Celdach 100 Injection

Oxaliplatin Injection, in combination with infusional fluorouracil and leucovorin, is indicated for: adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. treatment of advanced colorectal cancer. Oxaliplatin Injection is a platinum-based drug used in combination with infusional fluorouracil and leucovorin, which is indicated for: adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. ( 1 ) treatment of advanced colorectal cancer. ( 1 )

• Administer oxaliplatin 85 mg/m 2 as an intravenous infusion over 120 minutes concurrently with leucovorin over 120 minutes in separate bags, followed by fluorouracil on Day 1 of each 14-day cycle
• Administer fluorouracil and leucovorin on Day 2 as recommended
• Adjuvant Treatment : Continue treatment for up to 12 cycles or unacceptable toxicity
• Advanced Colorectal Cancer : Continue treatment until disease progression or unacceptable toxicity
• Recommended Dosage Administer oxaliplatin injection in combination with fluorouracil and leucovorin every 2 weeks
• For adjuvant treatment, continue treatment for up to 12 cycles or unacceptable toxicity
• For advanced colorectal cancer, continue treatment until disease progression or unacceptable toxicity
• Day 1 Administer oxaliplatin injection 85 mg/m 2 as an intravenous infusion over 120 minutes and leucovorin 200 mg/m 2 as an intravenous infusion over 120 minutes at the same time in separate bags, followed by fluorouracil 400 mg/m 2 as intravenous bolus over 2-4 minutes, followed by fluorouracil 600 mg/m 2 as a 22-hour continuous infusion
• Day 2 Administer leucovorin 200 mg/m 2 as an intravenous infusion over 120 minutes, followed by fluorouracil 400 mg/m 2 as intravenous bolus over 2-4 minutes, followed by fluorouracil 600 mg/m 2 as a 22-hour continuous infusion
• Refer to the prescribing information for fluorouracil and leucovorin for additional information. …

Injection: 50 mg (5 mg per mL) or 100 mg (5 mg per mL) clear, colorless solution in a single-dose vial. Injection: 50 mg (5 mg per mL) or 100 mg (5 mg per mL) in a single-dose vial ( 3 )

• The safety and effectiveness of oxaliplatin in pediatrics have not been established
• Safety and effectiveness were assessed across 4 open-label studies in 235 patients aged 7 months to 22 years with solid tumors
• In a multicenter, open-label, non-comparative, non-randomized study (ARD5531), oxaliplatin was administered to 43 patients with refractory or relapsed malignant solid tumors, mainly neuroblastoma and osteosarcoma
• The dose limiting toxicity (DLT) was sensory neuropathy at a dose of 110 mg/m 2 . …

In the adjuvant treatment trial [see Clinical Studies ( 14.1 )] , 400 patients who received oxaliplatin with fluorouracil/leucovorin were greater than or equal to 65 years. The effect of oxaliplatin in patients greater than or equal to 65 years was not conclusive. Patients greater than or equal to 65 years receiving oxaliplatin experienced more diarrhea and grade 3 to 4 neutropenia (45% vs 39%) compared to patients less than 65 years. …

• Hypersensitivity Reactions Advise patients of the potential risk of hypersensitivity and that oxaliplatin is contraindicated in patients with a history of hypersensitivity reactions to oxaliplatin and other platinum-based drugs
• Instruct patients to seek immediate medical attention for signs of severe hypersensitivity reaction such as chest tightness; shortness of breath; wheezing; dizziness or faintness; or swelling of the face, eyelids, or lips [see Warnings and Precautions ]
• Peripheral Sensory Neuropathy Advise patients of the risk of acute reversible or persistent-type neurosensory toxicity. …

• Oxaliplatin is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs
• Reactions have included anaphylaxis [see Warnings and Precautions ]
• History of hypersensitivity reaction to oxaliplatin or other platinum-based drugs

7.1 Drugs that Prolong the QT Interval QT interval prolongation and ventricular arrhythmias can occur with oxaliplatin [see Warnings and Precautions ( 5.7 )] . Avoid coadministration of oxaliplatin with medicinal products with a known potential to prolong the QT interval. 7.2 Use with Nephrotoxic Products Because platinum-containing species are eliminated primarily through the kidney, clearance of these products may be decreased by coadministration of potentially nephrotoxic compounds [see Clinical Pharmacology ( 12.3 )] . Avoid coadministration of oxaliplatin with medicinal products known to cause nephrotoxicity. …

Peripheral Sensory Neuropathy : Acute and delayed neuropathy can occur. Avoid topical application of ice. Reduce the dose or permanently discontinue oxaliplatin as recommended. ( 5.2 ) Severe Myelosuppression : Delay oxaliplatin until neutrophils are greater than or equal to 1.5 × 10 9 /L and platelets are greater than or equal to 75 × 10 9 /L. Withhold oxaliplatin for sepsis or septic shock. Dose reduce after recovery from grade 4 neutropenia, febrile neutropenia, or grade 3 to 4 thrombocytopenia as recommended. ( 5.3 ) Posterior Reversible Encephalopathy Syndrome (PRES) : Permanently discontinue oxaliplatin in patients who develop PRES. …

The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Peripheral Sensory Neuropathy [see Warnings and Precautions ( 5.2 )] Severe Myelosuppression [see Warnings and Precautions ( 5.3 )] Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions ( 5.4 )] Pulmonary Toxicity [see Warnings and Precautions ( 5.5 )] Hepatotoxicity [see Warnings and Precautions ( 5.6 )] QT Interval Prolongation and Ventricular Arrhythmias [see Warnings and Precautions ( 5.7 )] Rhabdomyolysis [see Warnings and Precautions ( 5.8 )] Hemorrhage [see Warnings and Precautions ( 5.9 )] Most common a …

8.1 Pregnancy Risk Summary Based on its direct interaction with DNA, oxaliplatin can cause fetal harm when administered to a pregnant woman. The available human data do not establish the presence or absence of major birth defects or miscarriage related to the use of oxaliplatin. …

The maximum dose of oxaliplatin that has been administered in a single infusion is 825 mg. Several cases of overdoses have been reported with oxaliplatin. Adverse reactions observed following an overdosage were grade 4 thrombocytopenia (less than 25,000/mm 3 ) without bleeding, anemia, sensory neuropathy (including paresthesia, dysesthesia, laryngospasm and facial muscle spasms), gastrointestinal disorders (including nausea, vomiting, stomatitis, flatulence, abdomen enlarged and grade 4 intestinal obstruction), grade 4 dehydration, dyspnea, wheezing, chest pain, respiratory failure, severe bra …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.