Oxaliplatin medac 50/100/150mg

Powder for solution for infusion

Your choice for first line!

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Oxaliplatin Medac (oxaliplatin for injection) is an antineoplastic agent for the treatment of colorectal cancer. Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1, 2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group.

Oxaliplatin Medac is supplied in vials containing 50mg, 100mg & 150mg of oxaliplatin as a sterile, preservative-free lyophilized powder for reconstitution. Oxaliplatin medac is a 3rd generation platinum compound with wide antitumor effect & have better safety profile than cisplatin. There is lack of cross resistance with cisplatin or carboplatin.

Indications:

As First line therapy for advanced colorectal carcinoma. Oxaliplatin medac, used in combination with infusional 5-FU/LV, is indicated for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed during or within 6 months of completion of first-line therapy with the combination of bolus 5-FU/LV and irinotecan.

Advantages:

• Standard adjuvant therapy for stage II & III Colon Cancer [8]
• Results into dramatic reduction in risk of recurrence [9]
• Has better efficacy & tolerability profile
• Offers reduced hematologic toxicity

Brief Prescribing Information:

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 tumor. Treatment of metastatic colorectal cancer. TOXICITY PROFILE Novel toxicity pattern from other platinum. Nausea and vomiting. Minimal myelosuppresion No nephro- ototoxicity. Results from the first 6 phase I trial ( oxali single drug). Dose: 130 mg/m2 every 3 weeks or 85mg/m2 every 2 weeks > 45 MG/M2: nausea and vomiting rapid onset Diarrhea in < 25% of cycles and < 1% severe Hematological toxicity was mild and sporadic. No significant alopecia, renal or ototoxicity Hematological: mild anemia thrombocitopenia grade 3-4 (3-5%) Neutropenia grade 3-4 (18-35%) Febrile neutropenia 4% (< 1% cycles) Gastrointestinal: nausea and vomiting 3-4 (<5%) diarrhea 3-4 (<3%), mucositis 3-4 (<2%) Dermatological: not complete alopecia. Allergies < 2% (grade 3-4). Thromboembolism 6-9% Rare: pulmonary fibrosis <1% Trade name: Oxaliplatin Medac Generic name: Oxaliplatin Composition: One vial with lyophilized powder contains 50/100mg Oxaliplatin. One ml of reconstituted concentrate solution contains Oxaliplatin 5mg (50mg/10ml & 100mg/20ml). Excipient: Lactose Monohydrate. Administration: Oxaliplatin is administered as a 2- to 6-hour intravenous infusion in 250 to 500 ml of 5% glucose 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 infusion should always precede that of 5-fluorouracil. Peak plasma time: 2 hr Concentration: 1.21µg/mL Protein bound: >90%; platinum accumulates in RBCs Vd: 440 L Terminal Half-life: 391 hr Clearance: 10.1 L/hr Excretion: Urine (54%); feces (2%) M.R.P: Oxaliplatin 50mg – 10,000/ PKR, Oxaliplatin 100mg – 20,000/ PKR, Oxaliplatin 150mg – 28,500/ PKR

• Product Name:
  Oxali 50mg | Oxali 100mg | Oxali 150mg

Ref: [8] Oncolog, October 2010, Vol 55, No 10
[9] Annals of Oncology 16 (supplement 2) ii33-ii140, 2005