Polivy: Uses, Side Effects and Dosage

Serious warnings and precautions box

What POLIVY is used for:

POLIVY is given to adults who have not had prior treatment for large B-cell lymphoma. Large B-cell lymphoma is a cancer that develops from “B-lymphocytes”; a type of blood cell. POLIVY is given in combination with four other medicines for cancer called rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP).

POLIVY is given to previously treated adults with diffuse large B-cell lymphoma that has come back or has not responded to at least one previous therapy and who cannot receive a stem cell transplant. POLIVY is given together with two other medicines called rituximab and bendamustine.

How POLIVY works:

POLIVY contains the active substance polatuzumab vedotin, an anti-cancer agent, which is made up of a monoclonal antibody linked to a substance intended to kill cancer cells. The monoclonal antibody part allows the substance to find and kill cancer cells in the body.

The ingredients in POLIVY are:

Medicinal ingredients: polatuzumab vedotin

Non-medicinal ingredients: polysorbate 20, sodium hydroxide, succinic acid, sucrose

POLIVY comes in the following dosage form(s):

Powder for concentrate for solution for infusion in a single-use vial containing 30 mg or 140 mg (20 mg per mL).

Do not use POLIVY if:

• you are allergic to polatuzumab or any of the other ingredients of this medicine or components of the container

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take POLIVY. Talk about any health conditions or problems you may have, including if you:

• have fever, cough, chest pain, fatigue, painful rash, sore throat, burning pain when passing urine, feeling weak or generally unwell
• are receiving treatment with other medications

• are taking, have recently taken or are planning to take grapefruit and grapefruit containing products

• sometimes feel sharp, jabbing, burning pain, prickling or tingling in your arms or legs
• have any history of liver problems. Your doctor will check your blood to test your liver function before and regularly during treatment.

• are pregnant, think you may be pregnant or are planning to have a baby

Other warnings you should know about:

POLIVY can make some existing conditions worse, or cause side effects. Also see section Possible side effects from using POLIVY.

• Infusion reactions can occur, which include fever, chills, rash or breathing problems within 24 hours of infusion. Patients should contact their healthcare professional if they experience signs and/or symptoms of infusion reactions.

• Liver toxicity (inflammation or damage to cells in the liver that can affect the normal function of the liver).

  • Injured liver cells may leak higher than normal amounts of certain substances (liver enzymes and bilirubin) into the bloodstream, resulting in elevated values in blood tests. In most cases, you will not have any symptoms but tell your healthcare professional straight away if you get yellowing of your skin that may also include yellowing in the whites of your eyes (jaundice). Your healthcare professional will check your blood to test your liver function before and regularly during treatment.

• Infections

  • Signs and symptoms of infections vary between individuals, tell your healthcare professional immediately if you develop symptoms of an infection such as fever, cough, chest pain, feeling tired, painful rash, sore throat, burning pain when passing urine, feeling weak or generally unwell.

• Drug leaking into tissues

  • POLIVY may leak out of the vein if it is accidentally punctured or damaged during the placement of an IV line or catheter. The drug that has leaked out may cause tissue injury with symptoms ranging from mild (redness, swelling, discomfort) to severe (blistering, dead tissue [necrosis], open sore [ulceration], skin infection [cellulitis]). The symptoms may appear within hours to days or may be delayed for weeks after the event.

  • To minimize the risk of POLIVY leaking into tissues:

    • Your healthcare providers will ensure good venous access prior to starting the infusion.
    • The infusion site will be continuously monitored throughout the infusion for any signs that your vein may be damaged.

    • If you notice any burning, tingling, pain, discomfort, swelling or redness at the infusion site, immediately report this to your healthcare professional, even if it

      • occurs after you have left the treatment facility.

• Decrease in blood cell counts (myelosuppression). Your healthcare professional will do blood tests to check your blood cell count.

  • Tell your healthcare professional immediately if you develop chills or shivering, have a fever, have headaches, feel tired, experience dizziness, look pale, have unusual bleeding, bruising under the skin, longer than usual bleeding after your blood has been drawn, or bleeding from your gums.

• Nerve Problems (Peripheral neuropathy) (problems with a change in the sensitivity of your skin).

  • Tell your healthcare professional immediately if you have any problems with a change in the sensitivity of your skin, especially in your hands or feet, such as numbness, tingling, a burning sensation, pain, or discomfort or weakness, or difficulty walking.
  • If you had any of these symptoms before treatment with POLIVY, tell your doctor straight away if you notice any changes in them. You may need an adjustment to your dose (see Section “Usual dose”)

• Brain Infection (Progressive Multifocal Leukoencephalopathy [PML]) (a very rare and life threatening infection in the brain).

  • Tell your healthcare professional immediately if you have memory loss, trouble speaking, difficulty walking, problems with your eyesight. If you had any of these symptoms before treatment with POLIVY, tell your doctor straight away if you notice any changes in them. You may need medical treatment.

• Sexual Health

  • Females must use contraception during treatment and for 9 months following the last dose of POLIVY.
  • Males must use contraception during treatment and for 6 months following the last dose of POLIVY.
  • POLIVY may impair a male’s ability to have children.

• Rapid Breakdown of Cancer Cells (Tumour Lysis Syndrome [TLS]) (the development of unusual levels of some chemicals, such as potassium and uric acid, in the blood caused by the fast breakdown of cancer cells during treatment)

  • Your healthcare professional will do blood tests to check for Tumour Lysis Syndrome.

• Driving and Operating Machinery

  • POLIVY may affect your ability to drive, cycle or use any tools or machines. If you get infusion related reactions or nerve damage, or if you feel tired, weak or dizzy, do not drive, cycle or use any tools or machines until the reaction stops.

• Pregnancy

  • It is important to tell your doctor before and during treatment if you are pregnant, think you may be pregnant, or are planning to get pregnant. This is because POLIVY can affect your baby’s health. You should not use this medicine if you are pregnant unless you and your doctor decide that the benefit to you outweighs the potential risk to the unborn baby.

• Breast-feeding

  • Do not breast-feed while receiving POLIVY and for at least 3 months after the last dose.

• Children and adolescents

  • Only patients 18 years of age and older will receive POLIVY. This is because there is no information about its use in younger patients.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with POLIVY:

• Grapefruit and grapefruit containing products

How to take POLIVY:

POLIVY is given under the supervision of a healthcare professional experienced in the administration of treatments for cancer patients.

Prior to receiving POLIVY, you will be given medications to help prevent fever and allergic reactions.

POLIVY is given into a vein, as a drip over 90 minutes for the initial dose and over 30 minutes for subsequent doses if you do not have problems during the initial dose. Your healthcare professional will determine how long your infusion will be.

Usual dose:

The dose of this medicine depends on your body weight. The usual starting dose of this medicine is 1.8 mg for each kilogram of your body weight.

If you have symptoms of nerve or skin pain or numbness, your doctor may lower your dose to 1.4 mg for each kilogram of your body weight.

Previously Untreated Patients:

You will be given 6 treatment cycles of POLIVY together with four other medicines called rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP). Each cycle lasts 21 days.

Previously Treated Patients:

You will be given 6 treatment cycles of POLIVY together with two other medicines called rituximab and bendamustine. Each cycle lasts 21 days.

Overdose:

Missed dose:

If you miss an appointment to have POLIVY administered, make another one straight away. For the treatment to be fully effective, it is very important not to miss a dose.

Possible side effects from using POLIVY:

These are not all the possible side effects you may feel when taking POLIVY. If you experience any side effects not listed here, contact your healthcare professional.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting side effects

Storage:

POLIVY will be stored by the healthcare professionals at the hospital or clinic. The storage details are as follows:

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
• Store in a refrigerator (2°C to 8°C).
• Do not freeze.
• Do not shake.
• Keep the container in the outer carton in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Your healthcare professional will properly dispose of any medicines that are no longer being used. These measures will help protect the environment.

If you want more information about POLIVY:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website www.rochecanada.com, or by calling 1-888-762-4388.

Last Revised: 2026-03-25

POLIVY^® is a registered trademark of F. Hoffmann-La Roche AG, used under license

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