Thiotepa Fresenius Kabi

Package Leaflet: 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

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor.
• If the patient experiences any side effects, including those not listed in this package leaflet, inform the doctor. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Thiotepa Fresenius Kabi and what is it 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 pack and other information

1. What is Thiotepa Fresenius Kabi and what is it 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

Tell the doctor if the patient:

• has liver or kidney function disorders,
• has heart or lung disease,
• has a history of seizures (epilepsy) or has had seizures in the past (especially if 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

Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy, breastfeeding, and fertility

Before starting treatment with Thiotepa Fresenius Kabi, inform the doctor about pregnancy or suspected pregnancy. 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, breastfeeding should be avoided 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 planning to have children after treatment, it is recommended to consult a genetic counseling center.

Driving and using machines

Some side effects of thiotepa, such as dizziness, headaches, and blurred vision, may impair the ability to drive and use machines.
In case of such symptoms, do 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 specific disease.

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 effect 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,
• sepsis (systemic inflammatory response),
• decrease in the number of white blood cells, platelets, and red blood cells (anemia),
• graft-versus-host disease (graft-versus-host disease),
• dizziness, headaches, blurred vision,
• uncontrolled shaking of the body (seizures),
• tingling, numbness, or tingling sensation (sensory disturbances),
• partial loss of movement ability,
• 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),
• skin redness (erythema),
• hair loss,
• back and abdominal pain, pain,
• muscle and joint pain,
• heart rhythm disorders (arrhythmias),
• lung tissue inflammation,
• 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 vessel obstruction,
• high blood pressure,
• 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 disorders,
• urinary bladder dysfunction,
• insufficient production of testosterone,
• insufficient production of thyroid hormone,
• hypopituitarism (underactive pituitary gland),
• confusional state.

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

• anxiety, disorientation,
• abnormal dilation of one of the brain arteries (cerebral aneurysm),
• elevated creatinine levels,
• allergic reactions,
• blockage of blood vessels (thrombosis),
• heart rhythm disorders (arrhythmias),
• heart failure,
• cardiovascular failure,
• hypoxia (oxygen deficiency),
• fluid accumulation in the lungs (pulmonary edema),
• lung 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,
• brain hemorrhage,
• cough,
• constipation and gastrointestinal disorders,
• intestinal obstruction,
• gastric perforation,
• muscle tone disorders,
• severe coordination disorders,
• bruising due to low platelet count,
• menopausal symptoms,
• malignant tumor (other new cancer process),
• brain dysfunction,
• infertility in men and women.

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

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

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

• high 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,
• brain damage (leukoencephalopathy) that can be life-threatening.

Reporting side effects

If any side effects occur, including those not listed in this package leaflet, inform the 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

Store the medicine 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 in a cool place (2°C – 8°C). Do not freeze.
After reconstitution, the solution is stable for 8 hours when stored at 2°C-8°C.
After dilution, the solution 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 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 2-8°C.
Any unused medicine or waste material should be disposed of in accordance with local regulations.

6. Contents of the pack 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 contents of the pack

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, 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 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 package leaflet:19.07.2024
--------------------------------------------------------------------------------------------------------------------
Information intended for healthcare professionals only:

PREPARATION GUIDELINES

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

Follow the procedures for the proper preparation and disposal of anticancer medicines. All transfer procedures require strict adherence to aseptic principles, especially the use of a laminar airflow cabinet and exhaust.
As with other cytotoxic agents, handle thiotepa with care during administration and preparation to avoid accidental contact with skin or mucous membranes. Accidental contact with thiotepa may cause local reactions. Wear protective gloves when preparing the infusion solution.
If thiotepa solution accidentally comes into contact with the skin, wash the skin immediately with water and soap. If thiotepa solution accidentally comes into contact with mucous membranes, rinse them immediately with a large amount of water.
Dosing and administration in children, adolescents, and adults
See section 4.2 of the Summary of Product Characteristics for dosing 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, draw up 1.5 mL of sterile water for injection, 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, draw up 10 mL of sterile water for injection, following aseptic procedures.
Inject the contents of the syringe into the vial through the rubber stopper.
Remove the syringe and needle and mix by repeated inversion.
Only use clear solutions without any solid particles. The reconstituted solution may sometimes exhibit 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 achieve a final thiotepa concentration between 0.5 and 1 mg/mL.
Administration method
Before administration, visually inspect the infusion solution for particulate matter. Solutions containing sediment 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 the infusion is completed, flush the inserted catheter with 5 mL of 0.9% sodium chloride injection solution.
Disposal
For single use only.
Dispose of any unused medicine or waste material in accordance with local regulations.