Dosing & Uses
Dosage Forms & Strengths
powder for injection
- 15mg
Bladder Cancer
Intravesical (superficial bladder cancer): 30-60 mg in 30-60 mL NS qWeek for 4 weeks; retain for 2 hours; if patient can not retain for 2 hr, dilute and use successive doses in 30 mL of sodium chloride 0.9% instead of 60 mL
Ovarian Cancer
0.3-0.4 mg/kg q1-4Weeks OR 0.2 mg/kg for 4-5 days q2-4Weeks
Effusions
Intracavitary: 0.6-0.8 mg/kg or 30-60 mg weekly
Leptomeningeal Metastases
1-10 mg/m² intrathecal in qWeek to 2 times/week as 1 mg/mL in sterile water for injection
High-dose IV Therapy for Bone Marrow Transplant
500 mg/m², up to 1,125 mg/m²
General Dosing Information
Refer to individual protocols
IM (unlabeled): 15-30 mg in various schedules
Interpericardial (unlabeled): 15-30 mg
Intratumor (unlabeled): 0.6-0.8 mg/kg q1-4Weeks
Monitor
CBC
Discontinue if WBC <3000/mm³ or platelets <150,000/mm³
Renal function
Renal Impairment
Caution; may require lower dose; limit use to cases where benefit outweigh risk
Hepatic Impairment
Caution; may require lower dose; limit use to cases where benefit outweigh risk
Other Indications & Uses
Bladder cancer, breast or ovary adenocarcinoma, Hodgkin's disease, NHL (largely superseded by other drugs)
Control of malignant pericardial/pleural/peritoneal effusions (intracavitary)
Off-label: meningeal neoplasms
Dosage Forms & Strengths
powder for injection
- 15mg
Sarcomas (Unlabeled)
25-65 mg/m² IV q3-4weeks
Hematopoietic Stem Cell Transplantation (Unlabeled)
300 mg/m qDay for 3 days (900 mg/m total) in chemotherapy combinations have been used
Bladder cancer
Intravesical (superficial bladder cancer): 30-60 mg in 30-60 mL NS qWeek for 4 weeks; retain for 2 hours; if patient can not retain for 2 hr, dilute and use successive doses in 30 mL of sodium chloride 0.9% instead of 60 mL
Ovarian cancer
0.3-0.4 mg/kg q1-4Weeks OR 0.2 mg/kg for 4-5 days q2-4Weeks
Effusions
Intracavitary: 0.6-0.8 mg/kg or 30-60 mg weekly
Leptomeningeal metastases
1-10 mg/m² intrathecal in qWeek to 2 times/week as 1 mg/mL in sterile water for injection
High-dose IV therapy for bone marrow transplant
500 mg/m², up to 1,125 mg/m²
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (7)
- adenovirus types 4 and 7 live, oral
thiotepa decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.
- deferiprone
deferiprone, thiotepa. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.
- influenza virus vaccine quadrivalent, adjuvanted
thiotepa decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- influenza virus vaccine trivalent, adjuvanted
thiotepa decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- palifermin
palifermin increases toxicity of thiotepa by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, thiotepa. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.
- tofacitinib
thiotepa, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (30)
- belatacept
belatacept and thiotepa both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- bendamustine
bendamustine, thiotepa. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- busulfan
busulfan, thiotepa. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- carmustine
carmustine, thiotepa. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- chlorambucil
chlorambucil, thiotepa. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- cholera vaccine
thiotepa decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- cisplatin
cisplatin, thiotepa. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- cyclophosphamide
cyclophosphamide, thiotepa. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- dacarbazine
dacarbazine, thiotepa. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- dengue vaccine
thiotepa decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- denosumab
thiotepa, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- eluxadoline
thiotepa increases levels of eluxadoline by affecting hepatic enzyme CYP2B6 metabolism. Use Caution/Monitor. As a precautionary measure due to incomplete information on the metabolism of eluxadoline, use caution when coadministered with strong CYP2B6 inhibitors.
- fingolimod
thiotepa increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .
- hydroxyurea
thiotepa, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Avoid combination. Combination may increase risk of myelosuppression.
- ifosfamide
ifosfamide, thiotepa. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- incobotulinumtoxinA
thiotepa increases levels of incobotulinumtoxinA by unspecified interaction mechanism. Use Caution/Monitor.
- influenza A (H5N1) vaccine
thiotepa decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.
- influenza virus vaccine (H5N1), adjuvanted
thiotepa decreases effects of influenza virus vaccine (H5N1), adjuvanted by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.
- isavuconazonium sulfate
thiotepa and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- lomustine
lomustine, thiotepa. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration with lomustine may increase the risk of immunosuppression and myelosuppression.
- mechlorethamine
mechlorethamine, thiotepa. pharmacodynamic synergism. Use Caution/Monitor. Coadministration with mechlorethamine may increase the risk of immunosuppression and myelosuppression.
- meningococcal group B vaccine
thiotepa decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.
- ofatumumab SC
ofatumumab SC, thiotepa. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- olaparib
thiotepa and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.
- siponimod
siponimod and thiotepa both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sipuleucel-T
thiotepa decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- streptozocin
streptozocin, thiotepa. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.
- trastuzumab
trastuzumab, thiotepa. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, thiotepa. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- zidovudine
thiotepa, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
Minor (2)
- vitamin A
vitamin A, thiotepa. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin A enhance the efficacy, and reduce toxicity, of antineoplastic drugs.
- vitamin E
vitamin E, thiotepa. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin E enhance the efficacy, and reduce toxicity, of antineoplastic drugs.
Adverse Effects
Frequency Not Defined
Asthenia
Fatigue
Seizures
Fever
Nausea
Vomiting
Loss of appetite
Stomatitis
Diarrhea
Myelosuppression
Leukemia
Immune hypersensitivity reaction
Oligozoospermia
Amenorrhea
Alopecia (slow)
Hyperpigmentation
Rash
Injection site pain
Warnings
Contraindications
Hypersensitivity
Hepatic, renal, bone marrow damage (maybe used in low dose if benefit>risk)
Cautions
Avoid pregnancy
May be mutagenic and teratogenic
Myelosuppression may occur
Secondary malignancies may develop (potentially carcinogenic)
Caution in hepatic impairment (may require dose reduction; use may also be contraindicated depending on type of hepatic impairment)
Caution in renal impairment (may require dose reduction; use may also be contraindicated depending on type of hepatic impairment)
Use appropriate precautions for handling and disposal
Pregnancy & Lactation
Pregnancy Category: D
Lactation: not known if excreted in breast milk, do not nurse
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Alkylating agent that produces crosslinking of DNA strands by reacting with phosphate groups to inhibit protein synthesis, DNA, and RNA
Pharmacokinetics
Half-life elimination: 2.4 hour (parent drug), 17.6 hr (metabolite)
Metabolism: Liver
Total body clearance: 446-419 mL/min
Excretion: Urine
Dialyzable: Yes
Administration
IV Incompatibilities
Additive: cisplatin
Y-site: cisplatin, filgrastim, minocycline, vinorelbine
IV Compatibilities
Solution: D5W(?), NS(?)
Y-site (partial list): acyclovir, allopurinol, ampicillin/sulbactam, bleomycin, carboplatin, clindamycin, cyclophosphamide, cytarabine, dacarbazine, dactinomycin, daunorubicin, dopamine, etoposide, etoposide phosphate, filgrastim, fluconazole, fluorouracil, gemcitabine, heparin, idarubicin, lorazepam, MgSO4, metronidazole, mitomycin, morphine, ondansetron, KCl, prochlorperazine, teniposide, tobramycin, vancomycin, vinblastine, vincristine
IV Preparation
Reconstitute in 1.5 mL SWI to 10 mg/mL which is stable for 8 hr at refrigeration; further dilution in NS, D5W, or LR should be used immediately (within 1 hr of preparation)
Standard IV dilution
- IVP: use 10 mg/mL solution
- IVPB: dose/250 mL D5W; further dilution in NS, D5W, or LR should be used immediately (within 1 hr of preparation)
- Continuous 24 hr IV infusion Dose >250 mg: QS to 50 mL (total volume) in NSDose 230-250 mg: QS to 45 mL (total volume) in NSDose 200-230 mg: QS to 40 mL (total volume) in NS
IV Administration
Administer over 1 min
Solutions should be filtered through a 0.22 micron filter prior to administration
1 mg/mL solution is considered isotonic
Storage
Store intact vials under refrigeration (2-8°C)
Protect from light
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Tepadina injection - | 15 mg vial |  | |
| Tepadina injection - | 100 mg vial |  | |
| Tepadina injection - | 15 mg vial |  | |
| Tepadina injection - | 100 mg vial |  | |
| thiotepa injection - | 15 mg vial |  | |
| thiotepa injection - | 15 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
thiotepa injection
THIOTEPA - INJECTION
(thigh-oh-TEP-uh)
COMMON BRAND NAME(S): Thioplex
WARNING: This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. A certain lab test (complete blood count) should be done while you are using this medication. Tell your doctor right away if you develop any of the following symptoms: unusual tiredness, pale skin, signs of infection (such as sore throat that doesn't go away, fever, chills), easy bruising/bleeding. See also How to Use and Side Effects sections.Although thiotepa is used to treat cancer, in some people this medication may also increase the risk of developing another form of cancer. Talk to your doctor about the risks and benefits of this medication.
USES: Thiotepa is used to treat cancer. It works by slowing or stopping the growth of cancer cells. Thiotepa is often given into the bladder to treat bladder cancer.Thiotepa is also used with other medications to prevent rejection of a stem cell transplant.
HOW TO USE: This medication is given by injection into a vein by a health care professional. Sometimes, thiotepa is injected directly into the tumor. Tell your doctor or nurse right away if you experience pain, burning, or redness at the injection site.For treatment of bladder cancer, thiotepa is usually given into the bladder through a tube (catheter). Your doctor may direct you to limit fluids for 8 to 12 hours before the medication is given. The solution is usually left in place for 2 hours and then drained out through the bladder tube. Your doctor may direct you to change positions every 15 minutes while the solution is in your bladder to make sure the solution treats all parts of your bladder.If you are using this medication to prevent rejection of a stem cell transplant, you should receive 2 doses of this medication 12 hours apart. During treatment, skin problems may occur. To reduce the risk of skin problems, shower or bathe with water and change any bandages or dressings at least twice a day until 48 hours after stopping treatment. Also, change your bed sheets daily while receiving treatment. See also Side Effects section.The dosage and how often the medication is given is based on your medical condition and response to treatment. Your doctor will do blood tests (complete blood count) to find the right dose for you. Your next dose may need to be rescheduled if your white blood cell count or platelets are too low.Learn how to handle, use, and discard chemotherapy and medical supplies safely. Consult your pharmacist. Wear gloves and wash your hands carefully after handling this drug. Avoid getting this medication in your eyes or on your skin. If the medication gets in your eye, wash the affected eye(s) well with water and contact your doctor. If the medication gets on your skin, wash the area well with soap and water.
SIDE EFFECTS: See also Warning section.Pain/redness at the injection site, dizziness, headache, blurred vision, fever, nausea, vomiting, stomach/abdominal pain, or loss of appetite may occur. Changes in diet such as eating several small meals or limiting activity may help lessen some of these effects. In some cases, drug treatment may be necessary to prevent or relieve nausea and vomiting. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Temporary hair loss is another common side effect. Normal hair growth should return after treatment has ended.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Painful sores on the lips, mouth, and throat may occur. To decrease the risk, limit hot foods and drinks, brush your teeth carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water.This medication may also cause very serious bleeding. Tell your doctor right away if any signs of serious bleeding occur, including: bloody/black/tarry stools, coughing up blood, nosebleeds that are frequent or hard to stop, dizziness/fainting, fast/irregular heartbeat, pale/gray/bluish skin, vomit that is bloody or looks like coffee grounds.Tell your doctor right away if you have any serious side effects, including: severe stomach/abdominal pain, lower back/side pain, painful/difficult urination, pink/dark urine.If you are using this medication to prevent rejection, tell your doctor right away if you have any serious side effects, including: signs of skin problems (such as changes in skin color, skin peeling/blisters), signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing of eyes/skin), mental/mood changes (such as confusion, hallucinations, changes in behavior).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using thiotepa, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially: bone marrow problems (such as low white blood cell count/platelets from previous chemotherapy/radiation treatment), kidney disease, liver disease.Thiotepa can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using thiotepa before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication can affect fertility in males. Ask your doctor for more details.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using thiotepa. Thiotepa may harm an unborn baby. Women should ask about reliable forms of birth control while using this medication and for 6 months after stopping treatment. Women should also take a pregnancy test before starting treatment. Men should ask about reliable forms of birth control while using this medication and for 1 year after stopping treatment. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: aspirin and other NSAIDs (such as ibuprofen), drugs that may harm the immune system (including chemotherapy, corticosteroids such as prednisone), live virus vaccines (such as oral polio vaccine, flu vaccine inhaled through the nose), nalidixic acid.Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, or aspirin) that may increase your risk of bleeding. Low-dose aspirin should be continued if prescribed by your doctor for heart attack or stroke prevention (usually 81-162 milligrams a day). Consult your doctor or pharmacist for more details.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Laboratory and/or medical tests (such as complete blood counts, kidney tests, liver tests) should be performed while you are being treated with the medication and for several weeks after your last dose to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised December 2021. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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