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, usually as part of 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 last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor 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

Get medical help right away if you have any very serious side effects, including:

• chest pain
• pain/swelling/warmth in the groin/calf

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 make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using obinutuzumab before having any immunizations/vaccinations. 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.

This medication may pass into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 6 months after the last dose. Consult your doctor before breastfeeding.

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. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. 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.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

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).