Yervoy

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ipilimumab 5 mg/mL;  

Available from:

Bristol-Myers Squibb (NZ) Limited

INN (International Name):

Ipilimumab 5 mg/mL

Dosage:

200 mg/40 mL

Pharmaceutical form:

Concentrate for injection

Composition:

Active: Ipilimumab 5 mg/mL   Excipient: Hydrochloric acid Mannitol Nitrogen Pentetic acid Polysorbate 80 Sodium chloride Sodium hydroxide Trometamol hydrochloride Water for injection

Units in package:

Vial, glass, 40 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bristol-Myers Squibb Co CPO

Therapeutic indications:

YERVOY, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma in adults, 18 years of age or older. YERVOY, in combination with OPDIVO (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic disease melanoma.

Product summary:

Package - Contents - Shelf Life: Vial, glass, - 40 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours opened stored at or below 25°C. before or after dilution to 1 - 4 mg/mL

Authorization date:

2011-09-07

Patient Information leaflet

YERVOY
®
CMI V9.0
1
YERVOY®
(YURE-VOY)
_Ipilimumab (ipi-lim-u-mab) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about YERVOY. It does
not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you receiving YERVOY
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR.
YOU SHOULD READ THIS LEAFLET
CAREFULLY AND KEEP IT IN A SAFE PLACE
TO REFER TO IT LATER.
WHAT IS YERVOY
USED FOR
YERVOY contains the active
substance ipilimumab, a protein
which helps your immune system to
attack and destroy cancer cells.
_TREATMENT WITH YERVOY _
YERVOY, as a single therapy is used
to treat skin cancer (unresectable or
advanced melanoma) in adults.
_TREATMENT WITH YERVOY IN _
_COMBINATION WITH NIVOLUMAB _
YERVOY in combination with
nivolumab is used to treat advanced
skin cancer (unresectable or
metastatic melanoma), a type of
advanced kidney cancer (renal cell
carcinoma) and malignant pleural
mesothelioma (a type of cancer that
affects the lining of the lung).
_TREATMENT WITH YERVOY IN _
_COMBINATION WITH NIVOLUMAB _
_AND CHEMOTHERAPY _
YERVOY in combination with
nivolumab and chemotherapy is used
to treat advanced lung cancer in
adults.
This medicine is available only with
a doctor's prescription.
YERVOY will be given to you in
hospital under the supervision of an
experienced doctor.
Ask your doctor if you have any
questions about why YERVOY has
been prescribed for you.
BEFORE YOU ARE
GIVEN YERVOY
_YOU SHOULD NOT BE GIVEN _
_YERVOY _
•
if you are allergic
(hypersensitive) to ipilimumab or
any of the other ingredients of
YERVOY. If you are not sure,
talk to your doctor.
CHECK WITH YOUR DOCTOR OR NURSE
BEFORE YOU ARE GIVEN YERVOY
•
if you take corticosteroids or
immunosuppressive therapy.
These are medicines which
reduce the functioning of your
immune system, and may make
you

Summary of Product characteristics

YERVOY Data Sheet V18.0
1
DATA SHEET
1.
PRODUCT NAME
YERVOY ® (ipilimumab) 5mg per 1mL concentrate solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 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.
CAS: 477202-00-9. YERVOY (ipilimumab (rch)) is a recombinant, fully
human monoclonal antibody
that binds to the cytotoxic T lymphocyte-associated antigen 4
(CTLA-4). Ipilimumab is an IgG1 kappa
immunoglobulin with an approximate molecular weight of 148 kDa.
Ipilimumab is produced in
mammalian (Chinese hamster ovary) cell culture.
EXCIPIENT 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 List of excipients.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
YERVOY is a sterile, preservative free liquid for intravenous (IV)
administration, which may contain
a small amount of visible translucent-to-white, amorphous ipilimumab
particulates.
YERVOY has a pH of 7.0 and an osmolarity of 260-300mOsm/kg. It is
supplied at a nominal
concentration of 5 mg/mL ipilimumab in 50-mg and 200-mg single-use
vials.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
_MELANOMA _
YERVOY, as monotherapy, is indicated for the treatment of patients
with unresectable or metastatic
melanoma in adults, 18 years of age or older.
YERVOY, in combination with nivolumab, is indicated for the treatment
of patients with unresectable
or metastatic melanoma. The approval of this indication is based on a
pre-specified comparison to
ipilimumab
monotherapy.
All
analyses
comparing
nivolumab
monotherapy
with
the
nivolumab/ipilimumab combination are descriptive.
_RENAL CELL CARCINOMA (RCC) _
YERVOY,
in
combination
with
nivolumab,
is
indicated
for
the
treatment
of
patients
with
intermediate/poor-risk, previously untreated advanced renal cell
carcinoma.
_NON-SMALL CELL LUNG CANCER (NSCLC) _
YERVOY, in combination with nivolumab an