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accord healthcare inc. - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 5 mg - temozolomide capsule is indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsule is indicated for the: - adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma; - treatment of adults with refractory anaplastic astrocytoma temozolomide is contraindicated in patients with a history of serious hypersensitivity reactions to: - temozolomide or any other ingredients in temozolomide capsules; and - dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3methyltriazen-1-yl)-imidazole-4-carboxamide. reactions to temozolomide have included anaphylaxis [see adverse reactions (6.2)]. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] and findings from animal studies, temozolomide can cause fetal harm when administered to a pregnant woman. available postmarketing reports describe cases of spontaneous abortions and congenital malformations, including polymalformations with central nervous system, facial, cardiac, skeletal, and genitourinary system anomalies with exposure to temozolomide during pregnancy. these cases report similar adverse developmental outcomes to those observed in animal studies. administration of temozolomide to rats and rabbits during the period of organogenesis caused numerous external, internal, and skeletal malformations at doses less than the maximum human dose based on body surface area (see data). advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data five consecutive days of oral administration of temozolomide at doses of 75 and 150 mg/m 2 (0.38 and 0.75 times the human dose of 200 mg/m 2 ) in rats and rabbits, respectively, during the period of organogenesis (gestation days 8 to 12) caused numerous malformations of the external and internal organs and skeleton in both species. in rabbits, temozolomide at the 150 mg/m 2 dose (0.75 times the human dose of 200 mg/m 2 ) caused embryolethality as indicated by increased resorptions. there are no data on the presence of temozolomide or its metabolites in human milk, the effects on a breastfed child, or the effects on milk production. because of the potential for serious adverse reactions, including myelosuppression from temozolomide in the breastfed children, advise women not to breastfeed during treatment with temozolomide and for 1 week after the last dose. temozolomide can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating temozolomide [see use in specific populations (8.1)]. contraception females advise females of reproductive potential to use effective contraception during treatment with temozolomide and for 6 months after the last dose. males because of the potential for embryofetal toxicity and genotoxic effects on sperm cells, advise male patients with pregnant partners or female partners of reproductive potential to use condoms during treatment with temozolomide and for 3 months after the last dose [see use in specific populations (8.1), nonclinical toxicology (13.1)]. advise male patients not to donate semen during treatment with temozolomide and for 3 months after the last dose. infertility temozolomide may impair male fertility [see nonclinical toxicology (13.1)] . limited data from male patients show changes in sperm parameters during treatment with temozolomide; however, no information is available on the duration or reversibility of these changes. safety and effectiveness of temozolomide have not been established in pediatric patients. safety and effectiveness of temozolomide capsules were assessed, but not established, in 2 open-label studies in pediatric patients aged 3 to18 years. in one study, 29 patients with recurrent brain stem glioma and 34 patients with recurrent high-grade astrocytoma were enrolled. in a second study conducted by the children’s oncology group (cog), 122 patients were enrolled, including patients with medulloblastoma/pnet (29), high grade astrocytoma (23), low grade astrocytoma (22), brain stem glioma (16), ependymoma (14), other cns tumors (9), and non-cns tumors (9). the adverse reaction profile in pediatric patients was similar to adults. in mk-7365-051, 15% of patients with newly diagnosed glioblastoma were 65 years and older. this study did not include sufficient numbers of patients aged 65 years and older to determine differences in effectiveness from younger patients. no overall differences in safety were observed between patients ≥65 years and younger patients. the catnon trial did not include sufficient numbers of patients aged 65 years and older to determine differences in safety or effectiveness when compared to younger patients. in mk-7365-006, 4% of patients with refractory anaplastic astrocytoma were 70 years and older. this study did not include sufficient numbers of patients aged 70 years and older to determine differences in effectiveness from younger patients. patients 70 years and older had a higher incidence of grade 4 neutropenia (25%) and grade 4 thrombocytopenia (20%) in the first cycle of therapy than patients less than 70 years of age [see warnings and precautions (5.1), adverse reactions (6.1)]. in the entire safety database for which hematologic data exist (n=932), 7% (4/61) and 10% (6/63) of patients >70 years experienced grade 4 neutropenia or thrombocytopenia in the first cycle, respectively. for patients ≤70 years, 7% (62/871) and 6% (48/879) experienced grade 4 neutropenia or thrombocytopenia in the first cycle, respectively. pancytopenia, leukopenia, and anemia also occurred. no dosage adjustment is recommended for patients with creatinine clearance (clcr) of 36 to 130 ml/min/m 2 [see clinical pharmacology (12.3)]. the recommended dose of temozolomide capsules has not been established for patients with severe renal impairment (clcr < 36 ml/min/m 2 ) or for patients with end-stage renal disease on dialysis. no dosage adjustment is recommended for patients with mild to moderate hepatic impairment (child pugh class a and b) [see clinical pharmacology (12.3)]. the recommended dose of temozolomide has not been established for patients with severe hepatic impairment (child-pugh class c).

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sun pharmaceutical industries, inc. - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 5 mg - temozolomide capsules are indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules are indicated for the: • adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma; • treatment of adults with refractory anaplastic astrocytoma. temozolomide is contraindicated in patients with a history of serious hypersensitivity reactions to: - temozolomide or any other ingredients in temozolomide capsules; and - dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide. reactions to temozolomide have included anaphylaxis [see adverse reactions (6.2)]. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)], temozolomide can cause fetal harm when administered to a pregnant woman. available postmarketing reports describe cases of spontaneous abortions and c

United States - English - NLM (National Library of Medicine)

ani pharmaceuticals, inc. - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 100 mg - temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. temozolomide capsules are contraindicated in patients with a history of hypersensitivity reactions to: reactions to temozolomide capsules have included anaphylaxis [see adverse reactions (6.2)] . risk summary based on its mechanism of action [see clinical pharmacology (12.1)] and findings from animal studies, temozolomide can cause fetal harm when administered to a pregnant woman. available postmarketing reports describe cases of spontaneous abortions and congenital malformations, including polymalformations with central nervous system, facial, cardiac, skeletal, and genitourinary system anomalies with exposure to temozolomide duri

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals llc - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 5 mg - temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. temozolomide is contraindicated in patients with a history of hypersensitivity reactions to: - temozolomide or any other ingredients in temozolomide capsules; and - dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide. reactions to temozolomide have included anaphylaxis [see adverse reactions (6.2)]. risk summary based on its mechanism of action [see clinical pharmacology (12.1)] and findings from animal studies, temozolomide can cause fetal harm when administered to a pregnant woman. available postmarketing reports describe cases of spontaneous abortions and congenital malformations, including polymalformations with central nervous system, facial, cardiac, skeletal, and genitourinary system anomalies with exposure to temozolomide during pregnancy. these cases report similar adverse developmental outcomes to those observed in animal studies. administration of temozolomide to rats and rabbits during the period of organogenesis caused numerous external, internal, and skeletal malformations at doses less than the maximum human dose based on body surface area (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data five consecutive days of oral administration of temozolomide at doses of 75 and 150 mg/m2 (0.38 and 0.75 times the human dose of 200 mg/m2 ) in rats and rabbits, respectively, during the period of organogenesis (gestation days 8-12) caused numerous malformations of the external and internal organs and skeleton in both species. in rabbits, temozolomide at the 150 mg/m2 dose (0.75 times the human dose of 200 mg/m2 ) caused embryolethality as indicated by increased resorptions. there are no data on the presence of temozolomide or its metabolites in human milk, the effects on a breastfed child, or the effects on milk production. because of the potential for serious adverse reactions, including myelosuppression from temozolomide in the breastfed children, advise women not to breastfeed during treatment with temozolomide and for at least 1 week after the final dose. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating temozolomide [see use in specific populations (8.1)] . contraception females temozolomide can cause embryo-fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with temozolomide and for at least 6 months after the last dose. males because of the potential for embryofetal toxicity and genotoxic effects on sperm cells, advise male patients with pregnant partners or female partners of reproductive potential to use condoms during treatment with temozolomide and for at least 3 months after the final dose [see use in specific populations (8.1) , nonclinical toxicology (13.1)] . advise male patients not to donate semen during treatment with temozolomide and for at least 3 months after the final dose. infertility temozolomide may impair male fertility [see nonclinical toxicology (13.1)] . limited data from male patients show changes in sperm parameters during treatment with temozolomide; however, no information is available on the duration or reversibility of these changes. safety and effectiveness of temozolomide have not been established in pediatric patients. safety and effectiveness of temozolomide capsules were assessed, but not established, in 2 open-label studies in pediatric patients aged 3 to 18 years. in one study, 29 patients with recurrent brain stem glioma and 34 patients with recurrent high-grade astrocytoma were enrolled. in a second study conducted by the children's oncology group (cog), 122 patients were enrolled, including patients with medulloblastoma/pnet (29), high grade astrocytoma (23), low grade astrocytoma (22), brain stem glioma (16), ependymoma (14), other cns tumors (9), and non-cns tumors (9). the adverse reaction profile in pediatric patients was similar to adults. in the newly diagnosed glioblastoma trial, study mk-7365-051, 15% of patients were 65 years and older. this study did not include sufficient numbers of patients aged 65 years and older to determine differences in effectiveness from younger patients. no overall differences in safety were observed between patients ≥ 65 years and younger patients. in the refractory anaplastic astrocytoma trial, study mk-7365-0006, 4% of patients were 70 years and older. this study did not include sufficient numbers of patients aged 70 years and older to determine differences in effectiveness from younger patients. patients 70 years and older had a higher incidence of grade 4 neutropenia (25%) and grade 4 thrombocytopenia (20%) in the first cycle of therapy than patients less than 70 years of age [see warnings and precautions (5.1), adverse reactions (6.1)] . no dosage adjustment is recommended for patients with creatinine clearance (clcr) of 36 to 130 ml/min/m2 [see clinical pharmacology (12.3)] . the recommended dose of temozolomide has not been established for patients with severe renal impairment (clcr < 36 ml/min/m2 ) or for patients with end-stage renal disease on dialysis. no dosage adjustment is recommended for patients with mild to moderate hepatic impairment (child pugh class a and b) [see clinical pharmacology (12.3)] . the recommended dose of temozolomide has not been established for patients with severe hepatic impairment (child-pugh class c).

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sandoz inc. - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 5 mg - temozolomide is indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. temozolomide 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. temozolomide is contraindicated in patients with a history of hypersensitivity reactions to: - temozolomide or any other ingredients in temozolomide; and - dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide. reactions to temozolomide have included anaphylaxis [see adverse reactions (6.2)]. risk summary based on its mechanism of action [see clinical pharmacology (12.1)] and findings from animal studies, temozolomide can cause fetal harm when administered to a pregnant woman. available postmarketing reports describe cases of spontaneous abortions and congeni

United States - English - NLM (National Library of Medicine)

ascend laboratories, llc - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 5 mg - temozolomide capsules, usp is indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. 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. temozolomide is contraindicated in patients with a history of hypersensitivity reactions to: • temozolomide or any other ingredients in temozolomide; and • dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide. reactions to temozolomide have included anaphylaxis [see adverse reactions ( 6.2 )]. risk summary based on its mechanism of action [see clinical pharmacology (12.1)] and findings from animal studies, temozolomide can cause fetal harm when administered to a pregnant woman. available postmarketing reports describ

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zydus pharmaceuticals usa inc. - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 5 mg - temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. temozolomide is contraindicated in patients with a history of hypersensitivity reactions to: - temozolomide or any other ingredients in temozolomide capsules; and - dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3methyltriazen-1-yl)-imidazole-4-carboxamide. reactions to temozolomide have included anaphylaxis [see adverse reactions (6.2)]. risk summary based on its mechanism of action [see clinical pharmacology (12.1)] and findings from animal studies, temozolomide can cause fetal harm when administered to a pregnant woman. available postmarketing reports describe

United States - English - NLM (National Library of Medicine)

roxane laboratories, inc. - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 5 mg - temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. temozolomide capsules are contraindicated in patients who have a history of hypersensitivity reaction (such as urticaria, allergic reaction including anaphylaxis, toxic epidermal necrolysis, and stevens-johnson syndrome) to any of its components. temozolomide capsules are also contraindicated in patients who have a history of hypersensitivity to dacarbazine, since both drugs are metabolized to 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (mtic). pregnancy category d. see warnings and precautions section. temozolomide can cause fetal harm when administered to a pregnant woman. five consecutive days of o

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avpak - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 20 mg - temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. temozolomide is contraindicated in patients who have a history of hypersensitivity reaction (such as urticaria, allergic reaction including anaphylaxis, toxic epidermal necrolysis, and stevens-johnson syndrome) to any of its components. temozolomide is also contraindicated in patients who have a history of hypersensitivity to dacarbazine (dtic), since both drugs are metabolized to 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (mtic). pregnancy category d. see warnings and precautions section. temozolomide can cause fetal harm when administered to a pregnant woman. five consecutive days of oral temozolomide administration of 0.38 and 0.75 times the highest recommended human dose (75 and 150 mg/m 2 ) in rats and rabbits, respectively, during the period of organogenesis caused numerous malformations of the external and internal soft tissues and skeleton in both species. doses equivalent to 0.75 times the highest recommended human dose (150 mg/m 2 ) caused embryolethality in rats and rabbits as indicated by increased resorptions. there are no adequate and well-controlled studies in pregnant women. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. women of childbearing potential should be advised to avoid becoming pregnant during therapy with temozolomide. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants and tumorigenicity shown for temozolomide in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of temozolomide to the mother. safety and effectiveness in pediatric patients have not been established. temozolomide capsules have been studied in 2 open-label studies in pediatric patients (aged 3 to 18 years) at a dose of 160 to 200 mg/m 2 daily for 5 days every 28 days. in one trial, 29 patients with recurrent brain stem glioma and 34 patients with recurrent high grade astrocytoma were enrolled. all patients had recurrence following surgery and radiation therapy, while 31% also had disease progression following chemotherapy. in a second study conducted by the children’s oncology group (cog), 122 patients were enrolled, including patients with medulloblastoma/pnet (29), high grade astrocytoma (23), low grade astrocytoma (22), brain stem glioma (16), ependymoma (14), other cns tumors (9), and non-cns tumors (9). the temozolomide toxicity profile in pediatric patients is similar to adults. table 10 shows the adverse reactions in 122 children in the cog study. table 10: adverse reactions reported in the pediatric cooperative group trial (≥10%) *these various tumors included the following: pnet-medulloblastoma, glioblastoma, low grade astrocytoma, brain stem tumor, ependymoma, mixed glioma, oligodendroglioma, neuroblastoma, ewing's sarcoma, pineoblastoma, alveolar soft part sarcoma, neurofibrosarcoma, optic glioma, and osteosarcoma. clinical studies of temozolomide did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. in the anaplastic astrocytoma study population, patients 70 years of age or older had a higher incidence of grade 4 neutropenia and grade 4 thrombocytopenia (2/8; 25%, p =0.31 and 2/10; 20%, p =0.09, respectively) in the first cycle of therapy than patients under 70 years of age [see  warnings and precautions (5.1) and adverse reactions (6.1) ] . in newly diagnosed patients with glioblastoma multiforme, the adverse reaction profile was similar in younger patients (<65 years) vs. older (≥65 years). caution should be exercised when temozolomide is administered to patients with severe renal impairment [see clinical pharmacology (12.3) ] . caution should be exercised when temozolomide is administered to patients with severe hepatic impairment [see clinical pharmacology (12.3) ] .

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lannett company, inc. - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 5 mg - temozolomide is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. temozolomide is indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. temozolomide is contraindicated in patients who have a history of hypersensitivity reaction (such as urticaria, allergic reaction including anaphylaxis, toxic epidermal necrolysis, and stevens-johnson syndrome) to any of its components. temozolomide is also contraindicated in patients who have a history of hypersensitivity to dacarbazine (dtic), since both drugs are metabolized to 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (mtic). pregnancy category d. see warnings and precautions section. temozolomide can cause fetal harm when administered to a pregnant woman. five consecutive days of oral temozolomide administration o