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 together with bendamustine (Bendeka, Treanda) and a medicine that contains rituximab (Rituxan).

Polatuzumab vedotin may also be used for reasons that are not listed in this medication guide.

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 decide how long you will be treated with these medicines.

You may receive other medications to help prevent serious side effects, allergic reactions, or infections. Continue taking these medicines for as long as your doctor has prescribed.

Polatuzumab vedotin affects your immune system. You may become more susceptible to infections, including serious or life-threatening infections. Your blood will need to be tested frequently, and further doses may be delayed based on the results.

Polatuzumab vedotin affects your immune system. You may become more susceptible to infections, including serious or fatal infections. Contact your doctor if you experience a fever, chills, cough, mouth sores, unusual bleeding or bruising, burning during urination, or issues with speech, thought, or muscle movement.

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 polatuzumab vedotin.

• 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.

Do not breastfeed while using this medicine, and for at least 2 months after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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, thinking, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Some side effects may happen 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.

Polatuzumab vedotin may cause serious side effects. Call your doctor immediately 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;
• 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 of polatuzumab vedotin 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.

Usual Adult Dose for Lymphoma:

1.8 mg/kg IV every 21 days for 6 cycles in combination with bendamustine and rituximab; administer this drug, bendamustine, and rituximab in any order on Day 1 of each cycle-The recommended dose of bendamustine is 90 mg/m2/day IV on Days 1 and 2 of each cycle-The recommended dose of rituximab is 375 mg/m2 IV on Day 1 of each cycle.Comments:-Premedicate with an antihistamine and antipyretic at least 30 minutes prior to therapy.-Administer the initial dose of this drug over 90 minutes. -Monitor patients for infusion-related reactions during the infusion and for a minimum of 90 minutes following completion of the initial dose. If the previous infusion was well tolerated, the subsequent dose may be administered as a 30-minute infusion and patients should be monitored during the infusion and for at least 30 minutes after completion of the infusion.-If a dose of this drug is missed, administer as soon as possible. Adjust the schedule of administration to maintain a 21-day interval between doses.Use: In combination with bendamustine and a rituximab product for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least 2 prior therapies

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

Since polatuzumab vedotin is given by a healthcare professional in a medical setting, an overdose is unlikely to happen.

Follow your doctor's instructions about any limits on food, drinks, or activities.

Sometimes, it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medications less effective.

Polatuzumab vedotin can damage your liver, especially if you are also using 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 also affect polatuzumab vedotin, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all the medicines you are currently taking and any medicine you start or stop using.