Thiotepa Side Effects Center

Last updated on RxList: 1/4/2022
Thiotepa Side Effects Center

What Is Thiotepa?

Thiotepa injection is a cancer (antineoplastic) medication used in the treatment of cancers of the breast, ovary, bladder, and others.

What Are Side Effects of Thiotepa?

Common side effects of Thiotepa include:

  • fatigue
  • weakness
  • nausea
  • vomiting
  • stomach pain
  • loss of appetite
  • redness or inflammation of the eyes
  • puffy eyelids
  • dizziness
  • headache
  • blurred vision
  • temporary hair loss
  • skin discoloration
  • rash or itching
  • injection site pain, or
  • decreased menstruation/missed menstrual periods in women and decreased sperm production in men.

Dosage for Thiotepa

Dosage of Thiotepa is individualized. Consult your doctor.

What Drugs, Substances, or Supplements Interact with Thiotepa?

Thiotepa may interact with “live” vaccines and other drugs. Tell your doctor all medications and supplements you use and all vaccines you have recently received.

Thiotepa During Pregnancy and Breastfeeding

Thiotepa is not recommended for use during pregnancy. It is harmful to a fetus. Men and women should talk to their doctors about using birth control during treatment with thiotepa. It is unknown if thiotepa passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Thiotepa 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.


Skin Cancer Symptoms, Types, Images See Slideshow
Thiotepa 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 Thiotepa (Thiotepa Injection)

Thiotepa Professional Information


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

  • Myelosuppression [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.

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.

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.


Effect Of Cytochrome CYP3A Inhibitors And Inducers

In vitro studies suggest that thiotepa is metabolized by CYP3A4 and CYP2B6 to its active metabolite TEPA. Avoid coadministration of strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ritonavir) and strong CYP3A4 inducers (e.g., rifampin, phenytoin) with thiotepa due to the potential effects on efficacy and toxicity [see CLINICAL PHARMACOLOGY]. Consider alternative medications with no or minimal potential to inhibit or induce CYP3A4. If concomitant use of strong CYP3A4 modulators cannot be avoided, closely monitor for adverse drug reactions.

Effect Of Thiotepa On Cytochrome CYP2B6 Substrates

In vitro studies suggest that thiotepa inhibits CYP2B6. Thiotepa may increase the exposure of drugs that are substrates of CYP2B6 in patients; however, the clinical relevance of this in vitro interaction is unknown [see CLINICAL PHARMACOLOGY]. The administration of thiotepa with cyclophosphamide in patients reduces the conversion of cyclophosphamide to the active metabolite, 4-hydroxycyclophosphamide; the effect appears sequence dependent with a greater reduction in the conversion to 4- hydroxycyclophosphamide when thiotepa is administered 1.5 hours prior to the intravenous administration of cyclophosphamide compared to administration of thiotepa after intravenous cyclophosphamide [see CLINICAL PHARMACOLOGY]. The reduction in 4-hydroxycyclophosphamide levels may potentially reduce efficacy of cyclophosphamide treatment.

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

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

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