OPDIVO nivolumab 240 mg in 24 mL (10 mg/mL) concentrate solution for IV infusion vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nivolumab, Quantity: 250 mg

Available from:

Bristol-Myers Squibb Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous Infusion

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Melanoma,OPDIVO, as monotherapy, is indicated for the adjuvant treatment of adults and adolescent patients 12 years and older with completely resected Stage IIB, IIC, III or IV melanoma.,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 platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of patients with resectable 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.,OPDIVO, as monotherapy, is indicated for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with progression on or after prior chemotherapy. In patients with tumour EGFR or ALK genomic aberrations, OPDIVO should be used after progression on or after targeted therapy.,Malignant Pleural Mesothelioma (MPM),OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.,Renal Cell Carcinoma (RCC),OPDIVO, in combination with ipilimumab, is indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.,OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma.,OPDIVO, as monotherapy, is indicated for the treatment of patients with advanced clear cell renal cell carcinoma after prior anti-angiogenic therapy.,Classical Hodgkin Lymphoma (cHL),OPDIVO, as monotherapy, is indicated for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant and treatment with brentuximab vedotin. The approval of this indication is based on objective response rate in a single arm study.,Squamous Cell Carcinoma of the Head and Neck (SCCHN),OPDIVO, as monotherapy, is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in patients progressing on or after platinum based therapy.,Urothelial Carcinoma (UC),OPDIVO, as monotherapy, is indicated for the adjuvant treatment of patients with muscle invasive urothelial carcinoma (MIUC) who are at high risk of recurrence after undergoing radical resection of MIUC.,OPDIVO, as monotherapy, is indicated for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma after prior platinum-containing therapy. The approval of this indication is based on objective response rate and duration of response in a single arm study.,Hepatocellular Carcinoma (HCC),OPDIVO, as monotherapy, is indicated for the treatment of patients with hepatocellular carcinoma after prior sorafenib therapy. This indication is approved based on objective response rate and duration of response in a single arm study. An improvement in survival or disease-related symptoms has not been established.,Oesophageal Squamous Cell Carcinoma (OSCC),OPDIVO in combination with ipilimumab 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 ? 1% as determined by a validated test.,OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy 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 ? 1% as determined by a validated test.,OPDIVO, as monotherapy, is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine and platinum based chemotherapy.,Adjuvant Oesophageal Cancer (OC) or Gastro-Oesophageal Junction Cancer (GOJC),OPDIVO, as monotherapy, is indicated for the adjuvant treatment of resected oesophageal or gastro-oesophageal junction cancer in patients who have received neoadjuvant chemoradiotherapy.,Gastric Cancer (GC), Gastro-oesophageal Junction Cancer (GOJC), or Oesophageal Adenocarcinoma (OAC),OPDIVO, in combination with fluoropyrimidine- and platinum-based combination chemotherapy, is indicated for the first-line treatment of patients with HER2 negative advanced or metastatic gastric or gastro-oesophageal junction or oesophageal adenocarcinoma.

Product summary:

Visual Identification: Clear to opalescent, colourless to pale yellow liquid for intravenous infusion that may contain few light particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2020-04-09

Patient Information leaflet

OPDIVO
®
(OP-DEE-VOH)
_Nivolumab (nee-vol-u-mab)_
CONSUMER MEDICINE INFORMATION
WARNINGS AND
PRECAUTIONS -
COMBINATION OF
OPDIVO AND
IPILIMUMAB
Both OPDIVO and ipilimumab 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 IMMEDI-
ATELY 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 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
skin cancer (unresectable or
metastatic melanoma). 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) , 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), 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.
_TREATMENT WITH OPDIV

Summary of Product characteristics

AU_PI_OPDIVO_V32.0
1
AUSTRALIAN PRODUCT INFORMATION
OPDIVO
®
(NIVOLUMAB)
WARNING: IMMUNE-RELATED ADVERSE REACTIONS WITH OPDIVO
AND IPILIMUMAB COMBINATION THERAPY
IMMUNE-RELATED ADVERSE REACTIONS ARE SEEN MORE FREQUENTLY, AND ARE
MORE SEVERE, WITH
OPDIVO AND IPILIMUMAB COMBINATION THERAPY THAN WITH OPDIVO OR
IPILIMUMAB
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 INCLUDE COLITIS, INTESTINAL
PERFORATION, HEPATITIS,
PNEUMONITIS,
HYPOPHYSITIS,
ADRENAL
INSUFFICIENCY,
TOXIC
EPIDERMAL
NECROLYSIS,
MYOCARDITIS, ENCEPHALITIS AND MYASTHENIA GRAVIS (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 SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION).
MONITORING AT LEAST
PRIOR TO EACH DOSE IS RECOMMENDED. ADVISE PATIENTS OF THE IMPORTANCE
OF IMMEDIATELY
REPORTING POSSIBLE SYMPTOMS.
PHYSICIANS SHOULD CONSULT THE IPILIMUMAB PRODUCT INFORMATION PRIOR TO
INITIATION OF
OPDIVO
IN
COMBINATION
WITH
IPILIMUMAB.
THE
COMBINATION
OF
OPDIVO
AND
IPILIMUMAB SHOULD BE ADMINISTERED AND MONITORED UNDER THE SUPERVISION
OF PHYSICIANS
EXPERIENCED WITH THE USE OF IMMUNOTHERAPY IN THE TREATMENT OF CANCER.
1.
NAME OF THE MEDICINE
Nivolumab
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg/mL concentrate solution for infusion
Each 1 mL of concentrate contains 10 mg of nivolumab.
One 10 mL vial contains 40 mg of nivolumab in 4 mL.
One 10 mL vial contains 100 mg of nivolumab in 10 mL
.
One 25 mL vial contains 240 mg of nivolumab in 24 mL.
OPDIVO (nivolumab (rch)) is a fully human anti-PD-1 monoclonal
antibody (IgG4) produced in
mammalian (Chinese hamster ovary) cells by recombinant