What is the most important information I should know about polatuzumab vedotin?
Polatuzumab vedotin affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, cough, mouth sores, unusual bleeding or bruising, burning when you urinate, or problems with speech, thought, or muscle movement.
What is polatuzumab vedotin?
Polatuzumab vedotin is used to treat diffuse large B-cell lymphoma after at least two other cancer treatments did not work or have stopped working.
Polatuzumab vedotin is given in combination with bendamustine (Bendeka, Treanda) and a medicine that contains rituximab (Rituxan).
Polatuzumab vedotin may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking polatuzumab vedotin?
Tell your doctor if you have ever had:
- liver disease; or
- nerve problems (neuropathy) in your hands and feet.
Polatuzumab vedotin can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.
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If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Do not use polatuzumab vedotin if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose.
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If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 5 months after your last dose.
- Tell your doctor right away if a pregnancy occurs while either the mother or the father is using polatuzumab vedotin.
This medicine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because polatuzumab vedotin can harm an unborn baby.
Do not breastfeed while using this medicine, and for at least 2 months after your last dose.
How should I take polatuzumab vedotin?
Polatuzumab vedotin is given as an infusion into a vein. A healthcare provider will give you this injection.
Polatuzumab vedotin is usually given once every 21 days, along with bendamustine and rituximab. Your doctor will determine how long to treat you with these medicines.
You may be given other medications to help prevent serious side effects, allergic reaction, or infections. Keep using these medicines for as long as your doctor has prescribed.
Polatuzumab vedotin affects your immune system. You may get infections more easily, even serious or fatal infections. Your blood will need to be tested often, and further doses may be delayed based on the results.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your polatuzumab vedotin injection.
What happens if I overdose?
Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while taking polatuzumab vedotin?
This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
What are the possible side effects of polatuzumab vedotin?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Polatuzumab vedotin may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.
Some side effects may occur during the injection. Tell your caregiver if you feel feverish, chilled, itchy, light-headed, or have wheezing, chest tightness, or trouble breathing within 24 hours after the injection.
Call your doctor at once if you have:
- easy bruising or bleeding (nosebleeds, bleeding gums);
- muscle weakness;
- cough with mucus, chest pain, feeling short of breath;
- pale skin, cold hands and feet, feeling light-headed;
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nerve problems --numbness, tingling, pain, burning sensation in your hands or feet, weakness, trouble walking;
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signs of infection --fever, chills, night sweats, cough, mouth sores, swollen glands, shallow breathing, pain or burning when you urinate, weight loss;
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signs of shingles --flu-like symptoms, tingly or painful blistering rash on one side of your body;
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liver problems --loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); or
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signs of tumor cell breakdown --confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.
Common side effects may include:
- fever, cough, tiredness, or other signs of infection;
- nerve problems; or
- diarrhea, loss of appetite.
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.
What other drugs will affect polatuzumab vedotin?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Polatuzumab vedotin can harm your liver, especially if you also use certain medicines for infections, tuberculosis, depression, birth control, hormone replacement, high cholesterol, heart problems, high blood pressure, seizures, pain, or arthritis (including Tylenol, Advil, Motrin, or Aleve).
Other drugs may affect polatuzumab vedotin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Where can I get more information?
Your doctor or pharmacist can provide more information about polatuzumab vedotin.
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.
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.
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