Polivy

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

polatuzumab vedotin

Available from:

Roche Registration GmbH

ATC code:

L01FX14

INN (International Name):

polatuzumab vedotin

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Lymphoma, B-Cell

Therapeutic indications:

Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

Product summary:

Revision: 5

Authorization status:

Authorised

Authorization date:

2020-01-16

Patient Information leaflet

35
B. PACKAGE LEAFLET
36
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
POLIVY 30 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
POLIVY 140 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
polatuzumab vedotin
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or nurse.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Polivy is and what it is used for
2.
What you need to know before you are given Polivy
3.
How Polivy is given
4.
Possible side effects
5.
How to store Polivy
6.
Contents of the pack and other information
1.
WHAT POLIVY IS AND WHAT IT IS USED FOR
WHAT POLIVY IS
Polivy is a cancer medicine that contains the active substance
“polatuzumab vedotin”.
It is always used together with other cancer medicines – see below
“What other medicines is Polivy
given with”.
WHAT POLIVY IS USED FOR
Polivy is given to treat “diffuse large B-cell lymphoma” that has
never been treated before.
Polivy is also given to treat “diffuse large B-cell lymphoma” that
has come back or has not got better:
•
after at least one previous therapy, and
•
when you cannot receive a stem cell transplant.
“Diffuse large B-cell lymphoma” is a cancer that comes from “B
lymphocytes” also called B-cells.
These are a type of blood cells.
HOW POLIVY WORKS
Polivy contains something called a ‘monoclonal antibody’and a
substance that can kill cancer called
‘MMAE’.
•
The “monoclonal antibody” part of the medicine attaches to a
target on B cells.
•
Once attached to B cells, the

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Polivy 30 mg powder for concentrate for solution for infusion.
Polivy 140 mg powder for concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Polivy 30 mg powder for concentrate for solution for infusion
Each vial of powder for concentrate for solution for infusion contains
30 mg of polatuzumab vedotin.
After reconstitution, each mL contains 20 mg of polatuzumab vedotin.
Polivy 140 mg powder for concentrate for solution for infusion
Each vial of powder for concentrate for solution for infusion contains
140 mg of polatuzumab vedotin.
After reconstitution, each mL contains 20 mg of polatuzumab vedotin.
Polatuzumab vedotin is an antibody-drug conjugate composed of the
anti-mitotic agent monomethyl
auristatin E (MMAE) covalently conjugated to a CD79b-directed
monoclonal antibody (recombinant
humanized immunoglobulin G1 [IgG1], produced in Chinese Hamster Ovary
cells by recombinant
DNA technology).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion (powder for
concentrate).
White to greyish-white lyophilized cake.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Polivy in combination with rituximab, cyclophosphamide, doxorubicin,
and prednisone (R-CHP) is
indicated for the treatment of adult patients with previously
untreated diffuse large B-cell lymphoma
(DLBCL).
Polivy in combination with bendamustine and rituximab is indicated for
the treatment of adult patients
with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are
not candidates for
haematopoietic stem cell transplant.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Polivy must only be administered under the supervision of