The drug Temomide is taken orally, on an empty stomach, at least 1 hour before meals. The prescribed dose should be taken using the lowest possible number of capsules. Capsules can not be opened or chewed, they should be swallowed whole, washed down with a glass of water.
The newly discovered multiform glioblastoma
Treatment of adult patients (over 18 years): primary treatment conduct in combination with radiotherapy. The drug Temomid is used in a dose of 75 mg / m2 daily for 42 days at the same time as radiotherapy (30 fractions in a total dose of 60 Gy). Dose reduction is not recommended, but the drug may be interrupted depending on the tolerability. Renewal of the drug is possible during the entire 42-day period of combined treatment and up to 49 days, but only if all of the following conditions are met:
-absolute number of neutrophils is not less than 1500 / μl,
-the number of platelets - not less than 100,000 / μl,
-the general toxicity criterion (CTC) is not higher than 1 degree (except for alopecia, nausea and vomiting).
During treatment, a blood test should be performed weekly, counting the number of cells.
Recommendations for dose reduction or withdrawal of Temomide during the combined phase of treatment are given in Table 1.
Table 1. Recommendations for dose reduction or withdrawal of Temomide in combination treatment with radiotherapy | Criterion of toxicity | Break in taking the drug Temomide * | Termination of Temomide | | Absolute number of neutrophils | > 500 / μL, but <1500 / μl | <500 / μL | | Platelet count | > 10000 / μL, but <100,000 / μL | <10000 / μL | | CTC non-hematological toxicity (with the exception of alopecia, nausea and vomiting) | 2 degree | 3 or 4 degree | |
* Renewal of Temomide preparation is possible if all of the following conditions are met: absolute neutrophil count not less than 1500 / μL, platelet count - not less than 100,000 / μL, total toxicity criterion (CTC) not higher than 1 degree (except for alopecia, nausea and vomiting) .
Adjuvant therapy is appointed 4 weeks after the completion of the combination therapy and is performed in the form of 6 additional cycles.
1- th cycle: The preparation Temomid is applied in a dose of 150 mg / m2 for 5 days followed by a 23-day interruption in treatment.
2- th cycle: the dose of Temomide can be increased to 200 mg / m2 per day, with the proviso that when the first cycle of treatment severity nonhematologic toxicity (according to the scale CTC toxicity) does not exceed 2 degrees (except for alopecia, nausea and vomiting), and the absolute neutrophil count was at least 1500 / ml, and the number platelets - not less than 100000 / mkl. If the 2nd cycle Temomid dose was not increased, it should not be increased and in subsequent cycles. If the 2nd cycle the dose was 200 mg / m, in the same daily dose of medication is assigned, and in subsequent cycles (no toxicity). In each cycle, the reception Temomid preparation was carried out for 5 consecutive days followed by 23 days rest.
Recommendations for dose reduction in the adjuvant phase of treatment are given in Tables 2 and 3.
On day 22 of treatment (21 days after taking the first dose of Temomide)
it is necessary to conduct a blood test with counting the number of cells.
The abolition or reduction of the dose of Temomide should be carried out in accordance with Table 3.
Table 2.Stages of the dose of Temomide with adjuvant therapy
| Step | Dose (mg / m / day) | Note | | -1 | 100 | Dose reduction taking into account previous toxicity (see Table 3) | | 0 | 150 | Dose during the 1st cycle | | 1 | 200 | Dose during 2-6 cycles (in the absence | | toxicity) | |
| Criterion of toxicity | Reduce the dose of Temomide preparation by 1 step (see Table 2) | Termination of Temomide | | Absolute number of neutrophils | <1000 / μL | * | | Platelet count | <50000 / μL | * | | CTC non-hematological toxicity (with the exception of alopecia, nausea and vomiting) | 3 degree | 4 degree * | |
* The drug Temomide should be discontinued if a dose reduction of <100 mg / m
2, and also in case of recurrence of non-hematological toxicity of the 3rd degree (except for alopecia, nausea and vomiting) after dose reduction.
Progressive or recurrent malignant glioma in the form of multiform glioblastoma or anaplastic astrocytoma (treatment of adults and children over 3 years old). A common metastasizing malignant, melanoma (treatment of adults).
Patients who had not previously undergone chemotherapy, the drug Temomide appointed at a dose of 200 mg / m2 1 time per day for 5 consecutive days, followed by a break in taking the drug for 23 days (the total duration of one treatment cycle is 28 days). For patients who had previously undergone chemotherapy, the initial dose is 150 mg / m2 1 per day; in the second cycle, the dose can be increased to 200 mg / m2 per day for 5 days, provided that on the 1st day of the next cycle the absolute number of neutrophils is not less than 1500 / μl, and the number of platelets is not less than 100,000 / μl.
Recommendations for modifying the dose of Temomide treatment progressive or recurrent malignant glioma or malignant melanoma
To start treatment with Temomide is possible only with an absolute number of neutrophils> 1500 / μL and platelets> 100,000 / μL. A complete clinical blood test should be performed on the 22nd day (the 21st day after taking the first dose), but no later than 48 hours after that day; then - weekly until the absolute number of neutrophils is above 1500 / μL, and the number of platelets does not exceed 100,000 / μl. With an absolute number of neutrophils less than 1000 / μL or platelets less than 50,000 / μl during any treatment cycle, the dose in the next cycle should be reduced by one step. Possible doses: 100 mg / m2, 150 mg / m2 and 200 mg / m2. The minimum recommended dose is 100 mg / m2.
Duration of treatment is maximum 2 years. If signs of disease progression appear, treatment with Temomide should be discontinued.