Pronunciation:

pol-a-TOOZ-ue-mab ve-DOE-tin - piiq

Brand Names:

• Polivy

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Polatuzumab Vedotin

Uses of This Medicine:

Polatuzumab vedotin-piiq injection is used together with other cancer medicines (eg, bendamustine, rituximab) to treat diffuse large B-cell lymphoma (DLBCL) that has come back a second or later time or after at least 2 other medicines did not work well. Lymphoma is a type of cancer where the body makes abnormal white blood cells.

Polatuzumab vedotin-piiq injection is also used together with other medicines (eg, 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), and who have an International Prognostic Index score of 2 or more.

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

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of polatuzumab vedotin-piiq injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age greater than 65 years of age to the effects of polatuzumab vedotin-piiq injection in the geriatric population. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

• Liver disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure 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 with the 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately 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. Also, your health care professional may 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 or 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.