Patient leaflet - Thiotepa 100 mg powder for concentrate for solution for infusion

1. WHAT THIOTEPA IS AND WHAT IT IS USED FOR

Thiotepa contains the active substance thiotepa, which belongs to a group of medicines called alkylating agents.

Thiotepa is used to prepare patients for bone marrow transplantation. It works by destroying bone marrow cells. This enables the transplantation of new bone marrow cells (haematopoietic progenitor cells), which in turn enable the body to produce healthy blood cells.

Thiotepa can be used in adults and children and adolescents.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE THIOTEPA

Do not use Thiotepa

if you are allergic to thiotepa,
if you are pregnant or think you may be pregnant,
if you are breast-feeding,
if you are receiving yellow fever vaccination, live virus and bacterial vaccines. Warning and precautions

You should tell your doctor if you have:

liver or kidney problems,
heart or lung problems,
seizures/ﬁts (epilepsy) or have had them in the past (if treated with phenytoin
or fosphenytoin).

Because Thiotepa destroys bone marrow cells responsible for producing blood cells, regular blood tests will be taken during treatment to check your blood cell counts. In order to prevent and manage infections, you will be given anti-infectives. Thiotepa may cause another type of cancer in the future. Your doctor will discuss this risk with you.

Other medicines and Thiotepa

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility

You must tell your doctor if you are pregnant or you think you may be pregnant

before you receive Thiotepa. You must not use Thiotepa during pregnancy. Both women and men using Thiotepa must use effective contraceptive methods during treatment. After cessation of treatment women must use effective contraceptive methods for at least 6 months and men for at least 3 months. It is not known whether this medicinal product is excreted in breast milk. As a precautionary measure, women must not breast-feed during treatment with Thiotepa.

Thiotepa can impair male and female fertility. Male patients should seek advise for sperm preservation before therapy is started.

Driving and using machines

It is likely that certain adverse events of thiotepa like dizziness, headache and blurred vision could affect your ability to drive and use machines. If you are affected, do not drive or use machines.

3. HOW TO USE THIOTEPA

Your doctor will calculate the dose according to your body surface or weight and your disease.

How Thiotepa is given

Thiotepa is administered by a qualiﬁed healthcare professional as an intravenous infusion (drip in a vein) after dilution of the individual vial. Each infusion will last 2-4 hours.

Frequency of administration

You will receive your infusions every 12 or 24 hours. The duration of treatment can last up to 5 days. Frequency of administration and duration of treatment depend on your disease.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Thiotepa can cause side effects, although not everybody gets them.

The most serious side effects of Thiotepa therapy or the transplant procedure may include:

decrease in circulating blood cell counts (intended effect of the medicine to prepare you for your transplant infusion)
infection
liver disorders including blocking of a liver vein
the graft attacks your body (graft versus host disease)
respiratory complications

Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.

Side effects of Thiotepa may occur with certain frequencies, which are deﬁned as follows:

Very common side effects (may affect more than 1 in 10 people)

increased susceptibility to infection
whole-body inﬂammatory state (sepsis)
decreased counts of white blood cells, platelets and red blood cells (anaemia)
the transplanted cells attack your body (graft versus host disease)
dizziness, headache, blurred vision
uncontrolled shaking of the body (convulsion)
sensation of tingling, pricking or numbness (paraesthesia)
partial loss of movement
cardiac arrest
nausea, vomiting, diarrhoea
inﬂammation of the mucosa of the mouth (mucositis)
irritated stomach, gullet, intestine
inﬂammation of the colon
anorexia, decreased appetite

Package leaﬂet: Information for the user

Thiotepa 100 mg

powder for concentrate for solution for infusion

thiotepa

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---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------cumulative dose of 370 mg/m² (10 mg/kg), during the time of the entire conditioning treatment.

MULTIPLE MYELOMA

The recommended dose is 185 mg/m²/day (5 mg/kg/day) as a single daily infusion before allogeneic HPCT, without exceeding the total maximum cumulative dose of 185 mg/m² (5 mg/kg), during the time of the entire conditioning treatment. LEUKAEMIA

The recommended dose ranges from 185 mg/m²/day (5 mg/kg/day) to 481 mg/m²/day (13 mg/kg/day) divided in one or two daily infusions, administered from 1 up to 2 consecutive days before allogeneic HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 555 mg/m² (15 mg/kg), during the time of the entire conditioning treatment.

THALASSEMIA

The recommended dose is 370 mg/m²/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mg/m² (10 mg/kg), during the time of the entire conditioning treatment.

Posology in paediatric patients

AUTOLOGOUS HPCT

Solid tumours

The recommended dose in solid tumours ranges from 150 mg/m²/day (6 mg/kg/day) to 350 mg/m²/day (14 mg/kg/day) as a single daily infusion, administered from 2 up to 3 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 1050 mg/m² (42 mg/kg), during the time of the entire conditioning treatment.

CNS TUMOURS

The recommended dose ranges from 250 mg/m²/day (10 mg/kg/day) to 350 mg/m²/day (14 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 1050 mg/m² (42 mg/kg), during the time of the entire conditioning treatment.

ALLOGENEIC HPCT

Haematological diseases

The recommended dose in haematological diseases ranges from 125 mg/m²/day (5 mg/kg/day) to 250 mg/m²/day (10 mg/kg/day) divided in one or two daily infusions, administered from 1 up to 3 consecutive days before allogeneic HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 375 mg/m² (15 mg/kg), during the time of the entire conditioning treatment.

LEUKAEMIA

The recommended dose is 250 mg/m²/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mg/m² (10 mg/kg), during the time of the entire conditioning treatment.

THALASSEMIA

The recommended dose ranges from 200 mg/m²/day (8 mg/kg/day) to 250 mg/m²/day (10 mg/kg/day) divided in two daily infusions, administered before

allogeneic HPCT without exceeding the total maximum cumulative dose of 250 mg/m² (10 mg/kg), during the time of the entire conditioning treatment. REFRACTORY CYTOPENIA

The recommended dose is 125 mg/m²/day (5 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before allogeneic HPCT, without exceeding the total maximum cumulative dose of 375 mg/m² (15 mg/kg), during the time of the entire conditioning treatment.

GENETIC DISEASES

The recommended dose is 125 mg/m²/day (5 mg/kg/day) as a single daily infusion, administered for 2 consecutive days before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mg/m² (10 mg/kg), during the time of the entire conditioning treatment.

SICKLE CELL ANAEMIA

Reconstitution

Thiotepa must be reconstituted with 10 ml of sterile water for injections. Using a syringe ﬁtted with a needle, aseptically withdraw 10 ml of sterile water for injections. Inject the content of the syringe into the vial through the rubber stopper. Remove the syringe and the needle and mix manually by repeated inversions. Only colourless solutions, without any particulate matter, must be used. Reconstituted solutions may occasionally show opalescence; such solutions can still be administered.

Further dilution in the infusion bag

The reconstituted solution is hypotonic and must be further diluted prior to administration with 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection (1000 ml if the dose is higher than 500 mg) or with an appropriate volume of sodium chloride 9 mg/ml (0.9%) in order to obtain a ﬁnal Thiotepa concentration between 0.5 and 1 mg/ml.

Administration

Thiotepa infusion solution should be inspected visually for particulate matter prior to administration. Solutions containing a precipitate should be discarded. The infusion solution must be administered to patients using an infusion set equipped with a 0.2 µm in-line ﬁlter. Filtering does not alter solution potency. Thiotepa should be aseptically administered as a 2 - 4 hours infusion under room temperature (about 25°C) and normal light conditions.

Prior to and following each infusion, the indwelling catheter line should be ﬂushed with approximately 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection.

Disposal

Thiotepa is for single use only.

Any unused product or waste material should be disposed of in accordance with local requirements.

high glucose in the blood
skin rash, itching, shedding
skin colour disorder (do not confuse with jaundice - see below)
redness of the skin (erythema)
hair loss
back and abdominal pain, pain
muscle and joint pain
abnormal electrical activity in the heart (arrhythmia)
inﬂammation of lung tissue
enlarged liver
altered organ function
blocking of a liver vein (Veno-Occlusive Disease, VOD)
yellowing of the skin and eyes (jaundice)
hearing impaired
lymphatic obstruction
high blood pressure
increased liver, renal and digestive enzymes
abnormal blood electrolytes
weight gain
fever, general weakness, chills
bleeding (haemorrhage)
nasal bleeding
general swelling due to ﬂuid retention (oedema)
pain or inﬂammation at the injection site
eye infection (conjunctivitis)
decreased sperm cell count
vaginal bleeding
absence of menstrual periods (amenorrhea)
memory loss
delaying in weight and height increase
bladder disfunction
underproduction of testosterone
insufﬁcient production of thyroid hormone
deﬁcient activity of the pituitary gland
confusional state

Common side effects (may affect up to 1 in 10 people)

anxiety, confusion
abnormal bulging outward of one of the arteries in the brain (intracranial
aneurysm)
creatinine elevated
allergic reactions
occlusion of a blood vessel (embolism)
heart rhythm disorder
heart inability
cardiovascular inability
oxygen deﬁciency
ﬂuid accumulation in the lungs (pulmonary oedema)
pulmonary bleeding
respiratory arrest
blood in the urine (haematuria) and moderate renal insufﬁciency
inﬂammation of the urinary bladder
discomfort in urination and decrease in urine output (disuria and oliguria)
increase in the amount of nitrogen components in the blood stream (BUN
increase)
cataract
inability of the liver
cerebral haemorrhage
cough
constipation and upset stomach
obstruction of the bowel
perforation of stomach
- changes in muscle tone
- gross lack of coordination of muscle movements
- bruises due to a low platelet count
- menopausal symptoms
- cancer (second primary malignancies)
- abnormal brain function
- male and female infertility

Uncommon side effects (may affect up to 1 in 100 people)

inﬂammation and exfoliation of the skin (erythrodermic psoriasis)
delirium, nervousness, hallucination, agitation
gastrointestinal ulcer
inﬂammation of the muscular tissue of the heart (myocarditis)
abnormal heart condition (cardiomyopathy)

Not known (frequency cannot be estimated from the available data)

increased blood pressure in the arteries (blood vessels) of the lungs (pulmonary arterial hypertension)
severe skin damage (e.g. severe lesions, bullae, etc.) potentially involving the full body surface which can be even life-threatening
damage to a component of the brain (the so called white matter) which can be even life-threatening (leukoencephalopathy).

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaﬂet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or AppleApp Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE THIOTEPA

Keep out of the sight and reach of children.

Do not use Thiotepa after the expiry date which is stated on the carton and vial label, after EXP. The expiry date refers to the last day of that month. Store and transport refrigerated (2°C - 8°C). Do not freeze.

Store in the original package in order to protect from light

After reconstitution the product is stable for 8 hours when stored at 2°C - 8°C. After dilution the product is stable for 24 hours when stored at 2°C - 8°C and for 4 hours when stored at 25°C. From a microbiological point of view, the product should be used immediately.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Thiotepa contains

The active substance is thiotepa. One vial contains 100 mg thiotepa. After reconstitution, each ml contains 10 mg thiotepa (10 mg/ml).
Thiotepa does not contain any other ingredients.

What Thiotepa looks like and contents of the pack

Thiotepa is a white crystalline powder supplied in a glass vial containing 100 mg thiotepa. Each carton contains 1 vial.

Marketing Authorisation Holder

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó 8, 8A e 8B, Fervença

2705-906 Terrugem SNT - Portugal

Manufacturer

Thymoorgan Pharmazie GmbH

Schiffgraben 23, 38690 Goslar - Germany

This leaﬂet was last revised in 08/2026.

Prescription needed?	Yes, prescription-only medicine (POM)
Active substance	Thiotepa
Strength	100 mg
Pharmaceutical form	Powder for solution for infusion
How is it taken	Intravenous
Excipients	None.
Is it available?	Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Shelf life	Unopened vial 24 months. After reconstitution Chemical and physical in-use stability after reconstitution has been demonstrated for 8 hours when stored at 2°C - 8°C. After dilution Chemical and physical in-use stability after dilution has been demonstrated for 24 hours when stored at 2°C - 8°C and for 4 hours when stored at 25°C. From a microbiological point of view, the product should be used immediately after dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than the above mentioned conditions when dilution has taken place in controlled and validated aseptic conditions.
Storage	Unopened vial Store and transport refrigerated (2°C – 8°C). Do not freeze. Store in the original package in order to protect from light. After reconstitution and dilution For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Drug group (ATC)	Antineoplastic agents, Alkylating Agents L Antineoplastic and immunomodulating agents L01 Antineoplastic agents L01A Alkylating agents L01AC Ethylene imines, antineoplastic alkylating drugs L01AC01 thiotepa
Marketing authorisation	PL 15413/0185 (first authorised 5 September 2025)
Marketing authorisation holder	Hikma Farmacêutica (Portugal), S.A.

Thiotepa 100 mg powder for concentrate for solution for infusion – patient leaflet, side effects, dosage