Temozolomide for Injection.

Effects and efficacy:
Temozolomide is used to treat: newly diagnosed glioblastoma multiforme, initially combined with radiotherapy, and then as maintenance therapy. Glioblastoma multiforme or anaplastic astrocytoma that relapses or progresses after conventional treatment.
Dosage and administration:
Temozolomide capsules should be taken on an empty stomach (at least one hour before meals). Antiemetics can be used before and after taking this product. If vomiting occurs after taking the medicine, the second dose cannot be taken that day. This product cannot be opened or chewed, and should be swallowed whole with a glass of water. If the capsule is damaged, avoid contact between the skin or mucous membranes and the powdered contents of the capsule. Temozolomide is first combined with local radiotherapy for adult patients with newly diagnosed glioblastoma multiforme (concurrent chemoradiotherapy period), followed by up to 6 cycles of temozolomide (TMZ) monotherapy (maintenance treatment period). During the concurrent chemoradiotherapy period, this product is taken orally at a daily dose of 75 mg/㎡ for 42 days, and local radiotherapy (60 Gy in 30 fractions) is received at the same time. The drug can be suspended according to the patient’s tolerance, but there is no need to reduce the dose. During the concurrent chemoradiotherapy period, if the following conditions are met: absolute neutrophil count ≥ 1.5 x 10⁹/L, platelet count ≥ 100×10⁹/, common toxicity criteria (CTC) – non-hematological toxicity ≤ Grade 1 (except alopecia, nausea and vomiting), this product can be used continuously for 42 days, up to 49 days. Complete blood cell counts should be performed every week during treatment. During the concurrent chemoradiotherapy period, this product should be suspended or terminated according to hematological and non-hematological toxicity criteria. During the maintenance treatment period, 4 weeks after the end of the concurrent chemoradiotherapy period, 6 cycles of this product monotherapy are performed. The dose of this product in the first cycle is 150mg/㎡/day, once a day for 5 days, and then the drug is stopped for 23 days. 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 neutrophil count (ANC) is ≥ 1.5x 10⁹/L and the platelet count is ≥ 100x 10⁹/L, the dose can be increased to 200 mg/㎡/day. If the dose is not increased in cycle 2, it should not be increased in subsequent cycles. The dose in subsequent cycles is maintained at 200mg/10⁹ daily unless toxicity occurs. The dose should be reduced as directed by the doctor during treatment. During treatment, a complete blood cell count should be performed on day 22 (21 days after the first dose of this product). The dose should be reduced or discontinued as directed by the doctor. Adult patients with glioblastoma multiforme or anaplastic astrocytoma who have relapsed or progressed after conventional treatment For patients who have not previously received chemotherapy, the oral dose of this product is 200mg/㎡ daily for 5 days. Each 28-day cycle is a cycle. For patients who have previously received chemotherapy, the starting dose of this product is 150mg/㎡/day. If the ANC on the first day of the next cycle is ≥ 1.5 x 10⁹/L and the platelet count is ≥ 100×10⁹/L, the dose of the second cycle is increased to 200mg/㎡/day. The dose of this product should be adjusted according to the lowest ANC and platelet count. The laboratory parameters for dose adjustment must meet the following laboratory parameters before the drug can be used: ANC ≥ 1.5 x10⁹/L and platelet count ≥ 100×10⁹/L. Perform a complete blood count on day 22 (21 days after the first dose) or within 48 hours of this day, and once a week thereafter until ANC ≥ 1.5×10⁹/L and platelet count ≥ 100 x10⁹/L. If the ANC is <1.0x 10⁹/L or the platelet count is <50×10⁹/L in any cycle, the dose must be reduced by one level in the next cycle. Dose levels include 100 mg/㎡, 150 mg/㎡, and 200 mg/㎡. The recommended minimum dose is 100 mg/㎡. In clinical trials, treatment continued until disease progression, up to 2 years. However, the optimal duration of treatment is unknown. Special populations Pediatric patients In children aged 3 years or older, the recommended oral dose of this product is 200 mg/㎡/day for 5 days, every 28 days as a cycle. For children who have previously received chemotherapy, the starting dose of this product is 150 mg/㎡/8 for 5 days; if no toxicity occurs, the dose is increased to 200 mg/㎡/day in the next cycle. Elderly patients According to the results of a population pharmacokinetic analysis conducted in patients aged 19-78 years, the clearance of TMZ is not affected by age. However, elderly patients (>70 years old) appear to be at greater risk of neutropenia and thrombocytopenia. Patients with impaired liver and kidney function: The pharmacokinetic results are similar in patients with normal liver function and those with mild to moderate liver function abnormalities; there is no data on the use of temozolomide in patients with severe liver function abnormalities (Child’s Classlll) or renal function abnormalities. According to the pharmacokinetic characteristics of temozolomide capsules, it is not necessary to reduce the dose of temozolomide for patients with severe liver and kidney dysfunction, but it should be used with caution. The recommended dose of temozolomide for injection is the same as that of oral capsules, for 90 minutes of intravenous infusion. This product must be infused intravenously. This product cannot be administered by other routes, such as intrathecal injection, intramuscular injection or subcutaneous injection. This product may only be administered through the same intravenous infusion line with 0.9% saline injection. This product is incompatible with glucose solution. Each bottle contains sterile, pyrogen-free temozolomide lyophilized powder. After dissolving in 41mL of sterile water for injection, the obtained solution contains 2.5mg/mL temozolomide. Bring the product to room temperature before dissolving it in sterile water for injection. Swirl gently during preparation, do not shake. Inspect the injection solution after preparation. Do not use if obvious particles appear in the bottle. The prepared solution cannot be diluted. After preparation, store at room temperature (25°C [77°F]). The prepared solution must be used within 14 hours, including the time of injection. Using aseptic technique, withdraw 40 mL from each bottle, prepare the complete dose according to the drug instructions, and inject it into an empty infusion set of appropriate capacity. When used clinically, PVC infusion sets containing DEHP (di(2-ethylhexyl) phthalate) should not be used. This product should be administered intravenously via an infusion pump over a period of 90 minutes. This product can only be administered by intravenous infusion. Flush the injection line before and after each infusion of this product. Because there is currently no data on the compatibility of this product with other intravenous drugs or additives, other drugs should not be given simultaneously through the same intravenous injection line.
Contraindications:
Contraindicated if allergic to this product. Contraindicated during pregnancy. Contraindicated during lactation. Use with caution if liver or kidney function is impaired.
Related dosage forms:
Injection, capsule