Opdivo

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Nivolumab 10 mg/mL;  ;  ;  

Tillgänglig från:

Bristol-Myers Squibb (NZ) Limited

INN (International namn):

Nivolumab 107 mg (=100mg/10mL)

Dos:

100 mg/10mL

Läkemedelsform:

Concentrate for infusion

Sammansättning:

Active: Nivolumab 10 mg/mL       Excipient: Hydrochloric acid Mannitol Pentetic acid Polysorbate 80 Sodium chloride Sodium citrate dihydrate Sodium hydroxide Water for injection

Receptbelagda typ:

Prescription

Tillverkad av:

Lonza Biologics Inc

Terapeutiska indikationer:

OPDIVO, as monotherapy is indicated for the treatment of patients with unresectable or metastatic melanoma. OPDIVO, in combination with YERVOY (ipilimumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. OPDIVO, as monotherapy, is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

Produktsammanfattning:

Package - Contents - Shelf Life: Vial, glass, Type 1 clear. Closure: film coated butyl rubber stopper + al crimp seal - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 48 hours not refrigerated stored at or below 25°C 7 days diluted stored at 2° to 8°C (Refrigerate, do not freeze). Product can be stored unrefrigerated (at or below 25 deg C) for up to 8 hours in this 7 day period

Tillstånd datum:

2016-01-14

Bipacksedel

OPDIVO CMI_V15.0
OPDIVO
®
(OP-DEE-VOH)
_Nivolumab (nee-vol-u-mab) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about OPDIVO. 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 OPDIVO
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 OPDIVO
USED FOR
OPDIVO contains the active
substance nivolumab, a protein
which helps your immune system to
attack and destroy cancer cells.
_TREATMENT WITH OPDIVO_
OPDIVO is used to treat advanced
melanoma (unresectable or
metastatic). OPDIVO is also used to
treat skin cancer (melanoma) after
surgical removal of the cancer.
OPDIVO is used to treat a type of
lung cancer (advanced squamous and
non squamous
non-small cell lung
cancer), a type of kidney
cancer
(clear cell renal cell carcinoma)
and a
type of head and neck cancer
(squamous cell cancer of the head
and neck), a type of blood cancer
called classical Hodgkin lymphoma,
a type of bladder cancer (urothelial
carcinoma) and a type of liver cancer
(hepatocellular carcinoma)
and a
type of food pipe cancer
(oesophageal cancer), if your cancer
has not responded, or if it has
stopped responding, to earlier
treatment.
OPDIVO may be used after
chemoradiotherapy followed by
surgical removal of cancer in your
oesophagus (food pipe) or gastro-
oesophageal junction (area which
connects your food pipe and
stomach).
_TREATMENT WITH OPDIVO IN _
_COMBINATION WITH IPILIMUMAB_
OPDIVO in combination with
ipilimumab is used to treat advanced
melanoma, (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 OPDIVO IN _
_COMBINAT

Produktens egenskaper

OPDIVO V28.0
1
DATA SHEET
1
PRODUCT NAME
OPDIVO 10 mg/mL concentrate for solution for infusion.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL of concentrate contains 10 mg of nivolumab.
Each 40 mg/4mL vial contains 40 mg of nivolumab in 4mL of solution.
Each 100 mg/10mL vial contains 100 mg of nivolumab in 10mL of
solution.
OPDIVO (nivolumab (rch)) is a fully human anti-PD-1 monoclonal
antibody (IgG4) produced in
mammalian (Chinese hamster ovary) cells by recombinant DNA technology.
_Excipient with known effect _
Each 1 mL of concentrate contains 0.1 mmol (or 2.5 mg) sodium.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear to opalescent, colorless to pale yellow liquid that may contain
few light particles. The solution
has a pH of approximately 6.0 and an osmolarity of approximately 340
mOsm/kg.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MELANOMA
OPDIVO, as monotherapy, is indicated for the adjuvant treatment of
patients with melanoma with
involvement of lymph nodes or metastatic disease who have undergone
complete resection.
OPDIVO, as monotherapy, is indicated for the treatment of patients
with unresectable or metastatic
melanoma.
OPDIVO, in combination with ipilimumab, 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.
NON-SMALL CELL LUNG CANCER (NSCLC)
OPDIVO, in combination with ipilimumab 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.
OPDIVO, as monotherapy, is indicated for the treatment of locally
advanced or metastatic squamous
non-small cell lung cancer (NSCLC) with progression on or after prior
chemotherapy.