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TEMODAL is a brand name for Temozolomide, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TEMODAL® (temozolomide) is indicated for: treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. treatment of adult patients with glioblastoma multiforme or anaplastic astrocytoma and documented evidence of recurrence or…
Verbatim from this product's HC label. Tap a section to expand.
). 5 x 109/L and platelets ≥100 x 109/L. 0 x 109/L or the platelet count is <50 x 109/L during any cycle, the next cycle should be reduced one dose level. Dose levels include 100 mg/m2, 150 mg/m2, and 200 mg/m2. The lowest recommended dose is 100 mg/m2.
Dose modification for TEMODAL® should be based on toxicities according to nadir ANC or platelet counts. Since women taking TEMODAL® were reported to have a higher incidence of grade 4 neutropenia and thrombocytopenia than men in the first cycle of therapy, they must be closely monitored for abnormal neutrophil and platelet counts.
2 Recommended Dose and Dosage Adjustment Adults Patients with Newly Diagnosed Glioblastoma Multiforme: Concomitant Phase TEMODAL® is administered at a dose of 75 mg/m2 daily for 42 days concomitant with radiotherapy (60 Gy administered in 30 fractions) followed by maintenance TEMODAL® for 6 cycles.
No dose reductions are recommended; however, dose interruptions may occur based on patient tolerance. 5 x 109/L; platelet count ≥100 x109/L; common toxicity criteria (CTC) non-hematological toxicity Grade ≤1 (except for alopecia, nausea and vomiting).
During treatment a complete blood count should be obtained weekly. TEMODAL® dosing should be interrupted or discontinued during concomitant phase according to the hematological and non- hematological toxicity criteria as noted in Table 1.
Table 1. 5 x 109/L; platelet count ≥100 x 109/L; CTC non-hematological toxicity Grade ≤1 (except for alopecia, nausea, vomiting). CTC = Common Toxicity Criteria. TEMODAL® (temozolomide) Page 6 of 54 Maintenance Phase Four weeks after completing the TEMODAL® + RT (Radiotherapy) phase, TEMODAL® is administered for an additional 6 cycles of maintenance treatment.
Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment. 5 x 109/L, and the platelet count is ≥100 x 109/L. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.
The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs. Dose reductions during the maintenance phase should be applied according to Tables 2 and 3. During treatment a complete blood count should be obtained on day 22 (21 days after the first dose of TEMODAL®).
and 4 DOSAGE AND ADMINISTRATION/Administration). Patients treated with TEMODAL® who experience myelosuppression, may experience prolonged pancytopenia, which may result in aplastic anemia, which in some cases has resulted in a fatal outcome.
In some cases, exposure to concomitant medications associated with aplastic anemia, including carbamazepine, phenytoin, and sulfamethoxazole/trimethoprim, complicates assessment. Hepatic/Biliary/Pancreatic Hepatotoxicity, including liver enzyme elevation, hyperbilirubinemia, cholestasis and hepatitis, has been observed with TEMODAL® use in the post-market setting (see 8 ADVERSE REACTIONS/Post- Market Adverse Drug Reactions).
Hepatic injury, including fatal hepatic failure, has been reported in patients treated with temozolomide. Baseline liver function tests should be performed prior to treatment initiation. If abnormal, physicians should assess the benefit/risk prior to initiating temozolomide including the potential for fatal hepatic failure.
For patients on a 42 day treatment cycle liver function tests should be repeated midway during this cycle. For all patients, liver function tests should be checked after each treatment cycle. For patients with significant liver function abnormalities, physicians should assess the benefit/risk of continuing treatment.
Liver toxicity may occur several weeks or more after the last treatment with temozolomide. In the absence of formal studies in patients suffering from severe hepatic dysfunction the treating physician should use his discretion in weighing the benefits of using TEMODAL® in this patient population against the potential risks.
Additionally, hepatitis due to hepatitis B virus (HBV) reactivation, in some cases resulting in death, has been reported. Patients should be screened for HBV infection before treatment initiation. Patients with evidence of current or prior HBV infection should be monitored for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following treatment with TEMODAL®.
2 Geriatrics Geriatrics (≥70 years old): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness. (see 7 WARNINGS AND PRECAUTIONS) 2 CONTRAINDICATIONS TEMODAL® is contraindicated in patients who have a history of hypersensitivity reaction to its components or to dacarbazine (DTIC).
The use of TEMODAL® is not recommended in patients with severe myelosuppression. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions TEMODAL® should be prescribed by a qualified healthcare professional who is experienced in the use of antineoplastic therapy.
The following are clinically significant adverse events: Myelosuppression including Neutropenia and Thrombocytopenia and prolonged pancytopenia, which may result in aplastic anemia, which in some cases has resulted in a fatal outcome (see 7 WARNINGS AND PRECAUTIONS /Hematologic/Myelosuppression).
Hepatic injury, including fatal hepatic failure, has been reported in patients treated with temozolomide (see 7 WARNINGS AND PRECAUTIONS /Hepatic/Biliary/Pancreatic). TEMODAL® may have to be discontinued or the dose may have to be adjusted (see 4 DOSAGE AND ADMINISTRATION).
5 x 109/L and platelets ≥100 x 109/L. 0 x 109/L or the platelet count is <50 x 109/L during any cycle, the next cycle should be reduced one dose level. Dose levels include 100 mg/m2, 150 mg/m2, and 200 mg/m2. The lowest recommended dose is 100 mg/m2.
Dose modification for TEMODAL® should be based on toxicities according to nadir ANC or platelet counts. Since women taking TEMODAL® were reported to have a higher incidence of grade 4 neutropenia and thrombocytopenia than men in the first cycle of therapy, they must be closely monitored for abnormal neutrophil and platelet counts.
2 Recommended Dose and Dosage Adjustment Adults Patients with Newly Diagnosed Glioblastoma Multiforme: Concomitant Phase TEMODAL® is administered at a dose of 75 mg/m2 daily for 42 days concomitant with radiotherapy (60 Gy administered in 30 fractions) followed by maintenance TEMODAL® for 6 cycles.
TEMODAL® is contraindicated in patients who have a history of hypersensitivity reaction to its components or to dacarbazine (DTIC). The use of TEMODAL® is not recommended in patients with severe myelosuppression.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The TEMODAL® dose should be reduced or discontinued according to Table 2. Table 2. TEMODAL® Dose Levels for Maintenance Treatment Dose Level Dose (mg/m2/day) Remarks -1 100 Reduction for prior toxicity 0 150 Dose during Cycle 1 1 200 Dose during Cycles 2–6 in absence of toxicity Table 3.
0 x 109/L See footnote b Platelet Count <50 x 109/L See footnote b CTC Non-hematological Toxicity (except for alopecia, nausea, vomiting) CTC Grade 3 CTC Grade 4b a: TEMODAL® dose levels are listed in Table 2. b: TEMODAL® is to be discontinued if dose reduction to <100 mg/m2 is required or if the same Grade 3 non- hematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
CTC = Common Toxicity Criteria.
Malignant Gliomas Showing Recurrence or Progression after Standard Therapy:
Adult patients: In patients previously untreated with chemotherapy, TEMODAL® is administered at a dose of 200 mg/m2 once daily for 5 days per 28-day cycle. For patients previously treated with chemotherapy, the initial dose is 150 mg/m2 once daily for 5 days, to be increased in the second cycle to 200 mg/m2 once daily for 5 days, providing there is no hematologic toxicity (see 7 WARNINGS AND PRECAUTIONS).
In the reference controlled trial of GBM, the majority of patients treated with TEMODAL® (90%) received more than one cycle and 22% of patients received 6 or more cycles. These patients received a total of 484 cycles of TEMODAL® in total; 60% of cycles at 200 mg/m2/day and 36% at 150 mg/m2/day.
In the single arm AA trial, 93% of patients received more than one cycle and 25% of patients continued on study for 12 months or greater. Eighty-eight percent of patients were receiving either their initial dose or a higher dose at the last cycle.
However, limited experience is available on the prolonged use of TEMODAL® in this patient population. TEMODAL® (temozolomide) Page 7 of 54 TEMODAL® therapy can be continued until disease progression. 3 Reconstitution Not Applicable. 4 Administration TEMODAL® Capsules TEMODAL® should be administered in the fasting state, at least one hour before a meal.
Antiemetic therapy may be administered prior to or following administration of TEMODAL®. If vomiting occurs after the dose is administered, a second dose should not be administered. Store TEMODAL® capsules between 15°C […]
Therapy should be discontinued for patients with evidence of active hepatitis B infection. Infection Cases of herpes simplex encephalitis (HSE), including cases with fatal outcomes, were reported mostly in association with concomitant radiotherapy.
All patients, particularly those with previous herpes simplex infection need to be monitored for signs and symptoms of HSE during the treatment. Monitoring and Laboratory Tests Baseline liver function tests should be performed prior to treatment initiation.
If abnormal, physicians should assess the benefit/risk prior to initiating temozolomide including the potential for fatal hepatic TEMODAL® (temozolomide) Page 10 of 54 failure. For patients on a 42 day treatment cycle liver function tests should be repeated midway during this cycle.
For all patients, liver function tests should be checked after each treatment cycle. Liver toxicity may occur several weeks or more after the last treatment with temozolomide. Patients should also be screened for HBV infection before treatment initiation.
Patients with evidence of current or prior HBV infection should be monitored for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following treatment with TEMODAL®. Therapy should be discontinued for patients with evidence of active hepatitis B infection.
Concomitant phase for adult patients with newly diagnosed glioblastoma multiforme:
TEMODAL® is administered at 75 mg/m2 daily for 42 days concomitant with radiotherapy (60 Gy administered in 30 fractions). A complete blood count should be obtained prior to initiation of treatment and weekly during treatment. TEMODAL® dosing should be interrupted or discontinued during concomitant phase according to the hematological and non-hematological toxicity criteria (see 4 DOSAGE AND ADMINISTRATION).
Maintenance phase for adults with newly diagnosed glioblastoma multiforme or treatment for patients with malignant gliomas showing recurrence or progression after standard therapy: TEMODAL® is administered at a dose of 150 or 200 mg/m2 once daily for 5 days per 28-day cycle.
5 x 109/L and platelets >100 x 109/L. 5 x 109/L and platelet count exceeds 100 x 109/L. 0 x 109/L or the platelet count is <50 x 109/L during any cycle, the next cycle should be reduced by one dose level, based upon the nadir blood count (see 4 DOSAGE AND ADMINISTRATION).
Dose levels include 100 mg/m2, 150 mg/m2 and 200 mg/m2. The lowest recommended dose is 100 mg/m2. Renal In the absence of formal studies in patients suffering from severe renal failure the treating physician should use his discretion in weighing the benefits of using TEMODAL® in this patient population against the potential risks.
Reproductive Health:
Female and Male Potential Female patients: Women of childbearing potential should be advised to use effective contraception during treatment with TEMODAL® therapy and in the six months after discontinuation of treatment.
Male patients:
TEMODAL® can have genotoxic effects. Effective contraception should also be used by male patients taking TEMODAL®. Men being treated with TEMODAL® are advised not to father a child during or up to 6 months after treatment and to seek advice on cryoconservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with TEMODAL®.
Respiratory Patients who received concomitant TEMODAL® and radiotherapy in a pilot trial for the prolonged 42 day schedule were shown to be at particular risk for developing Pneumocystis carinii pneumonia. Thus prophylaxis against Pneumocystis carinii pneumonia (PCP) is required for all patients receiving […]
No dose reductions are recommended; however, dose interruptions may occur based on patient tolerance. 5 x 109/L; platelet count ≥100 x109/L; common toxicity criteria (CTC) non-hematological toxicity Grade ≤1 (except for alopecia, nausea and vomiting).
During treatment a complete blood count should be obtained weekly. TEMODAL® dosing should be interrupted or discontinued during concomitant phase according to the hematological and non- hematological toxicity criteria as noted in Table 1.
Table 1. 5 x 109/L; platelet count ≥100 x 109/L; CTC non-hematological toxicity Grade ≤1 (except for alopecia, nausea, vomiting). CTC = Common Toxicity Criteria. TEMODAL® (temozolomide) Page 6 of 54 Maintenance Phase Four weeks after completing the TEMODAL® + RT (Radiotherapy) phase, TEMODAL® is administered for an additional 6 cycles of maintenance treatment.
Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment. 5 x 109/L, and the platelet count is ≥100 x 109/L. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.
The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs. Dose reductions during the maintenance phase should be applied according to Tables 2 and 3. During treatment a complete blood count should be obtained on day 22 (21 days after the first dose of TEMODAL®).
The TEMODAL® dose should be reduced or discontinued according to Table 2. Table 2. TEMODAL® Dose Levels for Maintenance Treatment Dose Level Dose (mg/m2/day) Remarks -1 100 Reduction for prior toxicity 0 150 Dose during Cycle 1 1 200 Dose during Cycles 2–6 in absence of toxicity Table 3.
0 x 109/L See footnote b Platelet Count <50 x 109/L See footnote b CTC Non-hematological Toxicity (except for alopecia, nausea, vomiting) CTC Grade 3 CTC Grade 4b a: TEMODAL® dose levels are listed in Table 2. b: TEMODAL® is to be discontinued if dose reduction to <100 mg/m2 is required or if the same Grade 3 non- hematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
CTC = Common Toxicity Criteria.
Malignant Gliomas Showing Recurrence or Progression after Standard Therapy:
Adult patients: In patients previously untreated with chemotherapy, TEMODAL® is administered at a dose of 200 mg/m2 once daily for 5 days per 28-day cycle. For patients previously treated with chemotherapy, the initial dose is 150 mg/m2 once daily for 5 days, to be increased in the second cycle […]