NIVOLUMAB BMS CONCENTRATE FOR SOLUTION FOR INFUSION 10MGML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Nivolumab

Available from:

BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.

ATC code:

L01XC17

Pharmaceutical form:

INFUSION, SOLUTION CONCENTRATE

Composition:

Nivolumab 10 mg/mL

Administration route:

INTRAVENOUS DRIP

Prescription type:

Prescription Only

Manufactured by:

Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company

Authorization status:

ACTIVE

Authorization date:

2016-11-09

Summary of Product characteristics

1
_ _
NIVOLUMAB BMS
CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML
1.
NAME OF THE MEDICINAL PRODUCT
Nivolumab BMS 10 mg/mL concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate contains 10 mg of nivolumab.
One vial of 4 mL contains 40 mg of nivolumab.
One vial of 10 mL contains 100 mg of nivolumab.
Nivolumab is produced in Chinese hamster ovary cells by recombinant
DNA technology.
Excipient with known effect
Each mL of concentrate contains 0.1 mmol (or 2.5 mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
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 osmolality of approximately 340
mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Melanoma
Nivolumab as monotherapy or in combination with ipilimumab is
indicated for the treatment of
advanced (unresectable or metastatic) melanoma in adults.
Relative
to
nivolumab
monotherapy,
an
increase
in
progression-free
survival
(PFS)
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).
Non-Small Cell Lung Cancer (NSCLC)
Nivolumab as monotherapy is indicated for the treatment of locally
advanced or metastatic non-small
cell lung cancer (NSCLC) after prior chemotherapy in adults.
Renal Cell Carcinoma (RCC)
Nivolumab as monotherapy is indicated for the treatment of of advanced
renal cell carcinoma after
prior therapy in adults.
2
_ _
Classical Hodgkin Lymphoma (cHL)
Nivolumab as monotherapy is indicated for the treatment of adult
patients with relapsed or refractory
classical Hodgkin lymphoma (cHL) after autologous stem cell transplant
(ASCT) and treatment with
brentuximab vedotin (see section 5.1).
Squamous Cell Cancer of the Head and Neck (SCCHN)
Nivolumab as monotherapy is indicated for the treatment of recurrent
or metastatic squamous cell
ca