Gazyvaro

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Obinutuzumab

Available from:

Roche Registration GmbH

ATC code:

L01XC15

INN (International Name):

obinutuzumab

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Leukemia, Lymphocytic, Chronic, B-Cell

Therapeutic indications:

Chronic Lymphocytic Leukaemia (CLL)Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy (see section 5.1).Follicular Lymphoma (FL)Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma.Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with follicular lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.

Product summary:

Revision: 16

Authorization status:

Authorised

Authorization date:

2014-07-22

Patient Information leaflet

48
B. PACKAGE LEAFLET
49
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GAZYVARO 1,000 MG CONCENTRATE FOR SOLUTION FOR INFUSION
obinutuzumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Gazyvaro is and what it is used for
2.
What you need to know before you are given Gazyvaro
3.
How Gazyvaro is given
_ _
4.
Possible side effects
5.
How to store Gazyvaro
_ _
6.
Content of the pack and other information
1.
WHAT GAZYVARO IS AND WHAT IT IS USED FOR
WHAT GAZYVARO IS
Gazyvaro contains the active substance obinutuzumab, which belongs to
a group of medicines called
“monoclonal antibodies”. Antibodies work by attaching themselves
to specific targets in your body.
WHAT GAZYVARO IS USED FOR
Gazyvaro can be used in adults to treat two different types of cancer
•
CHRONIC LYMPHOCYTIC LEUKAEMIA
(also called “CLL”)
-
Gazyvaro is used in patients who have not had any treatment for CLL
before and who
have other illnesses which make it unlikely that they would be able to
tolerate a full dose
of a different medicine used to treat CLL called fludarabine.
-
Gazyvaro is used together with another medicine for cancer called
chlorambucil.
•
FOLLICULAR LYMPHOMA
(also called “FL”)
-
Gazyvaro is used in patients who have not had any treatment for FL
-
Gazyvaro is used in patients who have had at least one treatment with
a medicine called
rituximab before and whose FL has come back or got worse during or
after this treatment.
-
At the start of treatment for FL, Gazyvaro is used together with other
medicines for
cancer.
-
Gazyvaro can then be used on its own for up to 2 years as a
“maintenance treatment”.
HOW GAZYVARO WORKS
•
CLL and FL are types of cance

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Gazyvaro 1,000 mg concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of 40 mL concentrate contains 1,000 mg obinutuzumab,
corresponding to a concentration
before dilution of 25 mg/mL.
Obinutuzumab is a Type II humanised anti-CD20 monoclonal antibody of
the IgG1 subclass derived
by humanisation of the parental B-Ly1 mouse antibody and produced in
the Chinese Hamster Ovary
cell line by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless to slightly brownish liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chronic lymphocytic leukaemia (CLL)
Gazyvaro in combination with chlorambucil is indicated for the
treatment of adult patients with
previously untreated CLL and with comorbidities making them unsuitable
for full-dose fludarabine
based therapy (see section 5.1).
Follicular lymphoma (FL)
Gazyvaro in combination with chemotherapy, followed by Gazyvaro
maintenance therapy in patients
achieving a response, is indicated for the treatment of patients with
previously untreated advanced FL
(see section 5.1)
Gazyvaro in combination with bendamustine followed by Gazyvaro
maintenance is indicated for the
treatment of patients with FL who did not respond or who progressed
during or up to 6 months after
treatment with rituximab or a rituximab-containing regimen.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Gazyvaro should be administered under the close supervision of an
experienced physician and in an
environment where full resuscitation facilities are immediately
available.
Posology
_Prophylaxis and premedication for tumour lysis syndrome (TLS) _
Patients with a high tumour burden and/or a high circulating
lymphocyte count (> 25 x 10
9
/L) and/or
renal impairment (CrCl < 70 mL/min) are considered at risk of TLS and
should receive prophylaxis.
3
Prophylaxis should consist of adequate hydration an