Pronunciation:

oh-bi-nue-TOOZ-ue-mab

Brand Names:

• Gazyva

Dosage Forms:

• Solution

Warnings:

Hepatitis B virus (HBV) reactivation can occur in patients receiving obinutuzumab or other CD20-directed cytolytic antibodies, which can progress to life-threatening or fatal fulminant hepatitis or hepatic failure. Screen patients at baseline for HBV infection. Monitor HBV-positive patients during and after treatment with obinutuzumab. If HBV reactivation occurs, discontinue obinutuzumab and concomitant medications. Life-threatening or fatal progressive multifocal leukoencephalopathy has also been reported .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Obinutuzumab injection is used together with other medicines (eg, chlorambucil) to treat chronic lymphocytic leukemia (CLL).

Obinutuzumab injection is also used together with bendamustine to treat follicular lymphoma after other medicines (eg, rituximab) did not work well. It is also used to treat patients who previously had untreated stage II bulky, III or IV follicular lymphoma and are at least having partial temporary recovery (remission) from their cancer. It interferes with the growth of cancer cells, which are eventually destroyed by the body. Obinutuzumab is an antineoplastic agent (cancer medicine).

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of obinutuzumab injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of obinutuzumab injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hepatitis B infection, history of or
• Hypotension (low blood pressure) or
• Neutropenia (low white blood cells) or
• Thrombocytopenia (low platelet count)—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight an infection.

• Serum sickness caused by obinutuzumab, history of—Should not be used in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed into one of your veins.

You may also receive extra fluids and other medicines (eg, allergy medicine, fever medicine, gout medicine, steroids) to help prevent unwanted side effects from the injection.

Do not use blood pressure medicines 12 hours before, during, and 1 hour after receiving this medicine.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for 6 months after your treatment ends. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause hepatitis B virus reactivation. Check with your doctor right away if you have any symptoms of liver problems, such as yellow skin or eyes, dark brown-colored urine, right-sided stomach pain, fever, or severe tiredness.

This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you have vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, or weak legs.

This medicine may cause an infusion reaction within a few hours after you receive it. Check with your doctor right away if you have chest pain, itching, hives, a rash, flushing of the face, dizziness, fainting, lightheadedness, trouble breathing, swelling of the face, tongue, and throat, a fever, or chills.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

Obinutuzumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever, chills, cough, hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause serious blood clotting problem, including disseminated intravascular coagulation (DIC). Check with your doctor right away if you have blood in the stools, blood in the urine, bruising, confusion, coughing or vomiting blood, persistent bleeding or oozing from puncture sites, mouth, or nose, rash, or trouble breathing.

While you are being treated with obinutuzumab, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Obinutuzumab may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Back pain

black, tarry stools

bleeding gums

blood in the urine or stools

chest tightness

chills

cough

fever

flushing

headache

hoarseness

lower back or side pain

nausea

painful or difficult urination

pale skin

pinpoint red spots on the skin

sore throat

trouble breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

Less common

Joint pain, stiffness, or swelling

stomach pain

swelling of the feet or lower legs

Rare

Bruising

confusion

coughing or vomiting blood

persistent bleeding or oozing from puncture sites, mouth, or nose

rash

Incidence not known

Blurred vision

dark urine

dizziness

drowsiness

general tiredness and weakness

light-colored stools

seizures

upper right abdominal or stomach pain

yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.