Thiotepa
Generic: THIOTEPA
Basic Information
Manufacturer
Dr.Reddy's Laboratories Inc.,
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRACAVITARY
FDA Set ID
a8c8bb14-0423-e4a3-8bf0-8a66ce05b1bb
Indications & Usage
1 INDICATIONS AND USAGE Thiotepa for injection is an alkylating drug indicated: For treatment of adenocarcinoma of the breast or ovary.
(1.2) For controlling intracavitary effusions secondaryto diffuse or localized neoplastic diseases of various serosal cavities.
(1.3) For treatmentof superficial papillary carcinoma of the urinary bladder.
(1.4) 1.2 Adenocarcinoma of the Breast or Ovary Thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary.
1.3 Malignant Effusions Thiotepa for injection is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities.
1.4 Superficial Papillary Carcinoma of the Urinary Bladder Thiotepa for injection is indicated for treatment of superficial papillary carcinoma of the urinary bladder.
Pediatric use information is approved for Adienne SA' s TEPADINA (thiotepa) for Injection.
However, due to Adienne SA's marketing exclusivity rights, the drug product is not labeled with that information.
1.2 Adenocarcinoma of the Breast or Ovary Thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary.
1.3 Malignant Effusions Thiotepa for injection is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities.
1.4 Superficial Papillary Carcinoma of the Urinary Bladder Thiotepa for injection is indicated for treatment of superficial papillary carcinoma of the urinary bladder.
Pediatric use information is approved for Adienne SA' s TEPADINA (thiotepa) for Injection.
However, due to Adienne SA's marketing exclusivity rights, the drug product is not labeled with that information.
(1.2) For controlling intracavitary effusions secondaryto diffuse or localized neoplastic diseases of various serosal cavities.
(1.3) For treatmentof superficial papillary carcinoma of the urinary bladder.
(1.4) 1.2 Adenocarcinoma of the Breast or Ovary Thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary.
1.3 Malignant Effusions Thiotepa for injection is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities.
1.4 Superficial Papillary Carcinoma of the Urinary Bladder Thiotepa for injection is indicated for treatment of superficial papillary carcinoma of the urinary bladder.
Pediatric use information is approved for Adienne SA' s TEPADINA (thiotepa) for Injection.
However, due to Adienne SA's marketing exclusivity rights, the drug product is not labeled with that information.
1.2 Adenocarcinoma of the Breast or Ovary Thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary.
1.3 Malignant Effusions Thiotepa for injection is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities.
1.4 Superficial Papillary Carcinoma of the Urinary Bladder Thiotepa for injection is indicated for treatment of superficial papillary carcinoma of the urinary bladder.
Pediatric use information is approved for Adienne SA' s TEPADINA (thiotepa) for Injection.
However, due to Adienne SA's marketing exclusivity rights, the drug product is not labeled with that information.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.1) ] Infection [see Warnings and Precautions (5.1) ] Hypersensitivity [see Warnings and Precautions (5.2)] Cutaneous Toxicity [see Warnings and Precautions (5.3) ] Hepatic Veno-Occlusive Disease [see Warnings and Precautions (5.5) ] Central Nervous System Toxicity [see Warnings and Precautions (5.6) ] Carcinogenicity [see Warnings and Precautions (5.7) ] The most common adverse reactions (incidence greater than 10%) were neutropenia, anemia, thrombocytopenia, elevated alanine aminotransferase, elevated aspartate aminotransferase, elevated bilirubin, mucositis, cytomegalovirus infection, hemorrhage, diarrhea, hematuria and rash.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 609-250-7990 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.
Adverse reactions with treatment of adenocarcinoma of the breast, adenocarcinoma of the ovary, malignant effusions and superficial papillary carcinoma of the urinary bladder Gastrointestinal: Nausea, vomiting, abdominal pain, anorexia.
General: Fatigue, weakness.
Febrile reaction and discharge from a subcutaneous lesion may occur as the result of breakdown of tumor tissue.
Hypersensitivity Reactions: Allergic reactions - rash, urticaria, laryngeal edema, asthma, anaphylactic shock, wheezing.
Local Reactions: Contact dermatitis, pain at the injection site.
Neurologic: Dizziness, headache, blurred vision.
Renal: Dysuria, urinary retention, chemical cystitis or hemorrhagic cystitis.
Reproductive: Amenorrhea, interference with spermatogenesis.
Respiratory: Prolonged apnea has been reported when succinylcholine was administered prior to surgery, following combined use of thiotepa and other anticancer agents.
It was theorized that this was caused by decrease of pseudocholinesterase activity caused by the anticancer drugs.
Skin: Dermatitis, alopecia.
Skin depigmentation has been reported following topical use.
Special Senses: Conjunctivitis.
Pediatric use information is approved for Adienne SA’s TEPADINA (thiotepa) for Injection.
However, due to Adienne SA’s marketing exclusivity rights, the drug product is not labeled with that information.
6.2 Postmarketing Experience 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 drug exposure.
The following adverse reactions have been identified during post approval use of thiotepa in preparative regimens prior to allogeneic or autologous hematopoietic progenitor (stem) cell transplantation (HSCT) in patients.
Blood and lymphatic system disorders: Febrile bone marrow aplasia.
Cardiac disorders: Bradycardia, cardiac failure congestive, cardio-respiratory arrest, pericardial effusion, pericarditis, right ventricular hypertrophy.
Congenital, familial and genetic disorders: Aplasia.
Ear and labyrinth disorders: Deafness.
Eye disorders: Blindness, eyelid ptosis, papilledema, strabismus.
Gastrointestinal disorders: Ascites, dysphagia, enterocolitis, gastritis, palatal disorder.
General disorders and administration site conditions: Device related infection, gait disturbance, malaise, multi-organ failure, pain.
Hepatobiliary disorders: Hepatomegaly.
Immune system disorders: Bone marrow transplant rejection, immunosuppression.
Infections and infestations: Acute sinusitis, bronchopulmonary aspergillosis, candida sepsis, enterococcal infection, Epstein- Barr virus infection, Escherichia sepsis, Fusarium infection, gastroenteritis, infection, lower respiratory tract infection fungal, lower respiratory tract infection viral, parainfluenza virus infection, Pneumonia legionella, relapsing fever, respiratory tract infection, sepsis, septic shock, Staphylococcal bacteremia, Staphylococcal infection, systemic candida, urinary tract infection.
Injury, poisoning and procedural complications: Refractoriness to platelet transfusion, subdural hematoma.
Investigations: Coagulation test abnormal, hemoglobin decreased, Klebsiella test positive, nuclear magnetic resonance imaging brain abnormal, transaminases increased, weight increased.
Metabolism and nutrition disorders: Hyponatremia.
Neoplasms benign, malignant and unspecified (incl.
cysts and polyps): Breast cancer metastatic, central nervous system lymphoma, leukemia recurrent, lymphoma, malignant neoplasm progression, metastatic neoplasm, post transplant lymphoproliferative disorder.
Nervous system disorders: Aphasia, brain injury, bulbar palsy, central nervous system lesion, cerebral microangiopathy, cerebral ventricle dilatation, cerebrovascular accident, cognitive disorder, convulsion, coordination abnormal, encephalitis, encephalopathy, hemiplegia, hypotonia, leukoencephalopathy, memory impairment, motor dysfunction, neurotoxicity, quadriparesis, speech disorder, tremor, VIIth nerve paralysis, white matter lesion.
Psychiatric disorders: Delirium, depression, disorientation, suicidal ideation.
Renal and urinary disorders: Renal failure, nephropathy toxic.
Respiratory, thoracic and mediastinal disorders: Acute respiratory distress, aspiration, dyspnea exertional, interstitial lung disease, lung disorder, pneumonitis, pulmonary arteriopathy, pulmonary sepsis, pulmonary veno-occlusive disease, respiratory distress, respiratory failure, pulmonary hypertension.
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome and toxic epidermal necrolysis.
Vascular disorders: Capillary leak syndrome.
Pediatric use information is approved for Adienne SA' s TEPADINA (thiotepa) for Injection.
However, due to Adienne SA's marketing exclusivity rights, the drug product is not labeled with that information.
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.
Adverse reactions with treatment of adenocarcinoma of the breast, adenocarcinoma of the ovary, malignant effusions and superficial papillary carcinoma of the urinary bladder Gastrointestinal: Nausea, vomiting, abdominal pain, anorexia.
General: Fatigue, weakness.
Febrile reaction and discharge from a subcutaneous lesion may occur as the result of breakdown of tumor tissue.
Hypersensitivity Reactions: Allergic reactions - rash, urticaria, laryngeal edema, asthma, anaphylactic shock, wheezing.
Local Reactions: Contact dermatitis, pain at the injection site.
Neurologic: Dizziness, headache, blurred vision.
Renal: Dysuria, urinary retention, chemical cystitis or hemorrhagic cystitis.
Reproductive: Amenorrhea, interference with spermatogenesis.
Respiratory: Prolonged apnea has been reported when succinylcholine was administered prior to surgery, following combined use of thiotepa and other anticancer agents.
It was theorized that this was caused by decrease of pseudocholinesterase activity caused by the anticancer drugs.
Skin: Dermatitis, alopecia.
Skin depigmentation has been reported following topical use.
Special Senses: Conjunctivitis.
Pediatric use information is approved for Adienne SA’s TEPADINA (thiotepa) for Injection.
However, due to Adienne SA’s marketing exclusivity rights, the drug product is not labeled with that information.
6.2 Postmarketing Experience 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 drug exposure.
The following adverse reactions have been identified during post approval use of thiotepa in preparative regimens prior to allogeneic or autologous hematopoietic progenitor (stem) cell transplantation (HSCT) in patients.
Blood and lymphatic system disorders: Febrile bone marrow aplasia.
Cardiac disorders: Bradycardia, cardiac failure congestive, cardio-respiratory arrest, pericardial effusion, pericarditis, right ventricular hypertrophy.
Congenital, familial and genetic disorders: Aplasia.
Ear and labyrinth disorders: Deafness.
Eye disorders: Blindness, eyelid ptosis, papilledema, strabismus.
Gastrointestinal disorders: Ascites, dysphagia, enterocolitis, gastritis, palatal disorder.
General disorders and administration site conditions: Device related infection, gait disturbance, malaise, multi-organ failure, pain.
Hepatobiliary disorders: Hepatomegaly.
Immune system disorders: Bone marrow transplant rejection, immunosuppression.
Infections and infestations: Acute sinusitis, bronchopulmonary aspergillosis, candida sepsis, enterococcal infection, Epstein- Barr virus infection, Escherichia sepsis, Fusarium infection, gastroenteritis, infection, lower respiratory tract infection fungal, lower respiratory tract infection viral, parainfluenza virus infection, Pneumonia legionella, relapsing fever, respiratory tract infection, sepsis, septic shock, Staphylococcal bacteremia, Staphylococcal infection, systemic candida, urinary tract infection.
Injury, poisoning and procedural complications: Refractoriness to platelet transfusion, subdural hematoma.
Investigations: Coagulation test abnormal, hemoglobin decreased, Klebsiella test positive, nuclear magnetic resonance imaging brain abnormal, transaminases increased, weight increased.
Metabolism and nutrition disorders: Hyponatremia.
Neoplasms benign, malignant and unspecified (incl.
cysts and polyps): Breast cancer metastatic, central nervous system lymphoma, leukemia recurrent, lymphoma, malignant neoplasm progression, metastatic neoplasm, post transplant lymphoproliferative disorder.
Nervous system disorders: Aphasia, brain injury, bulbar palsy, central nervous system lesion, cerebral microangiopathy, cerebral ventricle dilatation, cerebrovascular accident, cognitive disorder, convulsion, coordination abnormal, encephalitis, encephalopathy, hemiplegia, hypotonia, leukoencephalopathy, memory impairment, motor dysfunction, neurotoxicity, quadriparesis, speech disorder, tremor, VIIth nerve paralysis, white matter lesion.
Psychiatric disorders: Delirium, depression, disorientation, suicidal ideation.
Renal and urinary disorders: Renal failure, nephropathy toxic.
Respiratory, thoracic and mediastinal disorders: Acute respiratory distress, aspiration, dyspnea exertional, interstitial lung disease, lung disorder, pneumonitis, pulmonary arteriopathy, pulmonary sepsis, pulmonary veno-occlusive disease, respiratory distress, respiratory failure, pulmonary hypertension.
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome and toxic epidermal necrolysis.
Vascular disorders: Capillary leak syndrome.
Pediatric use information is approved for Adienne SA' s TEPADINA (thiotepa) for Injection.
However, due to Adienne SA's marketing exclusivity rights, the drug product is not labeled with that information.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 609-250-7990 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.
Adverse reactions with treatment of adenocarcinoma of the breast, adenocarcinoma of the ovary, malignant effusions and superficial papillary carcinoma of the urinary bladder Gastrointestinal: Nausea, vomiting, abdominal pain, anorexia.
General: Fatigue, weakness.
Febrile reaction and discharge from a subcutaneous lesion may occur as the result of breakdown of tumor tissue.
Hypersensitivity Reactions: Allergic reactions - rash, urticaria, laryngeal edema, asthma, anaphylactic shock, wheezing.
Local Reactions: Contact dermatitis, pain at the injection site.
Neurologic: Dizziness, headache, blurred vision.
Renal: Dysuria, urinary retention, chemical cystitis or hemorrhagic cystitis.
Reproductive: Amenorrhea, interference with spermatogenesis.
Respiratory: Prolonged apnea has been reported when succinylcholine was administered prior to surgery, following combined use of thiotepa and other anticancer agents.
It was theorized that this was caused by decrease of pseudocholinesterase activity caused by the anticancer drugs.
Skin: Dermatitis, alopecia.
Skin depigmentation has been reported following topical use.
Special Senses: Conjunctivitis.
Pediatric use information is approved for Adienne SA’s TEPADINA (thiotepa) for Injection.
However, due to Adienne SA’s marketing exclusivity rights, the drug product is not labeled with that information.
6.2 Postmarketing Experience 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 drug exposure.
The following adverse reactions have been identified during post approval use of thiotepa in preparative regimens prior to allogeneic or autologous hematopoietic progenitor (stem) cell transplantation (HSCT) in patients.
Blood and lymphatic system disorders: Febrile bone marrow aplasia.
Cardiac disorders: Bradycardia, cardiac failure congestive, cardio-respiratory arrest, pericardial effusion, pericarditis, right ventricular hypertrophy.
Congenital, familial and genetic disorders: Aplasia.
Ear and labyrinth disorders: Deafness.
Eye disorders: Blindness, eyelid ptosis, papilledema, strabismus.
Gastrointestinal disorders: Ascites, dysphagia, enterocolitis, gastritis, palatal disorder.
General disorders and administration site conditions: Device related infection, gait disturbance, malaise, multi-organ failure, pain.
Hepatobiliary disorders: Hepatomegaly.
Immune system disorders: Bone marrow transplant rejection, immunosuppression.
Infections and infestations: Acute sinusitis, bronchopulmonary aspergillosis, candida sepsis, enterococcal infection, Epstein- Barr virus infection, Escherichia sepsis, Fusarium infection, gastroenteritis, infection, lower respiratory tract infection fungal, lower respiratory tract infection viral, parainfluenza virus infection, Pneumonia legionella, relapsing fever, respiratory tract infection, sepsis, septic shock, Staphylococcal bacteremia, Staphylococcal infection, systemic candida, urinary tract infection.
Injury, poisoning and procedural complications: Refractoriness to platelet transfusion, subdural hematoma.
Investigations: Coagulation test abnormal, hemoglobin decreased, Klebsiella test positive, nuclear magnetic resonance imaging brain abnormal, transaminases increased, weight increased.
Metabolism and nutrition disorders: Hyponatremia.
Neoplasms benign, malignant and unspecified (incl.
cysts and polyps): Breast cancer metastatic, central nervous system lymphoma, leukemia recurrent, lymphoma, malignant neoplasm progression, metastatic neoplasm, post transplant lymphoproliferative disorder.
Nervous system disorders: Aphasia, brain injury, bulbar palsy, central nervous system lesion, cerebral microangiopathy, cerebral ventricle dilatation, cerebrovascular accident, cognitive disorder, convulsion, coordination abnormal, encephalitis, encephalopathy, hemiplegia, hypotonia, leukoencephalopathy, memory impairment, motor dysfunction, neurotoxicity, quadriparesis, speech disorder, tremor, VIIth nerve paralysis, white matter lesion.
Psychiatric disorders: Delirium, depression, disorientation, suicidal ideation.
Renal and urinary disorders: Renal failure, nephropathy toxic.
Respiratory, thoracic and mediastinal disorders: Acute respiratory distress, aspiration, dyspnea exertional, interstitial lung disease, lung disorder, pneumonitis, pulmonary arteriopathy, pulmonary sepsis, pulmonary veno-occlusive disease, respiratory distress, respiratory failure, pulmonary hypertension.
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome and toxic epidermal necrolysis.
Vascular disorders: Capillary leak syndrome.
Pediatric use information is approved for Adienne SA' s TEPADINA (thiotepa) for Injection.
However, due to Adienne SA's marketing exclusivity rights, the drug product is not labeled with that information.
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.
Adverse reactions with treatment of adenocarcinoma of the breast, adenocarcinoma of the ovary, malignant effusions and superficial papillary carcinoma of the urinary bladder Gastrointestinal: Nausea, vomiting, abdominal pain, anorexia.
General: Fatigue, weakness.
Febrile reaction and discharge from a subcutaneous lesion may occur as the result of breakdown of tumor tissue.
Hypersensitivity Reactions: Allergic reactions - rash, urticaria, laryngeal edema, asthma, anaphylactic shock, wheezing.
Local Reactions: Contact dermatitis, pain at the injection site.
Neurologic: Dizziness, headache, blurred vision.
Renal: Dysuria, urinary retention, chemical cystitis or hemorrhagic cystitis.
Reproductive: Amenorrhea, interference with spermatogenesis.
Respiratory: Prolonged apnea has been reported when succinylcholine was administered prior to surgery, following combined use of thiotepa and other anticancer agents.
It was theorized that this was caused by decrease of pseudocholinesterase activity caused by the anticancer drugs.
Skin: Dermatitis, alopecia.
Skin depigmentation has been reported following topical use.
Special Senses: Conjunctivitis.
Pediatric use information is approved for Adienne SA’s TEPADINA (thiotepa) for Injection.
However, due to Adienne SA’s marketing exclusivity rights, the drug product is not labeled with that information.
6.2 Postmarketing Experience 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 drug exposure.
The following adverse reactions have been identified during post approval use of thiotepa in preparative regimens prior to allogeneic or autologous hematopoietic progenitor (stem) cell transplantation (HSCT) in patients.
Blood and lymphatic system disorders: Febrile bone marrow aplasia.
Cardiac disorders: Bradycardia, cardiac failure congestive, cardio-respiratory arrest, pericardial effusion, pericarditis, right ventricular hypertrophy.
Congenital, familial and genetic disorders: Aplasia.
Ear and labyrinth disorders: Deafness.
Eye disorders: Blindness, eyelid ptosis, papilledema, strabismus.
Gastrointestinal disorders: Ascites, dysphagia, enterocolitis, gastritis, palatal disorder.
General disorders and administration site conditions: Device related infection, gait disturbance, malaise, multi-organ failure, pain.
Hepatobiliary disorders: Hepatomegaly.
Immune system disorders: Bone marrow transplant rejection, immunosuppression.
Infections and infestations: Acute sinusitis, bronchopulmonary aspergillosis, candida sepsis, enterococcal infection, Epstein- Barr virus infection, Escherichia sepsis, Fusarium infection, gastroenteritis, infection, lower respiratory tract infection fungal, lower respiratory tract infection viral, parainfluenza virus infection, Pneumonia legionella, relapsing fever, respiratory tract infection, sepsis, septic shock, Staphylococcal bacteremia, Staphylococcal infection, systemic candida, urinary tract infection.
Injury, poisoning and procedural complications: Refractoriness to platelet transfusion, subdural hematoma.
Investigations: Coagulation test abnormal, hemoglobin decreased, Klebsiella test positive, nuclear magnetic resonance imaging brain abnormal, transaminases increased, weight increased.
Metabolism and nutrition disorders: Hyponatremia.
Neoplasms benign, malignant and unspecified (incl.
cysts and polyps): Breast cancer metastatic, central nervous system lymphoma, leukemia recurrent, lymphoma, malignant neoplasm progression, metastatic neoplasm, post transplant lymphoproliferative disorder.
Nervous system disorders: Aphasia, brain injury, bulbar palsy, central nervous system lesion, cerebral microangiopathy, cerebral ventricle dilatation, cerebrovascular accident, cognitive disorder, convulsion, coordination abnormal, encephalitis, encephalopathy, hemiplegia, hypotonia, leukoencephalopathy, memory impairment, motor dysfunction, neurotoxicity, quadriparesis, speech disorder, tremor, VIIth nerve paralysis, white matter lesion.
Psychiatric disorders: Delirium, depression, disorientation, suicidal ideation.
Renal and urinary disorders: Renal failure, nephropathy toxic.
Respiratory, thoracic and mediastinal disorders: Acute respiratory distress, aspiration, dyspnea exertional, interstitial lung disease, lung disorder, pneumonitis, pulmonary arteriopathy, pulmonary sepsis, pulmonary veno-occlusive disease, respiratory distress, respiratory failure, pulmonary hypertension.
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome and toxic epidermal necrolysis.
Vascular disorders: Capillary leak syndrome.
Pediatric use information is approved for Adienne SA' s TEPADINA (thiotepa) for Injection.
However, due to Adienne SA's marketing exclusivity rights, the drug product is not labeled with that information.