Oxaliplatin for injection

This product has the general toxicity of platinum compounds. Species-specific cardiac toxicity occurs. This product does not have the renal toxicity of cisplatin, nor the bone marrow toxicity of carboplatin. This product is a new platinum derivative, which acts on DNA by producing alkylated conjugates to form intra-chain and inter-chain crosslinks, thereby inhibiting DNA synthesis and replication. This product binds to DNA rapidly, taking up to 15 minutes, while the binding of cisplatin to DNA is divided into two phases, including a delayed phase after 48 hours. One hour after administration in the human body, its presence can be shown by measuring the adducts in white blood cells. The synthesis of DNA during replication, and the subsequent separation of DNA, RNA and synthesis of cellular proteins are all inhibited. This product can be used to treat some cell lines that are resistant to cisplatin.

The main ingredient of this product is oxaliplatin. Its chemical name is: (1R-trans)-(1,2-cyclohexanediamine-N,N)[oxalate (Z-)-O,O]platinum.

This product is white or off-white freeze-dried loose mass or powder.

It can be used alone or in combination with fluorouracil for patients with colorectal cancer metastasis who have failed treatment with fluorouracil.

When used alone or in combination, the recommended dose is 130 mg/m2 per body surface area, added to 250-500 ml of 5% glucose solution and infused for 2-6 hours. If no major toxicity occurs, the drug is administered once every 3 weeks (21 days). The dose is adjusted based on safety, especially neurological safety.

1. Hematopoietic system: This product has certain hematotoxicity. When used alone, it may cause the following adverse reactions: anemia, leukopenia, granulocytopenia, thrombocytopenia, sometimes up to grade 3 or 4. When used in combination with 5-fluorouracil, hematological toxicity such as neutropenia and thrombocytopenia increases; 2. Digestive system: This product used alone may cause nausea, vomiting, and diarrhea. These symptoms are sometimes severe. When used in combination with 5-fluorouracil, these side effects increase significantly. It is recommended to give preventive and/or therapeutic antiemetic drugs; 3. Nervous system: Peripheral sensory neuropathy characterized by peripheral neuritis. Sometimes it may be accompanied by spasms and sensory disturbances around the mouth, upper respiratory tract and upper digestive tract. Even

1. It is contraindicated for those who are allergic to platinum derivatives. 2. It should be used with caution during pregnancy and lactation.

Precautions during pregnancy and lactation: May be toxic to the fetus. This product is contraindicated during pregnancy. Studies on excretion through breast milk have not been conducted, and it is contraindicated during lactation.

Due to incompatibility with sodium chloride and alkaline solutions (especially 5-fluorouracil), this product should not be mixed with the above preparations or administered simultaneously through the same vein. In vitro studies have shown that in the presence of compounds such as erythromycin, salicylates, paclitaxel and sodium valproate, the protein binding of this product has no significant changes. In vivo studies in animals and humans have shown that it has a synergistic effect when used in combination with 5-fluorouracil.

Keep in a light-proof and sealed place

50 mg