Yervoy 200mg40ml concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ipilimumab

Available from:

Bristol-Myers Squibb Pharmaceuticals Ltd

INN (International Name):

Ipilimumab

Dosage:

5mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010500; GTIN: 5012712004158

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
YERVOY 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
ipilimumab
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.

If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What YERVOY is and what it is used for
2.
What you need to know before you use YERVOY
3.
How to use YERVOY
4.
Possible side effects
5.
How to store YERVOY
6.
Contents of the pack and other information
1.
WHAT YERVOY IS AND WHAT IT IS USED FOR
YERVOY contains the active substance ipilimumab, a protein which helps
your immune system to
attack and destroy cancer cells by your immune cells.
Ipilimumab alone is used to treat advanced melanoma (a type of skin
cancer) in adults and adolescents
12 years of age and older.
Ipilimumab in combination with nivolumab, is used to treat advanced
melanoma (a type of skin
cancer) in adults.
As YERVOY may be given in combination with nivolumab, it is important
that you also read the
package leaflet for this medicine. If you have any questions about
nivolumab, please ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE YERVOY
YOU SHOULD NOT BE GIVEN YERVOY

if you are
ALLERGIC
to ipilimumab or any of the other ingredients of this medicine (listed
in
Section 6 "Contents of the pack and other information"). TALK TO YOUR DOCTOR
if you are not
sure.
WARNINGS AND PRECAUTIONS

Talk to your doctor before using YERVOY.
-
INFLAMMATION OF THE INTESTINES (COLITIS)
which can worsen to bleedings or bowel perforation.
Signs and symptoms of colitis may include diarrhoea (watery, loose or
soft stools), an
increased number of bowel movements than usual, blood in your stools
or darker-coloured
stools, pain or tenderness in your stomach area.
-
PROBLEMS WITH YOUR LUNGS
such as breathing difficult

Summary of Product characteristics

OBJECT 1
YERVOY 5 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 05-Jun-2018 | Bristol-Myers
Squibb Pharmaceuticals
limited
1. Name of the medicinal product
YERVOY 5 mg/ml concentrate for solution for infusion
2. Qualitative and quantitative composition
Each ml of concentrate contains 5 mg ipilimumab.
One 10 ml vial contains 50 mg of ipilimumab.
One 40 ml vial contains 200 mg of ipilimumab.
Ipilimumab is a fully human anti-CTLA-4 monoclonal antibody (IgG1κ)
produced in Chinese hamster
ovary cells by recombinant DNA technology.
Excipients with known effect:
Each ml of concentrate contains 0.1 mmol sodium, which is 2.30 mg
sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate).
Clear to slightly opalescent, colourless to pale yellow liquid that
may contain light (few) particulates and
has a pH of 7.0 and an osmolarity of 260-300 mOsm/kg.
4. Clinical particulars
4.1 Therapeutic indications
YERVOY as monotherapy is indicated for the treatment of advanced
(unresectable or metastatic)
melanoma in adults, and adolescents 12 years of age and older (see
section 4.4).
YERVOY in combination with nivolumab is indicated for the treatment of
advanced (unresectable or
metastatic) melanoma in adults.
Relative to nivolumab monotherapy, an increase in progression-free
survival (PFS) and overall survival
(OS) for the combination of nivolumab with ipilimumab is established
only in patients with low tumour
PD-L1 expression (see sections 4.4 and 5.1).
4.2 Posology and method of administration
Treatment must be initiated and supervised by specialist physicians
experienced in the treatment of
cancer.
Posology
_YERVOY as monotherapy_
_Adults and adolescents 12 years of age and older_
The recommended induction regimen of YERVOY is 3 mg/kg administered
intravenously over a 90-
minute period every 3 weeks for a total of 4 doses. Patients should
receive the entire induction regimen (4
doses) as tolerated, regardless