polatuzumab vedotin

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.

• 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.
• 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.

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.

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?

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?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of polatuzumab vedotin?

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.

• 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;
• nerve problems --numbness, tingling, pain, burning sensation in your hands or feet, weakness, trouble walking;
• signs of infection --fever, chills, night sweats, cough, mouth sores, swollen glands, shallow breathing, pain or burning when you urinate, weight loss;
• signs of shingles --flu-like symptoms, tingly or painful blistering rash on one side of your body;
• liver problems --loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes); or
• 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.