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Temozolomide Prescribing Information

This information is not for clinical use. These highlights do not include all the information needed to use Temozolomide safely and effectively. Before taking Temozolomide please consult with your doctor. See full prescribing information for Temozolomide.

Recent Changes

Warnings and Precautions, Hepatotoxicity (5.5) 05/2015
Side Effects (6.2) 09/2015

Indications And Usage

Temozolomide capsules are an alkylating drug indicated for the treatment of adult patients with: Newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and then as maintenance treatment. (1.1) Refractory anaplastic astrocytoma patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. (1.2) 1.1 Newly Diagnosed Glioblastoma Multiforme Temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. 1.2 Refractory Anaplastic Astrocytoma 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.

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Dosage And Administration

TABLE 1: Temozolomide Dosing Interruption or Discontinuation During Concomitant Radiotherapy and Temozolomide
Toxicity TMZ InterruptionTreatment with concomitant TMZ could be continued when all of the following conditions were met: absolute neutrophil count greater than or equal to 1.5 × 109/L; platelet count greater than or equal to 100 × 109/L; CTC nonhematological toxicity less than or equal to Grade 1 (except for alopecia, nausea, vomiting). TMZ Discontinuation
TMZ = temozolomide; CTC = Common Toxicity Criteria.
Absolute Neutrophil Count greater than or equal to 0.5 and less than 1.5 × 109/L less than 0.5 × 109/L
Platelet Count greater than or equal to 10 and less than 100 × 109/L less than 10 × 109/L
CTC Nonhematological Toxicity (except for alopecia, nausea, vomiting) CTC Grade 2 CTC Grade 3 or 4

Dosage Forms And Strengths

Temozolomide capsules for oral administration 5 mg: Green cap printed in black ink "Temozolomide", White Opaque Body, printed in black ink "5 mg" 20 mg: Orange cap printed in black ink "Temozolomide", White Opaque Body, printed in black ink "20 mg" 100 mg: Red cap printed in black ink "Temozolomide", White Opaque Body, printed in black ink "100 mg" 140 mg: Light blue cap printed in black ink "Temozolomide", White Opaque Body, printed in black ink "140 mg" 180 mg: Light Caramel printed in black ink "Temozolomide", White Opaque Body, printed in black ink "180mg" 250 mg: Grey cap printed in black ink "Temozolomide", White Opaque Body, printed in black ink "250 mg" 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg capsules. (3)

Contraindications

Known hypersensitivity to any Temozolomide capsules component or to dacarbazine (DTIC). (4.1) 4.1 Hypersensitivity 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).

Warning and Cautions

Myelosuppression - monitor Absolute Neutrophil Count (ANC) and platelet count prior to dosing and throughout treatment. Geriatric patients and women have a higher risk of developing myelosuppression. (5.1) Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukemia, have been observed. (5.2) Pneumocystis carinii pneumonia (PCP) - prophylaxis required for all patients receiving concomitant Temozolomide and radiotherapy for the 42-day regimen for the treatment of newly diagnosed glioblastoma multiforme. (5.3) All patients, particularly those receiving steroids, should be observed closely for the development of lymphopenia and PCP. (5.4) Complete blood counts should be obtained throughout the treatment course as specified. (5.4) Hepatotoxicity – fatal and severe hepatotoxicity have been reported. Perform liver function tests at baseline, midway through the first cycle, prior to each subsequent cycle, and approximately two to four weeks after the last dose of Temozolomide. (5.5) Fetal harm can occur when administered to a pregnant woman. Women should be advised to avoid becoming pregnant when receiving Temozolomide. (5.6) 5.1 Myelosuppression 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) ≥ 1.5 × 109/L and a platelet count ≥ 100 × 109/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 × 109/L and platelet count exceeds 100 × 109/L. Geriatric patients and women have been shown in clinical trials to have a higher risk of developing myelosuppression. 5.2 Myelodysplastic Syndrome Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukemia, have been observed. 5.3 Pneumocystis carinii Pneumonia For treatment of newly diagnosed glioblastoma multiforme: Prophylaxis against Pneumocystis carinii pneumonia (PCP) is required for all patients receiving concomitant Temozolomide and radiotherapy for the 42-day regimen. There may be a higher occurrence of PCP when temozolomide is administered during a longer dosing regimen. However, all patients receiving temozolomide, particularly patients receiving steroids, should be observed closely for the development of PCP regardless of the regimen. 5.4 Laboratory Tests For the concomitant treatment phase with RT, a complete blood count should be obtained prior to initiation of treatment and weekly during treatment. For the 28-day treatment cycles, a complete blood count should be obtained prior to treatment on Day 1 and on Day 22 (21 days after the first dose) of each cycle. Blood counts should be performed weekly until recovery if the ANC falls below 1.5 × 109/L and the platelet count falls below 100 × 109/L [see Recommended Dosing and Dose Modification Guidelines (2.1)]. 5.5 Hepatotoxicity Fatal and severe hepatotoxicity have been reported in patients receiving Temozolomide. Perform liver function tests at baseline, midway through the first cycle, prior to each subsequent cycle, and approximately two to four weeks after the last dose of Temozolomide. 5.6 Use in Pregnancy Temozolomide can cause fetal harm when administered to a pregnant woman. Administration of Temozolomide to rats and rabbits during organogenesis at 0.38 and 0.75 times the maximum recommended human dose (75 and 150 mg/m2), respectively, caused numerous fetal malformations of the external organs, soft tissues, and skeleton in both species [see Use in Specific Populations (8.1)].

Adverse Reactions

The most common adverse reactions (≥ 10% incidence) are: alopecia, fatigue, nausea, vomiting, headache, constipation, anorexia, convulsions, rash, hemiparesis, diarrhea, asthenia, fever, dizziness, coordination abnormal, viral infection, amnesia, and insomnia. (6.1) The most common Grade 3 to 4 hematologic laboratory abnormalities (≥ 10% incidence) that have developed during treatment with temozolomide are: lymphopenia, thrombocytopenia, neutropenia, and leukopenia. (6.1) Allergic reactions have also been reported. (6) To report SUSPECTED ADVERSE REACTIONS, contact XXXXX at 1-XXX-XXX-XXXX or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Newly Diagnosed Glioblastoma Multiforme: During the concomitant phase (Temozolomide + radiotherapy), adverse reactions including thrombocytopenia, nausea, vomiting, anorexia, and constipation were more frequent in the Temozolomide + RT arm. The incidence of other adverse reactions was comparable in the two arms. The most common adverse reactions across the cumulative Temozolomide experience were alopecia, nausea, vomiting, anorexia, headache, and constipation (see Table 7 ). Forty-nine percent (49%) of patients treated with Temozolomide reported one or more severe or life-threatening reactions, most commonly fatigue (13%), convulsions (6%), headache (5%), and thrombocytopenia (5%). Overall, the pattern of reactions during the maintenance phase was consistent with the known safety profile of Temozolomide. TABLE 7: Number (%) of Patients with Adverse Reactions: All and Severe/Life Threatening (Incidence of 5% or Greater) Concomitant Phase RT Alone (n = 285) Concomitant Phase RT + TMZ (n = 288)Once patient who was randomized to RT only arm received RT + temozolomide. Maintenance Phase TMZ (n = 224) All Grade ≥3 All Grade ≥3 All Grade ≥3 RT + TMZ = radiotherapy plus temozolomide; NOS = not otherwise specified. Note: Grade 5 (fatal) adverse reactions are included in the Grade ≥ 3 column. Subjects Reporting any Adverse Reaction 258 (91) 74 (26) 266 (92) 80 (28) 206 (92) 82 (37) Body as a Whole – General Disorders Anorexia 25 (9) 1 (< 1) 56 (19) 2 (1) 61 (27) 3 (1) Dizziness 10 (4) 0 12 (4) 2 (1) 12 (5) 0 Fatigue 139 (49) 15 (5) 156 (54) 19 (7) 137 (61) 20 (9) Headache 49 (17) 11 (4) 56 (19) 5 (2) 51 (23) 9 (4) Weakness 9 (3) 3 (1) 10 (3) 5 (2) 16 (7) 4 (2) Central and Peripheral Nervous System Disorders Confusion 12 (4) 6 (2) 11 (4) 4 (1) 12 (5) 4 (2) Convulsions 20 (7) 9 (3) 17 (6) 10 (3) 25 (11) 7 (3) Memory Impairment 12 (4) 1 (< 1) 8 (3) 1 (< 1) 16 (7) 2 (1) Disorders of the Eye Vision Blurred 25 (9) 4 (1) 26 (9) 2 (1) 17 (8) 0 Disorders of the Immune System Allergic Reaction 7 (2) 1 (< 1) 13 (5) 0 6 (3) 0 Gastrointestinal System Disorders Abdominal Pain 2 (1) 0 7 (2) 1 (<1) 11 (5) 1 (<1) Constipation 18 (6) 0 53 (18) 3 (1) 49 (22) 0 Diarrhea 9 (3) 0 18 (6) 0 23 (10) 2 (1) Nausea 45 (16) 1 (< 1) 105 (36) 2 (1) 110 (49) 3 (1) Stomatitis 14 (5) 1 (< 1) 19 (7) 0 20 (9) 3 (1) Vomiting 16 (6) 1 (< 1) 57 (20) 1 (< 1) 66 (29) 4 (2) Injury and Poisoning Radiation Injury NOS 11 (4) 1 (< 1) 20 (7) 0 5 (2) 0 Musculoskeletal System Disorders Arthralgia 2 (1) 0 7 (2) 1 (<1) 14 (6) 0 Platelet, Bleeding and Clotting Disorders Thrombocytopenia 3 (1) 0 11 (4) 8 (3) 19 (8) 8 (4) Psychiatric Disorders Insomnia 9 (3) 1 (<1) 14 (5) 0 9 (4) 0 Respiratory System Disorders Coughing 3 (1) 0 15 (5) 2 (1) 19 (8) 1 (<1) Dyspnea 9 (3) 4 (1) 11 (4) 5 (2) 12 (5) 1 (<1) Skin and Subcutaneous Tissue Disorders Alopecia 179 (63) 0 199 (69) 0 124 (55) 0 Dry Skin 6 (2) 0 7 (2) 0 11 (5) 1 (<1) Erythema 15 (5) 0 14 (5) 0 2 (1) 0 Pruritus 4 (1) 0 11 (4) 0 11 (5) 0 Rash 42 (15) 0 56 (19) 3 (1) 29 (13) 3 (1) Special Senses Other, Disorders Taste Perversion 6 (2) 0 18 (6) 0 11 (5) 0 Myelosuppression (neutropenia and thrombocytopenia), which is a known dose-limiting toxicity for most cytotoxic agents, including Temozolomide, was observed. When laboratory abnormalities and adverse reactions were combined, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic reactions were observed in 8% of the patients, and Grade 3 or Grade 4 platelet abnormalities, including thrombocytopenic reactions, were observed in 14% of the patients treated with Temozolomide. Refractory Anaplastic Astrocytoma: Tables 8 and 9 show the incidence of adverse reactions in the 158 patients in the anaplastic astrocytoma study for whom data are available. In the absence of a control group, it is not clear in many cases whether these reactions should be attributed to temozolomide or the patients' underlying conditions, but nausea, vomiting, fatigue, and hematologic effects appear to be clearly drug-related. The most frequently occurring adverse reactions were nausea, vomiting, headache, and fatigue. The adverse reactions were usually NCI Common Toxicity Criteria (CTC) Grade 1 or 2 (mild to moderate in severity) and were self-limiting, with nausea and vomiting readily controlled with antiemetics. The incidence of severe nausea and vomiting (CTC Grade 3 or 4) was 10% and 6%, respectively. Myelosuppression (thrombocytopenia and neutropenia) was the dose-limiting adverse reaction. It usually occurred within the first few cycles of therapy and was not cumulative. Myelosuppression occurred late in the treatment cycle and returned to normal, on average, within 14 days of nadir counts. The median nadirs occurred at 26 days for platelets (range: 21- 40 days) and 28-days for neutrophils (range: 1-44 days). Only 14% (22/158) of patients had a neutrophil nadir and 20% (32/158) of patients had a platelet nadir, which may have delayed the start of the next cycle. Less than 10% of patients required hospitalization, blood transfusion, or discontinuation of therapy due to myelosuppression. In clinical trial experience with 110 to 111 women and 169 to 174 men (depending on measurements), there were higher rates of Grade 4 neutropenia (ANC < 500 cells/μL) and thrombocytopenia (< 20,000 cells/μL) in women than men in the first cycle of therapy (12% vs. 5% and 9% vs. 3%, respectively). In the entire safety database for which hematologic data exist (N = 932), 7% (4/61) and 9.5% (6/63) of patients over age 70 experienced Grade 4 neutropenia or thrombocytopenia in the first cycle, respectively. For patients less than or equal to age 70, 7% (62/871) and 5.5% (48/879) experienced Grade 4 neutropenia or thrombocytopenia in the first cycle, respectively. Pancytopenia, leukopenia, and anemia have also been reported. TABLE 8: Adverse Reactions in the Anaplastic Astrocytoma Trial in Adults (≥ 5%) No. (%) of Temozolomide Patients (N = 158) All Reactions Grade 3/4 Any Adverse Reaction 153 (97) 79 (50) Body as a Whole Headache 65 (41) 10 (6) Fatigue 54 (34) 7 (4) Asthenia 20 (13) 9 (6) Fever 21 (13) 3 (2) Back pain 12 (8) 4 (3) Cardiovascular Edema peripheral 17 (11) 1 (1) Central and Peripheral Nervous System Convulsions 36 (23) 8 (5) Hemiparesis 29 (18) 10 (6) Dizziness 19 (12) 1 (1) Coordination abnormal 17 (11) 2 (1) Amnesia 16 (10) 6 (4) Insomnia 16 (10) 0 Paresthesia 15 (9) 1 (1) Somnolence 15 (9) 5 (3) Paresis 13 (8) 4 (3) Urinary incontinence 13 (8) 3 (2) Ataxia 12 (8) 3 (2) Dysphasia 11 (7) 1 (1) Convulsions local 9 (6) 0 Gait abnormal 9 (6) 1 (1) Confusion 8 (5) 0 Endocrine Adrenal hypercorticism 13 (8) 0 Gastrointestinal System Nausea 84 (53) 16 (10) Vomiting 66 (42) 10 (6) Constipation 52 (33) 1 (1) Diarrhea 25 (16) 3 (2) Abdominal pain 14 (9) 2 (1) Anorexia 14 (9) 1 (1) Metabolic Weight increase 8 (5) 0 Musculoskeletal System Myalgia 8 (5) Psychiatric Disorders Anxiety 11 (7) 1 (1) Depression 10 (6) 0 Reproductive Disorders Breast pain, female 4 (6) Resistance Mechanism Disorders Infection viral 17 (11) 0 Respiratory System Upper respiratory tract infection 13 (8) 0 Pharyngitis 12 (8) 0 Sinusitis 10 (6) 0 Coughing 8 (5) 0 Skin and Appendages Rash 13 (8) 0 Pruritus 12 (8) 2 (1) Urinary System Urinary tract infection 12 (8) 0 Micturition increased frequency 9 (6) 0 Vision Diplopia 8 (5) 0 Vision abnormalBlurred vision; visual deficit; vision changes; vision troubles 8 (5) TABLE 9: Adverse Hematologic Effects (Grade 3 to 4) in the Anaplastic Astrocytoma Trial in Adults TemozolomideChange from Grade 0 to 2 at baseline to Grade 3 or 4 during treatment. Hemoglobin 7/158 (4%) Lymphopenia 83/152 (55%) Neutrophils 20/142 (14%) Platelets 29/156 (19%) WBC 18/158 (11%) 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of Temozolomide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug exposure. Dermatologic disorders: Toxic epidermal necrolysis and Stevens-Johnson syndrome Immune system disorders: Allergic reactions, including anaphylaxis. Erythema multiforme, which resolved after discontinuation of Temozolomide and, in some cases, recurred upon rechallenge. Hematopoietic disorders: Prolonged pancytopenia, which may result in aplastic anemia and fatal outcomes [see Warnings and Precautions (5.1)]. Hepatobiliary disorders: Fatal and severe hepatotoxicity, elevation of liver enzymes, hyperbilirubinemia, cholestasis, and hepatitis [see Warnings and Precautions (5.5)]. Infections and infestations: Opportunistic infections including Pneumocystis pneumonia (PCP) [see Warnings and Precautions (5.3)], primary and reactivated cytomegalovirus (CMV), and reactivation of hepatitis B infections including some cases with fatal outcomes. Pulmonary disorders: Interstitial pneumonitis, pneumonitis, alveolitis, and pulmonary fibrosis. Endocrine disorders: Diabetes insipidus

Drug Interactions

Valproic acid: decreases oral clearance of temozolomide. (7.1) 7.1 Valproic Acid Administration of valproic acid decreases oral clearance of temozolomide by about 5%. The clinical implication of this effect is not known [see Clinical Pharmacology (12.3)].

Use In Specific Populations

Nursing mothers: Not recommended. (8.3) Pediatric use: No established use. (8.4) Hepatic/Renal Impairment: Caution should be exercised when Temozolomide is administered to patients with severe renal or hepatic impairment. (8.6, 8.7) 8.1 Pregnancy 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/m2) 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/m2) 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. 8.3 Nursing Mothers 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. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. Temozolomide Capsules have been studied in 2 open-label studies in pediatric patients (aged 3-18 years) at a dose of 160 to 200 mg/m2 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%) No. (%) of Temozolomide Patients (N = 122)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. Body System/Organ Class Adverse Reaction All Reactions Grade 3/4 Subjects Reporting an AE 107 (88) 69 (57) Body as a Whole Central and Peripheral Nervous System Central cerebral CNS cortex 22 (18) 13 (11) Gastrointestinal System Nausea 56 (46) 5 (4) Vomiting 62 (51) 4 (3) Platelet, Bleeding and Clotting Thrombocytopenia 71 (58) 31 (25) Red Blood Cell Disorders Decreased Hemoglobin 62 (51) 7 (6) White Cell and RES Disorders Decreased WBC 71 (58) 21 (17) Lymphopenia 73 (60) 48 (39) Neutropenia 62 (51) 24 (20) 8.5 Geriatric Use 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) 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). 8.6 Renal Impairment Caution should be exercised when Temozolomide is administered to patients with severe renal impairment [see Clinical Pharmacology (12.3)]. 8.7 Hepatic Impairment Caution should be exercised when Temozolomide is administered to patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].

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