Temomedac capsules are used to treat:
adult patients with newly diagnosed glioblastoma multiforme in combination with radiotherapy and then as monotherapy; children aged 3 years and older and adult patients with malignant glioma in the form of glioblastoma multiforme or anaplastic astrocytoma in the presence of relapse or progression of the disease after standard therapy.
Composition
The active substance is temozolomide (one capsule contains 100 mg of temozolomide).
Excipients: anhydrous lactose, sodium starch glycolate (type A), colloidal anhydrous silica, tartaric acid, stearic acid; titanium dioxide (E 171), gelatin, shellac, propylene glycol, yellow iron oxide (E 172), red iron oxide (E 172).
Contraindication
hypersensitivity to the components of the drug or dacarbazine (DTIK); severe myelosuppression.
Method of application
The drug "Temomedac" should only be prescribed by a doctor with experience in oncological therapy of brain tumors.
"Temomedac" (capsules) should be taken on an empty stomach.
Swallow the capsule whole with a glass of water. Do not open or chew the capsule.
If vomiting occurs after taking the drug, you should not take a second dose of the drug on the same day.
At the same time, antiemetic therapy can be administered.
Adult patients with newly diagnosed glioblastoma multiforme
Temomedac is used in combination with focal radiotherapy (combination phase), followed by 6 cycles of temozolomide monotherapy (monotherapy phase).
Treatment phase "Temomedac" accompanied by radiotherapy
Temomedac is administered orally at a dose of 75 mg/m2 daily for 42 days in combination with radiotherapy (60 Gy in 30 fractions). Dose reduction is not recommended; the decision to interrupt or discontinue Temomedac should be made weekly based on hematological and non-hematological toxicity criteria. At this dose, Temomedac can be continued from 42 days of combination therapy to 49 days if all of the following conditions are met:
absolute neutrophil count ≥ 1.5 × '109/L; platelet count ≥ 100 × '109/L; general toxicity criteria (GTC): non-hematological toxicity ≤ grade 1 (except alopecia, nausea and vomiting).
During treatment, a complete blood count should be performed weekly. Temomedac should be interrupted or discontinued during the maintenance phase, taking into account hematological and non-hematological toxicity criteria.
Monotherapy
4 weeks after the completion of the Temomedac + radiotherapy phase, Temomedac is administered for 6 additional cycles of therapy. The dose during Cycle 1 (monotherapy) is 150 mg/m2 once daily for 5 days of a 28-day cycle (5 days with Temomedac, 23 days without the drug). The dose of Temomedac for Cycle 2 is increased to 200 mg/m2 per day if the CBT: non-hematological toxicity during Cycle 1 was ≤ grade 2 (except for alopecia, nausea and vomiting), absolute neutrophil count ≥ 1.5 × 109/l, platelet count ≥ 100 × '109/l. If the dose was not increased in Cycle 2, the dose is not increased in subsequent cycles. The dose of 200 mg/m2 per day for the first 5 days of each subsequent cycle remains, except in the case of toxicity. In each cycle, Temomedac is administered for 5 consecutive days followed by a 23-day break.
During treatment, a complete blood count should be performed on day 22 (day 21 after the first dose).
Recurrent or progressive malignant glioma in adults and children over 3 years of age
The therapy cycle is 28 days. For patients who have not previously received chemotherapy, Temomedac is prescribed 1 time per day at a dose of 200 mg / m 2 for 5 days with a subsequent 23-day break. For patients who have previously received chemotherapy, the initial dose is 150 mg / m 2 1 time per day for 5 days in cycle 2 the dose can be increased to 200 mg / m 2 1 time per day for 5 days provided that there is no hematological toxicity.
Application features
Pregnant women
There are no data on the use of the drug in pregnant women. "Temomedak" should not be prescribed to pregnant women. If it is necessary to use the drug during pregnancy, the woman should be informed of the potential risk to the fetus. Women of reproductive age should be advised to use effective methods of contraception to prevent pregnancy during treatment with the drug "Temomedak".
It is not known whether Temomedac passes into breast milk, so breastfeeding should be discontinued during treatment.
Drivers
The ability to drive and use machines may be slightly impaired when taking Temomedac due to the possibility of fatigue and drowsiness.
Doses of 500, 750, 1000 and 1250 mg/m2 (total dose per 5-day cycle) were clinically evaluated. Dose-dependent hematological toxicity developed at all doses used, but, as expected, was more pronounced at the high doses used. An overdose of 10,000 mg (total dose in one cycle for 5 days) was allowed by one patient, which resulted in pancytopenia, Pyrex, multiorgan failure and death. Patients who used the recommended doses (150-200 mg/m2) for more than 5 days (up to 64 days) have been reported to develop bone marrow suppression (with or without infection), in some cases severe and prolonged, with fatal outcome.
In case of overdose, it is recommended to perform a hematological study and, if necessary, conduct supportive therapy.
Side effects
In patients receiving temozolomide, both as part of combination therapy with radiotherapy and as subsequent monotherapy in the treatment of newly diagnosed glioblastoma multiforme or as monotherapy in the treatment of recurrent or progressive malignant glioma, the following adverse reactions most often occurred: nausea, vomiting, constipation, anorexia, headache and fatigue.
Storage conditions
Store below 30°C in the original, tightly closed bottle in order to protect from moisture. Keep out of the reach of children.
Shelf life - 3 years.
