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Common name: Temozolomide
Trade name: Teqing
Full names: Temozolomide, Teqing, Temozolomide, temodar, TZM, Temozolamide, temosolomide
Indications:
This product is used to treat: Newly diagnosed glioblastoma multiforme is treated initially with radiation therapy and subsequently as adjuvant therapy.
Glioblastoma multiforme or anaplastic astrocytoma that recurs or progresses after conventional treatment.
Usage and dosage:
Adult patients with newly diagnosed glioblastoma multiforme:
Concurrent radiotherapy and chemotherapy period: Oral administration of this product at a daily dose of 75 mg/m for 42 days, concurrently with radiotherapy (60 Gy in 30 fractions); followed by 6 cycles of adjuvant therapy with this product. Medication may be withheld based on patient tolerance, but dose reduction is not necessary. During the concurrent chemoradiotherapy period, if the following conditions are met: absolute white blood cell count ≥1.5×10/L, platelet count ≥1.5×10/L, common toxicity criteria (CTC) - non-hematological toxicity ≤ grade 1 (except alopecia, nausea and vomiting), this product can be used continuously for 42 days until 49 days. Complete blood counts should be performed weekly during treatment.
Adjuvant treatment period: 4 weeks after the end of the concurrent chemoradiotherapy period with this product, 6 cycles of adjuvant treatment with this product will be performed. The dose of this product in the first cycle is 150 mg/m/day, once daily for 5 days, followed by 23 days of drug withdrawal. At the beginning of cycle 2, if the non-hematological toxicity of CTC in cycle 1 is ≤ grade 2 (except alopecia, nausea and vomiting), the absolute white blood cell count (ANC) ≥ 1.5 × 10/L and the platelet count ≥ 100 × 10/L, the dose can be increased to 200 mg/m/day. If the dose is not increased in cycle 2, the dose should not be increased in subsequent cycles. Unless toxicity occurs, the dose in subsequent cycles will be maintained at 200 mg/m per day.
Patients with glioblastoma multiforme or anaplastic astrocytoma who have relapsed or progressed after conventional therapy:
Adult patients: The starting dose of this product for patients who have previously received chemotherapy is 150 mg/m/day for 5 days. If the ANC on the first day of the next cycle is ≥1.5×10/L and the platelet count is ≥100×10/L, the dose in the second cycle is increased to 200 mg/m/day. The dose of this product should be adjusted based on the ANC and platelet count nadir.
Pediatric patients: In children 3 years of age or older who have previously received chemotherapy, the starting oral dose of this product is 150 mg/m/day for 5 days in each 28-day cycle; if no toxicity occurs, the dose is increased to 200 mg/m/day for the next cycle.
All patients:
This product should be taken on an empty stomach (at least one hour before eating). Antiemetics can be used before and after taking this product. If you experience vomiting after taking the medicine, you cannot take the second dose that day.
This product should not be opened or chewed and should be swallowed whole with a glass of water. If the capsule is damaged, avoid contact of skin or mucous membranes with the powdery contents of the capsule.
Adverse Reactions:
Main adverse reactions include nausea, vomiting, fatigue, and hematological reactions
Other frequently reported adverse events include fatigue, constipation, and headache.
Loss of appetite, diarrhea, rash, fever, weakness and drowsiness have also been reported.
Uncommon adverse events are abdominal pain, pain, dizziness, weight loss, malaise, dyspnea, alopecia, stiffness, pruritus, dyspepsia, abnormal taste, paresthesia, and petechiae.
Contraindications:
Contraindicated for those allergic to temozolomide capsules or dacarbazine (DTIC).
Contraindicated during pregnancy (see Medication for Pregnant and Lactating Women)
Contraindicated for patients with severe bone marrow suppression.
Notes:
In a small trial in which treatment was extended to 42 days, patients who received this product combined with radiation therapy were at high risk for Pneumocystis carinii pneumonia. Therefore, prevention of Pneumocystis carinii pneumonia is required in all patients receiving 42 days (maximum 49 days) of combined therapy.
The incidence of Pneumocystis carinii pneumonia may be higher during treatment with temozolomide during longer-term dosing regimens. Regardless of treatment regimen, all patients treated with temozolomide (especially those receiving steroids) should be closely observed for the possibility of developing Pneumocystis carinii pneumonia.
Antiemetic treatment: Nausea and vomiting are often associated with this product. Antiemetics can be used before and after taking this product. The guiding principles are:
Patients with newly diagnosed glioblastoma multiforme: Antiemetic prophylaxis is recommended before starting combined therapy with temozolomide, and antiemetic prophylaxis is highly recommended during adjuvant therapy.
Patients with recurrent or progressive glioma: Patients who have experienced severe (grade 3 or 4) vomiting during previous treatment cycles require antiemetic treatment.
Patients receiving temozolomide may develop myelosuppression, including persistent pancytopenia, which may lead to aplastic anemia and, in some cases, fatal outcome. In some cases, concomitant use of other drugs associated with aplastic anemia (including carbamazepine, phenytoin, and trimethoprim-sulfamethoxazole) can make evaluation more difficult.
Male patients: Male patients taking temozolomide should take effective contraceptive measures. Temozolomide is genotoxic, so men should use contraception during treatment and for 6 months after the end of treatment. Because treatment with temozolomide has the potential to cause irreversible infertility, sperm should be cryopreserved prior to treatment with temozolomide.
Patients with impaired liver and renal function: The pharmacokinetic results of patients with normal liver function are similar to those of patients with mild to moderate abnormal liver function; there is no data on the use of temozolomide in patients with severe abnormal liver function (Child’s Class III) or abnormal renal function. According to the pharmacokinetic characteristics of temozolomide capsules, it is not necessary to reduce the dosage of temozolomide in patients with severe hepatic and renal insufficiency, but extra caution is required during application.
Usage in pregnant and lactating women: There have been no studies on the use of this drug in pregnant women. In preclinical studies in rats and rabbits, teratogenicity and/or fetal toxicity have been reported at 150 mg/m. Therefore, temozolomide should not be routinely used in pregnant women, and if the drug must be used during pregnancy, the patient should be informed of the potential risk to the fetus. Women who may become pregnant should be discouraged from becoming pregnant while receiving temozolomide or within 6 months of discontinuing temozolomide treatment. It is unknown whether temozolomide is excreted in breast milk, so temozolomide capsules should not be used by breastfeeding women.
Storage:
Shield, seal, and store at 2-30℃.
Mechanism of action:
Temozolomide is an imidazotetrazine alkylating agent with anti-tumor activity. Under the physiological pH state of the systemic circulation, it is rapidly converted into the active product MTIC (3-methyl-(triazine-1-)imidazole-4-carboxamide). The cytotoxic effect of MTIC is mainly manifested by the alkylation of the oxygen atom at position 6 and the nitrogen atom at position 7 of guanine on the DNA molecule. Exerts cytotoxic effects through mismatch repair of methylation adducts.