Trecondi 5 g powder for solution for infusion
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Trecondi 1g powder for solution for infusion
Trecondi 5g powder for solution for infusion
treosulfan
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Trecondi is and what it is used for
- What you need to know before Trecondi is administered to you
- How to use Trecondi
- Possible side effects
- How to store Trecondi
- Contents of the pack and other information
1. What Trecondi is and what it is used for
Trecondi contains the active substance treosulfan, which belongs to a group of medicines called alkylating agents. Treosulfan is used to prepare patients for a bone marrow transplant (hematopoietic stem cell transplant). Treosulfan destroys cells in the bone marrow and allows the transplantation of new cells into the bone marrow to promote the production of healthy blood cells.
Trecondi is used as conditioning treatment prior to hematopoietic stem cell transplantation in adults, adolescents, and children over 1 month of age with cancer and non-cancerous disorders.
2. What you need to know before Trecondi is administered to you
Do not take Trecondi
- if you are allergic to treosulfan;
- if you have an uncontrolled active infection;
- if you have severe heart, lung, liver, or kidney disease;
- if you have a hereditary DNA repair disorder, or a disease that reduces your ability to repair DNA (which carries your genetic information);
- if you are pregnant or think you might be.
Warnings and precautions
Trecondi is a cytotoxic medicine that destroys cells and is used to reduce the number of blood cells. This is the intended effect at the recommended dose. You will have periodic blood tests during treatment to ensure your blood cell counts are not too low.
To prevent and treat infections, you will be given certain medicines such as antibiotics, antifungals, or antivirals.
Trecondi may increase the risk of developing another cancer in the future.
Since inflammation of the mouth mucosa is a common side effect of this medicine, you must pay special attention to your oral hygiene. Preventive measures are recommended, such as using mouthwashes (e.g., with barrier protectants, antibiotics) or applying ice to the oral cavity (which reduces blood flow to the mouth mucosa and decreases the amount of treosulfan reaching the cells).
You must not receive live vaccines during treatment with treosulfan.
Trecondi may cause menopausal symptoms (absence of menstruation).
Children and adolescents
Very rarely, epileptic seizures (convulsions) may occur in infants under 4 months of age. Children under 1 year of age may experience more severe respiratory side effects than older children. Your child will be monitored for signs of nerve-related side effects or breathing problems.
Diaper dermatitis with sores in the area around the anus (perianal) may occur in infants and children wearing diapers, because treosulfan excreted in urine can damage the skin. Therefore, diapers should be changed frequently during the 6–8 hours following administration of the medicine.
There is insufficient information on the use of treosulfan in children under 1 month of age.
Other medicines and Trecondi
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines.
Pregnancy, breastfeeding, and fertility
You must not become pregnant during treatment with this medicine and for 6 months after treatment ends. Use an effective method of contraception while you or your partner are receiving this medicine.
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
You must stop breastfeeding before starting treatment with this medicine.
If you are a man receiving treatment with this medicine, you must not father a child during treatment and for 6 months after treatment ends.
This medicine may cause infertility and prevent you from becoming pregnant after treatment. If you wish to have children, you should discuss this with your doctor before starting treatment. Men should seek advice about the possibility of preserving sperm before starting treatment.
Driving and use of machines
This medicine may cause nausea, vomiting, and dizziness, which could reduce your ability to drive or operate machinery. Do not drive or operate machinery if you experience these effects.
3. How to use Trecondi
Use in adults
This medicine is used in combination with fludarabine.
The recommended dose is 10–14 g/m² of body surface area (calculated according to weight and height).
Use in children and adolescents
This medicine is used in combination with fludarabine and, in most cases, also with thiotepa. The recommended dose is 10–14 g/m² of body surface area.
How Trecondi is administered
A doctor will administer this medicine to you. It is given by intravenous infusion over 2 hours for 3 days prior to the infusion of hematopoietic stem cells.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Serious adverse effects
The most serious adverse effects of treatment with treosulfan or transplantation are:
- reduction in blood cell counts, which is the intended effect of the medicine to prepare you for the pre-transplant infusion (all patients: very common);
- infections caused by bacteria, viruses, and fungi (adults: common; children and adolescents: very common);
- blockage of a vein in the liver (adults: uncommon; children and adolescents: frequency not known);
- inflammation of the lung (pneumonia) (adults: very common).
Your doctor will periodically monitor your blood cell counts and liver enzymes to detect and manage these events.
Adults
Below is a list of all other adverse effects according to their frequency.
Very common (may affect more than 1 in 10 people)
- decrease in white blood cells with fever (febrile neutropenia);
- inflammation of the lining of various parts of the body, especially in the mouth (which may cause ulcers), diarrhea, nausea, vomiting;
- fatigue;
- elevated blood bilirubin (a liver pigment, often a sign of liver problems).
Common (may affect up to 1 in 10 people)
- bloodstream infection (sepsis);
- allergic reactions;
- decreased appetite;
- difficulty sleeping (insomnia);
- headache, dizziness;
- changes and abnormalities in heart rhythm (heartbeat is irregular, too fast, or too slow);
- high or low blood pressure, flushing;
- difficulty breathing, nosebleeds;
- mouth pain, stomach inflammation, stomach discomfort, abdominal pain; constipation, difficulty swallowing, stomach or esophageal pain;
- a type of rash with flat or raised red spots on the skin (maculopapular rash), red spots on the skin (purpura), redness of the skin (erythema), hand-foot syndrome (tingling, numbness, swelling, pain, or redness in the palms of the hands or soles of the feet), itching, hair loss;
- pain in arms or legs, back pain, bone pain, joint pain;
- sudden decrease in kidney function, blood in urine;
- fluid retention in the body causing swelling (edema), fever, chills;
- elevated liver enzymes, increased C-reactive protein (a marker of inflammation in the body), weight gain, weight loss.
Uncommon (may affect up to 1 in 100 people)
- abnormal control of blood sugar levels, including high or low blood sugar;
- confusion;
- bleeding in the brain, nerve problems in arms or legs with symptoms such as numbness, increased or decreased sensitivity, tingling, and burning (peripheral sensory neuropathy);
- sensation of spinning (dizziness);
- bruising;
- fluid around the lung (pleural effusion), throat inflammation, inflammation or pain of the larynx, hiccups;
- bleeding in the mouth, sensation of swelling, dry mouth;
- a type of rash with red spots and sometimes purple areas or blisters in the center (erythema multiforme), acne, rash, dry skin;
- muscle pain;
- pain in the urinary tract;
- chest pain not related to heart problems, pain;
- elevated blood alkaline phosphatase level (your doctor will check this parameter).
Frequency not known (cannot be estimated from available data)
- potentially life-threatening condition following bloodstream infection (septic shock);
- different cancer caused by chemotherapy (secondary malignant neoplasm);
- increased acidity in the blood;
- abnormal brain function (encephalopathy), repetitive, involuntary, or restless movements and rapid speech (extrapyramidal disorder), fainting, sensation of tingling, itching, or numbness (paresthesia);
- dry eye;
- heart unable to pump enough blood to meet the body's needs (heart failure), heart attack, fluid in the sac surrounding the heart (pericardial effusion);
- blockage of a blood vessel (embolism);
- sore throat, hoarseness, cough;
- gastrointestinal bleeding, inflammation of the colon, inflammation of the esophagus, inflammation of the anus;
- liver damage caused by medicines, enlargement of the liver;
- skin inflammation (dermatitis), skin tissue death, skin ulcer, bronze-colored skin pigmentation;
- kidney failure, inflammation of the urinary bladder with bleeding (hemorrhagic cystitis), pain during urination (dysuria);
- elevated blood lactate dehydrogenase level (a substance indicating tissue or cellular damage).
Children and adolescents
Below is a list of all other adverse effects according to their frequency.
Very common (may affect more than 1 in 10 people)
- inflammation of the mucosa (especially in the mouth) with ulcers, diarrhea, nausea, vomiting, abdominal pain;
- liver damage;
- itching, hair loss;
- fever;
- elevated blood level of a liver enzyme (ALT).
Common (may affect up to 1 in 10 people)
- headache;
- sore throat, nosebleeds;
- difficulty swallowing, inflammation of the anus, mouth pain;
- redness or peeling of most of the body's skin (exfoliative dermatitis), a type of rash with flat or raised red spots on the skin (maculopapular rash), rash, redness of the skin (erythema), hives, skin pain, bronze-colored skin pigmentation;
- chills;
- elevated blood levels of a liver enzyme (AST) and bilirubin (a liver pigment, often a sign of liver problems), elevated C-reactive protein (a marker of inflammation in the body).
Frequency not known (cannot be estimated from available data)
- different cancer caused by chemotherapy (secondary malignant neoplasm);
- decrease in white blood cells with fever (febrile neutropenia);
- less acid than normal in the blood (alkalosis), abnormal blood electrolyte levels, low blood magnesium levels, decreased appetite;
- seizures, sensation of tingling, pricking, or numbness (paresthesia);
- bleeding in the eye, dry eye;
- leakage of fluids from capillaries (small blood vessels), high blood pressure, low blood pressure;
- reduced supply of oxygen to different parts of the body (hypoxia), cough;
- inflammation of the colon, stomach discomfort, inflammation of the rectal lining, gum pain, esophageal pain, constipation;
- enlargement of the liver;
- skin ulcer, a type of rash with red spots and sometimes purple areas or blisters in the center (erythema multiforme), blistering skin disease with fluid-filled blisters (bullous dermatitis), acne, hand-foot syndrome (tingling, numbness, swelling, pain, or redness in the palms of the hands or soles of the feet), diaper dermatitis with ulcers in the area around the anus;
- pain in arms or legs;
- decreased kidney function, kidney failure, inflammation of the urinary bladder (cystitis), blood in urine;
- redness of the scrotal skin, pain in the penis;
- accumulation of fluid in tissues causing facial swelling, fatigue, pain;
- elevated blood level of a liver enzyme (gamma-glutamyl transferase).
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is an effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Trecondi
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the carton after EXP. The expiry date is the last day of the month indicated.
No special storage conditions are required.
For storage conditions after reconstitution of the medicine, see the information for healthcare professionals provided below.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Trecondi
The active substance is treosulfan. This medicine contains no other ingredients.
Trecondi 1 g powder for solution for infusion
1 vial of powder contains 1 g of treosulfan.
Trecondi 5 g powder for solution for infusion
1 vial of powder contains 5 g of treosulfan.
After reconstitution, 1 ml of solution contains 50 mg of treosulfan.
Nature of the product and pack size
White crystalline powder in a glass vial with a rubber stopper and an aluminium seal.
Trecondi is available in packs of 1 or 5 vials (Type I glass).
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
medac
Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Tel.: +49 4103 8006-0
Fax: +49 4103 8006-100
E-mail: [email protected]
Date of the most recent review of this leaflet: 11/2023
Other sources of information
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu. Links to other websites on rare diseases and orphan medicinal products are also provided.
This information is intended for healthcare professionals only:
As with all cytotoxic substances, appropriate precautions must be taken when handling treosulfan.
The medicine must be reconstituted by trained personnel. During handling of treosulfan, inhalation and direct contact with skin or mucous membranes must be avoided (the use of suitable disposable protective gloves, goggles, gowns, and masks is recommended). Contaminated areas of the body should be thoroughly rinsed with water and soap, while eyes should be rinsed with sodium chloride solution 9 mg/ml (0.9%). If available, it is recommended to work in a specially designed safety workstation equipped with a laminar flow cabinet and an absorbent, impermeable disposable pad. Caution and appropriate measures are recommended for the disposal of waste materials (syringes, needles, etc.) used in the reconstitution of cytotoxic medicines. Luer-Lock connectors should be used with all syringes and equipment. Use of large-bore needles is recommended to minimize pressure and the potential for aerosol formation. Aerosols can also be reduced by using a venting needle.
Pregnant healthcare workers must not handle cytotoxic agents.
Instructions for reconstitution of treosulfan:
- Treosulfan should be reconstituted in its original glass container. Reconstituted treosulfan solutions may be transferred into a larger glass vial, polyvinyl chloride (PVC) bag, or polyethylene (PE) bag.
- To avoid solubility issues, warm the diluent—sodium chloride solution 4.5 mg/ml (0.45%)—to 25°C–30°C (not higher); for example, in a water bath.
- Carefully dislodge the treosulfan powder from the inner surface of the vial by shaking. This step is very important, as wetting the powder may cause it to adhere to the surface in clumps. If this occurs, shake the vial vigorously to dissolve the compacted mass.
- Reconstitute each vial of Trecondi containing 1 g of treosulfan with 20 ml of pre-warmed sodium chloride solution 4.5 mg/ml (0.45%) (at a maximum of 30°C), with agitation.
Reconstitute each vial of Trecondi containing 5 g of treosulfan with 100 ml of pre-warmed sodium chloride solution 4.5 mg/ml (0.45%) (at a maximum of 30°C), with agitation.
To prepare the sodium chloride solution 4.5 mg/ml (0.45%), equal volumes of sodium chloride solution 9 mg/ml (0.9%) and water for injections may be mixed.
Reconstituted infusion solution
The reconstituted solution contains 50 mg of treosulfan per ml and appears as a clear, colourless solution.
Solutions showing signs of precipitation must not be used.
After reconstitution with sodium chloride solution 4.5 mg/ml (0.45%), chemical and physical stability has been demonstrated for 3 days at 25°C.
From a microbiological standpoint, unless the reconstitution method excludes the risk of microbial contamination, the medicine should be used immediately. If not used immediately, the duration and conditions of storage during use are the responsibility of the user.
Do not store the reconstituted solution in the refrigerator (between 2°C and 8°C), as precipitation may occur.
Treosulfan has mutagenic and carcinogenic potential. Residual medicine and materials used for reconstitution and administration must be destroyed according to standard procedures applicable to antineoplastic agents, in compliance with current regulations on the disposal of hazardous waste.