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Tepadina
Thiotepa
$212.00
15mg · 1 vial
BrandBranded medicine· By Adienne
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FDA boxed warningSevere myelosuppression and carcinogenicity
TEPADINA may cause severe marrow suppression, and high doses may cause marrow ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters. Hematopoietic progenitor (stem) cell transplantation (HSCT) is required to prevent potentially fatal complications of the prolonged myelosuppression after high doses of TEPADINA
TEPADINA should be considered potentially carcinogenic in humans
May cause severe marrow suppression or ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters.
Potentially carcinogenic in humans.
About Tepadina
Overview
Tepadina is a prescription medicine containing thiotepa, supplied as a powder in a vial for preparation before use. It treats adenocarcinoma of the breast or ovary, superficial papillary cancer of the bladder, and cancer-related fluid buildup in body cavities. It is also used with busulfan and cyclophosphamide before a donor stem cell transplant to reduce the risk of graft rejection in children with class 3 beta-thalassemia. Thiotepa acts as an alkylating agent, a type of medicine with activity against tumors.
What it treats
- Reducing the risk of donor stem cell graft rejection in children with class 3 beta-thalassemia, when used with high-dose busulfan and cyclophosphamide before transplantation. - Adenocarcinoma of the breast or ovary. - Controlling cancer-related fluid buildup in body cavities. - Superficial papillary carcinoma of the urinary bladder.
Safety information
Side effects
Common side effects include low white blood cell counts, anemia, low platelet counts, raised liver enzymes or bilirubin, mouth sores and inflammation, cytomegalovirus infection, bleeding, diarrhea, blood in the urine and rash. Other reported effects include nausea, vomiting, abdominal pain, loss of appetite, tiredness, weakness, hair loss and pain at the injection site. Contact a doctor promptly for signs of infection, unusual bleeding, marked weakness, blood in the urine or difficulty urinating. Tepadina can severely suppress bone marrow function, reducing blood cell counts. Regular blood tests are needed during treatment. Seek urgent medical attention for a severe allergic reaction, including hives, wheezing or throat swelling; blistering or peeling skin; or new confusion, hallucinations, marked drowsiness or seizures. Serious brain and nervous system toxicity, including fatal brain dysfunction, has occurred. Other serious risks include blockage of small blood vessels in the liver and an increased risk of developing another cancer. Heart failure, kidney failure, respiratory failure and severe skin reactions, including Stevens–Johnson syndrome and toxic epidermal necrolysis, have also been reported after use in stem cell transplant preparation. The frequency of these reports and their relationship to Tepadina cannot always be established.
FDA boxed warning
Severe myelosuppression and carcinogenicity
TEPADINA may cause severe marrow suppression, and high doses may cause marrow ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters. Hematopoietic progenitor (stem) cell transplantation (HSCT) is required to prevent potentially fatal complications of the prolonged myelosuppression after high doses of TEPADINA
TEPADINA should be considered potentially carcinogenic in humans
May cause severe marrow suppression or ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters.
Potentially carcinogenic in humans.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not use Tepadina if you have a history of a severe allergic reaction to thiotepa. Live or attenuated vaccines must not be given during treatment or until its immune-suppressing effects have resolved. Conditions requiring particular caution include: • Bone marrow suppression, especially after previous chemotherapy or radiation. Tepadina can severely reduce blood cell counts, increasing the risk of infection, bleeding and anemia. Regular blood counts are required. A stem cell donor must be available before starting the preparative regimen for class 3 beta-thalassemia. • Moderate or severe kidney or liver impairment, which requires closer and extended monitoring for toxicity. • High-dose treatment, which can cause serious skin reactions and severe nervous system toxicity, including potentially fatal brain dysfunction. High-dose treatment with busulfan and cyclophosphamide can also cause blockage of small blood vessels in the liver. • Pregnancy or plans to conceive. Tepadina can harm an unborn baby. Pregnancy status should be checked before treatment. Women who could become pregnant should use highly effective contraception during treatment and for 6 months afterward. Men with partners who could become pregnant should use effective contraception during treatment and for 1 year afterward. Report pregnancy immediately. • Breastfeeding: do not breastfeed during treatment. Tepadina may impair fertility in women and men. Men should discuss sperm preservation before treatment. It also increases the risk of developing another cancer. Safety and effectiveness have not been established in newborns, in children treated for the cancers listed in this label, or in older adults receiving the transplant preparative regimen for class 3 beta-thalassemia. Evidence in adults aged 65 and over treated for those cancers is limited.
Interactions
Tepadina (thiotepa) should not be used with strong CYP3A4 inhibitors, such as itraconazole, clarithromycin or ritonavir, or strong CYP3A4 inducers, such as rifampin or phenytoin. These medicines may affect how well Tepadina works and its toxicity. Your doctor may consider alternatives; if combined use cannot be avoided, close monitoring for side effects is needed. Tepadina may increase exposure to medicines broken down by the enzyme CYP2B6, although the clinical importance of this interaction is unknown. Thiotepa can reduce the conversion of cyclophosphamide into its active form, potentially reducing cyclophosphamide’s effectiveness. The order in which these medicines are given affects this interaction, so your treating team should coordinate their administration.
Using Tepadina
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label TEPADINA (THIOTEPA) INJECTION, POWDER, FOR SOLUTION TEPADINA (THIOTEPA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC] (DailyMed, retrieved 19 September 2026).
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