Xalipat — Oxaliplatin 100 mg/50 ml Injection, 1 Vial

Xalipat 100 is supplied as a sterile liquid concentrate for intravenous infusion after dilution.

Qualitative and Quantitative Composition:

• • Active Ingredient: Oxaliplatin IP — 2 mg per 1 ml (total 100 mg oxaliplatin per 50 ml vial).
• • Excipients: Water for injection IP — q.s. Free of preservatives and chloride salts.

Packaging Configuration: Clear sterile concentrate in a 50 ml glass vial (1 Vial per pack). Enclosed in an outer cardboard carton along with the official package insert. The carton features prominent "Oxaliplatin Injection IP" and "Xalipat 100" branding (with Hindi translation "झालीपॅट १००"), strength declaration "100 mg / 50 ml", orange-green accent graphics, and the official corporate logo of KLAB (Khandelwal Laboratories Private Limited, Thane / Mumbai, India).

Pharmacodynamics:
Oxaliplatin is an antineoplastic compound belonging to a distinct class of platinum complexes containing a 1,2-diaminocyclohexane (DACH) carrier group and an oxalate ligand. Biotransformation generates reactive hydrated platinum species that covalently bind to guanine and cytosine bases of DNA. This forms interstrand and intrastrand DNA cross-links, blocking DNA and RNA synthesis and inducing tumor cell apoptosis. Oxaliplatin exhibits synergistic cytotoxicity when combined with 5-fluorouracil and folinic acid.

Pharmacokinetics:

• • Distribution: Following a 2-hour IV infusion, only 15% of the administered platinum remains in systemic circulation, with 85% rapidly distributing into tissues. Irreversible plasma protein binding (primarily to albumin and erythrocytes) exceeds 90%.
• • Metabolism: Undergoes extensive non-enzymatic biotransformation in physiological fluids to form active hydrated reactive species.
• • Elimination: Platinum is primarily cleared via renal excretion in urine (approx. 54% within 48 hours). Elimination from deep tissue stores and red blood cells is prolonged, with a terminal half-life (T1/2) of approximately 40 days.

Xalipat 100 is indicated for the treatment of adult patients with the following malignancies:

• • Colorectal Carcinoma: Adjuvant treatment of Stage III (Duke's C) colon cancer following complete surgical resection of the primary tumor (in combination with 5-fluorouracil and folinic acid).
• • Metastatic Colorectal Cancer: Treatment of advanced or metastatic colorectal carcinoma in combination chemotherapy (FOLFOX / XELOX).
• • Gastric and Esophageal Cancers: Treatment of advanced gastric or esophagogastric junction adenocarcinoma (in fluoropyrimidine-based combinations).
• • Pancreatic and Ovarian Malignancies: Off-label or specialized protocol component as determined by institutional oncology boards.

Prescription, dose calculation, and intravenous administration of Xalipat 100 must be conducted strictly under the supervision of a qualified medical oncologist in specialized cancer institutions.

Administration Guidelines and Special Instructions:
The product is intended strictly for intravenous infusion after dilution.

• ⚠️ NEVER dilute with 0.9% Sodium Chloride Injection or any chloride-containing solutions! Contact with chloride ions causes chemical degradation of oxaliplatin.
• ⚠️ Dilute EXCLUSIVELY with 5% Dextrose Solution to achieve a final concentration between 0.2 mg/ml and 0.7 mg/ml.
• ⚠️ DO NOT use aluminum-containing needles or infusion sets, as aluminum reacts with platinum compounds causing precipitation and loss of potency.

Dosing Regimen:
The recommended dose of oxaliplatin in adjuvant or metastatic settings is 85 mg/m² body surface area administered as an IV infusion over 2 to 6 hours every 2 weeks (FOLFOX protocol). Dose adjustments are based on clinical tolerance and neurotoxicity severity.

Administration of Xalipat 100 is contraindicated in:

• • Hypersensitivity: Known hypersensitivity to oxaliplatin, other platinum compounds, or inactive excipients.
• • Pregnancy and Lactation: Established teratogenic and embryotoxic risks.
• • Myelosuppression: Baseline neutrophil count less than 1,500/µl or platelet count less than 100,000/µl prior to initiation.
• • Pre-existing Neuropathy: Peripheral sensory neuropathy with functional impairment prior to first cycle.
• • Severe Renal Impairment: Creatinine clearance less than 30 ml/min.

Potential pharmaceutical and pharmacological interactions must be evaluated:

• • Incompatibility with Alkaline and Chloride Solutions: Incompatible with 0.9% NaCl, basic solutions, and 5-fluorouracil. Infusion lines must be flushed with 5% Dextrose prior to 5-FU administration.
• • Nephrotoxic / Ototoxic Drugs (aminoglycosides, loop diuretics): Concomitant use increases the risk of additive renal and auditory toxicity.
• • Aluminum Components: Do not use equipment containing aluminum parts.

Pregnancy:
Xalipat 100 is strictly contraindicated during pregnancy due to genotoxic and embryofetal toxicity. Effective contraception is required during treatment and for 6 months (females) and 3 months (males) post-therapy.

Lactation:
Breastfeeding is strictly prohibited during oxaliplatin administration.

Treatment with oxaliplatin is associated with a distinct adverse reaction profile:

• • Nervous System (Very Common): Peripheral sensory neuropathy characterized by paresthesia, dysesthesia of extremities triggered or exacerbated by cold exposure, and acute laryngopharyngeal dysesthesia.
• • Hematologic System: Anemia, leukopenia, neutropenia, thrombocytopenia, febrile neutropenia.
• • Gastrointestinal Tract: Nausea, vomiting, diarrhea, stomatitis, anorexia, abdominal pain.
• • Allergic Reactions: Bronchospasm, angioedema, urticaria, anaphylactic shock.
• • General Disorders: Fatigue, dysgeusia, alopecia, elevated hepatic enzymes and bilirubin.

Symptoms:
Overdose manifests as severe neurotoxicity, profound myelosuppression (neutropenia and thrombocytopenia), intractable vomiting, and severe diarrhea.

Treatment:
No specific antidote exists. Discontinue drug administration immediately, monitor hematologic and vital parameters, and administer supportive care (G-CSF, broad-spectrum antimicrobials).

Storage Requirements for Xalipat 100:

• 🌡️ Temperature Range: Store at temperatures below 30 °C (86 °F). Do not freeze.
• ☀️ Light Protection: Store in original outer carton to protect from light exposure.
• 💧 Diluted Solution Stability: Diluted solutions in 5% Dextrose are chemically stable for 6 hours at room temperature (25 °C) or 24 hours under refrigeration (2–8 °C). From a microbiological standpoint, infuse immediately.
• 👶 Safety Precautions: Keep out of reach of children. Classified as a Cytotoxic Agent.
• ⏳ Shelf Life: Stated on carton and vial label. Do not use past expiration date. Prescription-only medicine.

To verify the authenticity of original Xalipat 100 manufactured by Khandelwal Laboratories (KLAB), check the following visual security elements:

• ✅ KLAB Corporate Logo: Large stylized brown-red "KLAB" emblem printed on the front carton face with "Khandelwal Laboratories Private Limited" typography.
• ✅ Product Title Layout: Clear presentation combining generic "Oxaliplatin Injection IP" with brand "Xalipat 100" and Hindi subtext "झालीपॅट १००".
• ✅ Graphic Accent: Package design incorporates a vertical orange-green arrow/stripe graphic on a white background.
• ✅ Warning Boxes: Prominent red and green text boxes stating "Warning: Cytotoxic Agent", "Special Instruction: For I.V. Infusion. To be diluted with 5% dextrose solution", and "CAUTION: Not to be sold by retail without the prescription of a registered Medical Practitioner".
• ✅ Manufacturer Details: Plant location details clearly printed: B-1, Wagle Industrial Estate, Thane 400 604, Regd. Office: Mumbai, India.