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APO-TEMOZOLOMIDE is a brand name for Temozolomide, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ................................................................................... 3 CONTRAINDICATIONS ........................................................................................................ 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Clinical trial experience in patients treated with temozolomide capsules Newly Diagnosed Patients with Glioblastoma Multiforme Table 1 provides treatment emergent adverse events, in (causality not determined during clinical trials) patients with newly diagnosed glioblastoma multiforme during the concomitant and maintenance phases of treatment.
Table 1.
Temozolomide and radiotherapy:
Treatment-emergent events during concomitant and maintenance treatment Body System Temozolomide + concomitant radiotherapy n=288* n (%) Temozolomide maintenance therapy n=224 n (%) Total n=288 n (%) Infections and Infestations Candidiasis oral Herpes simplex Herpes zoster Infection Influenza–like symptoms Pharyngitis Wound infection 4 (1%) 4 (1%) 0 (0%) 4 (1%) 0 (0%) 2 (1%) 2 (1%) 5 (2%) 2 (1%) 3 (1%) 8 (4%) 3 (1%) 1 (<1%) 0 (0%) 7 (2%) 6 (2%) 3 (1%) 12 (4%) 3 (1%) 3 (1%) 2 (1%) Blood and the lymphatic system disorders Anemia Febrile neutropenia Leukopenia Lymphopenia Neutropenia Thrombocytopenia Petechiae 3 (1%) 2 (1%) 6 (2%) 7 (2%) 6 (2%) 11 (4%) 1 (<1%) 4 (2%) 4 (2%) 5 (2%) 2 (1%) 7 (3%) 19 (8%) 2 (1%) 6 (2%) 6 (2%) 10 (3%) 7 (2%) 10 (3%) 29 (10%) 3 (1%) Endocrine disorders Cushingoid 4 (1%) 2 (1%) 6 (2%) Metabolism and nutrition disorders Anorexia Alkaline phosphatase increased Hyperglycemia Hypokalemia Weight decreased Weight increased 56 (19%) 3 (1%) 7 (2%) 2 (1%) 5 (2%) 4 (1%) 61 (27%) 1 (<1%) 3 (1%) 1 (<1%) 7 (3%) 3 (1%) 91 (32%) 4 (1%) 9 (3%) 3 (1%) 11 (4%) 6 (2%) Page 9 of 55 Table 1.
Temozolomide and radiotherapy:
Treatment-emergent events during concomitant and maintenance treatment Body System Temozolomide + concomitant radiotherapy n=288* n (%) Temozolomide maintenance therapy n=224 n (%) Total n=288 n (%) Psychiatric disorders Agitation Amnesia Anxiety Apathy Behavior disorder Depression Emotional lability Hallucination Insomnia 2 (1%) 0 (0%) 5 (2%) 2 (1%) 2 (1%) 3 (1%) 5 (2%) 2 (1%) 14 (5%) 1 (<1%) 2 (1%) 8 (4%) 1 (<1%) 1 (<1%) 6 (3%) 7 (3%) 2 (1%) 9 (4%) 3 (1%) 2 (1%) 10 (3%) 3 (1%) 2 (1%) 8 (3%) 10 (3%) 4 (1%) 18 (6%) Nervous system disorders Aphasia Ataxia Cerebral hemorrhage Balance impaired Cognition impaired Concentration impaired Confusion Consciousness decreased Convulsions Coordination abnormal Dizziness Dysphasia Extrapyramidal disorder Gait abnormal Headache Hemiparesis Hemiplegia Hyperesthesia Hypoesthesia Memory impairment Neurological disorder (NOS) Neuropathy Paresthesia Peripheral neuropathy Sensory disturbance Somnolence Speech disorder Status epilepticus Tremor 9 (3%) 3 (1%) 2 (1%) 5 (2%) 2 (1%) 6 (2%) 11 (4%) 5 (2%) 17 (6%) 0 (0%) 12 (4%) 4 (1%) 2 (1%) 4 (1%) 56 (19%) 4 (1%) 0 (0%) 2 (1%) 2 (1%) 8 (3%) 3 (1%) 8 (3%) 6 (2%) 2 (1%) 0 (0%) 5 (2%) 6 (2%) 2 (1%) 7 (2%) 5 (2%) 3 (1%) 0 (0%) 4 (2%) 0 (0%) 6 (3%) 12 (5%) 1 (<1%) 25 (11%) 2 (1%) 12 (5%) 9 (4%) 0 (0%) 3 (1%) 51 (23%) 8 (4%) 2 (1%) 2 (1%) 1 (<1%) 16 (7%) 6 (3%) 6 (3%) 4 (2%) 4 (2%) 2 (1%) 5 (2%) 9 (4%) 0 (0%) 9 (4%) 11 (4%) 5 (2%) 2 (1%) 9 (3%) 2 (1%) 10 (3%) 22 (8%) 6 (2%) 36 (13%) 2 (1%) 22 (8%) 10 (3%) 2 (1%) 7 (2%) 87 (30%) 10 (3%) 2 (1%) 3 (1%) 3 (1%) 21 (7%) 7 (2%) 12 (4%) 7 (2%) 5 (2%) 2 (1%) 10 (3%) 14 (5%) 2 (1%) 14 (5%) Page 10 of 55 Table 1.
Serious Warnings and Precautions APO-TEMOZOLOMIDE should be prescribed by a qualified healthcare professional who is experienced in the use of antineoplastic therapy. The following are clinically significant adverse events: Myelosuppression including Neutropenia and Thrombocytopenia and prolonged pancytopenia, which may result in aplastic anemia, which in some cases has resulted in a fatal outcome (see WARNINGS AND PRECAUTIONS / Hematologic/Myelosuppression).
Hepatic injury, including fatal hepatic failure, has been reported in patients treated with temozolomide (see WARNINGS AND PRECAUTIONS / Hepatic /Biliary/Pancreatic). APO-TEMOZOLOMIDE may have to be discontinued or the dose may have to be adjusted (see DOSAGE AND ADMINISTRATION).
General The treating physician should use his discretion with respect to the use of APO-TEMOZOLOMIDE in patients with poor performance status, severe debilitating diseases or infection when the risk of treatment outweighs the potential benefit to the patient.
Drug Interactions:
Co-administration with valproic acid was associated with a small but statistically significant decrease in clearance of temozolomide. The combination of temozolomide with other chemotherapeutic agents has not been fully evaluated. Combination with other alkylating agents is likely to result in increased myelosuppression.
Gastrointestinal Antiemetic therapy:
Nausea and vomiting are very commonly associated with temozolomide, and guidelines are provided: Patients with newly diagnosed glioblastoma multiforme: – anti-emetic prophylaxis is recommended prior to the initial dose of concomitant temozolomide, – anti-emetic prophylaxis is strongly recommended during the maintenance phase.
Patients with recurrent or progressive glioma:
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Temozolomide in Canada.
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Temozolomide and radiotherapy:
Treatment-emergent events during concomitant and maintenance treatment Body System Temozolomide + concomitant radiotherapy n=288* n (%) Temozolomide maintenance therapy n=224 n (%) Total n=288 n (%) Eye disorders Diplopia Eye pain Eyes dry Hemianopia Vision blurred Vision disorder Visual acuity reduced Visual field defect 1 (<1%) 3 (1%) 1 (<1%) 2 (1%) 26 (9%) 2 (1%) 2 (1%) 4 (1%) 5 (2%) 2 (1%) 2 (1%) 1 (<1%) 17 (8%) 2 (1%) 3 (1%) 5 (2%) 6 (2%) 4 (1%) 2 (1%) 2 (1%) 33 (11%) 4 (1%) 4 (1%) 7 (2%) Ear and labyrinth disorders Deafness Earache Hearing impairment Hyperacusis Otitis media Tinnitus Vertigo 1 (<1%) 3 (1%) 8 (3%) 2 (1%) 2 (1%) 4 (1%) 1 (<1%) 2 (1%) 3 (1%) 10 (4%) 1 (<1%) 0 (0%) 4 (2%) 3 (1%) 2 (1%) 5 (2%) 13 (5%) 2 (1%) 2 (1%) 6 (2%) 3 (1%) Cardiac disorders Palpitation 2 (1%) 0 (0%) 2 (1%) Vascular disorders Deep venous thrombosis Edema Edema leg Edema peripheral Embolism pulmonary Hemorrhage Hypertension 5 (2%) 6 (2%) 6 (2%) 0 (0%) 0 (0%) 7 (2%) 2 (1%) 4 (2%) 2 (1%) 4 (2%) 3 (1%) 2 (1%) 7 (3%) 1 (<1%) 8 (3%) 8 (3%) 9 (3%) 3 (1%) 2 (1%) 13 (5%) 3 (1%) Respiratory, thoracic and mediastinal disorders Bronchitis Coughing Dyspnea Nasal congestion Pneumonia Upper respiratory infection Sinusitis 0 (0%) 15 (5%) 11 (4%) 2 (1%) 4 (1%) 4 (1%) 1 (<1%) 2 (1%) 19 (8%) 12 (5%) 1 (<1%) 2 (1%) 2 (1%) 2 (1%) 2 (1%) 26 (9%) 19 (7%) 3 (1%) 6 (2%) 6 (2%) 3 (1%) Page 11 of 55 Table 1.
Temozolomide and radiotherapy:
Treatment-emergent events during concomitant and maintenance treatment Body System Temozolomide + concomitant radiotherapy n=288* n (%) Temozolomide maintenance therapy n=224 n (%) Total n=288 n (%) Gastrointestinal disorders Abdominal distension Abdominal pain Constipation Diarrhea Dyspepsia Dysphagia Fecal incontinence Gastrointestinal disorder Gastroenteritis Hemorrhoids Mouth dry Nausea Stomatitis Vomiting 1 (<1%) 7 (2%) 53 (18%) 18 (6%) 9 (3%) 6 (2%) 0 (0%) 1 (<1%) 0 (0%) 1 (<1%) 1 (<1%) 105 (36%) 19 (7%) 57 (20%) 2 (1%) 11 (5%) 49 (22%) 23 (10%) 4 (2%) 6 (3%) 2 (1%) 2 (1%) 2 (1%) 2 (1%) 5 (2%) 110 (49%) 20 (9%) 66 (29%) 3 (1%) 15 (5%) 87 (30%) 36 (13%) 10 (3%) 9 (3%) 2 (1%) 3 (1%) 2 (1%) 3 (1%) 6 (2%) 165 (57%) 36 (13%) 106 (37%) Skin and subcutaneous tissue disorders Alopecia Dermatitis Dry skin Erythema Exfoliation dermatitis Photosensitivity reaction Pigmentation abnormal Pruritus Rash Sweating increased 199 (69%) 8 (3%) 7 (2%) 14 (5%) 4 (1%) 2 (1%) 4 (1%) 11 (4%) 56 (19%) 1 (<1%) 124 (55%) 1 (<1%) 11 (5%) 2 (1%) 0 (0%) 0 (0%) 2 (1%) 11 (5%) 29 (13%) 2 (1%) 208 (72%) 9 (3%) 17 (6%) 16 (6%) 4 (1%) 2 (1%) 5 (2%) 20 (7%) 74 (26%) 3 (1%) Musculoskeletal and connective tissue disorders Arthralgia Back pain Musculoskeletal pain Muscle weakness Myalgia Myopathy 7 (2%) 2 (1%) 2 (1%) 8 (3%) 3 (1%) 3 (1%) 14 (6%) 3 (1%) 4 (2%) 6 (3%) 7 (3%) 3 […]
Patients who have experienced severe (Grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy.
Page 5 of 55 Hematologic Myelosuppression:
Temozolomide is an alkylating antitumor drug. Severe myelosuppression can occur, and is a dose limiting side effect. Temozolomide is associated with Grade 3 and Grade 4 neutropenia and Grade 3 and Grade 4 thrombocytopenia. Prior to dosing and during treatment, proper hematologic monitoring must be performed.
APO-TEMOZOLOMIDE may have to be discontinued or the dose may have to be adjusted (see WARNINGS AND PRECAUTIONS/ Monitoring and Laboratory Tests, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION/Administration). Patients treated with temozolomide who experience myelosuppression, may experience 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. Hepatic/Biliary/Pancreatic Hepatotoxicity, including liver enzyme elevation, hyperbilirubinemia, cholestasis and hepatitis, has been observed with temozolomide use in the post-market setting (see ADVERSE REACTIONS/Post-Market Adverse Drug Reactions).
Hepatic injury, including fatal hepatic failure, has been reported in patients treated with temozolomide. Baseline liver function tests should be performed prior to treatment initiation. If abnormal, physicians should assess the benefit/risk prior to initiating temozolomide including the potential for fatal hepatic failure.
For patients on a 42 day treatment cycle liver function tests should be repeated midway during this cycle. For all patients, liver function tests should be checked after each treatment cycle. For patients with significant liver function abnormalities, physicians should assess the benefit/risk of continuing treatment.
Liver toxicity may occur several weeks or more after the last treatment with temozolomide. In the absence of formal studies in patients suffering from severe hepatic dysfunction the treating physician should use his discretion in weighing the benefits of using APO- TEMOZOLOMIDE in this patient population against the potential risks.
Additionally, hepatitis due to hepatitis B virus (HBV) reactivation, in some cases resulting in death, has been reported. Patients should be screened for HBV infection before treatment initiation. Patients with evidence of current or prior HBV infection should be monitored for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following treatment with APO-TEMOZOLOMIDE.
Therapy should be discontinued for patients with evidence of active hepatitis B infection. Infection Cases of herpes simplex encephalitis (HSE), including cases with fatal outcomes, were reported mostly in association with concomitant radiotherapy.
All patients, particularly those with previous herpes simplex infection need to be monitored for signs and symptoms of HSE during the treatment. Page 6 of 55 Renal In the absence of formal studies in patients suffering from severe renal failure the treating physician should use his discretion in weighing the benefits of using APO-TEMOZOLOMIDE in this patient population against the potential risks.
Respiratory Patients who received concomitant temozolomide and radiotherapy in a pilot trial for the prolonged 42 day schedule were shown to be at particular risk for developing Pneumocystis carinii pneumonia. Thus prophylaxis against Pneumocystis carinii pneumonia (PCP) is required for all patients receiving concomitant temozolomide and radiotherapy for the 42 day regimen (with a maximum of 49 days).
There may be a higher occurrence of PCP when temozolomide is administered during a longer dosing regimen. However, all patients receiving APO- TEMOZOLOMIDE, particularly patients receiving steroids should be observed closely for the development of PCP regardless of the regimen.
Cases of interstitial pneumonitis/pneumonitis have been reported in post-marketing experience. These events have the potential to be fatal. Sexual Function/Reproduction Male patients: […]