BAVENCIO

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

AVELUMAB

Beschikbaar vanaf:

MERCK SERONO LTD

farmaceutische vorm:

CONCENTRATE FOR SOLUTION FOR INFUSION

Samenstelling:

AVELUMAB 20 MG / 1 ML

Toedieningsweg:

I.V

Prescription-type:

Required

Geproduceerd door:

MERCK SERONO S.A., SWITZERLAND

therapeutische indicaties:

Metastatic Merkel Cell CarcinomaBavencio is indicated for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).Locally Advanced or Metastatic Urothelial CarcinomaFirst-Line Maintenance Treatment of Urothelial CarcinomaBAVENCIO is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.Previously-Treated Urothelial CarcinomaBAVENCIO is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who:• Have disease progression during or following platinum-containing chemotherapy• Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy Advanced Renal Cell CarcinomaBAVENCIO in combination with axitinib is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Autorisatie datum:

2022-12-31

Bijsluiter

Important safety information
to minimise the risk of
immune-related side effects
(adverse reactions)
PATIENT INFORMATION BROCHURE
INFORMATION FOR PATIENTS
This patient information brochure was approved by the Ministry of
Health during June 2022.
BAVENCIO
®
(avelumab)
2
3
Introduction
Your doctor has prescribed you BAVENCIO
®
(avelumab) to treat your disease.
This brochure will serve as a guide to your treatment, including what
to expect
while you are taking this medicine. This guide will explain some of
the side
effects that might occur while you undergo treatment with BAVENCIO
®
and
how to recognize them. You will also learn why it is important to
report any
symptoms to your doctor right away.
About BAVENCIO
®
(avelumab)
BAVENCIO
® IS A MEDICINE USED TO TREAT SOME TYPES OF CANCER.
BEFORE YOU START BAVENCIO
®
Tell your doctor about any medications you are taking, have recently
taken, or
might take. Make sure your doctor knows if you:
• Have an autoimmune disease (a condition where the body attacks
its own cells)
• Have human immunodeficiency virus (HIV) infection or acquired
immune
deficiency syndrome (AIDS)
• Have ever had chronic viral infection of the liver, including
hepatitis B (HBV) or
hepatitis C (HCV)
• Receive medicines to suppress your immune system
• Have had an organ transplant
• Are taking or have recently taken any other medicines
• Are pregnant, think you may be pregnant, or are planning to have a
baby
• Could become pregnant. You must use effective contraceptives while
you are
being treated with BAVENCIO
®
and for at least 1 month after your last dose
• Are breast-feeding or plan to breast-feed. Do not breast feed
while receiving
BAVENCIO
®
and for at least 1 month after your last dose
Doctor Stamp
Glue
Alert Card
Here
4
5
What you should know about
your treatment
HOW YOU RECEIVE BAVENCIO
® (AVELUMAB)
BAVENCIO
®
will be given to you in a hospital or clinic under the supervision of
an
experienced doctor. Your doctor will give you BAVENCIO
®
through an infusion
(a drip)

Productkenmerken

1
Prescribing Information
BAVENCIO
1.
NAME OF THE MEDICINAL PRODUCT
Bavencio 20 mg/mL concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate contains 20 mg of avelumab.
One vial of 10 mL contains 200 mg of avelumab.
Avelumab is a human monoclonal IgG1 antibody directed against the
immunomodulatory cell surface
ligand protein PD-L1 and produced in Chinese hamster ovary cells by
recombinant DNA technology.
Patient safety information booklet and card
The marketing of Bavencio is subject to a risk management plan (RMP)
including a 'Patient safety
information booklet' and 'Patient card'. The 'Patient safety
information booklet' and the 'Patient
card', emphasize important safety information that the patient should
be aware of before and during
treatment.
Please explain to the patient the need to review the booklet and the
card before starting treatment.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear, colourless to slightly yellow solution. The solution pH is in
the range of 5.0 - 5.6 and the
osmolality is between 285 and 350 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Metastatic Merkel Cell Carcinoma
Bavencio is indicated for the treatment of adult patients with
metastatic Merkel cell carcinoma (MCC).
Locally Advanced or Metastatic Urothelial Carcinoma
_First-Line Maintenance Treatment of Urothelial Carcinoma _
Bavencio is indicated for the maintenance treatment of patients with
locally advanced or metastatic
urothelial carcinoma (UC) that has not progressed with first-line
platinum-containing chemotherapy.
2
_Previously-Treated Urothelial Carcinoma _
Bavencio is indicated for the treatment of patients with locally
advanced or metastatic urothelial
carcinoma (UC) who:
-
Have disease progression during or following platinum-containing
chemotherapy
-
Have disease progression within 12 months of neoadjuvant or adjuvant
treatment with
platinum-containing chemotherap