YERVOY ipilimumab (rch) 50mg in 10mL (5mg/mL) concentrate solution for IV infusion vial

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

Ipilimumab, Quantity: 53.5 mg

Διαθέσιμο από:

Bristol-Myers Squibb Australia Pty Ltd

INN (Διεθνής Όνομα):

Ipilimumab

Φαρμακοτεχνική μορφή:

Injection, concentrated

Σύνθεση:

Excipient Ingredients: trometamol hydrochloride; sodium chloride; mannitol; pentetic acid; polysorbate 80; sodium hydroxide; hydrochloric acid; water for injections

Οδός χορήγησης:

Intravenous

Μονάδες σε πακέτο:

One 10mL glass vial containing 50mg ipilimumab

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

Melanoma,YERVOY, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma.,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 and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations.,Malignant Pleural Mesothelioma (MPM),YERVOY, in combination with nivolumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.,Oesophageal Squamous Cell Carcinoma (OSCC),YERVOY in combination with nivolumab is indicated for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression greater than or equal to 1% as determined by a validated test.

Περίληψη προϊόντος:

Visual Identification: Clear to slightly opalescent, colourless to pale yellow aqueous solution. May contain particles.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2011-07-04

Φύλλο οδηγιών χρήσης

YERVOY
®
(YURE-VOY)
_Ipilimumab (ipi-lim-u-mab)_
CONSUMER MEDICINE INFORMATION
WARNINGS AND
PRECAUTIONS
Both YERVOY and nivolumab act
on your immune system and may
cause inflammation in parts of
your body. Inflammation may
cause serious damage to your body
and some inflammatory conditions
may be life-threatening.
These side effects are most likely
to begin during treatment, howev-
er, side effects can show up
months after your last infusion.
IT IS IMPORTANT TO TELL
YOUR DOCTOR IF YOU HAVE,
OR DEVELOP, ANY OF THE
SYMPTOMS LISTED UNDER
POSSIBLE SIDE EFFECTS.
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 advanced skin cancer
(unresectable or metastatic
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
que

Αρχείο Π.Χ.Π.

AU_PI_YERVOY_V15.0
1
AUSTRALIAN PRODUCT INFORMATION
YERVOY
®
(IPILIMUMAB)
WARNING: IMMUNE-RELATED ADVERSE REACTIONS
YERVOY CAN CAUSE SEVERE AND LIFE-THREATENING IMMUNE-RELATED ADVERSE
REACTIONS.
IMMUNE-RELATED ADVERSE REACTIONS ARE SEEN MORE FREQUENTLY, AND ARE
MORE SEVERE, WITH
YERVOY
AND
NIVOLUMAB
COMBINATION
THERAPY
THAN
WITH
YERVOY
OR
NIVOLUMAB
MONOTHERAPY.
IMMUNE-RELATED ADVERSE REACTIONS CAN INVOLVE ANY ORGAN SYSTEM. THE
MAJORITY OF THESE
INITIALLY MANIFEST DURING TREATMENT; HOWEVER, A MINORITY CAN OCCUR
WEEKS TO MONTHS AFTER
DISCONTINUATION. SOME IMMUNE-RELATED ADVERSE REACTIONS CAN BE
PERMANENT (SUCH AS THYROID
DYSFUNCTION AND DIABETES MELLITUS).
LIFE-THREATENING
OR
FATAL
IMMUNE-RELATED
ADVERSE
REACTIONS
THAT
HAVE
OCCURRED
WITH
YERVOY MONOTHERAPY OR YERVOY AND NIVOLUMAB COMBINATION THERAPY INCLUDE
COLITIS,
INTESTINAL
PERFORATION,
HEPATITIS,
PNEUMONITIS,
HYPOPHYSITIS,
ADRENAL
INSUFFICIENCY,
TOXIC
EPIDERMAL NECROLYSIS, MYOCARDITIS, ENCEPHALITIS, MYASTHENIA GRAVIS AND
NEUROPATHY (SEE
SECTIONS 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE AND 4.8 ADVERSE
EFFECTS).
EARLY DIAGNOSIS AND APPROPRIATE MANAGEMENT ARE ESSENTIAL TO MINIMISE
LIFE-THREATENING
COMPLICATIONS (SEE SECTIONS 4.2 DOSE AND METHOD OF ADMINISTRATION, 4.4
SPECIAL WARNINGS AND
PRECAUTIONS FOR USE AND 4.8 ADVERSE EFFECTS). MONITORING AT LEAST
PRIOR TO EACH DOSE IS
RECOMMENDED. ADVISE PATIENTS OF THE IMPORTANCE OF IMMEDIATELY
REPORTING SYMPTOMS.
PHYSICIANS SHOULD CONSULT THE NIVOLUMAB PRODUCT INFORMATION PRIOR TO
INITIATION OF YERVOY
IN COMBINATION WITH NIVOLUMAB. YERVOY MONOTHERAPY AND YERVOY IN
COMBINATION WITH
NIVOLUMAB
THERAPY
SHOULD
BE
ADMINISTERED
AND
MONITORED
UNDER
THE
SUPERVISION
OF
PHYSICIANS EXPERIENCED IN THE TREATMENT OF CANCER.
1
NAME OF THE MEDICINE
Ipilimumab
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg/mL concentrate solution for infusion
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.
YERVOY (ipilimumab (rch)) is a recombinant, fully hu