Tepadina

Last reviewed on RxList: 2/18/2020
Tepadina Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Tepadina?

Tepadina (thiotepa) for injection is an alkylating drug indicated to reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia; for treatment of adenocarcinoma of the breast or ovary; for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities and for treatment of superficial papillary carcinoma of the urinary bladder. Tepadina is available in generic form.

What Are Side Effects of Tepadina?

Common side effects of Tepadina include:

Dosage for Tepadina

The recommended dose of Tepadina depends on the condition being treated.

What Drugs, Substances, or Supplements Interact with Tepadina?

Tepadina may interact with itraconazole, clarithromycin, ritonavir, rifampin, and phenytoin. Tell your doctor all medications and supplements you use.

Tepadina During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Tepadina; it may harm a fetus. It is unknown if Tepadina passes into breast milk. Because of the potential for adverse effects on a nursing infant, breastfeeding while receiving Tepadina is not recommended.

Additional Information

Our Tepadina (thiotepa) for Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Tepadina Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • sores or white patches in or around your mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;
  • confusion, hallucinations;
  • headache, drowsiness, changes in behavior or personality;
  • problems with memory, speech, or thought;
  • a seizure;
  • twitching muscles, overactive reflexes, problems with coordination or movement;
  • blood in your urine;
  • low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
  • liver problems--rapid weight gain, stomach pain and bloating, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • low blood cell counts;
  • signs of infection (fever, chills, sore throat, muscle aches);
  • blood in your urine;
  • mouth sores; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tepadina (Thiotepa for Injection)

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Tepadina Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Myelosuppression [see WARNINGS AND PRECAUTIONS]
  • Infection [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity [see WARNINGS AND PRECAUTIONS].
  • Cutaneous Toxicity [see WARNINGS AND PRECAUTIONS]
  • Hepatic Veno-Occlusive Disease [see WARNINGS AND PRECAUTIONS]
  • Central Nervous System Toxicity [see WARNINGS AND PRECAUTIONS]
  • Carcinogenicity [see WARNINGS AND PRECAUTIONS]

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.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 The Preparative Regimen For Class 3 Beta-Thalassemia

The safety of TEPADINA was evaluated by retrospective analysis of 76 pediatric patients with class 3 beta-thalassemia who underwent allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) using busulfan and cyclophosphamide with TEPADINA (n=25) or without TEPADINA (n=51) [ ]. Adverse reactions were abstracted retrospectively from the medical records. The safety of TEPADINA was evaluated by retrospective analysis of 76 pediatric patients with class 3 betathalassemia who underwent allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) using busulfan and cyclophosphamide with TEPADINA (n=25) or without TEPADINA (n=51) [ ].

Adverse reactions were abstracted retrospectively from the medical records.

Serious adverse events that occurred in the TEPADINA-treated and control cohort were, respectively: gastrointestinal hemorrhage (4% vs 2%), pneumonia (4% vs 0), seizure (4% vs 2%), subarachnoid hemorrhage (4% vs 0) and veno-occlusive disease (4% vs 2%). By 90 days after HSCT, grades 2 to 4 acute graft-versus-host disease was observed in 7 (28%) patients in the TEPADINA cohort and in 13 (26%) patients in the control cohort. By 1-year after transplantation, chronic graft-versus-host disease was observed in 8 (35%) of 23 evaluable patients in the TEPADINA cohort, and 7 (14%) of 49 evaluable patients in the control cohort.Serious adverse events that occurred in the TEPADINA-treated and control cohort were, respectively: gastrointestinal hemorrhage (4% vs 2%), pneumonia (4% vs 0), seizure (4% vs 2%), subarachnoid hemorrhage (4% vs 0) and veno-occlusive disease (4% vs 2%). By 90 days after HSCT, grades 2 to 4 acute graft-versus-host disease was observed in 7 (28%) patients in the TEPADINA cohort and in 13 (26%) patients in the control cohort. By 1-year after transplantation, chronic graft-versus-host disease was observed in 8 (35%) of 23 evaluable patients in the TEPADINA cohort, and 7 (14%) of 49 evaluable patients in the control cohort.

Adverse reactions occurring in at least 5% of patients treated with TEPADINA from start of the preparative regimen through 30 days after transplantation are shown in Table 3.Adverse reactions occurring in at least 5% of patients treated with TEPADINA from start of the preparative regimen through 30 days after transplantation are shown in Table 3.

Table 3: Common Adverse Reactions (>5%) Occurring Through 30 Days After Transplantation In Patients With Class 3 Beta-Thalassemia Using Busulfan And Cyclophosphamide With Or Without TEPADINA in the Preparative Regimen

Preparative Regimen of Busulfan and Cyclophosphamide
With TEPADINA
With TEPADINA
N=25 patients (%)
N=25 patients (%)
Without TEPADINA
Without TEPADINA
N=51 patients (%)
N=51 patients (%)
Adverse ReactionAdverse ReactionAny GradeAny GradeGrade 3-51Any GradeGrade 3-51
Mucositis216 (64%)
16 (64%)
16 (64%)
16 (64%)
4 (16%)
4 (16%)
4 (16%)
4 (16%)
22 (43%)
22 (43%)
22 (43%)
22 (43%)
1 (2%)
1 (2%)
1 (2%)
1 (2%)
Cytomegalovirus Infection
Cytomegalovirus Infection
Cytomegalovirus Infection
Cytomegalovirus Infection
12 (48%)
12 (48%)
12 (48%)
12 (48%)
0015 (29%)
15 (29%)
15 (29%)
15 (29%)
0
Hemorrhage37 (28%)
7 (28%)
7 (28%)
7 (28%)
2 (8%)
2 (8%)
2 (8%)
2 (8%)
12 (24%)
12 (24%)
12 (24%)
12 (24%)
3 (6%)
3 (6%)
3 (6%)
3 (6%)
Diarrhea6 (24%)
6 (24%)
6 (24%)
6 (24%)
07 (14%)
7 (14%)
7 (14%)
7 (14%)
2 (4%)
2 (4%)
2 (4%)
2 (4%)
Hematuria45 (20%)
5 (20%)
5 (20%)
5 (20%)
010 (20%)
10 (20%)
10 (20%)
10 (20%)
3 (6%)
3 (6%)
3 (6%)
3 (6%)
Rash53 (12%)
3 (12%)
3 (12%)
3 (12%)
011 (22%)
11 (22%)
11 (22%)
11 (22%)
0
Intracranial Hemorrhage62 (8%)
2 (8%)
2 (8%)
2 (8%)
1 (4%)
1 (4%)
1 (4%)
1 (4%)
00
Pseudomonas Infection2 (8%)
2 (8%)
2 (8%)
2 (8%)
000
Severe, life-threatening or fatal
1Severe, life-threatening or fatal
Mucositis includes mouth hemorrhage, mucosal inflammation and stomatitis
2Mucositis includes mouth hemorrhage, mucosal inflammation and stomatitis
Hemorrhage includes all hemorrhage terms
3Hemorrhage includes all hemorrhage terms Hematuria includes cystitis hemorrhagic and hematuria
4Hematuria includes cystitis hemorrhagic and hematuria
Rash includes dermatitis exfoliative, palmar erythema, rash, rash maculo-papular, rash pruritic and skin toxicity
5Rash includes dermatitis exfoliative, palmar erythema, rash, rash maculo-papular, rash pruritic and skin toxicity
6Hemorrhage Intracranial includes hemorrhage intracranial and subarachnoid hemorrhage

All patients in the TEPADINA-treated and control cohorts developed profound cytopenias, including neutropenia, anemia, thrombocytopenia. Table 4 shows the selected chemistry abnormalities that occurred from start of the preparative regimen through 30 days after transplantation.All patients in the TEPADINA-treated and control cohorts developed profound cytopenias, including neutropenia, anemia, thrombocytopenia.

Table 4 shows the selected chemistry abnormalities that occurred from start of the preparative regimen through 30 days after transplantation.

Preparative Regimen of Busulfan and Cyclophosphamide
With TEPADINA
With TEPADINA
N=25 patients (%)
Without TEPADINA
Without TEPADINA
N=51 patients (%)
Adverse ReactionAny GradeGrade 3-4Any GradeGrade 3-4
Elevated alanine aminotransferase22 (88%)
22 (88%)
22 (88%)
22 (88%)
6 (24%)
6 (24%)
6 (24%)
6 (24%)
49 (96%)
49 (96%)
49 (96%)
49 (96%)
14 (27%)
14 (27%)
14 (27%)
14 (27%)
Elevated aspartate aminotransferase20 (80%)
20 (80%)
20 (80%)
20 (80%)
4 (16%)
4 (16%)
4 (16%)
4 (16%)
45 (88%)
45 (88%)
45 (88%)
45 (88%)
9 (18%)
9 (18%)
9 (18%)
9 (18%)
Elevated total bilirubin20 (80%)
20 (80%)
20 (80%)
20 (80%)
4 (16%)
4 (16%)
4 (16%)
4 (16%)
39 (77%)
39 (77%)
2 (4%)
2 (4%)

Adverse Reactions with Treatment of adenocarcinoma of the breast, adenocarcinoma of the ovary, malignant effus ions and s uperficial 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.

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 TEPADINA in preparative regimens prior to allogeneic or autologous hematopoietic progenitor (stem) cell transplantation (HSCT) in adult and pediatric patients.

Blood and lymphatic system disorders: Febrile bone marrow aplasia.

Cardiac disorder: 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.

Infection and infestation: 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.

Read the entire FDA prescribing information for Tepadina (Thiotepa for Injection)

© Tepadina Patient Information is supplied by Cerner Multum, Inc. and Tepadina Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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