- Approval Id
- 5eb71e519e18df6b
- Drug Name
- OXACCORD OXALIPLATIN CONCENTRATE FOR SOLUTION FOR INFUSION USP 5 MG/ML
- Product Name
- OXACCORD OXALIPLATIN CONCENTRATE FOR SOLUTION FOR INFUSION USP 5 MG/ML
- Approval Number
- SIN16046P
- Approval Date
- 2020-11-20
- Registrant
- ACCORD HEALTHCARE PRIVATE LIMITED
- Licence Holder
- ACCORD HEALTHCARE PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INFUSION, SOLUTION CONCENTRATE
- Dosage
- **Posology and method of administration**
Posology
FOR ADULTS ONLY
The recommended dose for oxaliplatin in adjuvant setting is 85 mg/m2 intravenously, repeated every two weeks for 12 cycles (6 months).
The recommended dose for oxaliplatin in treatment of metastatic colorectal cancer is 85 mg/m2 intravenously, repeated every 2 weeks until disease progression or unacceptable toxicity.
The dose should be adjusted according to tolerability (see section _Special warnings and precautions for use_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
**Oxaliplatin should always be administered before fluoropyrimidines – i.e. 5-fluorouracil (5-FU).**
Oxaliplatin is administered as a 2- to 6-hour intravenous infusion in 250 to 500 ml of glucose 5% (50mg/ml) solution to give a concentration between 0.2 mg/ml and 0.70 mg/ml; 0.70 mg/ml is the highest concentration in clinical practice for an oxaliplatin dose of 85 mg/m2.
Oxaliplatin has mainly been used in combination with continuous infusion 5-fluorouracil (5-FU) based regimens. For the two-weekly treatment schedule, 5-fluorouracil (5-FU) regimens combining bolus and continuous infusion were used.
Special Populations
_Renal impairment_
Oxaliplatin must not be administered in patients with severe renal impairment (see sections _Contraindications_ and _Pharmacokinetic properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In patients with mild to moderate renal impairment, the recommended dose of oxaliplatin is 85 mg/m2 (see sections _Special warnings and precautions for use_ and _Pharmacokinetic properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
_Hepatic insufficiency_
In a phase I study including patients with several levels of hepatic impairment, the frequency and severity of hepatobiliary disorders appeared to be related to progressive disease and impaired liver function tests at baseline. No specific dose adjustment for patients with abnormal liver function tests was performed during clinical development.
_Elderly patients_
No increase in severe toxicities was observed when oxaliplatin was used as a single agent or in combination with 5-fluorouracil (5-FU) in patients over the age of 65. Therefore, no specific dose adjustment is required for elderly patients.
_Paediatric patients_
There is no relevant indication for use of oxaliplatin in children. The effectiveness of oxaliplatin single agent in the paediatric populations with solid tumours has not been established (see section _Pharmacodynamic properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Method of administration
Oxaliplatin is administered by intravenous infusion.
The administration of oxaliplatin does not require hyperhydration.
Oxaliplatin diluted in 250 to 500 ml of glucose 5% (50mg/ml) solution to obtain a concentration not less than 0.2 mg/ml must be infused either via a central venous line or into a peripheral vein over 2 to 6 hours.
Oxaliplatin infusion must always precede the administration of 5-fluorouracil (5-FU).
In the event of extravasation, administration must be discontinued immediately.
_Instructions for use_
Oxaliplatin must be diluted before use. Only glucose 5% (50mg/ml) solution should be used to dilute the concentrate for solution for infusion product. (see section _Special precautions for disposal and other handling_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Route Of Administration
- INTRAVENOUS
- Indication Info
- **Therapeutic indications**
Oxaliplatin in combination with 5-fluorouracil (5-FU) and folinic acid (FA) is indicated for:
- Adjuvant treatment of stage III (Duke’s C) colon cancer after complete resection of primary tumour.
- Treatment of metastatic colorectal cancer.
- Contraindications
- **Contraindications**
Oxaliplatin is contraindicated in patients who:
- have a known history of hypersensitivity to the active substance or to any of the excipients listed in section List of excipients – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_
- are breast feeding
- have myelosuppression prior to starting first course, as evidenced by baseline neutrophils < 2 × 109/L and/or platelet count of < 100 × 109/L
- have a peripheral sensory neuropathy with functional impairment prior to first course
- have a severely impaired renal function (creatinine clearance <30 ml/min) (see section _Pharmacokinetic properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
- Atc Code
- L01XA03
- Atc Item Name
- oxaliplatin
- Pharma Manufacturer Name
- ACCORD HEALTHCARE PRIVATE LIMITED
- Company Detail Path
- /organization/7b2062edde9ff0f1/accord-healthcare-private-limited
