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adverse reactions
6. ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Myelosuppression [see Warnings and Precautions ( 5.1 )]. • Myelodysplastic Syndrome and Secondary Malignancies [see Warnings and Precautions ( 5.2 )]. • Pneumocystis Pneumonia [see Warnings and Precautions ( 5.3 )]. • Hepatotoxicity [see Warnings and Precautions ( 5.4 )]. The most common adverse reactions (≥ 20% incidence) are: alopecia, fatigue, nausea, vomiting, headache, constipation, anorexia, and convulsions. ( 6.1 ) The most common Grade 3 to 4 hematologic laboratory abnormalities (≥ 10% incidence) in patients with anaplastic astrocytoma are: decreased lymphocytes, decreased platelets, decreased neutrophils, and decreased leukocytes.( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories LLC at 1-877-ASC-RX01 (877-272-7901) 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 The safety of TEMOZOLOMIDE was evaluated in Study MK-7365-051 [see Clinical Studies ( 14.1 )]. 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%). The most common adverse reactions (≥20%) across the cumulative TEMOZOLOMIDE experience were alopecia, fatigue, nausea, and vomiting. Table 3 summarizes the adverse reactions in Newly Diagnosed Glioblastoma Trial. Overall, the pattern of reactions during the maintenance phase was consistent with the known safety profile of TEMOZOLOMIDE. TABLE 3: Adverse Reactions (≥5%) in Patients Receiving TEMOZOLOMIDE in Newly Diagnosed Glioblastoma Trial Adverse Reactions Concomitant Phase Maintenance Phase Radiation Therapy and TEMOZOLAMIDE N=288* Radiation Therapy Alone N=285 TEMOZOLOMIDE N=224 All Grades (%) Grade ≥3 (%) All Grades (%) Grade ≥3 (%) All Grades (%) Grade ≥3 (%) Skin and Subcutaneous Tissue Alopecia 69 63 55 Rash 19 1 15 13 1 Dry Skin 2 2 5 <1 Pruritus 4 1 5 Erythema 5 5 1 General Fatigue 54 7 49 5 61 9 Anorexia 19 1 9 <1 27 1 Headache 19 2 17 4 23 4 Weakness 3 2 3 1 7 2 Dizziness 4 1 4 5 Gastrointestinal System Nausea 36 1 16 <1 49 1 Vomiting 20 <1 6 <1 29 2 Constipation 18 1 6 22 Diarrhea 6 3 10 1 Stomatitis 7 5 <1 9 1 Abdominal Pain 2 <1 1 5 <1 Eye Vision Blurred 9 1 9 1 8 Injury Radiation Injury NOS 7 4 <1 2 Central and Peripheral Nervous System Convulsions 6 3 7 3 11 3 Memory Impairment 3 <1 4 <1 7 1 Confusion 4 1 4 2 5 2 Special Senses Other Taste Perversion 6 2 5 Respiratory System Coughing 5 1 1 8 <1 Dyspnea 4 2 3 1 5 <1 Psychiatric Insomnia 5 3 <1 4 Immune System Allergic Reaction 5 2 <1 3 Platelet, Bleeding and Clotting Thrombocytopenia 4 3 1 8 4 Musculoskeletal System Arthralgia 2 <1 1 6 *One patient who was randomized to radiation therapy only arm received radiation therapy and TEMOZOLOMIDE. NOS=not otherwise specified. Note : Grade 5 (fatal) adverse reactions are included in the Grade ≥3 column. When laboratory abnormalities and adverse reactions were combined, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic reactions were observed in 8% of patients, and Grade 3 or Grade 4 platelet abnormalities including thrombocytopenic reactions, were observed in 14% of patients. Refractory Anaplastic Astrocytoma The safety of TEMOZOLOMIDE was evaluated in Study MK-7365-006 [see Clinical Studies ( 14.2 )]. 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. The most common adverse reactions (≥20%) were nausea, vomiting, headache, fatigue, constipation, and convulsions. Tables 4 and 5 summarize the adverse reactions and hematological laboratory abnormalities in Refractory Anaplastic Astrocytoma Trial. TABLE 4: Adverse Reactions (≥5%) in Patients Receiving TEMOZOLOMIDE in Refractory Anaplastic Astrocytoma Trial Adverse Reactions TEMOZOLOMIDE N=158 All Reactions (%) Grades 3-4 (%) Gastrointestinal System Nausea 53 10 Vomiting 42 6 Constipation 33 1 Diarrhea 16 2 Abdominal pain 9 1 Anorexia 9 1 General Headache 41 6 Fatigue 34 4 Asthenia 13 6 Fever 13 2 Back pain 8 3 Central and Peripheral Nervous System Convulsions 23 5 Hemiparesis 18 6 Dizziness 12 1 Coordination abnormal 11 1 Amnesia 10 4 Insomnia 10 Paresthesia 9 1 Somnolence 9 3 Paresis 8 3 Urinary incontinence 8 2 Ataxia 8 2 Dysphasia 7 1 Convulsions local 6 Gait abnormal 6 1 Confusion 5 Cardiovascular Edema peripheral 11 1 Resistance Mechanism Infection viral 11 Endocrine Adrenal hypercorticism 8 Respiratory System Upper respiratory tract infection 8 Pharyngitis 8 Sinusitis 6 Coughing 5 Skin and Appendages Rash 8 Pruritus 8 1 Urinary System Urinary tract infection 8 Micturition increased frequency 6 Psychiatric Anxiety 7 1 Depression 6 Reproductive Disorders Breast pain, female 6 Metabolic Weight increase 5 Musculoskeletal System Myalgia 5 Vision Diplopia 5 Vision abnormal* 5 *This term includes blurred vision; visual deficit; vision changes; and vision troubles. TABLE 5: Grade 3 to 4 Adverse Hematologic Laboratory Abnormalities in Refractory Anaplastic Astrocytoma Trial TEMOZOLOMIDE *,† Decreased lymphocytes 55% Decreased platelets 19% Decreased neutrophils 14% Decreased leukocytes 11% Decreased hemoglobin 4% *Change from Grade 0 to 2 at baseline to Grade 3 or 4 during treatment. †Denominator range= 142, 158 Hematological Toxicities for Advanced Gliomas: In clinical trial experience with 110 to 111 females and 169 to 174 males (depending on measurements), females experienced higher rates of Grade 4 neutropenia (ANC < 0.5 x 10 9 /L) and thrombocytopenia (< 20 x 10 9 /L) than males 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 > 70 years experienced Grade 4 neutropenia or thrombocytopenia in the first cycle, respectively. For patients ≤ 70 years, 7% (62/871) and 5.5% (48/879) experienced Grade 4 neutropenia or thrombocytopenia in the first cycle, respectively. Pancytopenia, leukopenia, and anemia also occurred. Adverse reactions with TEMOZOLOMIDE for injection Adverse reactions that were reported in 35 patients who received TEMOZOLOMIDE for injection that were not reported in patients who received TEMOZOLOMIDE capsules were pain, irritation, pruritus, warmth, swelling, and erythema at infusion site; petechiae; and hematoma. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval 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: Toxic epidermal necrolysis and Stevens-Johnson syndrome Immune System: Hypersensitivity reactions, including anaphylaxis. Erythema multiforme, which resolved after discontinuation of TEMOZOLOMIDE and, in some cases, recurred upon rechallenge. Hematopoietic: Prolonged pancytopenia, which may result in aplastic anemia and fatal outcomes. Hepatobiliary : Fatal and severe hepatotoxicity, elevation of liver enzymes, hyperbilirubinemia, cholestasis, and hepatitis Infections: Serious opportunistic infections, including some cases with fatal outcomes, with bacterial, viral (primary and reactivated), fungal, and protozoan organisms. Pulmonary: Interstitial pneumonitis, pneumonitis, alveolitis, and pulmonary fibrosis. Endocrine : Diabetes insipidus