Thiotepa Riemser (Thiotepa) 15 mg
Alkylating agent for conditioning before hematopoietic stem cell transplantation
Thiotepa Riemser is a potent alkylating chemotherapy medicine containing the active substance thiotepa. Supplied as a 15 mg lyophilized powder for concentrate for solution for infusion, it is used exclusively in a hospital setting as part of conditioning regimens before hematopoietic stem cell transplantation (HSCT). Thiotepa Riemser works by destroying bone marrow cells, enabling the body to accept transplanted stem cells that will produce healthy new blood cells. It is approved for use in both adults and children.
Quick Facts
Key Takeaways
- Thiotepa Riemser 15 mg is an alkylating agent used exclusively as conditioning treatment before hematopoietic stem cell transplantation (HSCT) in both adults and children.
- It is administered as an intravenous infusion over 2–4 hours, typically every 12 or 24 hours for up to 5 consecutive days in a specialized hospital transplant unit.
- The most serious side effects include severe myelosuppression, life-threatening infections, hepatic veno-occlusive disease, and graft-versus-host disease.
- Thiotepa can impair fertility in both men and women – sperm banking and fertility counseling should be discussed before treatment begins.
- This medication must never be used during pregnancy or breastfeeding, and live vaccines are contraindicated during and after treatment.
What Is Thiotepa Riemser and What Is It Used For?
Thiotepa Riemser belongs to a group of chemotherapy medicines known as alkylating agents (ATC code L01AC01). These drugs work by forming covalent bonds with DNA molecules inside cells, creating cross-links between DNA strands that prevent the cell from dividing and ultimately lead to cell death. In the context of stem cell transplantation, this cytotoxic effect is deliberately used to ablate (destroy) the patient's existing bone marrow, clearing space for the transplanted donor or autologous stem cells.
The primary clinical use of Thiotepa Riemser is as a conditioning agent prior to hematopoietic stem cell transplantation (HSCT). Conditioning is a critical preparatory phase during which high-dose chemotherapy – often combined with other agents such as busulfan, cyclophosphamide, or melphalan – is administered to achieve two key goals: myeloablation (destruction of the existing bone marrow) and immunosuppression (suppression of the immune system to prevent rejection of transplanted cells).
Thiotepa has a unique pharmacological advantage in its ability to cross the blood-brain barrier, making it particularly valuable in conditioning regimens for patients with central nervous system (CNS) involvement, including primary CNS lymphoma and CNS tumors in both adults and children. This property distinguishes it from many other alkylating agents used in transplant conditioning and gives thiotepa a particularly important role in neuro-oncology protocols.
Thiotepa Riemser is supplied as a sterile, white lyophilized (freeze-dried) powder in glass vials containing 15 mg of thiotepa. It is reconstituted with sterile water and further diluted in sodium chloride solution before administration as a slow intravenous infusion. Because of its potent cytotoxic action, preparation and administration must always be performed by trained healthcare professionals using appropriate safety equipment within a specialized transplant center.
Approved Indications
Thiotepa Riemser is approved for use in conditioning regimens before both autologous HSCT (using the patient's own stem cells) and allogeneic HSCT (using donor stem cells) across a broad range of conditions:
- Hematological malignancies: Lymphoma (Hodgkin and non-Hodgkin), multiple myeloma, acute and chronic leukemia, and primary CNS lymphoma
- Solid tumors: Breast cancer, ovarian cancer, CNS tumors (including medulloblastoma and gliomas), and germ cell tumors
- Non-malignant conditions (primarily pediatric): Beta-thalassemia, sickle cell anemia, refractory cytopenia, aplastic anemia, and certain inherited metabolic and immunodeficiency disorders
Thiotepa Riemser is suitable for use in adults, adolescents, and children. The specific dosing, scheduling, and combination with other chemotherapy agents depend on the type of transplant, the underlying disease, and whether the patient is an adult or a child. All treatment is conducted under the supervision of experienced transplant physicians in specialized healthcare centers with comprehensive support services.
What Should You Know Before Receiving Thiotepa Riemser?
Before your treatment team begins administering Thiotepa Riemser, a comprehensive pre-transplant evaluation is performed. This assessment typically includes a physical examination, blood tests (complete blood count, liver and kidney function, electrolytes, infection screening), echocardiogram or other cardiac evaluation, pulmonary function tests, and imaging studies. Your medical history will be reviewed carefully, particularly any previous chemotherapy, radiation therapy, or chronic illnesses that could affect your tolerance of conditioning therapy.
Contraindications
Thiotepa Riemser should not be administered in the following situations:
- Hypersensitivity: Known allergy to thiotepa or any of the excipients in the formulation
- Pregnancy: Thiotepa is teratogenic and embryotoxic. Women who are pregnant or suspected of being pregnant must not receive this medication
- Breastfeeding: It is unknown whether thiotepa is excreted in human breast milk. Breastfeeding must be discontinued during treatment as a precaution
- Live vaccines: Vaccination with live viral or bacterial vaccines (including yellow fever vaccine) is contraindicated due to the severe immunosuppression caused by thiotepa
Warnings and Precautions
Before initiating treatment with Thiotepa Riemser, your healthcare team will carefully evaluate your overall health status. Inform your physician if you have any of the following conditions, as they may affect your treatment:
- Liver or kidney problems: Impaired hepatic or renal function may affect how the drug is metabolized and excreted, potentially increasing toxicity. Thiotepa is primarily metabolized by hepatic cytochrome P450 enzymes
- Heart or lung conditions: Pre-existing cardiac or pulmonary disease may increase the risk of treatment-related complications such as cardiac arrhythmias and pulmonary toxicity
- Seizure disorders: Patients with epilepsy or a history of seizures require careful monitoring. Those taking phenytoin or fosphenytoin should inform their doctor, as drug interactions may occur
- Previous chemotherapy or radiotherapy: Cumulative toxicity from prior cytotoxic therapy may increase the risk of organ damage during conditioning
- Active infection: Any ongoing infection should be adequately treated before starting conditioning, as the expected immunosuppression could cause it to become life-threatening
Because Thiotepa Riemser destroys bone marrow cells responsible for producing blood cells, severe myelosuppression is an expected and intended effect. Your medical team will perform regular blood tests throughout treatment to monitor blood cell counts and initiate supportive care including infection prevention, blood product transfusions, and growth factor support as needed. Profound pancytopenia typically persists until engraftment of the transplanted stem cells, which usually occurs 10–30 days after transplantation depending on the graft source.
Like many alkylating agents, thiotepa may increase the risk of developing a secondary cancer in the future, including myelodysplastic syndromes, acute leukemia, and solid tumors. This is a known class effect of cytotoxic chemotherapy. Your oncologist will discuss this risk with you as part of the informed consent process, weighing it against the significant survival benefit provided by stem cell transplantation for your underlying condition. Long-term follow-up with screening for secondary malignancies is standard practice.
Pregnancy and Breastfeeding
Thiotepa Riemser poses significant risks to reproductive health and fetal development. If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, you must inform your healthcare team before receiving this medication. Animal studies have shown that thiotepa is teratogenic and mutagenic, and human case reports confirm the risk of congenital malformations when administered during pregnancy.
- Pregnancy: Thiotepa is contraindicated during pregnancy. Pregnancy must be ruled out with a test before treatment begins. Both men and women must use effective contraception throughout treatment and for at least six months after completion
- Male fertility: Men should seek advice about sperm banking before treatment begins. Men should not father children during treatment and for one year after the end of treatment due to potential genotoxic effects on sperm
- Female fertility: Thiotepa may impair female fertility, potentially causing premature ovarian failure. Discuss fertility preservation options (such as egg or embryo freezing, or ovarian tissue cryopreservation) with your medical team before treatment begins
- Breastfeeding: Women must not breastfeed during treatment with Thiotepa Riemser, as the drug may pass into breast milk and harm the nursing infant
Driving and Operating Machinery
Certain side effects of Thiotepa Riemser – including dizziness, headache, blurred vision, fatigue, and cognitive impairment – may impair your ability to drive or operate machinery safely. If you experience any of these symptoms, refrain from driving or using machinery until they fully resolve. Discuss any concerns with your healthcare provider. During the immediate post-transplant period, patients are typically hospitalized or under close outpatient supervision and should not drive.
Children and the Elderly
Thiotepa Riemser is approved for use in both pediatric and adult populations, but dosing and supportive care requirements differ. In children, particular attention is paid to long-term effects on growth, endocrine function (thyroid, adrenal, gonadal), neurocognitive development, and fertility. In elderly patients, comorbidities and reduced organ function may require dose adjustment and more intensive supportive care. Long-term follow-up is essential for all patients after HSCT conditioning with thiotepa.
How Does Thiotepa Riemser Interact with Other Drugs?
Thiotepa is metabolized primarily by the cytochrome P450 enzyme system, particularly CYP2B6 and CYP3A4. Any medication that inhibits or induces these enzymes can potentially alter the plasma concentration of thiotepa and its active metabolite TEPA (triethylenephosphoramide), which may affect both efficacy and toxicity. Because conditioning regimens for stem cell transplantation typically involve multiple chemotherapy agents, the potential for cumulative toxicity and drug interactions is an important clinical consideration that transplant physicians evaluate carefully when designing treatment protocols.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Live vaccines (e.g., yellow fever, BCG, MMR, varicella) | Risk of severe or fatal infection from live organism in immunocompromised host | Contraindicated – do not administer during or after treatment until immune reconstitution |
| Phenytoin / Fosphenytoin | Altered seizure control; potential enzyme induction affecting thiotepa levels | Close monitoring required; dose adjustment may be needed, alternative anticonvulsant may be preferred |
| Other alkylating agents (cyclophosphamide, busulfan, melphalan) | Additive myelosuppression, mucositis, and organ toxicity | Expected in conditioning regimens; doses carefully calculated with pharmacokinetic monitoring where available |
| CYP2B6 / CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) | Increased thiotepa plasma concentration; reduced conversion to active metabolite TEPA | May alter efficacy/toxicity balance; inform your medical team before starting or stopping |
| CYP2B6 / CYP3A4 inducers (e.g., rifampicin, carbamazepine, St John's Wort) | Accelerated metabolism of thiotepa, potentially reducing efficacy | Avoid where possible; if necessary, close clinical monitoring required |
| Nephrotoxic drugs (aminoglycosides, amphotericin B, platinum compounds) | Additive risk of kidney toxicity | Monitor renal function closely; dose adjustment may be needed |
Minor Interactions and Clinical Considerations
While the interactions listed above are the most clinically significant, patients should always provide a complete medication history to their healthcare team. This includes prescription medications, over-the-counter drugs, herbal supplements (such as St John's Wort, which can induce drug metabolism), and vitamins. Because thiotepa is exclusively administered in a hospital setting under close medical supervision, the transplant team will carefully review all concomitant medications and make necessary adjustments to minimize interaction risks.
It is also important to note that after stem cell transplantation, patients typically receive multiple supportive medications including anti-infective prophylaxis (antibacterial, antifungal, and antiviral agents), immunosuppressants (to prevent or treat graft-versus-host disease in allogeneic transplants), growth factors (such as filgrastim), and supportive care for mucositis and nausea. All of these are managed by the transplant team with careful attention to potential interactions with thiotepa.
General anesthetics and benzodiazepines may be required for certain procedures during hospitalization and can theoretically interact with thiotepa metabolism. The transplant pharmacist plays a key role in reviewing and reconciling all medications throughout the treatment course to minimize interaction-related risks.
What Is the Correct Dosage of Thiotepa Riemser?
Thiotepa Riemser dosing is highly specialized and varies considerably depending on multiple factors including the patient's age, body surface area or weight, the type of HSCT being performed, and the underlying condition being treated. The drug is always administered in combination with other conditioning agents as part of a carefully planned protocol. The 15 mg vial strength allows precise dosing for both small and large patients when combined as needed. Doses below represent recommended ranges from international guidelines and approved European Medicines Agency (EMA) product labeling.
Adult Dosing
Autologous HSCT – Hematological Diseases
Lymphoma
125–300 mg/m²/day (3.38–8.10 mg/kg/day) as a single daily infusion for 2–4 consecutive days. Maximum cumulative dose: 900 mg/m² (24.32 mg/kg). Commonly combined with BCNU (carmustine) and etoposide in BEAM-like protocols.
CNS Lymphoma
185 mg/m²/day (5 mg/kg/day) as a single daily infusion for 2 consecutive days. Maximum cumulative dose: 370 mg/m² (10 mg/kg). Often combined with busulfan in TBC-type protocols where CNS penetration is critical.
Multiple Myeloma
150–250 mg/m²/day (4.05–6.76 mg/kg/day) as a single daily infusion for 3 consecutive days. Maximum cumulative dose: 750 mg/m² (20.27 mg/kg). Typically part of high-dose melphalan-based conditioning for tandem autologous transplant.
Autologous HSCT – Solid Tumors
Breast Cancer
120–250 mg/m²/day (3.24–6.76 mg/kg/day) as a single daily infusion for 3–5 consecutive days. Maximum cumulative dose: 800 mg/m² (21.62 mg/kg). Historically used in high-dose conditioning for metastatic breast cancer.
CNS Tumors
125–250 mg/m²/day (3.38–6.76 mg/kg/day) in one or two daily infusions for 3–4 consecutive days. Maximum cumulative dose: 750 mg/m² (20.27 mg/kg). Used in medulloblastoma and other malignant CNS tumors due to blood-brain barrier penetration.
Ovarian Cancer
250 mg/m²/day (6.76 mg/kg/day) as a single infusion for 2 consecutive days. Maximum cumulative dose: 500 mg/m² (13.51 mg/kg).
Germ Cell Tumors
150–250 mg/m²/day (4.05–6.76 mg/kg/day) as a single daily infusion for 3 consecutive days. Maximum cumulative dose: 750 mg/m² (20.27 mg/kg). Used as salvage therapy for refractory disease in TI-CE or CE regimens.
Allogeneic HSCT – Hematological Diseases
Lymphoma
370 mg/m²/day (10 mg/kg/day) divided into two daily infusions. Maximum cumulative dose: 370 mg/m² (10 mg/kg).
Leukemia (Acute & Chronic)
185–481 mg/m²/day (5–13 mg/kg/day) in one or two daily infusions for 1–2 consecutive days. Maximum cumulative dose: 555 mg/m² (15 mg/kg).
Multiple Myeloma
185 mg/m²/day (5 mg/kg/day) as a single daily infusion. Maximum cumulative dose: 185 mg/m² (5 mg/kg).
Thalassemia
370 mg/m²/day (10 mg/kg/day) divided into two daily infusions. Maximum cumulative dose: 370 mg/m² (10 mg/kg).
Pediatric Dosing
Pediatric dosing is weight-based and depends on the type of transplant and underlying disease. Thiotepa is particularly valuable in pediatric transplantation because of its ability to cross the blood-brain barrier. The following are key dosage ranges:
Autologous HSCT
Solid Tumors (including CNS tumors)
150–350 mg/m²/day (6–14 mg/kg/day) as a single daily infusion for 2–3 consecutive days. Maximum cumulative dose: 1,050 mg/m² (42 mg/kg). Common in tandem transplant protocols for high-risk neuroblastoma and medulloblastoma.
Allogeneic HSCT
Leukemia
250 mg/m²/day (10 mg/kg/day) divided into two daily infusions. Maximum cumulative dose: 250 mg/m² (10 mg/kg).
Thalassemia
200–250 mg/m²/day (8–10 mg/kg/day) divided into two daily infusions. Maximum cumulative dose: 250 mg/m² (10 mg/kg).
Sickle Cell Anemia
250 mg/m²/day (10 mg/kg/day) divided into two daily infusions. Maximum cumulative dose: 250 mg/m² (10 mg/kg).
Refractory Cytopenia
125 mg/m²/day (5 mg/kg/day) as a single daily infusion for 3 consecutive days. Maximum cumulative dose: 375 mg/m² (15 mg/kg).
Genetic and Metabolic Diseases
125 mg/m²/day (5 mg/kg/day) as a single daily infusion for 2 consecutive days. Maximum cumulative dose: 250 mg/m² (10 mg/kg). Used in inherited metabolic disorders and primary immunodeficiencies.
How Thiotepa Riemser Is Administered
Thiotepa Riemser is supplied as a white lyophilized (freeze-dried) powder in a glass vial containing 15 mg of thiotepa. Before administration, the powder must be reconstituted with 1.5 mL of sterile water for injection to produce a concentrate of 10 mg/mL. This concentrate is then further diluted in 500 mL of 0.9% sodium chloride solution (or 1,000 mL if the dose exceeds 500 mg) to achieve a final concentration between 0.5 and 1 mg/mL for administration.
The diluted solution is administered as an intravenous infusion over 2–4 hours at room temperature using an infusion set equipped with a 0.2 μm in-line filter. The indwelling central venous catheter is flushed with approximately 5 mL of 0.9% sodium chloride solution before and after each infusion to ensure the complete dose is delivered and to prevent extravasation. Each infusion is given every 12 or 24 hours, and the course of treatment may last up to 5 days depending on the protocol.
Preparation of Thiotepa Riemser must be performed aseptically by trained pharmacy staff under a laminar airflow cytotoxic safety cabinet. Personal protective equipment including chemotherapy-rated gloves, gown, and eye protection is mandatory. Patients receive premedication to reduce nausea and vomiting, and are monitored throughout the infusion for signs of hypersensitivity or cardiac effects.
Missed Dose
Because Thiotepa Riemser is administered in a carefully scheduled protocol within an inpatient or specialized outpatient setting, missed doses are uncommon. If a planned dose cannot be given at the scheduled time due to clinical instability or other reasons, the transplant team will determine the appropriate action – which may involve delay, dose modification, or rescheduling – based on the specific protocol requirements and the patient's condition. Patients do not self-administer this medication.
Overdose
There is no specific antidote for thiotepa overdose. In the event of overdose, the primary concern is profound myelosuppression with potential life-threatening pancytopenia, as well as severe organ toxicity affecting the liver, kidneys, gastrointestinal tract, and central nervous system. Treatment would be supportive, focusing on blood product transfusions, infection management, electrolyte correction, and organ support. Any suspected overdose should be managed by the experienced transplant team in an intensive care setting. Hemodialysis is not typically effective because of thiotepa's extensive tissue distribution.
What Are the Side Effects of Thiotepa Riemser?
Like all chemotherapy medicines, Thiotepa Riemser can cause side effects, though not everyone experiences all of them. Many side effects are expected consequences of the drug's mechanism of action and the transplantation process itself. Your medical team will closely monitor you throughout treatment and provide supportive care to manage these effects. The side effects are categorized below by frequency according to international reporting standards (MedDRA frequency conventions).
Very Common
- Increased susceptibility to infections and sepsis (blood poisoning)
- Decreased white blood cells, platelets, and red blood cells (anemia)
- Graft-versus-host disease (transplanted cells attack the body)
- Dizziness, headache, blurred vision, seizures
- Tingling, numbness, or pins-and-needles sensation (paresthesia)
- Cardiac arrest, arrhythmia (abnormal heart rhythm)
- Nausea, vomiting, diarrhea, loss of appetite
- Mucositis (inflammation of mouth and digestive tract lining)
- Skin rash, itching, skin peeling, redness, hair loss
- Back pain, abdominal pain, muscle and joint pain
- Lung tissue inflammation, enlarged liver
- Hepatic veno-occlusive disease (blockage of liver veins), jaundice
- Elevated liver, kidney, and digestive enzymes
- High blood sugar, electrolyte imbalances, weight gain
- Fever, general weakness, chills, bleeding, nosebleeds
- Edema (generalized swelling), eye infection (conjunctivitis)
- Hearing impairment, high blood pressure, lymphatic obstruction
- Decreased sperm count, vaginal bleeding, absent menstruation
- Memory loss, confusion, delayed growth (in children)
- Insufficient thyroid hormone or testosterone production
- Pituitary gland insufficiency, bladder dysfunction
Common
- Anxiety, confusion, brain hemorrhage
- Intracranial aneurysm (abnormal bulging of a brain artery)
- Elevated creatinine levels, allergic reactions
- Blood vessel blockage (embolism), heart rhythm disturbances
- Heart failure, cardiovascular failure, oxygen deficiency
- Pulmonary edema (fluid in lungs), lung bleeding, respiratory arrest
- Blood in urine, bladder inflammation, reduced urine output
- Cataract (lens clouding), liver failure
- Cough, constipation, bowel obstruction, stomach perforation
- Bruising due to low platelets, menopausal symptoms
- Secondary cancers, male and female infertility
Uncommon
- Skin inflammation and peeling (erythrodermic psoriasis)
- Delirium, nervousness, hallucinations, agitation
- Gastrointestinal ulcers
- Myocarditis (inflammation of heart muscle)
- Cardiomyopathy (disease of heart muscle)
Frequency Not Known
- Pulmonary arterial hypertension (elevated blood pressure in lung arteries)
- Severe skin damage (extensive lesions, large blisters) – potentially life-threatening
- Leukoencephalopathy (damage to white brain matter) – potentially life-threatening
Contact your healthcare team immediately if you develop signs of infection (fever, chills, sore throat), unusual bleeding or bruising, severe abdominal pain, difficulty breathing, sudden severe headache, yellowing of skin or eyes, chest pain, palpitations, or any other new or worsening symptoms during or after treatment. Hepatic veno-occlusive disease typically presents with weight gain, tender liver enlargement, jaundice, and fluid retention – these require urgent evaluation.
It is important to remember that many of these side effects are expected as part of the conditioning and transplantation process. Your transplant team has extensive experience in managing these complications and will provide comprehensive supportive care throughout your treatment journey, including prophylactic antimicrobials, antiemetics, growth factors, nutritional support, mucositis care, and immediate access to blood products. Not all patients experience all listed side effects, and the severity and duration vary between individuals depending on age, underlying disease, and the specific conditioning regimen.
Long-term follow-up after HSCT with thiotepa conditioning includes monitoring for late effects such as endocrine dysfunction (thyroid, gonadal, growth hormone deficiency), infertility, cataracts, cardiovascular disease, pulmonary dysfunction, neurocognitive impairment, and secondary malignancies. Structured survivorship clinics provide this ongoing care over many years post-transplant.
How Should Thiotepa Riemser Be Stored?
Proper storage of Thiotepa Riemser is essential to maintain the drug's stability and ensure patient safety. As a hospital-administered medication, storage is managed by pharmacy and nursing staff according to strict cytotoxic-handling protocols. The following storage requirements apply:
- Unopened vials: Store and transport refrigerated at 2–8°C (36–46°F). Do not freeze – freezing can damage the powder structure
- Protect from light: Keep vials in the original carton until use
- After reconstitution: The reconstituted concentrate (10 mg/mL) is stable for 8 hours when stored at 2–8°C
- After dilution: The diluted infusion solution is stable for 24 hours when stored at 2–8°C, or 4 hours at room temperature (20–25°C)
- From a microbiological standpoint: The product should be used immediately after preparation; if not used immediately, in-use storage times and conditions are the responsibility of the user
- Do not use after the expiration date printed on the carton and vial label
- Keep out of sight and reach of children
Unused medicine and waste material should be disposed of in accordance with local regulations for cytotoxic waste, typically through dedicated incineration pathways. Healthcare professionals handling Thiotepa Riemser should follow standard precautions for cytotoxic agents, including the use of protective gloves (double nitrile gloves recommended), chemotherapy-rated gown, respiratory protection where appropriate, and preparation under a laminar airflow safety cabinet using strict aseptic technique. In case of accidental skin contact, the area should be washed immediately and thoroughly with soap and water. Mucous membranes should be flushed with copious amounts of water, and any exposure reported to occupational health services.
What Does Thiotepa Riemser Contain?
Thiotepa Riemser has an unusually simple formulation. The product contains only the active substance thiotepa with no additional excipients (inactive ingredients). This makes it one of the simplest pharmaceutical formulations available and reduces the risk of reactions to added ingredients.
Active Substance
- Thiotepa (N,N',N''-triethylenethiophosphoramide; CAS 52-24-4) – 15 mg per vial
Other Ingredients
None. The vial contains only thiotepa as a sterile lyophilized powder.
Available Presentations
| Presentation | Content | After Reconstitution | Packaging |
|---|---|---|---|
| 15 mg vial | 15 mg thiotepa (white lyophilized powder) | 10 mg/mL (reconstituted with 1.5 mL sterile water) | 1 clear glass vial with rubber stopper and aluminum seal per carton |
The reconstituted solution may occasionally appear slightly opalescent or contain small, fine white flakes. This is due to inherent polymerization of the thiotepa molecule and does not indicate degradation. Such solutions may still be used for further dilution in the infusion bag. However, solutions that contain visible particles after further dilution should not be administered and must be discarded.
All reconstituted and diluted solutions must be inspected visually before administration. The infusion must be delivered through an infusion set equipped with a 0.2 μm in-line filter, which does not affect the drug's potency. Thiotepa Riemser is intended for single use only – any unused portion must be discarded according to local protocols for cytotoxic waste disposal.
Marketing Authorization Holder and Manufacturer
Thiotepa Riemser is manufactured and marketed by Riemser Pharma GmbH, a European pharmaceutical company specializing in hospital-use medicines including oncology products. The product is distributed through approved hospital pharmacy channels in accordance with national and European regulations for cytotoxic medicinal products.
Frequently Asked Questions About Thiotepa Riemser
Thiotepa Riemser is used exclusively as a conditioning treatment before hematopoietic stem cell transplantation (HSCT). It works by destroying bone marrow cells, making it possible for transplanted stem cells to engraft and produce new healthy blood cells. It is used in both autologous (patient's own cells) and allogeneic (donor cells) transplants for hematological malignancies (lymphoma, leukemia, multiple myeloma), solid tumors (breast, ovarian, CNS tumors), and non-malignant conditions in children (thalassemia, sickle cell anemia, genetic diseases).
Thiotepa Riemser is given as an intravenous infusion (IV drip) over 2 to 4 hours by qualified healthcare professionals in a hospital transplant unit. The 15 mg powder is first reconstituted with 1.5 mL sterile water and then further diluted in 500–1,000 mL of 0.9% sodium chloride solution. Infusions are given every 12 or 24 hours for up to 5 consecutive days, depending on the treatment protocol and underlying condition.
The most serious side effects include severe myelosuppression (drastically reduced blood cell counts), life-threatening infections including sepsis, hepatic veno-occlusive disease (blockage of liver veins), graft-versus-host disease (in allogeneic transplants), cardiac arrest and arrhythmias, respiratory complications, and secondary cancers. Regular blood monitoring and comprehensive supportive care are essential during and after treatment.
Yes, Thiotepa Riemser is approved for use in children and adolescents. Pediatric indications include solid tumors (particularly CNS tumors such as medulloblastoma), leukemia, thalassemia, sickle cell anemia, refractory cytopenia, and certain genetic and metabolic diseases. Dosing is based on body surface area or weight and is adjusted according to the specific condition and type of transplant. Pediatric treatment is conducted by specialized pediatric transplant teams with expertise in managing the unique needs of younger patients.
Yes, thiotepa can impair fertility in both men and women. Male patients should consider sperm banking before treatment begins and should not father children during treatment or for one year after treatment ends. Effective contraception is mandatory during treatment. Female patients should discuss fertility preservation options (egg, embryo, or ovarian tissue cryopreservation) with their medical team. Women must not breastfeed during treatment. Long-term effects on endocrine function, including thyroid and gonadal function, require ongoing monitoring after transplantation.
Live vaccines are strictly contraindicated during and after treatment with Thiotepa Riemser due to the severe immunosuppression it causes. This includes vaccines for yellow fever, measles-mumps-rubella (MMR), varicella, rotavirus, and BCG. After stem cell transplantation, patients typically undergo a revaccination schedule starting several months post-transplant, once the immune system has recovered sufficiently. Your transplant team will advise you on the appropriate timing for each vaccination based on immune reconstitution and your individual protocol.
Thiotepa has the relatively unusual ability to cross the blood-brain barrier effectively, which allows it to reach therapeutic concentrations in the central nervous system. This makes it particularly valuable in conditioning regimens for CNS lymphoma, medulloblastoma, and other brain tumors where most chemotherapy agents fail to penetrate sufficiently. This property explains its central role in many pediatric neuro-oncology protocols.
References and Medical Sources
This article is based on the following peer-reviewed sources and international guidelines:
- European Medicines Agency (EMA). Thiotepa – Summary of Product Characteristics (SmPC). Accessed 2025.
- European Society for Blood and Marrow Transplantation (EBMT). The EBMT Handbook: Hematopoietic Stem Cell Transplantation and Cellular Therapies, 7th Edition, 2019.
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List, 2023.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Hematopoietic Cell Transplantation, 2025.
- Holtick U, et al. “Thiotepa-based high-dose therapy for autologous stem cell transplantation in lymphoma: a retrospective study from the EBMT.” Bone Marrow Transplantation. 2019;54(7):932–940.
- Chabannon C, et al. “Hematopoietic stem cell transplantation in its 60s: A platform for cellular therapies.” Science Translational Medicine. 2018;10(436):eaap9630.
- Bernaudin F, et al. “Long-term results of related myeloablative stem-cell transplantation to cure sickle cell disease.” Blood. 2007;110(7):2749–2756.
- British National Formulary (BNF). Thiotepa monograph. National Institute for Health and Care Excellence (NICE). Accessed 2025.
- WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD Index – L01AC01 Thiotepa. Accessed 2025.
- U.S. Food and Drug Administration (FDA). Thiotepa (Tepadina) Prescribing Information. Accessed 2025.
Medical Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians in oncology, hematology, and clinical pharmacology. All content follows the GRADE evidence framework and adheres to guidelines from the EMA, WHO, EBMT, NCCN, and FDA.
iMedic Medical Editorial Team – specialists in oncology and clinical pharmacology with expertise in hematopoietic stem cell transplantation.
iMedic Medical Review Board – independent panel ensuring accuracy, completeness, and adherence to current international evidence-based guidelines.
Published: | Last reviewed: | Evidence Level: 1A