OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 10 MGML

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

Nivolumab

Disponível em:

BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.

Código ATC:

L01FF01

Forma farmacêutica:

INFUSION, SOLUTION CONCENTRATE

Composição:

Nivolumab 10mg/mL

Via de administração:

INTRAVENOUS DRIP

Tipo de prescrição:

Prescription Only

Fabricado por:

Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company

Status de autorização:

ACTIVE

Data de autorização:

2016-04-04

Características técnicas

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_ _
OPDIVO
®
(NIVOLUMAB)
CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML
1.
NAME OF THE MEDICINAL PRODUCT
OPDIVO 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.
One vial of 12 mL contains 120 mg of nivolumab.
One vial of 24 mL contains 240 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
OPDIVO 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).
OPDIVO as monotherapy is indicated for the adjuvant treatment of
adults with melanoma with involvement of
lymph nodes or metastatic disease who have undergone complete
resection.
Non-Small Cell Lung Cancer (NSCLC)
OPDIVO, in combination with ipilimumab and 2 cycles of platinum-based
chemotherapy, is indicated for the first-
line treatment of metastatic or recurrent NSCLC in adult patients with
no EGFR or ALK genomic tumor mutations.
OPDIVO as monotherapy is indicated for the treatment of locally
advanced or metastatic non-small cell lung
cancer (NSCLC) after prior chemotherapy in adults.
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Neoadjuvant treatment of NSCLC
OPDIVO, in combination with platinum-doublet c