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Product Description
POLIVY is an anti-cancer medicine that contains the active substance Polatuzumab vedotin. It is used for the treatment of adult patients who have 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 greater. DLBCL is a cancer that targets white blood cells known as B-cell lymphocytes. It is used with other cancer medicines also.
It belongs to a class of antibody-drug conjugates. It consists of 3 components: A monoclonal antibody that binds specifically to the CD79b protein (this protein is expressed specifically in the majority of B-cells), an anti-cancer agent, MMAE, a linker that attaches the anti-cancer agent to the monoclonal antibody. Upon binding to CD79b, Polivy is taken up by the B cell, releasing the anticancer agent directly into the cell to destroy it.
Inform the doctor If you have any infection, peripheral neuropathy, an autoimmune disease, Tumor Lysis Syndrome, diabetes, kidney or liver disease.
Inform the doctor about all your medical conditions, prescription and non-prescription drugs, vitamin supplements, herbal medications, since Polivy can interact with them. Polivy can cause an allergic reaction in some patients therefore it is necessary to read the complete composition list and consult the doctor in case of any ingredient that induces allergies.
Consult the doctor if you are planning, on a pregnancy or breastfeeding.
It is advisable to avoid driving and operating heavy machinery during the course of Polivy.
Indications of POLIVY Injection
POLIVY indicated for the treatment of adult patients who have 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 greater. DLBCL is a cancer that targets white blood cells known as B-cell lymphocytes
Therapeutic Effects of POLIVY Injection
POLIVY Injection contains Polatuzumab vedotin, a CD79b-directed antibody-drug conjugate. It consists of 3 components: A monoclonal antibody that binds specifically to the CD79b protein (this protein is expressed specifically in the majority of B-cells), an anti-cancer agent, MMAE, a linker that attaches the anti-cancer agent to the monoclonal antibody. Upon binding to CD79b, Polivy is taken up by the B cell, and the anticancer agent is release directly into the cell, destroying it.
Directions for Use
POLIVY is usually given as an intravenous infusion. This medication may be used in combination with other medications. The dosage and duration of treatment will depend on the individual’s condition and response to the medication. Your doctor will decide the dose and frequency of administration based on your health condition.
A trained healthcare doctor/Nurse will administer POLIVY. So, do not self-administer.
Storage
POLIVY Injection should be stored in refrigerator at 2°C to 8°C. Do not freeze. Do not shake.
If you are traveling, carefully follow all patient instructions for storing your medicine during travel. Avoid extreme heat or cold.
Keep in the original container to protect from light and moisture.
Keep POLIVY Injection out of sight and reach of children.
Common:
- Fever
- Cough
- Nausea & Vomiting
- Sore throat and runny nose
- Respiratory tract infection
- Pneumonia
- Diarrhea or constipation
- Soreness or inflammation of the mouth and gut (mucositis)
- Abdominal pain
- Fatigue
- Decreased appetite
- Weight loss
- Hair loss
- Changes in blood test results
Serious:
- Severe allergic reactions (rashes, itching, difficulty in breathing, fever)
- 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.
Tell a doctor or nurse straight away, if you notice any of the side effects above.
Contraindications
POLIVY Injection is contraindicated in patients with a known hypersensitivity to POLIVY or any of the excipients.
Drug Interactions
POLIVY might interact with other medicines. Therefore, it is recommended to inform your doctor about all the prescriptions you have.
Safety Advices for POLIVY Tablet
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It is recommended to avoid alcohol while being treated with POLIVY. Alcohol can hinder the liver’s ability to metabolize medication. Polivy can worsen any liver-related side effect and may elevate liver damage. Consult your doctor if you have history of Alcohol intake.
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POLIVY Injection is not recommended for use in pregnancy as it may harm your fetus. Hence, if you are pregnant or planning pregnancy, inform your doctor before taking POLIVY Injection. Using effective birth control methods while on treatment is suggested.
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Avoid breastfeeding your baby while on the treatment with POLIVY, as it may pass through breast milk. Consult your doctor if you are breastfeeding before taking this medication.
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POLIVY may cause dizziness, lightheadedness, or fainting in some patients. Therefore, avoid driving or operating machines that require mental concentration until you are not alert.
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If you have any lung-related symptoms, such as difficulty breathing, consult your doctor before taking POLIVY, as Pneumonia is the most common side effect of Polivy. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.
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If you have a pre-existing or a history of liver problems, consult your doctor as POLIVY may impact liver function and could lead to jaundice. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.
Consult Your Doctor
If you have a pre-existing or a history of kidney disease, inform your doctor. Your doctor may adjust the dose of this medicine or prescribe a suitable alternative based on your condition.
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Polivy is not recommended for use in children as the safety and efficacy are not established.
- 1. Roche Products Limited, Electronic Medical Compendium (EMC),[Revised on Apr 2022][Accessed on Jan 2024] https://www.medicines.org.uk/emc/files/pil.11028.pdf
- 2. Roche Products Limited, Inc, Food and Drug Safety Administration (FDA), [Revised on Apr 2023] [Accessed on Jan 2024] https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761121s008lbl.pdf
- 3. KD Tripathi, Essentials of Medical Pharmacology, Chemotherapy For Neoplastic Diseases, 7th edition, 2013, 930
- 4.. Goodman & Gilman's, The Pharmacological Basis of Therapeutics, Pharmacotherapy for Neoplastic Diseases, 12th edition, 2011, 1206
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