Thiotepa Injection
Thiotepa Injection is an alkylating chemotherapy drug used before stem cell transplant in children with class 3 beta-thalassemia, and to treat breast or ovarian adenocarcinoma, fluid buildup from cancer, and superficial papillary carcinoma of the bladder.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 12 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Thiotepa Injection is an older alkylating chemotherapy drug (it damages DNA so fast-growing cells cannot divide). It has been on the market since about 1959, is available as a generic, and is given by specialist teams for breast, ovarian and superficial bladder cancers, for fluid buildup caused by cancer, and to prepare children with class 3 beta-thalassemia for a stem cell transplant. It is a tough drug, and beyond low blood counts, people most often notice mouth sores, diarrhea and rash. Its boxed warning is for severe bone marrow suppression, which can cause serious or fatal infection or bleeding, plus a possible risk of causing cancer, so blood counts are watched and fever, bleeding, skin changes or confusion should be reported promptly.
Clinical pearls
- Bathe at least twice daily through 48 hours after each dose, because thiotepa passes out through the skin.
- Itraconazole, clarithromycin, ritonavir, rifampin and phenytoin should be avoided, since they can change thiotepa’s effect and toxicity.
- Women should avoid pregnancy for 6 months after the last dose, and men need effective contraception for 1 year after.
- Live or weakened vaccines must wait until the immune effects of treatment have fully resolved.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Thiotepa can severely suppress the bone marrow, which can lead to serious or even fatal infection or bleeding. High doses can wipe out the marrow's ability to make blood cells. A stem cell transplant is then needed to prevent life-threatening complications.
Your blood counts will be monitored. The drug should also be considered potentially cancer-causing in humans. Report fever, signs of infection or unusual bleeding right away.
Patient information guide A plain-language walkthrough of Thiotepa Injection, written from its FDA label.
What Thiotepa Injection is used for
▾
Thiotepa Injection treats several conditions. The label ties these uses to Tepadina.
- Tepadina, with high-dose busulfan and cyclophosphamide, reduces the risk of graft rejection before stem cell transplant in children with class 3 beta-thalassemia.
- Tepadina treats adenocarcinoma of the breast or ovary.
- Tepadina controls fluid buildup in body cavities (serosal cavities) caused by cancer.
- Tepadina treats superficial papillary carcinoma of the urinary bladder.
How Thiotepa Injection works
▾
Thiotepa is an alkylating drug. It releases chemical groups that attach to DNA and break its bonds, including at a building block called guanine. This damages the DNA in rapidly dividing cells and keeps them from copying themselves.
Thiotepa Injection dosage
▾
Thiotepa Injection is given by healthcare professionals, and food does not apply. The route depends on the use.
- Transplant preparation: intravenous infusion through a central venous catheter over 3 hours, given twice about 12 hours apart before transplant.
- Breast or ovarian cancer: intravenous infusion, with doses 1 to 4 weeks apart.
- Fluid buildup: given into the affected body cavity at 1 to 4 week intervals.
- Bladder cancer: placed in the bladder by catheter, held about 2 hours, usually weekly for 4 weeks.
Your team adjusts the schedule using blood counts. Follow their instructions.
Dosing details from the FDA-approved label
From the Thiotepa Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Class 3 beta-thalassemia (pediatric patients, allogeneic HSCT)
- Two administrations of 5 mg/kg given by intravenous infusion approximately 12 hours apart on Day -6 before allogeneic HSCT in conjunction with high-dose busulfan and cyclophosphamide
- Infuse via a central venous catheter over 3 hours using an infusion set equipped with a 0.2 micron in-line filter
- Flush the catheter with approximately 5 mL of 0.9% Sodium Chloride Injection prior to and following each infusion; take precautions to prevent skin toxicity
- Adenocarcinoma of the breast or ovary
- 0.3 mg/kg to 0.4 mg/kg by intravenous infusion
- Doses should be given at 1 to 4 week intervals
- Initially the higher dose in the given range is commonly administered
- Maintenance dose adjusted weekly on the basis of pre-treatment control blood counts and subsequent blood counts; maintenance dosages should not be administered more frequently than weekly
- Malignant effusions
- 0.6 mg/kg to 0.8 mg/kg intracavitary
- Doses should be given at 1 to 4 week intervals
- Initially the higher dose in the given range is commonly administered
- Maintenance dose adjusted weekly on the basis of pre-treatment control blood counts and subsequent blood counts; maintenance dosages should not be administered more frequently than weekly
- Superficial papillary carcinoma of the urinary bladder
- 60 mg in 30 mL to 60 mL of 0.9% Sodium Chloride Injection into the bladder by catheter
- Solution should be retained for 2 hours
- Usual course of treatment is once a week for 4 weeks
- If the patient cannot retain 60 mL for 2 hours, the dose may be given in a volume of 30 mL; course may be repeated if necessary, but second and third courses must be given with caution since bone-marrow depression may be increased
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION The recommended dosage of TEPADINA for class 3 beta-thalassemia is two administrations of 5 mg/kg given by intravenous infusion approximately 12 hours apart on Day -6 before allogeneic HSCT in conjunction with high-dose busulfan and cyclophosphamide. (2.1) The recommended dosage of TEPADINA for treatment of adenocarcinoma of the breast or ovary is 0.3 mg/kg to 0.4 mg/kg by intravenous infusion. (2.1) The recommended dosage of TEPADINA for treatment of malignant effusions is 0.6 mg/kg to 0.8 mg/kg intracavitary. (2.1) The recommended dosage of TEPADINA for treatment of superficial papillary carcinoma of the urinary bladder is 60 mg in 30 mL to 60 mL of 0.9% Sodium Chloride Injection into the bladder by catheter. (2.1) See Full Prescribing Information for preparation and administration instructions. (2.2 , 2.3) 2.1 Recommended Dosage Class 3 Beta-Thalassemia The recommended dosage of TEPADINA in pediatric patients is two administrations of 5 mg/kg given by intravenous infusion approximately 12 hours apart on Day -6 before allogeneic HSCT in conjunction with high-dose busulfan and cyclophosphamide as outlined in Table 1. See Prescribing Information for cyclophosphamide and busulfan for information on these drugs. Table 1: Dosage Regimen For Allogeneic HSCT In Pediatric Patients With Class 3 Beta-Thalassemia Treatment Day prior to transplantation Day ‑10 Day ‑9 Day ‑8 Day ‑7 Day ‑6 Day ‑5 Day ‑4 Day ‑3 Day ‑2 Day ‑1 Day 0 Busulfan intravenous weight-based dose * ▲ ▲ ▲ ▲ TEPADINA intravenous 5 mg/kg twice ▲ Cyclophosphamide intravenous 40 mg/kg/day ▲ ▲ ▲ ▲ Stem cell Infusion ▲ *Busulfan intravenous weight-based dose: 1 mg/kg every 6 hours for patients less than 9 kg; 1.2 mg/kg every 6 hours for patients 9 kg to 16 kg; 1.1 mg/kg every 6 hours for patients 16.1 kg to 23 kg; 0.95 mg/kg every 6 hours for patients 23.1 kg to 34 kg; 0.8 mg/kg every 6 hours for patients more than 34 kg. Infuse TEPADINA via a central venous catheter over 3 hours using an infusion set equipped with a 0.2 micron in-line filter. Prior to and following each infusion, flush the catheter with approximately 5 mL of 0.9% Sodium Chloride Injection. TEPADINA is excreted through the skin of patients receiving high-dose therapy. Take precautions to prevent skin toxicity [ see Warnings and Precautions ( 5.3 ) ] .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Thiotepa Injection side effects
▾
The most common side effects reported include:
Common side effects
- Low blood counts (neutropenia, anemia, thrombocytopenia)
- Mouth sores and irritation (mucositis)
- Diarrhea
- Bleeding
- Rash
- Blood in the urine (hematuria)
- Raised liver tests
- Cytomegalovirus infection
- Low white cells, red cells and platelets
When to get medical help
- Fever, chills or other signs of infection, because thiotepa can severely lower blood counts
- Unusual bleeding or bruising
- Signs of a serious allergic reaction, such as wheezing, swelling of the throat, hives or trouble breathing
- Confusion, memory problems, seizures, severe drowsiness or hallucinations
- Skin blistering, peeling or severe skin discoloration
- Signs of liver problems, such as yellowing of the skin or eyes, or abdominal swelling and pain
- Pregnancy while on treatment or soon after
Other reported effects include nausea, vomiting, fatigue, dizziness and headache. Seek help right away for signs of infection, unusual bleeding, allergic reactions, severe skin reactions, confusion or seizures.
Thiotepa Injection warnings and precautions
▾
- Severe bone marrow suppression can cause fatal infection or bleeding. Blood counts are checked weekly during treatment and for at least 3 weeks after.
- Serious allergic reactions, including anaphylaxis, can occur.
- Skin reactions such as discoloration, itching, blistering and peeling can occur, especially in skin folds. Bathe at least twice daily through 48 hours after a dose, and change bed sheets daily.
- Liver veno-occlusive disease can occur with high doses combined with busulfan and cyclophosphamide.
- High doses can cause central nervous system toxicity, including fatal encephalopathy (brain dysfunction).
- It carries a risk of second cancers, including leukemia and myelodysplastic syndromes.
- Death has occurred after bladder administration from absorbed drug suppressing the marrow.
Thiotepa Injection interactions
▾
Several drugs can change how thiotepa works.
- Strong CYP3A4 inhibitors (itraconazole, clarithromycin, ritonavir): may affect thiotepa's effectiveness and toxicity, so they should be avoided.
- Strong CYP3A4 inducers (rifampin, phenytoin): same concern, so they should be avoided.
- Cyclophosphamide: thiotepa reduces its conversion to its active form, especially if thiotepa is given first.
- CYP2B6 substrate drugs: thiotepa may raise their levels.
- Live or attenuated vaccines: avoid until immune effects have resolved.
Interactions listed in the FDA-approved label
From the Thiotepa Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ritonavir): Thiotepa is metabolized by CYP3A4 and CYP2B6 to its active metabolite TEPA, so there are potential effects on efficacy and toxicity. Avoid co-administration; consider alternative medications with no or minimal potential to inhibit or induce CYP3A4. If concomitant use cannot be avoided, closely monitor for adverse drug reactions.
- Strong CYP3A4 inducers (e.g., rifampin, phenytoin): Thiotepa is metabolized by CYP3A4 and CYP2B6 to its active metabolite TEPA, so there are potential effects on efficacy and toxicity. Avoid co-administration; consider alternative medications with no or minimal potential to inhibit or induce CYP3A4. If concomitant use cannot be avoided, closely monitor for adverse drug reactions.
- CYP2B6 substrates: Thiotepa inhibits CYP2B6 in vitro and may increase the exposure of CYP2B6 substrate drugs; the clinical relevance is unknown.
- Cyclophosphamide: Thiotepa reduces the conversion of cyclophosphamide to its active metabolite 4-hydroxycyclophosphamide, with a greater reduction when thiotepa is given 1.5 hours prior to intravenous cyclophosphamide than after it; this may potentially reduce efficacy of cyclophosphamide treatment.
Read the label’s full interactions text
7 DRUG INTERACTIONS 7.1 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 co-administration of strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ritonavir) and strong CYP3A4 inducers (e.g., rifampin, phenytoin) with TEPADINA due to the potential effects on efficacy and toxicity [see Clinical Pharmacology ( 12.3 ) ] . 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. 7.2 Effect of TEPADINA on Cytochrome CYP2B6 Substrates In vitro studies suggest that thiotepa inhibits CYP2B6. TEPADINA 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 ( 12.3 ) ] . 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 ( 12.3 ) ] . The reduction in 4-hydroxycyclophosphamide levels may potentially reduce efficacy of cyclophosphamide treatment.
7.1 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 co-administration of strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ritonavir) and strong CYP3A4 inducers (e.g., rifampin, phenytoin) with TEPADINA due to the potential effects on efficacy and toxicity [see Clinical Pharmacology ( 12.3 ) ] .
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Thiotepa Injection
▾
- Do not use if you have a known allergy to thiotepa.
- Existing liver, kidney or bone marrow damage is probably a contraindication. It may be used at low dose with close testing if the need outweighs the risk.
- Pregnancy: it can cause fetal harm, so pregnancy status is checked first.
- Women should avoid pregnancy during treatment and for 6 months after. Men should use effective contraception during treatment and for 1 year after.
- Do not breastfeed during treatment.
- Fertility may be affected.
- Moderate to severe kidney or liver impairment calls for closer monitoring for toxicity.
- Older adults: doses are chosen cautiously, starting low.
- Safety in neonates is not established.
Thiotepa Injection overdose
▾
Overdose can severely lower white cells and platelets, leading to bleeding and infection. There is no known antidote. Transfusions of whole blood or platelets have helped, and thiotepa can be removed by dialysis.
What Thiotepa Injection does in the body
▾
Thiotepa is toxic to the blood-forming system, and this effect is dose-related. Falling white cell or platelet counts signal the need to reduce or stop the dose. The relationship between exposure and effectiveness or safety has not been characterized.
How your body processes Thiotepa Injection
▾
After intravenous infusion, thiotepa reaches its peak level near the end of the infusion. The liver breaks it down, partly through CYP3A4 and CYP2B6, into an active metabolite called TEPA. Half-life is short, roughly 1.4 to 3.7 hours in adults, and TEPA lasts longer. Less than 2% of the dose leaves unchanged in urine.
How to store Thiotepa Injection
▾
stored and transported refrigerated at 2° to 8°C (36° to 46°F). Do not freeze.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Thiotepa Injection
146 supplements and herbal products have documented interactions with Thiotepa Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 3
- Moderate · 102
- Minor · 41
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Thiotepa Injection has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Thiotepa Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Thiotepa Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is Thiotepa Injection for?
▾
How will I get it?
▾
What side effects should I expect?
▾
Why do I need to shower so often?
▾
Can I take it during pregnancy?
▾
Do my other medicines matter?
▾
Is Thiotepa Injection available over the counter?
▾
When was Thiotepa Injection first available?
▾
Who makes Thiotepa Injection?
▾
Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Thiotepa Injection on HelloPharmacist
Thiotepa Injection forms and strengths (how it comes)
Thiotepa Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Tepadina is used with high-dose busulfan and cyclophosphamide before stem cell transplant to reduce graft rejection in children with class 3 beta-thalassemia.
- Tepadina is used for adenocarcinoma of the breast or ovary.
- Tepadina is used for controlling fluid buildup in body cavities caused by cancer.
- Tepadina is used for superficial papillary carcinoma of the urinary bladder.
- Tepadina for transplant preparation is given by intravenous infusion through a central venous catheter over 3 hours.
- Tepadina for breast or ovarian cancer is given by intravenous infusion, with doses 1 to 4 weeks apart.
- Tepadina for fluid buildup is given into the body cavity, often through the same tubing used to drain the fluid.
- Tepadina for bladder cancer is placed into the bladder by catheter and held for about 2 hours, usually once weekly for 4 weeks.
Show 1 more strength Show fewer strengths
Thiotepa Injection on the U.S. market: products, makers and brands
How Thiotepa Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
9 companies list 19 Thiotepa Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 1959. Brand names on the directory include Tepadina, Thioplex, Tepylute; the rest are generics.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Compare Thiotepa Injection products
A representative set of FDA-listed product records for Thiotepa Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 15 mg | Intracavitary, Intravenous, Intravesical | Amneal Pharmaceuticals LLC | NDA | View NDC → |
| 100 mg | Intracavitary, Intravenous, Intravesical | Amneal Pharmaceuticals LLC | NDA | View NDC → |
| 200 mg | Intracavitary, Intravenous, Intravesical | Amneal Pharmaceuticals LLC | NDA | View NDC → |
| 400 mg | Intracavitary, Intravenous, Intravesical | Amneal Pharmaceuticals LLC | NDA | View NDC → |
| 15 mg | Intracavitary, Intravenous, Intravesical | Dr.Reddy's Laboratories Inc., | ANDA | View NDC → |
| 100 mg | Intracavitary, Intravenous, Intravesical | Dr.Reddy's Laboratories Inc., | ANDA | View NDC → |
| 100 mg | Intracavitary, Intravenous, Intravesical | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 15 mg | Intracavitary, Intravenous, Intravesical | Gland Pharma Limited | ANDA | View NDC → |
| 100 mg | Intracavitary, Intravenous, Intravesical | Gland Pharma Limited | ANDA | View NDC → |
| 15 mg/1.5 mL | Intracavitary, Intravenous, Intravesical | Hikma Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 100 mg | Intracavitary, Intravenous, Intravesical | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 15 mg | Intracavitary, Intravenous, Intravesical | Meitheal Pharmaceuticals Inc | ANDA | View NDC → |
| 100 mg | Intracavitary, Intravenous, Intravesical | Meitheal Pharmaceuticals Inc | ANDA | View NDC → |
| 15 mg | Intracavitary, Intravenous, Intravesical | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 100 mg | Intracavitary, Intravenous, Intravesical | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 15 mg/1.5 mL | Intracavitary, Intravenous, Intravesical | Sagent Pharmaceuticals | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Shorla Oncology Inc. × 2 listings | NDA | View NDC → |
Showing 19 of 19 products — FDA National Drug Code Directory. See every product, package size and price: browse all 19 Thiotepa Injection NDCs →
Thiotepa Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Thiotepa Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Thiotepa Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Thiotepa Injection FDA approval history
How Thiotepa Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Thiotepa Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Thiotepa recalls since July 2021.
✅No Thiotepa recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 10473 2 dose forms · 6 strengths
-
Dose form (SCDF) Injectable Solution RxCUI 375319In current FDA listingsClinical drug / strength (SCD) 10 MG/MLRxCUI 2709440 -
Dose form (SCDF) Injection RxCUI 1660003In current FDA listingsClinical drug / strength (SCD) 1.5 ML thiotepa 10 MG/MLRxCUI 270070915 MGRxCUI 1660009100 MGRxCUI 1660004200 MGRxCUI 2712232400 MGRxCUI 2734124
Look up RxCUI 10473 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Thiotepa Injection supply and shortage status
Whether Thiotepa Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Thiotepa Injection brand names
Thiotepa Injection is sold under 3 brand names in the FDA directory — Tepadina, Thioplex, Tepylute. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Thiotepa Injection: manufacturers and labelers
9 companies list Thiotepa Injection products with the FDA. By number of product records, the largest are Amneal Pharmaceuticals LLC, Hikma Pharmaceuticals USA Inc., Dr.Reddy's Laboratories Inc.,. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Thiotepa Injection drug class (RxNorm)
Thiotepa Injection belongs to the Alkylating Drug class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Thiotepa Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Amneal Pharmaceuticals LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →