Nedaplatin for injection

Pharmacological action: Nedaplatin is an analogue of cisplatin. After entering the cell, the bond between the alcohol oxygen on the glycolate group and platinum is broken, and water combines with platinum, resulting in the formation of ionic substances (active substances or hydrates). Then, the broken glycolate ligand becomes unstable and is released, producing a variety of ionic substances that bind to DNA. This product binds to DNA in the same way as cisplatin and inhibits DNA replication, thereby producing anti-tumor activity. In addition, it has been confirmed that when reacting with DNA, the base site bound by this product is the same as that of cisplatin. Toxicological study: Repeated administration toxicity: The results of toxicological studies on intravenous administration of this product in rats twice a week for one month, daily (once) for one month, once a week for 6 months, and once a week for 6 weeks in dogs showed that the toxicity of this product is similar to that of cisplatin, and the main toxic target organs are blood (red blood cells and platelets decrease), kidneys, and pancreas. Genetic toxicity: This product is positive in the Ames test. The results of the in vitro (human lymphocytes) and in vivo (mouse bone marrow cells) chromosome aberration tests show that this product can cause a significant increase in the chromosome aberration rate. Reproductive toxicity: This product is teratogenic when injected intravenously during the organ formation period of rabbits at a dose of 500μg/kg, and the dose with no effect on the fetus is 250μg/kg. When the dose of 540μg/kg is administered to rats, it can cause delayed ossification of the fetus, but has no significant effect on its appearance, skeletal system, development and other functions.

The main ingredient is nedaplatin.

This product is off-white or slightly yellow loose lumps or powder.

It is mainly used for solid tumors such as head and neck cancer, small cell lung cancer, non-small cell lung cancer, and esophageal cancer.

Before use, dissolve it with saline, dilute it to 500ml, and drip it intravenously. The drip time should not be less than 1 hour. After the drip is finished, continue to drip more than 1000ml. The recommended dose is 80-100mg/m2 per administration, once per course of treatment, and the next course of treatment can be carried out after an interval of 3-4 weeks.

The main adverse reaction of this product is bone marrow suppression, which is manifested as a decrease in white blood cells, platelets, and hemoglobin; other common adverse reactions include digestive tract symptoms such as nausea, vomiting, loss of appetite, abnormal liver and kidney function, ototoxicity, and hair loss. Although the incidence of other adverse reactions is low, they should be of concern: 1. Serious adverse reactions: 1) Symptoms of anaphylactic shock (0.1-5%): If symptoms of anaphylactic shock (flush, dyspnea, chills, decreased blood pressure, etc.) occur, you should observe carefully, and if abnormalities are found, stop the drug immediately and take appropriate measures. 2) Bone marrow suppression (frequency unknown): manifested as erythropenia, anemia, leukopenia, neutropenia, thrombocytopenia, and bleeding tendency (0.1-5%), you should carefully observe the peripheral blood picture, and if abnormalities are found, you should extend the dosing interval, reduce the dose or stop the drug and take appropriate measures. 3) Abnormal renal function (0.1-5%): Increased blood urea nitrogen and blood creatinine, decreased creatinine clearance, increased β2 globulin, hematuria, proteinuria, oliguria, compensatory acidosis and increased uric acid, etc. If abnormalities are found, careful examination should be conducted as to whether to continue the administration. 4) Adams-Stokes Syndrome: There have been reports of deaths from Adams-Stokes Syndrome caused by the use of this product. 5) Hearing impairment, hearing loss, tinnitus (frequency unknown): This product can cause toxic reactions in the oto-nervous system, manifested as hearing impairment, hearing loss, and tinnitus. Appropriate hearing tests should be performed during medication and the patient's condition should be observed. If abnormalities are found, the drug should be discontinued and appropriate treatment should be given; patients who have used other platinum preparations before treatment and have hearing loss and renal dysfunction before medication should pay special attention. 6) Interstitial pneumonia (unknown frequency): Patients with interstitial pneumonia accompanied by fever, cough, dyspnea, and abnormal chest X-ray should be carefully observed. If abnormalities are found, the drug should be discontinued and appropriate treatment should be given with drugs such as adrenocortical hormones. 7) Syndrome of inappropriate antidiuretic hormone secretion (SIADH) (unknown frequency): manifested as hyponatremia, hypoosmotic pressure, increased sodium ion excretion in urine, accompanied by hypertonic urine, impaired consciousness, etc. If these symptoms are found, the drug should be discontinued and appropriate methods such as limiting water intake should be adopted. 2. Other adverse reactions: frequency of more than 5% 0.1-5%; type; peripheral nerve function disorders such as nervous system spasm, headache, cold hands and feet; increased renal BUN (11.4%), low serum creatinine clearance, hematuria, proteinuria, oliguria, compensatory acidosis, hypoglycemia (25.3%), increased β2 microglobulin, increased uric acid, and increased NAC. Digestive system: nausea, vomiting (74.9%), loss of appetite (59.5%), diarrhea, intestinal obstruction, abdominal pain, constipation, stomatitis, etc. Circulatory system: abnormal electrocardiogram (tachycardia, ST wave depression), myocardial damage; Respiratory system: dyspnea; Urinary system: urinary pain, dysuria; Allergic symptoms: hypersensitivity reactions (eczema, redness), rash, etc.; Liver: increased AST (GOT) (11.9%), increased bilirubin, increased AL-P, increased LDH, increased ALT (GPT) (12.3%), decreased serum total protein, decreased serum albumin, electrolyte sodium, potassium, chloride and other electrolyte abnormalities, others such as hair loss, general fatigue, fever, phlebitis, edema, flushing, herpes, leukocytosis (transient).

The following patients are contraindicated: 1. Those with obvious bone marrow suppression and severe liver and kidney dysfunction. 2. Those who are allergic to other platinum preparations and dextran. 3. Pregnant women, those who may become pregnant, and those with severe complications.

Precautions for children: No experiments have been conducted on this project and there are no reliable references. Precautions for pregnancy and lactation: 1. Animal experiments have observed that this product has teratogenic and fetal death effects, so pregnant women and patients who may become pregnant are prohibited from using this product. 2. It has been reported that similar drugs such as cisplatin can be secreted through breast milk, so breastfeeding women should stop breastfeeding when taking this drug. Precautions for the elderly: 1. This product is mainly excreted through the kidneys. Since the renal function of the elderly is generally impaired and the excretion is delayed, the possibility of bone marrow suppression should be observed. 2. The recommended initial dose for elderly patients is 80 mg/m2.

1. When this product is used in combination with other anti-tumor drugs (such as alkylating agents, antimetabolites, anti-tumor antibiotics, etc.) and radiotherapy, the bone marrow suppression effect may be enhanced. 2. When used in combination with aminoglycoside antibiotics and vancomycin hydrochloride, the damage to renal function and hearing organs may increase.

Keep sealed.

10mg

24 months

Simcere Pharmaceutical Co., Ltd.

• Founded in:

  1998-09-10

• Address:

  No. 99, Huakang Road, Jiangbei New District, Nanjing, Jiangsu Province

• Tax NO.:

  91320100135665907G

• Registered Funds:

  1.60281382 million yuan

• Website:

  Log in to view

• Email:

  Log in to view