OXALIPLATIN MYLAN 5mg/ml Solution for Injection

What is OXALIPLATIN MYLAN 5mg/ml

OXALIPLATIN MYLAN 5mg/ml is a prescription medication that contains the active ingredient Oxaliplatin, a platinum-based chemotherapeutic agent. It is supplied as a 10 ml solution for injection in a glass vial and is primarily used in combination with other medications for the treatment of advanced colorectal cancer and adjuvant treatment following surgery.

• Belongs to the class of platinum-containing antineoplastic agents.
• Typically used in combination with fluorouracil (5-FU) and leucovorin in FOLFOX regimens.
• Designed to be administered intravenously by a healthcare professional.
• Approved for use in adults for treating metastatic or advanced colorectal cancer.

The medicine acts by disrupting the DNA replication of cancer cells, leading to cell death. Its efficacy and relatively tolerable side effect profile make it a cornerstone in the management of colorectal cancer.

How to use OXALIPLATIN MYLAN 5mg/ml

OXALIPLATIN MYLAN 5mg/ml must be administered under the supervision of a qualified oncologist or healthcare provider experienced in chemotherapy delivery.

• Administered via intravenous infusion over a period of 2 to 6 hours, depending on the regimen and co-administered drugs.
• It should never be given as a rapid intravenous injection.
• Must be diluted with 5% glucose solution before infusion; never use saline (NaCl) due to risk of degradation.
• Patients should be pre-hydrated to reduce the risk of renal toxicity.
• Appropriate antiemetic prophylaxis (e.g., ondansetron) is often given prior to administration to reduce nausea and vomiting.
• Dosing should be based on body surface area (BSA) and adjusted according to patient response and toxicity.

Monitoring during and after administration is essential to identify any immediate hypersensitivity reactions or side effects. Renal and hepatic functions, as well as complete blood counts, should be routinely assessed before each treatment cycle.

Mode of Action OXALIPLATIN MYLAN 5mg/ml

Oxaliplatin exerts its anticancer activity through interaction with DNA, disrupting its structure and function.

• Forms reactive platinum complexes in the body after administration.
• These complexes bind to DNA, creating crosslinks between and within DNA strands.
• Crosslinking prevents DNA replication and transcription, leading to cellular apoptosis (programmed cell death).
• Particularly effective against rapidly dividing cancer cells due to their higher DNA replication rate.
• Unlike other platinum compounds, Oxaliplatin causes less nephrotoxicity and ototoxicity but has distinct neurotoxicity effects.

This mechanism is non-phase-specific, meaning it affects cells regardless of the phase they are in during the cell cycle. The result is inhibition of tumor growth and eventual cancer cell death.

OXALIPLATIN MYLAN 5mg/ml Interactions OXALIPLATIN MYLAN 5mg/ml

Oxaliplatin can interact with several other medications and substances. It is important to review a patient's full medication list before initiating therapy.

• Other nephrotoxic drugs (e.g., aminoglycosides, amphotericin B): May increase the risk of renal impairment.
• Live vaccines: Use of live or live-attenuated vaccines is not recommended during chemotherapy due to immunosuppression.
• Anticoagulants (e.g., warfarin): May require more frequent monitoring of INR due to altered platelet counts and liver metabolism.
• 5-Fluorouracil (5-FU) and leucovorin: Commonly co-administered; potential for enhanced toxicity, especially gastrointestinal and hematologic.
• Drugs causing peripheral neuropathy (e.g., vincristine): May potentiate neurotoxic effects.

Patients should avoid alcohol and limit exposure to cold (to prevent acute neuropathy). Also, they should report all supplements or over-the-counter drugs to the healthcare provider before starting therapy.

Dosage of OXALIPLATIN MYLAN 5mg/ml

Dosage must be individualized and adjusted based on factors like renal function, hematologic parameters, and toxicity. The drug is usually dosed according to body surface area (BSA).

• Standard dose: 85 mg/m² IV every 2 weeks when combined with 5-FU and leucovorin (FOLFOX regimen).
• Adjuvant setting: Similar dose and frequency over 6 months post-colon resection.
• Monotherapy: Not commonly used as monotherapy due to improved outcomes in combination regimens.
• Renal impairment: Dose adjustments recommended for patients with moderate renal impairment; contraindicated in severe impairment.
• Hepatic impairment: Caution is advised; no standard dosage modifications, but monitoring is essential.

In case of severe adverse reactions like grade 3-4 neutropenia or neuropathy, dose reduction or treatment delay is recommended. All dosing decisions must be made in consultation with an oncologist.

Possible side effects of OXALIPLATIN MYLAN 5mg/ml

Like most chemotherapy agents, Oxaliplatin has a range of side effects, from mild to potentially life-threatening. Patients should be closely monitored during treatment.

• Very Common:
  • Peripheral neuropathy (especially cold-induced)
  • Nausea and vomiting
  • Diarrhea
  • Myelosuppression (neutropenia, thrombocytopenia, anemia)
  • Fatigue
• Common:
  • Allergic reactions (rash, fever, hypotension)
  • Stomatitis
  • Liver enzyme elevation
• Rare:
  • Severe hypersensitivity reactions (anaphylaxis)
  • Interstitial lung disease
  • Renal failure

Most side effects are manageable with supportive care and dose modifications. However, long-term peripheral neuropathy can persist and may impact quality of life significantly.

OXALIPLATIN MYLAN 5mg/ml Contraindications OXALIPLATIN MYLAN 5mg/ml

OXALIPLATIN MYLAN 5mg/ml should not be used in patients who meet the following contraindication criteria:

• Hypersensitivity to oxaliplatin or other platinum-containing compounds (e.g., cisplatin).
• Severe renal impairment (creatinine clearance < 30 ml/min).
• Pregnancy and lactation: Not recommended due to potential teratogenicity and excretion in breast milk.
• Peripheral sensory neuropathy with functional impairment prior to treatment.
• Bone marrow suppression: If baseline neutrophil or platelet counts are too low, treatment should be delayed or avoided.

Assessment of risks and benefits should always be performed before initiating treatment, especially in patients with complex medical conditions.

Storage of OXALIPLATIN MYLAN 5mg/ml

Proper storage of OXALIPLATIN MYLAN 5mg/ml is essential to maintain its stability and efficacy.

• Store in a refrigerator at 2°C to 8°C.
• Do not freeze—freezing may cause irreversible damage to the solution.
• Keep in the original packaging to protect from light.
• Once diluted, the solution should be used within a specific time frame, usually 24 hours if stored in a refrigerator or 6 hours at room temperature (check local protocols).
• Keep out of reach of children and never use after the expiration date printed on the label.

Healthcare providers must follow cytotoxic handling protocols during storage, preparation, and disposal to prevent contamination and occupational exposure.