Polatuzumab vedotin-piiq (Intravenous)

Polatuzumab vedotin-piiq injection is used along with other cancer medicines (for example, bendamustine, rituximab) to treat diffuse large B-cell lymphoma (DLBCL) that has returned for a second time or later, or after at least 2 other medicines have not worked well. Lymphoma is a type of cancer where the body produces abnormal white blood cells.

Polatuzumab vedotin-piiq injection is also used with other medicines (for example, rituximab, cyclophosphamide, doxorubicin, and prednisone) to treat previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL), in patients who have an International Prognostic Index score of 2 or higher.

Polatuzumab vedotin-piiq works by interfering with the growth of cancer cells, which are then destroyed by the body.

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

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

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Women should use an effective form of birth control to avoid pregnancy during treatment and for at least 3 months after the last dose. Men should use an effective form of birth control to avoid pregnancy in sexual partners during treatment and for at least 5 months after the last dose. If you think a pregnancy has occurred while using this medicine, tell your doctor right away.

Talk with your doctor if you plan to have children after receiving this medicine. Some men may become infertile (unable to have children).

Check with your doctor right away if you have burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet, unsteadiness or awkwardness, or weakness in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

This medicine may cause an infusion reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a fever, chills, trouble breathing, lightheadedness, fainting, or chest pain within a few hours after you receive it.

This medicine can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination. These could be symptoms of an infection.

This medicine may cause a rare and serious 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 muscle weakness in the legs.

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, rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking it must be balanced against the benefits it may provide. This is a decision you will make with your doctor. For this medicine, consider the following:

Allergies

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

Pediatric

Appropriate studies have not been performed on how polatuzumab vedotin-piiq injection affects children. Safety and effectiveness have not been established.

Geriatric

Appropriate studies have not been performed on how polatuzumab vedotin-piiq injection affects individuals over 65 years of age. Safety and effectiveness have not been established.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together. In other cases, two different medicines may be used together even if an interaction could happen. In such cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtimes or with specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss the use of your medicine with food, alcohol, or tobacco with your healthcare professional.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Infection (e.g., pneumonia, herpes virus)—May reduce your body's ability to fight an infection.

• Liver disease, moderate to severe—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

• Peripheral neuropathy (nerve problem)—Use with caution. May worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

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

More common

• Back pain
• black, tarry stools
• bleeding gums
• blood in urine or stools
• bone pain
• burning, numbness, tingling, or painful sensations
• chest pain or tightness
• confusion
• cough or hoarseness
• dry mouth
• fast or irregular heartbeat
• fever or chills
• flushing
• headache
• increased thirst
• lightheadedness or fainting
• loss of appetite
• lower back, side, or stomach pain
• mood or mental changes
• muscle pain or cramps
• nausea or vomiting
• numbness or tingling in the mouth, fingers, hands, or feet
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• seizures
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach cramps
• swelling of the feet or lower legs
• swollen glands
• tremor
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness
• weakness in the arms, hands, legs, or feet

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. Your health care professional may also 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, are bothersome, or if you have any questions about them:

More common

• Body aches or pain
• change in taste
• constipation
• cracked lips
• diarrhea
• difficulty in moving
• difficulty in swallowing
• dizziness
• ear congestion
• hair loss or thinning
• joint pain
• loss of voice
• muscle stiffness
• runny or stuffy nose
• skin rash
• sneezing
• sores, ulcers, or white spots on lips, tongue, or inside mouth
• weight loss

Less common

• Blurred vision

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.

In the U.S.

• Polivy

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Polatuzumab Vedotin

Find detailed information on biosimilars for this medication.

Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to stay in place for at least 90 minutes every 21 days for 6 cycles.

You may also receive other medicines (eg, allergy medicine, fever medicine) 30 to 60 minutes before starting treatment with this medicine.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.