Thiotepa Fresenius Kabi

Leaflet attached to the packaging: information for the user

Thiotepa Fresenius Kabi, 15 mg, powder for concentrate for solution for infusion

Thiotepa Fresenius Kabi, 100 mg, powder for concentrate for solution for infusion

Thiotepa

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor. See section 4.

Table of contents of the leaflet

• 1. What Thiotepa Fresenius Kabi is and what it is used for
• 2. Important information before using Thiotepa Fresenius Kabi
• 3. How to use Thiotepa Fresenius Kabi
• 4. Possible side effects
• 5. How to store Thiotepa Fresenius Kabi
• 6. Contents of the packaging and other information

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

Thiotepa Fresenius Kabi contains the active substance thiotepa, which belongs to the group of alkylating agents.
Thiotepa Fresenius Kabi is used to prepare the patient for bone marrow transplantation. The action of the medicine involves destroying bone marrow cells. This allows for the transplantation of new bone marrow cells (stem cells of the hematopoietic system), which in turn enables the body to produce healthy blood cells.
Thiotepa Fresenius Kabi can be used in adults and children and adolescents.

2. Important information before using Thiotepa Fresenius Kabi

When not to use Thiotepa Fresenius Kabi

• if the patient is allergic to thiotepa,
• if the patient is pregnant or thinks she may be pregnant,
• if the patient is breastfeeding,
• during vaccination against yellow fever, live virus and bacterial vaccines.

Warnings and precautions

The patient should inform their doctor if they:

• have liver or kidney function disorders,
• have heart or lung disease,
• have a history of seizures (epilepsy) or have had seizures in the past (especially if they were treated with phenytoin or fosphenytoin).

Since thiotepa destroys bone marrow cells responsible for producing blood cells, regular blood tests will be performed during treatment to monitor blood cell count.
To prevent infections and treat them, anti-infective agents will be used.
Thiotepa may cause another type of cancer in the future. The doctor will provide information about this risk.

Thiotepa Fresenius Kabi and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy, breastfeeding, and fertility

Before starting treatment with Thiotepa Fresenius Kabi, the patient should inform their doctor if they are pregnant or think they may be pregnant. Thiotepa Fresenius Kabi should not be used during pregnancy.
Both women and men using thiotepa must use effective methods of preventing pregnancy during treatment. After treatment, women must use effective methods of preventing pregnancy for at least 6 months, and men for at least 3 months.
It is not known whether the medicine passes into breast milk. As a precaution, women should not breastfeed during treatment with Thiotepa Fresenius Kabi.
Thiotepa Fresenius Kabi may impair fertility in men and women. Before starting treatment, men should try to preserve their sperm.
If the patient plans to have children after treatment, they should consult a genetic counseling center.

Driving and using machines

It is likely that some side effects of thiotepa, such as dizziness, headaches, and blurred vision, may affect the ability to drive and use machines.
If such symptoms occur, the patient should not drive or operate machines.

Thiotepa Fresenius Kabi contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means that the medicine is considered "sodium-free".

3. How to use Thiotepa Fresenius Kabi

The doctor will determine the dose of the medicine based on the patient's body surface area or weight and the disease being treated.

How Thiotepa Fresenius Kabi is administered

The medicine is administered by qualified medical personnel in the form of an infusion, after dissolving the contents of the vial.
The infusion lasts from 2 to 4 hours.

Frequency of administration

The infusion is administered every 12 hours or every 24 hours. The duration of treatment is up to 5 days.
The frequency of administration and duration of treatment depend on the type of disease.

4. Possible side effects

Like all medicines, Thiotepa Fresenius Kabi can cause side effects, although not everybody gets them.
The most serious side effects associated with thiotepa or bone marrow transplantation are:

• decrease in the number of circulating blood cells (intended action of the medicine to prepare for transplantation),
• infection,
• liver disease, including blockage of the hepatic vein,
• graft-versus-host disease (graft-versus-host disease),
• respiratory complications. The doctor will regularly monitor blood cell count and liver enzyme activity to detect and treat these side effects.

Side effects associated with thiotepa may occur with a certain frequency, which is defined as follows:

Very common (may occur in more than 1 in 10 patients):

• increased susceptibility to infections,
• systemic inflammatory response (sepsis),
• decrease in the number of white blood cells, platelets, and red blood cells (anemia),
• graft-versus-host disease,
• dizziness, headaches, blurred vision,
• uncontrolled shaking of the body (seizures),
• tingling, numbness, or tingling sensation (sensory disturbances),
• partial loss of ability to move,
• cardiac arrest,
• nausea, vomiting, diarrhea,
• mouth ulcers,
• irritation of the stomach, esophagus, and intestines,
• inflammation of the colon,
• loss of appetite, decreased appetite,
• increased blood glucose levels,
• skin rash, itching, hives,
• skin discoloration (not to be confused with jaundice - see below),
• redness of the skin (flushing),
• hair loss,
• back and abdominal pain, pain,
• muscle and joint pain,
• disturbances in heart rhythm (arrhythmias),
• inflammation of lung tissue,
• enlargement of the liver,
• organ dysfunction,
• blockage of the hepatic vein (hepatic veno-occlusive disease),
• yellowing of the skin and eyes (jaundice),
• hearing impairment,
• lymphatic obstruction,
• hypertension,
• increased activity of liver, kidney, and digestive enzymes,
• electrolyte disturbances,
• weight gain,
• fever, general weakness, chills,
• bleeding (hemorrhage),
• nosebleeds,
• generalized edema due to fluid retention,
• pain and inflammation at the injection site,
• eye infection (conjunctivitis),
• decreased sperm count,
• vaginal bleeding
• absence of menstrual bleeding,
• memory loss,
• delayed weight gain and growth disturbances,
• urinary bladder dysfunction,
• insufficient production of testosterone,
• insufficient production of thyroid hormone,
• hypopituitarism,
• confusional state.

Common (may occur in less than 1 in 10 patients):

• anxiety, disorientation,
• abnormal dilation of one of the brain arteries (intracranial aneurysm),
• elevated creatinine levels,
• allergic reactions,
• blockage of blood vessels (thrombosis),
• arrhythmias,
• heart failure,
• cardiovascular failure,
• hypoxia,
• fluid accumulation in the lungs (pulmonary edema),
• pulmonary bleeding,
• respiratory arrest,
• blood in the urine (hematuria) and moderate kidney failure,
• urinary tract infection,
• discomfort during urination and decreased urine output (dysuria and oliguria),
• increased levels of nitrogen compounds in the blood (elevated BUN),
• cataract,
• liver failure,
• cerebral hemorrhage,
• cough,
• constipation and gastrointestinal upset,
• intestinal obstruction,
• perforation of the stomach,
• muscle tone disturbances,
• severe coordination disturbances,
• bruising due to low platelet count,
• menopausal symptoms,
• malignant tumor (another new tumor process),
• brain dysfunction,
• infertility in men and women.

Uncommon (may occur in less than 1 in 100 patients):

• inflammation and peeling of the skin (exfoliative dermatitis),
• confusion, nervousness, hallucinations, agitation,
• ulcers of the stomach and intestines,
• inflammation of the heart muscle (myocarditis),
• abnormal heart condition (cardiomyopathy).

Frequency not known (frequency cannot be estimated from available data):

• increased blood pressure in the pulmonary arteries (pulmonary hypertension),
• severe skin damage (e.g. severe changes, blisters, etc.) that can cover the entire body surface and even be life-threatening,
• damage to the white matter of the brain (leukoencephalopathy), which can be life-threatening.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Thiotepa Fresenius Kabi

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after EXP.
The expiry date refers to the last day of the month stated.
Store and transport at a refrigerated temperature (2°C – 8°C). Do not freeze.
After reconstitution, the solution is stable for 8 hours when stored at a temperature of 2°C-8°C.
After dilution, the solution is stable for 24 hours when stored at a temperature of 2°C-8°C and for 4 hours when stored at a temperature of 25°C.
From a microbiological point of view, the solution should be used immediately. If the solution is not used immediately, the user is responsible for the storage time and conditions before use.
The storage time should not exceed 24 hours at a temperature of 2-8°C.
Any unused medicine or waste material should be disposed of in accordance with local regulations.

6. Contents of the packaging and other information

What Thiotepa Fresenius Kabi contains

• The active substance of the medicine is thiotepa. Thiotepa Fresenius Kabi, 15 mg, powder for concentrate for solution for infusion One vial contains 15 mg of thiotepa.

Thiotepa Fresenius Kabi, 100 mg, powder for concentrate for solution for infusion One vial contains 100 mg of thiotepa.
After reconstitution, each mL of solution contains 10 mg of thiotepa (10 mg/mL).

• The other ingredient of the medicine is sodium carbonate.

What Thiotepa Fresenius Kabi looks like and what the pack contains

Thiotepa Fresenius Kabi, 15 mg, powder for concentrate for solution for infusion Thiotepa Fresenius Kabi is a white powder or disc in a glass vial containing 15 mg of thiotepa.
Thiotepa Fresenius Kabi, 100 mg, powder for concentrate for solution for infusion Thiotepa Fresenius Kabi is a white powder or disc in a glass vial containing 100 mg of thiotepa.
The pack contains 1 vial.

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Importer

Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany
To obtain more detailed information about this medicine, you should contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

This medicine is authorized for use in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet:19.07.2024
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Information intended for healthcare professionals only:

GUIDELINES FOR PREPARATION

Thiotepa Fresenius Kabi, 15 mg, powder for concentrate for solution for infusion

Thiotepa Fresenius Kabi, 100 mg, powder for concentrate for solution for infusion

Thiotepa

1. PRESENTATION

Thiotepa Fresenius Kabi (15 mg and 100 mg) is available as a powder for concentrate for solution for infusion. Thiotepa Fresenius Kabi should be reconstituted and diluted immediately before administration.

2. SPECIAL PRECAUTIONS FOR DISPOSAL AND PREPARATION OF THE MEDICINE FOR ADMINISTRATION

General information
Procedures for the proper preparation and disposal of anticancer medicines should be followed. All transfer procedures require strict adherence to aseptic principles, particularly the use of a laminar airflow hood and exhaust.
As with other cytotoxic agents, caution should be exercised during handling and preparation of thiotepa solutions to avoid accidental contact with the skin or mucous membranes. Accidental contact with thiotepa may cause local reactions. During preparation of the infusion solution, it is recommended to wear protective gloves. If accidental contact with thiotepa solution occurs, the skin should be washed immediately with water and soap. If accidental contact with thiotepa solution occurs with mucous membranes, they should be rinsed immediately with a large amount of water.
Dosage and administration in children, adolescents, and adults
See section 4.2 of the Summary of Product Characteristics for dosage and administration of thiotepa in children and adolescents and adults.
Reconstitution
Thiotepa Fresenius Kabi, 15 mg, powder for concentrate for solution for infusion Thiotepa Fresenius Kabi should be dissolved in 1.5 mL of sterile water for injection.
Using a syringe with a needle, 1.5 mL of sterile water for injection should be drawn up, following aseptic procedures.
Thiotepa Fresenius Kabi, 100 mg, powder for concentrate for solution for infusion Thiotepa Fresenius Kabi should be dissolved in 10 mL of sterile water for injection.
Using a syringe with a needle, 10 mL of sterile water for injection should be drawn up, following aseptic procedures.
The contents of the syringe should be injected into the vial through the rubber stopper.
The syringe and needle should be removed and the vial rotated several times.
Only clear solutions without any solid particles should be used. The reconstituted solution may sometimes show opalescence; such solutions can still be administered.
Further dilution in an infusion bag
The prepared solution is hypotonic and must be further diluted before administration in 500 mL of sodium chloride 9 mg/mL (0.9%) injection solution (1000 mL if the dose is greater than 500 mg) or in an appropriate volume of sodium chloride 9 mg/mL (0.9%) injection solution to obtain a thiotepa solution with a final concentration between 0.5 and 1 mg/mL.
Method of administration
Before administration, the infusion solution should be visually inspected for particulate matter. Solutions containing precipitates should be discarded.
The infusion solution must be administered to patients using an infusion set equipped with a 0.2 μm filter. Filtration does not affect the potency of the solution.
Before each infusion and after completed infusion, the inserted catheter should be flushed with 5 mL of 0.9% sodium chloride injection solution.
Disposal
For single use only.
Any unused medicine or waste material should be disposed of in accordance with local regulations.