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Drug Catalog - Product Detail

TEMOZOLOMIDE CAP 100 MG 14 CT

NDC Mfr Size Str Form
67877-0539-14 ASCEND LABORATORIES 14 100MG CAPSULE
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Generic Name
TEMOZOLOMIDE
Substance Name
TEMOZOLOMIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA207658
Description
11. DESCRIPTION Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]- as -tetrazine-8-carboxamide. The structural formula of temozolomide is: The material is a white to light tan/light pink powder with a molecular formula of C 6 H 6 N 6 O 2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMOZOLOMIDE can be administered orally and intravenously. 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. TEMOZOLOMIDE Capsules, USP: 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, USP are as follows: · TEMOZOLOMIDE 5 mg : lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3.0 mg). · TEMOZOLOMIDE 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg). · TEMOZOLOMIDE 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3.0 mg), and stearic acid (6.0 mg). · TEMOZOLOMIDE 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg). · TEMOZOLOMIDE 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg). · TEMOZOLOMIDE 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9.0 mg), and stearic acid (13.5 mg). The body of the capsules is made of gelatin and titanium dioxide and is opaque white. The cap is also made of gelatin and the colors may vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, and ferric oxide. · TEMOZOLOMIDE 5 mg: The opaque green cap contains gelatin, titanium dioxide, iron oxide yellow and FD&C Blue 2. · TEMOZOLOMIDE 20 mg: The opaque yellow cap contains gelatin, titanium dioxide and iron oxide yellow. · TEMOZOLOMIDE 100 mg: The opaque flesh cap contains gelatin, titanium dioxide and iron oxide red. · TEMOZOLOMIDE 140 mg: The transparent blue cap contains gelatin, FD&C Blue #2, and titanium dioxide. · TEMOZOLOMIDE 180 mg: The opaque orange cap contains gelatin, titanium dioxide and iron oxide red. · TEMOZOLOMIDE 250 mg: The opaque white cap contains gelatin and titanium dioxide. chemical-structure
How Supplied
16. HOW SUPPLIED/STORAGE AND HANDLING TEMOZOLOMIDE is a cytotoxic drug. Follow applicable special handling and disposal procedures. TEMOZOLOMIDE Capsules, USP are supplied in amber glass bottles, with child-resistant polypropylene caps (not supplied in sachets) containing the following capsule strengths: TEMOZOLOMIDE Capsules USP, 5 mg: Have opaque white bodies with opaque green caps. The capsule body is imprinted with the dosage strength. They are supplied as follows: Bottles: 5-count – NDC 67877-537-07 14-count – NDC 67877-537-14 TEMOZOLOMIDE Capsules USP, 20 mg: Have opaque white bodies with opaque yellow caps. The capsule body is imprinted with the dosage strength. They are supplied as follows: Bottles: 5-count – NDC 67877-538-07 14-count – NDC 67877-538-14 TEMOZOLOMIDE Capsules USP, 100 mg: Have opaque white bodies with opaque flesh caps. The capsule body is imprinted with the dosage strength. They are supplied as follows: Bottles: 5-count – NDC 67877-539-07 14-count – NDC 67877-539-14 TEMOZOLOMIDE Capsules USP, 140 mg: Have opaque white bodies with transparent blue caps. The capsule body is imprinted with the dosage strength. They are supplied as follows: Bottles: 5-count – NDC 67877-540-07 14-count – NDC 67877-540-14 TEMOZOLOMIDE Capsules USP, 180 mg: Have opaque white bodies with opaque orange caps. The capsule body is imprinted with the dosage strength. They are supplied as follows: Bottles: 5-count – NDC 67877-541-07 14-count – NDC 67877-541-14 TEMOZOLOMIDE Capsules USP, 250 mg: Have opaque white bodies with opaque white caps. The capsule body is imprinted with the dosage strength. They are supplied as follows: Bottles: 5-count – NDC 67877-542-07 Store TEMOZOLOMIDE Capsules at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Indications & Usage
1. INDICATIONS AND USAGE TEMOZOLOMIDE Capsules, USP are an alkylating drug indicated for the treatment of adult patients with: • Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1 ) • Refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. ( 1.2 ) 1.1 Newly Diagnosed Glioblastoma TEMOZOLOMIDE Capsules, USP is indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. 1.2 Refractory Anaplastic Astrocytoma TEMOZOLOMIDE Capsules , USP is indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
Dosage and Administration
2. DOSAGE AND ADMINISTRATION Administer either orally or intravenously. Newly Diagnosed Glioblastoma: o 75 mg/m 2 once daily for 42 days concomitant with focal radiotherapy followed by initial maintenance dose of 150 mg/m 2 once daily for Days 1 to 5 of each 28-day cycle for 6 cycles. May increase maintenance dose to 200 mg/ m 2 for cycles 2 – 6 based on toxicity. ( 2.1 ) o Provide Pneumocystis pneumonia (PCP) prophylaxis during concomitant phase and continue in patients who develop lymphopenia until resolution to grade 1 or less. ( 2.1 ) Refractory Anaplastic Astrocytoma: Initial dose of 150 mg/m 2 once daily on Days 1 to 5 of each 28-day cycle. ( 2.2 ) 2.1 Recommended Dosage and Dosage Modifications for Newly Diagnosed Glioblastoma Administer TEMOZOLOMIDE either orally once daily for 42 consecutive days during the concomitant phase with focal radiotherapy and then once daily on Days 1 to 5 of each 28-day cycle for 6 cycles during the maintenance phase. Provide Pneumocystis pneumonia (PCP) prophylaxis during the concomitant phase and continue in patients who develop lymphocytopenia until resolution to grade 1 or less [see Warnings and Precautions ( 5.3 )]. Concomitant Phase The recommended dosage of TEMOZOLOMIDE is 75 mg/m 2 either orally or intravenously once daily for 42 days (up to 49 days) concomitant with focal radiotherapy (60 Gy administered in 30 fractions). Focal radiotherapy includes the tumor bed or resection site with a 2- to 3-cm margin. Obtain a complete blood count weekly. No dose reductions are recommended during the concomitant phase. The recommended dosage modifications during the concomitant phase are provided in Table 1 . TABLE 1: Temozolomide Dosage Modifications During Concomitant Phase Adverse Reaction Interruption Discontinuation Absolute Neutrophil Count Withhold TEMOZOLOMIDE if ANC is greater than or equal to 0.5 x 10 9 /L and less than 1.5 x 10 9 /L. Resume TEMOZOLOMIDE when ANC is greater than or equal to 1.5 x 10 9 /L. Discontinue TEMOZOLOMIDE if platelet count is less than 0.5 x 10 9 /L. Platelet Count Withhold TEMOZOLOMIDE if platelet count is greater than or equal to 10 x 10 9 /L and less than 100 x 10 9 /L. Resume TEMOZOLOMIDE when platelet count is greater than or equal to 100 x 10 9 /L. Discontinue TEMOZOLOMIDE if platelet count is less than 10 x 10 9 /L. Non-hematological Adverse Reaction (except for alopecia, nausea, vomiting) Withhold TEMOZOLOMIDE if Grade 2 adverse reaction occurs. Resume TEMOZOLOMIDE when resolution to Grade 1 or less. Discontinue TEMOZOLOMIDE if Grade 3 or 4 adverse reaction occurs. Maintenance Phase Beginning 4 weeks after Concomitant Phase completion, administer TEMOZOLOMIDE either orally or intravenously once daily on Days 1 to 5 of each 28-day cycle for 6 cycles. The recommended dosage of TEMOZOLOMIDE is as follows: • Cycle 1: 150 mg/m 2 per day • Cycles 2 to 6: May increase to 200 mg/m 2 per day if the following conditions are met before starting cycle 2. If the dose was not escalated at the onset of Cycle 2, do not increase the dose for Cycles 3 to 6. o Nonhematologic toxicity is grade 2 or less (except for alopecia, nausea, and vomiting) o ANC is greater than or equal to 1.5 x 10 9 /L and o Platelet count is greater than or equal to 100 x 10 9 /L. Obtain a complete blood count on Day 22 and then weekly until the ANC is above 1.5 x 10 9 /L and the platelet count is above 100 x 10 9 /L. Do not start the next cycle until the ANC and platelet count exceed these levels. The recommended dosage modifications during the maintenance phase are provided in Table 2. If TEMOZOLOMIDE is withheld, reduce the dose for the next cycle by 50 mg/m 2 per day. Permanently discontinue TEMOZOLOMIDE in patients who are unable to tolerate a dose of 100 mg/m 2 per day. TABLE 2: Temozolomide Dosage Modifications During Maintenance Treatment Toxicity Interruption Discontinuation Absolute Neutrophil Count Withhold TEMOZOLOMIDE if ANC less than 1 x 10 9 /L. When ANC is above 1.5 x 10 9 /L, resume TEMOZOLOMIDE at reduced dose for the next cycle. Unable to tolerate a dose of 100 mg/m 2 per day. Platelet Count Withhold TEMOZOLOMIDE if platelet less than 50 x 10 9 /L. When platelet count is above 100 x 10 9 /L, resume TEMOZOLOMIDE at reduced dose for the next cycle. Unable to tolerate a dose of 100 mg/m 2 per day. Non-hematological Adverse Reaction (except for alopecia, nausea, vomiting) Withhold TEMOZOLOMIDE if Grade 3 adverse reaction. When resolved to grade 1 or less, resume TEMOZOLOMIDE at reduced dose for the next cycle. Recurrent Grade 3 after dose reduction. Grade 4 Unable to tolerate a dose of 100 mg/m 2 per day. 2.2 Recommended Dosage and Dosage Modifications for Refractory Anaplastic Astrocytoma The recommended initial dosage of TEMOZOLOMIDE is 150 mg/m 2 once daily on Days 1 to 5 of each 28-day cycle. Increase the TEMOZOLOMIDE dose to 200 mg/m 2 per day if the following conditions are met at the nadir and on Day 1 of the next cycle: • ANC is greater than or equal to 1.5 x 10 9 /L and • Platelet count is greater than or equal to 100 x 10 9 /L Continue TEMOZOLOMIDE until disease progression or unacceptable toxicity. In the clinical trial, treatment could be continued for a maximum of 2 years, but the optimum duration of therapy is not known. Obtain a complete blood count on Day 22 and then weekly until the ANC is above 1.5 x 10 9 /L and the platelet count is above 100 x 10 9 /L. Do not start the next cycle until the ANC and platelet count exceed these levels. If the ANC is less than 1 x 10 9 /L or the platelet count is less than 50 x 10 9 /L during any cycle, reduce the TEMOZOLOMIDE dose for the next cycle by 50 mg/m 2 per day. Permanently discontinue TEMOZOLOMIDE in patients who are unable to tolerate a dose of 100 mg/m 2 per day. 2.3 Preparation and Administration TEMOZOLOMIDE is a cytotoxic drug. Follow applicable special handling and disposal procedures 1 . TEMOZOLOMIDE capsules Administer TEMOZOLOMIDE consistently with respect to food (fasting vs.nonfasting) [see Clinical Pharmacology 12.3 )] . To reduce nausea and vomiting, take TEMOZOLOMIDE on an empty stomach or at bedtime and consider antiemetic therapy prior to and/or following TEMOZOLOMIDE administration. Swallow TEMOZOLOMIDE capsules whole. Do not open or chew capsules. If capsules are accidentally opened or damaged, take precautions to avoid inhalation or contact with the skin or mucous membranes. In case of powder contact, the hands should be washed.