Oxaliplatin-Phares
Generic Name
Oxaliplatin
Manufacturer
Phares Pharmaceuticals
Country
Egypt
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| oxaliplatin phares 5 mg injection | ৳ 5,140.00 | N/A |
Description
Overview of the medicine
Oxaliplatin is a platinum-based antineoplastic agent used in the treatment of various cancers, primarily colorectal cancer. It works by damaging cancer cell DNA, leading to cell death.
Uses & Indications
Dosage
Adults
Typically 85 mg/m² administered as a 2 to 6-hour intravenous infusion every 2 weeks, in combination with other chemotherapeutic agents. Dose adjustments may be needed based on toxicity.
Elderly
No specific dose adjustment is generally required for elderly patients, but close monitoring for adverse reactions, especially neuropathy and renal function, is recommended.
Renal_impairment
For patients with moderate renal impairment (creatinine clearance 30-59 mL/min), a reduced starting dose (e.g., 65 mg/m²) may be considered. Not recommended for severe renal impairment (creatinine clearance <30 mL/min).
How to Take
Administer as an intravenous infusion only, after dilution in 250-500 mL of 5% Dextrose Injection. Infusion duration should be 2 to 6 hours. Never administer undiluted or via bolus injection. Avoid using aluminum-containing materials during preparation and administration.
Mechanism of Action
Oxaliplatin forms DNA adducts, leading to interstrand and intrastrand cross-links. This inhibits DNA synthesis and transcription, ultimately causing apoptosis in rapidly dividing cancer cells.
Pharmacokinetics
Onset
Rapid onset after infusion; platinum-DNA adducts form quickly.
Excretion
Primarily renal excretion (approximately 50% of the administered dose within 48 hours).
Half life
Parent drug: <10 minutes. Platinum in plasma ultrafiltrate: terminal half-life of approximately 391 hours.
Absorption
Administered intravenously, hence 100% bioavailability. Rapid distribution from plasma.
Metabolism
Undergoes rapid and non-enzymatic biotransformation in plasma to form various active and inactive platinum-containing species.
Side Effects
Contraindications
- Known hypersensitivity to oxaliplatin or other platinum-containing compounds.
- Pre-existing myelosuppression (e.g., neutrophil count <2 x 10^9/L and/or platelet count <100 x 10^9/L) before the first cycle.
- Pre-existing peripheral sensory neuropathy with functional impairment before the first cycle.
- Severe renal impairment (creatinine clearance <30 mL/min).
Drug Interactions
Warfarin
Close monitoring of INR is advised due to potential for altered coagulation.
Nephrotoxic agents
Increased risk of renal toxicity when co-administered with other nephrotoxic drugs.
Myelosuppressive agents
Increased risk of bone marrow suppression when used with other myelosuppressive agents.
Live attenuated vaccines
Increased risk of infection; avoid concurrent use.
Storage
Store intact vials at 2°C to 8°C (refrigerate). Protect from light. Do not freeze. Reconstituted or diluted solutions should be used immediately or within 24 hours if refrigerated.
Overdose
There is no known antidote for oxaliplatin overdose. Management involves supportive care for symptoms such as myelosuppression, severe neuropathy, or liver/kidney dysfunction. Hemodialysis may be considered for removing platinum from plasma ultrafiltrate, but its efficacy is not fully established.
Pregnancy & Lactation
Pregnancy Category D: Can cause fetal harm when administered to a pregnant woman. Should not be used during pregnancy. Lactation: It is unknown whether oxaliplatin or its metabolites are excreted in human milk. Due to potential serious adverse reactions in breastfed infants, breastfeeding is contraindicated during treatment.
Side Effects
Contraindications
- Known hypersensitivity to oxaliplatin or other platinum-containing compounds.
- Pre-existing myelosuppression (e.g., neutrophil count <2 x 10^9/L and/or platelet count <100 x 10^9/L) before the first cycle.
- Pre-existing peripheral sensory neuropathy with functional impairment before the first cycle.
- Severe renal impairment (creatinine clearance <30 mL/min).
Drug Interactions
Warfarin
Close monitoring of INR is advised due to potential for altered coagulation.
Nephrotoxic agents
Increased risk of renal toxicity when co-administered with other nephrotoxic drugs.
Myelosuppressive agents
Increased risk of bone marrow suppression when used with other myelosuppressive agents.
Live attenuated vaccines
Increased risk of infection; avoid concurrent use.
Storage
Store intact vials at 2°C to 8°C (refrigerate). Protect from light. Do not freeze. Reconstituted or diluted solutions should be used immediately or within 24 hours if refrigerated.
Overdose
There is no known antidote for oxaliplatin overdose. Management involves supportive care for symptoms such as myelosuppression, severe neuropathy, or liver/kidney dysfunction. Hemodialysis may be considered for removing platinum from plasma ultrafiltrate, but its efficacy is not fully established.
Pregnancy & Lactation
Pregnancy Category D: Can cause fetal harm when administered to a pregnant woman. Should not be used during pregnancy. Lactation: It is unknown whether oxaliplatin or its metabolites are excreted in human milk. Due to potential serious adverse reactions in breastfed infants, breastfeeding is contraindicated during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from manufacturing date, when stored according to recommendations.
Availability
Available in hospitals and specialized pharmacies
Approval Status
Approved by major regulatory bodies
Patent Status
Patent expired, generic versions available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials, such as the MOSAIC and XELOXA studies, have demonstrated Oxaliplatin's efficacy in adjuvant and metastatic colorectal cancer settings, often in combination regimens.
Lab Monitoring
- Complete Blood Count (CBC) with differential before each cycle and as clinically indicated.
- Liver function tests (ALT, AST, bilirubin) before each cycle.
- Kidney function tests (serum creatinine, BUN) before each cycle.
- Neurological examination to monitor for peripheral neuropathy.
Doctor Notes
- Careful assessment of pre-existing neuropathy and ongoing monitoring of neurological symptoms is critical to manage dose adjustments and prevent irreversible damage.
- Pre-medication with antiemetics and corticosteroids is crucial to mitigate acute hypersensitivity reactions and infusion-related symptoms.
- Closely monitor complete blood count, liver, and kidney function tests before each cycle and throughout treatment.
Patient Guidelines
- Immediately report any numbness, tingling, pain, or discomfort in hands, feet, or around the mouth, especially when exposed to cold.
- Avoid exposure to cold temperatures, cold drinks, and cold objects for a few days after infusion to reduce acute neuropathy symptoms.
- Report any signs of infection (fever, chills) or unusual bleeding/bruising promptly.
- Stay well-hydrated and follow antiemetic regimen to manage nausea and vomiting.
Missed Dose Advice
If a dose is missed, contact your healthcare provider immediately to determine if the dose should be given or rescheduled. Do not double the next dose to compensate for a missed one.
Driving Precautions
Oxaliplatin may cause fatigue, dizziness, and visual disturbances (e.g., transient vision loss). Patients should be advised to exercise caution when driving or operating machinery if they experience these side effects.
Lifestyle Advice
- Maintain good oral hygiene to prevent stomatitis and infections.
- Eat a balanced diet, preferably small, frequent meals, and avoid irritant foods.
- Engage in gentle physical activity if tolerated, but avoid strenuous exercise.
- Avoid alcohol consumption during treatment as it may exacerbate side effects.
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