Opdivo 10mgml Concentrate for solution for infusion

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

NIVOLUMAB

Available from:

DKSH MALAYSIA SDN. BHD.

INN (International Name):

NIVOLUMAB

Units in package:

12 ml; 4ml mL; 10ml mL

Manufactured by:

Swords Laboratories Unlimited Company t/a Bristol-Myers Squibb Cruiserath Biologics

Patient Information leaflet

Not Applicable

Summary of Product characteristics

1
_ _
OPDIVO
™
(NIVOLUMAB)
INJECTION CONCENTRATE 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
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 is indicated for the treatment of advanced
(unresectable or metastatic)
melanoma in adults.
Adjuvant treatment of melanoma
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 (see
section 5.1).
Non-Small Cell Lung Cancer (NSCLC)
OPDIVO is indicated for the treatment of patients with locally
advanced or metastatic non-small cell
lung cancer with disease progression on or after platinum-based
chemotherapy. Patients with EGFR or
ALK genomic tumor aberrations should have disease progression on
approved therapy for these
aberrations prior to receiving OPDIVO
Neoadjuvant treatment of NSCLC
2
_ _
OPDIVO, in combination with platinum-doublet chemotherapy, is
indicated as neoadjuvant treatment
of adult patients with resectable (tumors
≥ 4cm or node positive) non-small cell lung cancer
(NSCLC).
Renal Cell Carcinoma (RCC)
OPDIVO as monotherapy, is indicated for the treatment of adult
patients with advanced or metastatic
renal cell carcinoma (RCC) who have recei