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

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).

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

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).

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

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

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - temozolomide, quantity: 250 mg - capsule, hard - excipient ingredients: sodium lauryl sulfate; lactose; stearic acid; gelatin; titanium dioxide; sodium starch glycollate; tartaric acid; colloidal anhydrous silica; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; shellac; iron oxide black; simethicone; strong ammonia solution; potassium hydroxide - temodal capsules are indicated for the treatment of patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment; recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy. temodal capsules are also indicated as first line treatment for patients with advanced metastatic malignant melanoma.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - temozolomide, quantity: 180 mg - capsule, hard - excipient ingredients: tartaric acid; lactose; iron oxide yellow; titanium dioxide; silicon dioxide; gelatin; sodium lauryl sulfate; sodium starch glycollate; iron oxide red; stearic acid; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; simethicone - temodal capsules are indicated for the treatment of : patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment; recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy. temodal capsules are also indicated as first line treatment for patients with advanced metastatic malignant melanoma.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - temozolomide, quantity: 140 mg - capsule, hard - excipient ingredients: lactose; sodium starch glycollate; sodium lauryl sulfate; stearic acid; indigo carmine; gelatin; tartaric acid; silicon dioxide; titanium dioxide; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; shellac; iron oxide black; simethicone; strong ammonia solution; potassium hydroxide - temodal capsules are indicated for the treatment of : patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment; recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy. temodal capsules are also indicated as first line treatment for patients with advanced metastatic malignant melanoma.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - temozolomide, quantity: 100 mg - capsule, hard - excipient ingredients: tartaric acid; sodium lauryl sulfate; iron oxide red; lactose; colloidal anhydrous silica; stearic acid; gelatin; sodium starch glycollate; titanium dioxide; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; shellac; iron oxide black; simethicone; strong ammonia solution; potassium hydroxide - temodal capsules are indicated for the treatment of patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment; recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy. temodal capsules are also indicated as first line treatment for patients with advanced metastatic malignant melanoma.