Thiotepa Fresenius Kabi 15 mg – patient leaflet, side effects, dosage

1. What Thiotepa Fresenius Kabi is and what it is used for

Thiotepa Fresenius Kabi contains the active

substance thiotepa, which belongs to a group of

medicines called alkylating agents.

Thiotepa Fresenius Kabi 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 Fresenius Kabi

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 contraception 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 advice for sperm preservation

before therapy is started.

If there is a desire to have children after

completion of the therapy, genetic counselling is

recommended in advance

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.

Thiotepa Fresenius Kabi contains sodium

This medicine contains less than 1 mmol sodium

(23 mg) per vial, that is to say essentially ‘sodium-

free’.

3. How to use Thiotepa Fresenius Kabi

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, this medicine 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
• 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

Ireland

HPRA Pharmacovigilance Website: www.hpra.ie

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Thiotepa Fresenius Kabi

Mockup / GBR/IRL

Thiotepa Fresenius Kabi

Mockup / GBR/IRL

5. How to store Thiotepa Fresenius Kabi

Keep this medicine out of the sight and reach of

children.

Do not use this medicine 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.

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. 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 24

hours at 2-8°C.

Any unused product or waste material should be

disposed of in accordance with local requirements.

6. Contents of the pack and other information

What Thiotepa Fresenius Kabi contains

• The active substance is thiotepa.

  Thiotepa Fresenius Kabi 15 mg powder for

  concentrate for solution for infusion

  One vial contains 15 mg thiotepa.

  Thiotepa Fresenius Kabi 100 mg powder for

  concentrate for solution for infusion

  One vial contains 100 mg thiotepa.

  After reconstitution, each ml contains 10 mg

  thiotepa (10 mg/ml).

• other ingredient is sodium carbonate.

What Thiotepa Fresenius Kabi looks like and contents of the pack

Thiotepa Fresenius Kabi 15 mg powder for

concentrate for solution for infusion

Thiotepa Fresenius Kabi is a white powder or cake

supplied in a glass vial containing 15 mg thiotepa.

Thiotepa Fresenius Kabi 100 mg powder for concentrate for solution for infusion Thiotepa Fresenius Kabi is a white powder or cake supplied in a glass vial containing 100 mg thiotepa. Each carton contains 1 vial.

Marketing Authorisation Holder

For UK(NI)/IE: Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg v.d.Höhe Germany

For UK(GB): Fresenius Kabi Ltd Cestrian Court Eastgate Way, Manor Park Runcorn, Cheshire, WA7 1NT United Kingdom

Manufacturer

Fresenius Kabi Deutschland GmbH Pfingstweide 53 61169 Friedberg Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in May 2024.