycles 2 through 6 Day 1 AND every 2 months for 2 years thereafter
DURATION OF TREATMENT: Patients who achieve stable disease, complete response, or partial response to the initial 6 cycles of this drug in combination with bendamustine should continue on this drug 1000 mg IV as monotherapy for 2 years
-If a planned dose of this drug is missed, the missed dose should be administered as soon as possible and the dosing schedule should be adjusted accordingly.
-During concomitant treatment with bendamustine, adjust the dosing schedule accordingly.
-During monotherapy, maintain the original dosing schedule for subsequent doses.

PREMEDICATION TO PREVENT INFUSION RELATED REACTIONS (IRR):
-CYCLE 1, Day 1): All patients should receive acetaminophen (650 to 1000 mg) AND an antihistamine (e.g., diphenhydramine 50 mg) at least 30 minutes prior to infusion AND an IV glucocorticoid (dexamethasone 20 mg or methylprednisolone 80 mg) at least 1 hour prior to infusion.
-ALL SUBSEQUENT INFUSIONS: All patients should receive acetaminophen (650 to 1000 mg) at least 30 minutes prior to infusion.
-If patients experienced Grade 1 or 2 IRR with the previous infusion: Administer an antihistamine (e.g., diphenhydramine 50 mg) in addition to acetaminophen (650 to 1000 mg) at least 30 minutes prior to infusion.
-If patients experienced Grade 3 IRR with the previous infusion OR have a lymphocyte count greater than 25 X 10(9)/L prior to next treatment: Administer an IV glucocorticoid (dexamethasone 20 mg or methylprednisolone 80 mg) at least 1 hour prior to infusion, in addition to acetaminophen (650 to 1000 mg) and an antihistamine (e.g., diphenhydramine 50 mg) at least 30 minutes prior to infusion.

RATE OF ADMINISTRATION:
Cycle 1, Day 1 (1000 mg): Infuse at 50 mg/hr IV; the rate can be escalated in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr
Cycle 1, Day 8 (1000 mg) and Day 15 (1000 mg) AND Cycles 1 through 6, Day 1 (1000 mg) AND monotherapy every 2 months for 2 years (1000 mg): If no infusion reaction occurred during the previous infusion and the final infusion rate was 100 mg/hr or faster, infusions can be started at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr

Comments:
-Administration should be by a healthcare professional with appropriate medical support to manage severe infusion reactions that can be fatal if they occur.
-Premedicate before each infusion to reduce infusion related reactions.
-Do not administer as an IV push or bolus.
-Patients with high tumor burden, high circulating absolute lymphocyte counts (greater than 25 x 10(9)/L) or renal impairment are considered at risk of tumor lysis syndrome and should receive prophylaxis. Premedicate with antihyperuricemics (e.g., allopurinol, rasburicase) and ensure adequate hydration prior to start of therapy. Continue prophylaxis prior to each subsequent infusion, as needed.
-Hypotension may occur during the IV infusion. The clinician may consider withholding antihypertensive treatments for 12 hours prior to and throughout each infusion and for the first hour after administration.
-Monitor blood counts at regular intervals.
-Patients with Grade 3 to 4 neutropenia lasting more than one week should receive antimicrobial prophylaxis until resolution of neutropenia to Grade 1 or 2. -Antiviral and antifungal prophylaxis should be considered.
-Treatment interruption should be considered if patients experience an infection, Grade 3 or 4 cytopenia, or a Grade 2 or greater nonhematologic toxicity.

Use: In combination with bendamustine followed by this drug as monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab containing regimen

Renal Dose Adjustments

Mild to moderate renal impairment (CrCl 30 mL/min or greater): No adjustment recommended
Severe renal impairment: Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

INFUSION REACTIONS IN CLL AND FL PATIENTS:
GRADE 1 to 2 (mild to moderate):
-Reduce infusion rate or interrupt infusion and treat symptoms.
-Upon resolution of symptoms, continue or resume infusion.
-If no further infusion reaction symptoms occur, infusion rate escalation may resume at the increments and intervals as appropriate for the treatment cycle dose.
-For CLL patients only: The Day 1 infusion rate may be increased back up to 25 mg/hr after 1 hour but not increased further.
GRADE 3 (severe):
-Interrupt infusion and manage symptoms.
-Upon resolution of symptoms, consider restarting the infusion at no more than half the previous rate (the rate used at the time the infusion reaction occurred).
-If no further infusion reaction symptoms occur, 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 at rechallenge.
-For CLL patients only: The Day 1 infusion rate may be increased back up to 25 mg/hr after 1 hour but not increased further.
GRADE 4 (life threatening):
-Stop infusion immediately and permanently discontinue therapy.

Precautions

US BOXED WARNINGS:
-Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death.
-Progressive Multifocal Leukoencephalopathy (PML) resulting in death.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

ADMINISTRATION ADVICE:
Day 1: Administer at 25 mg/hr over 4 hours. Do not increase the infusion rate.
Day 2: Administer at 50 mg/hr. The rate of the infusion can be escalated in increments of 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr.
All subsequent infusions: Start at a rate of 100 mg/hr. May increase by 100 mg/hr every 30 minutes to a maximum rate of 400 mg/ hr.

PREMEDICATION GUIDELINES:
Premedications:
-Acetaminophen: 650 mg to 1000 mg at least 30 minutes before the infusion.
and/or
-Antihistamine (e.g. diphenhydramine 50 mg) at least 30 minutes before the infusion.
and/or
-IV glucocorticoid (dexamethasone 20 mg IV or methylprednisolone 80 mg IV) at least one hour prior to the infusion.

Premeds should be given as follows:

-Initial cycle, Day 1 and Day 2: Acetaminophen, antihistamine, and IV glucocorticoid
Subsequent cycles:
-Acetaminophen should be given prior to each infusion for all patients.
-Patients with a Grade 1 or greater infusion related reaction (IRR) with the previous infusion: Acetaminophen and antihistamine
-Patients with a Grade 3 IRR with the previous infusion, or with a lymphocyte count greater than 25 x 10(9)/L: Acetaminophen, antihistamine and IV glucocorticoid

STORAGE REQUIREMENTS:
-Refrigerate at 36F to 46F (2C to 8C)
-Protect from light
-Do not freeze
-Do not shake

RECONSTITUTION/PREPARATION:
-Refer to the manufacturer product information for complete preparation instructions.

IV COMPATIBILITY:
-Refer to the manufacturer product information for complete IV compatibility information.

GENERAL:
-If a planned dose is missed, administer the missed dose as soon as possible and adjust dosing schedule accordingly.
-Patients with neutropenia are recommended to receive antimicrobial prophylaxis throughout the treatment period. Antiviral and antifungal prophylaxis should be considered.

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