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temozolomide
Overview
What is temozolomide?
Temozolomide capsules for oral administration contain temozolomide USP, an imidazotetrazine derivative. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]--tetrazine-8-carboxamide. The structural formula is:
Temozolomide, USP is a white to light pink/light tan powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. It is sparingly soluble in water, soluble in dimethyl sulfoxide, and practically insoluble in toluene. The molecule is stable at acidic pH (< 5) and labile at pH > 7; hence temozolomide can be administered orally. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH.
Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients for temozolomide capsules are as follows: anhydrous lactose, colloidal silicon dioxide, gelatin, stearic acid, sodium lauryl sulfate, sodium starch glycolate, tartaric acid, and titanium dioxide. The 5 mg capsule shell contains FD&C Blue 1, FD&C Red 3, and iron oxide yellow. The 20 mg capsule shell contains iron oxide yellow. The 100 mg capsule shell contains FD&C Red 3, and D&C Yellow 10. The 140 mg capsule shell contains FD&C Blue 1, and FD&C Red 3. The 180 mg capsule shell contains iron oxide black, iron oxide red, and iron oxide yellow. The capsule shells are imprinted with black pharmaceutical ink which contains following inactive ingredients: butyl alcohol, dehydrated alcohol, iron oxide black, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, and purified water.
What does temozolomide look like?
What are the available doses of temozolomide?
Temozolomide capsules for oral administration
What should I talk to my health care provider before I take temozolomide?
How should I use temozolomide?
Temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.
Dosage of temozolomide must be adjusted according to nadir neutrophil and platelet counts in the previous cycle and the neutrophil and platelet counts at the time of initiating the next cycle. For temozolomide dosage calculations based on body surface area (BSA) see . For suggested capsule combinations on a daily dose see .
Patients with Newly Diagnosed High Grade Glioma
Concomitant Phase
Temozolomide is administered at 75 mg/m daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions) followed by maintenance temozolomide for 6 cycles. Focal RT includes the tumor bed or resection site with a 2 to 3cm margin. No dose reductions are recommended during the concomitant phase; however, dose interruptions or discontinuation may occur based on toxicity.
The temozolomide dose should be continued throughout the 42-day concomitant period up to 49 days if all of the following conditions are met: absolute neutrophil count greater than or equal to 1.5 x 10/L, platelet count greater than or equal to 100 x 10/L, common toxicity criteria (CTC) non hematological toxicity less than or equal to Grade 1 (except for alopecia, nausea, and vomiting). During treatment a complete blood count should be obtained weekly.
Temozolomide dosing should be interrupted or discontinued during concomitant phase according to the hematological and non-hematological toxicity criteria as noted in . pneumonia (PCP) prophylaxis is required during the concomitant administration of temozolomide and radiotherapy, and should be continued in patients who develop lymphocytopenia until recovery from lymphocytopenia (CTC Grade less than or equal to 1).
Maintenance Phase
Cycle 1
Four weeks after completing the temozolomide+RT phase, temozolomide is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m once daily for 5 days followed by 23 days without treatment.
Cycles 2 to 6
At the start of Cycle 2, the dose can be escalated to 200 mg/m, if the CTC nonhematologic toxicity for Cycle 1 is Grade less than or equal to 2 (except for alopecia, nausea, and vomiting), absolute neutrophil count (ANC) is greater than or equal to 1.5 x 10/L, and the platelet count is greater than or equal to 100 x 10/L. The dose remains at 200 mg/m per day for the first 5 days of each subsequent cycle except if toxicity occurs. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.
Dose Reduction or Discontinuation During Maintenance
Dose reductions during the maintenance phase should be applied according to and .
During treatment, a complete blood count should be obtained on Day 22 (21 days after the first dose of temozolomide) or within 48 hours of that day, and weekly until the ANC is above 1.5 x 10/L (1500/μL) and the platelet count exceeds 100 x 10/L (100,000/μL). The next cycle of temozolomide should not be started until the ANC and platelet count exceed these levels. Dose reductions during the next cycle should be based on the lowest blood counts and worst nonhematologic toxicity during the previous cycle. Dose reductions or discontinuations during the maintenance phase should be applied according to and .
TMZ=Temozolomide; CTC=Common Toxicity Criteria.
Patients with Refractory Anaplastic Astrocytoma
For adults the initial dose is 150 mg/m once daily for 5 consecutive days per 28- day treatment cycle. For adult patients, if both the nadir and day of dosing (Day 29, Day 1 of next cycle) ANC are greater than or equal to 1.5 x 10/L (1500/μL) and both the nadir and Day 29, Day 1 of next cycle platelet counts are greater than or equal to 100 x 10/L (100,000/μL), the temozolomide dose may be increased to 200 mg/m/day for 5 consecutive days per 28-day treatment cycle. During treatment, a complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until the ANC is above 1.5 x 10/L (1500/μL) and the platelet count exceeds 100 x 10/L (100,000/μL).
The next cycle of temozolomide should not be started until the ANC and platelet count exceed these levels. If the ANC falls to less than 1.0 x 10/L (1000/μL) or the platelet count is less than 50 x 10/L(50,000/μL) during any cycle, the next cycle should be reduced by 50 mg/m , but not below 100 mg/m ,the lowest recommended dose (see ). Temozolomide therapy can be continued until disease progression. In the clinical trial, treatment could be continued for a maximum of 2 years, but the optimum duration of therapy is not known.
TABLE 4
What interacts with temozolomide?
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What are the warnings of temozolomide?
Sorry No Records found
What are the precautions of temozolomide?
Sorry No Records found
What are the side effects of temozolomide?
Sorry No records found
What should I look out for while using temozolomide?
Known hypersensitivity to any temozolomide component or to dacarbazine (DTIC). ()
What might happen if I take too much temozolomide?
Doses of 500, 750, 1000, and 1250 mg/m(total dose per cycle over 5 days) have been evaluated clinically in patients. Dose-limiting toxicity was hematologic and was reported with any dose but is expected to be more severe at higher doses. An overdose of 2000 mg per day for 5 days was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multi-organ failure, and death. There are reports of patients who have taken more than 5 days of treatment (up to 64 days), with adverse reactions reported including bone marrow suppression, which in some cases was severe and prolonged, and infections and resulted in death. In the event of an overdose, hematologic evaluation is needed. Supportive measures should be provided as necessary.
How should I store and handle temozolomide?
Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) Atorvastatin calcium tablets are supplied as white, oval, biconvex film-coated tablets of atorvastatin calcium containing 10, 20, 40 and 80 mg atorvastatin.10 mg tablets20 mg tablets40 mg tablets80 mg tabletsStorageFOR YOUR PROTECTION:Atorvastatin calcium tablets are supplied as white, oval, biconvex film-coated tablets of atorvastatin calcium containing 10, 20, 40 and 80 mg atorvastatin.10 mg tablets20 mg tablets40 mg tablets80 mg tabletsStorageFOR YOUR PROTECTION:Atorvastatin calcium tablets are supplied as white, oval, biconvex film-coated tablets of atorvastatin calcium containing 10, 20, 40 and 80 mg atorvastatin.10 mg tablets20 mg tablets40 mg tablets80 mg tabletsStorageFOR YOUR PROTECTION:Atorvastatin calcium tablets are supplied as white, oval, biconvex film-coated tablets of atorvastatin calcium containing 10, 20, 40 and 80 mg atorvastatin.10 mg tablets20 mg tablets40 mg tablets80 mg tabletsStorageFOR YOUR PROTECTION:Atorvastatin calcium tablets are supplied as white, oval, biconvex film-coated tablets of atorvastatin calcium containing 10, 20, 40 and 80 mg atorvastatin.10 mg tablets20 mg tablets40 mg tablets80 mg tabletsStorageFOR YOUR PROTECTION:Atorvastatin calcium tablets are supplied as white, oval, biconvex film-coated tablets of atorvastatin calcium containing 10, 20, 40 and 80 mg atorvastatin.10 mg tablets20 mg tablets40 mg tablets80 mg tabletsStorageFOR YOUR PROTECTION:Atorvastatin calcium tablets are supplied as white, oval, biconvex film-coated tablets of atorvastatin calcium containing 10, 20, 40 and 80 mg atorvastatin.10 mg tablets20 mg tablets40 mg tablets80 mg tabletsStorageFOR YOUR PROTECTION:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Temozolomide is not directly active but undergoes rapid nonenzymatic conversion at physiologic pH to the reactive compound 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (MTIC). The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA. Alkylation (methylation) occurs mainly at the O and N positions of guanine.
Non-Clinical Toxicology
Known hypersensitivity to any temozolomide component or to dacarbazine (DTIC). ()Patients treated with temozolomide may experience myelosuppression, including 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. Prior to dosing, patients must have an absolute neutrophil count (ANC) greater than or equal to 1.5 × 10/L and a platelet count greater than or equal to 100 × 10/L. A complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until the ANC is above 1.5 × 10/L and platelet count exceeds 100 × 10/L. Geriatric patients and women have been shown in clinical trials to have a higher risk of developing myelosuppression.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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