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obinutuzumab

Generic Name: obinutuzumab (OH bi nue TOOZ ue mab)
Brand Name: Gazyva

What is obinutuzumab?

Obinutuzumab is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Obinutuzumab is used in combination with another cancer medicine called chlorambucil to treat chronic lymphocytic leukemia.

Obinutuzumab is also used in combination with a cancer medicine called bendamustine to treat follicular lymphoma (a type of non-Hodgkin lymphoma).

Obinutuzumab may also be used for purposes not listed in this medication guide.

What is the most important information I should know about obinutuzumab?

If you have ever had hepatitis B, obinutuzumab can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

Obinutuzumab may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking.

What should I discuss with my healthcare provider before receiving obinutuzumab?

You should not receive obinutuzumab if you are allergic to it.

To make sure obinutuzumab is safe for you, tell your doctor if you have:

  • hepatitis B or other liver problems;

  • heart disease;

  • high blood pressure;

  • an active or recent infection; or

  • if you take a blood thinner (warfarin, Coumadin, Jantoven), or other medicine used to prevent blood clots (clopidogrel, Plavix, Ticlid, and others).

It is not known whether obinutuzumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether obinutuzumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How is obinutuzumab given?

Obinutuzumab is injected into a vein through an IV. A healthcare provider will give you this injection.

Obinutuzumab is given in a 28-day treatment cycle, and you may only need to take the medicine during the first 1 to 2 weeks of each cycle. Your doctor will determine how long to treat you with obinutuzumab.

You may be given other medications to prevent certain side effects of obinutuzumab.

Obinutuzumab can lower blood cells that help your blood to clot. This can make it easier for you to bleed from an injury. Your blood may need to be tested often.

If you have ever had hepatitis B, obinutuzumab can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your obinutuzumab injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving obinutuzumab?

Do not receive a "live" vaccine while using obinutuzumab. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Obinutuzumab side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Obinutuzumab may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy or nauseated, or have chest pain, trouble breathing, vomiting, or diarrhea.

Tell your caregiver right away if you have:

  • fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

  • dizziness, confusion, vision problems, loss of balance or coordination, problems with speech or walking;

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • signs of tumor cell breakdown--lower back pain, blood in your urine, little or no urinating; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse, feeling short of breath; confusion, fainting.

Common side effects may include:

  • fever;

  • cough; or

  • muscle or joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Obinutuzumab dosing 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

What other drugs will affect obinutuzumab?

Other drugs may interact with obinutuzumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about obinutuzumab.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.03. Revision Date: 2016-03-10, 12:37:49 PM.

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