1 g and 5 g of powder for infusion,
treosulfan solution
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 bone marrow transplantation ( hematopoietic stem cell transplantation ). Treosulfan destroys the bone marrow cells and enables the transplantation of new bone marrow cells so that the body can produce healthy blood cells.
Trecondi is used as treatment before blood stem cell transplantation in adults with cancer and other diseases (non-malignant diseases) and adolescents and children over one month of age with cancer.
What you need to know before you are given Trecondi
Do not use Trecondi
- if you are allergic to treosulfan
- if you have an active uncontrolled infection
- if you have severe heart, lung, liver, or kidney disease
- if you have hereditary DNA repair deficiency, which is a condition that reduces the ability to repair DNA (which contains your genetic information)
- if you are pregnant or think you may be pregnant.
Warnings and precautions
Trecondi is a cell-killing (cytotoxic) medicine used to reduce the number of blood cells. At the recommended dose, this is the desired effect. Blood samples will be taken regularly during the treatment to check that the blood cell count does not become too low.
To prevent and treat infection, you will receive medicines, such as antibiotics, antifungal medicines, and antiviral medicines.
Trecondi can increase the risk of getting another form of cancer in the future.
Since inflammation of the oral mucosa is a common side effect of this medicine, you must be careful with your oral hygiene. For preventive purposes, the use of mouth rinses (e.g. with barrier-protecting or bactericidal effect) or ice in the oral cavity (reduces blood flow to the oral mucosa and reduces the amount of treosulfan reaching the cells) is recommended.
You must not be vaccinated with live vaccines (certain types of vaccines) during treatment with treosulfan.
Trecondi can cause menopause-like symptoms (missing periods).
Children and young people
In very rare cases, seizures may occur in infants under 4 months of age. Children under 1 year of age can have more serious side effects that affect breathing, compared to older children. Your child will be monitored for signs of side effects affecting the nerves and breathing problems.
Diaper rash with ulcers in the area around the rectal opening can occur in infants, young children, and infants because treosulfan excreted in the urine can damage the skin. Therefore, the child’s nappy should be changed frequently for 6–8 hours after each dose of this medicine.
There is not enough information on the use of treosulfan in children younger than 1 month.
Other medicines and Trecondi
Tell your doctor if you are taking, have recently taken, or might be taking any other medicines, even those without a prescription.
Pregnancy, breastfeeding, and fertility
You must not become pregnant during treatment with this medicine and up to 6 months after treatment. Use effective contraception when either you or your partner receives this medicine.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
You should stop breastfeeding before starting treatment with this medicine.
If you are a man and are treated with this medicine, you must not make a woman pregnant during treatment and up to 6 months after treatment.
This medicine can make you infertile and it is not certain that you can get pregnant after treatment with it. If you are concerned about your ability to have children, you should discuss this with the doctor before treatment. Men should ask if there is an option to save sperm before starting the treatment.
Driving ability and use of machinery
This medicine may cause nausea, vomiting, and dizziness, which may impair the ability to drive and use machines. If you suffer from these symptoms, you should not drive a motor vehicle or use machinery.
How Trecondi is used
Use for adults
This medicine is used in combination with the medicine fludarabine.
The recommended dose is 10–14 g/m² body surface (calculated based on height and body weight).
Use for children and adolescents
This medicine is used in combination with the medicine fludarabine and most cases also with the medicine thiotepa. The recommended dose is 10–14 g/m² body surface.
How Trecondi is given
You will be given this medicine by your doctor. It is given by drip ( infusion ) into a vein over 2 hours for 3 days before the blood stem cell infusion.
If you have been given too much Trecondi
As this medicine is given by a doctor, you will receive the correct dose. If you still think you have been given more of this medicine than you should, tell your doctor or nurse as soon as possible.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
The most serious side effects of treosulfan treatment or stem cell transplantation are:
- decreased number of blood cells, which is the intended effect of the medicine to prepare you for the transplant infusion (all patients: very common)
- infection caused by bacteria, viruses, and fungi (all patients: very common)
- blockage of a vein going to the liver (adults: less common; children and adolescents: have been reported)
- pneumonia ( pneumonitis ) (adults: less common)
The doctor will check your blood levels and liver enzymes to detect and treat these side effects.
Adults
All other side effects are listed below according to how common they are.
Very common (may affect more than 1 in 10 users)
- decreased number of white blood cells with fever (febrile neutropenia )
- inflammation of the mucous membrane in various parts of the body, especially in the mouth (which can cause ulcers), diarrhea, nausea, vomiting, stomach pain
- fatigue
- increased level of bilirubin (a pigment in the liver which is often a sign of liver problems) in the blood
Common (may affect up to 1 in 10 users)
- blood poisoning ( sepsis )
- allergic reactions
- decreased appetite
- sleep problems (insomnia)
- headache, dizziness
- changes and abnormalities in heart rhythm (heartbeats are irregular, too fast or too slow)
- high blood pressure, flushing
- breathing difficulties, nosebleeds
- pain in the mouth, inflammation of the stomach, upset stomach, constipation, difficulty swallowing
- a type of rash with flat or raised red bumps on the skin (maculopapular rash), red dots on the skin (purpura), reddening of the skin ( erythema ), hand-foot syndrome (palms or soles of the feet tingling, numbness, swelling, and pain, or becoming red), itching, hair loss
- pain in arms or legs, back pain, bone pain, joint pain, muscle pain
- sudden deterioration of kidney function, blood in the urine
- fluid accumulation in the body causing swelling ( edema ), fever, chills
- increase in liver enzymes, increase in C-reactive protein (a marker of inflammation in the body), weight gain, weight loss
Uncommon (may affect up to 1 in 100 users)
- high blood sugar
- confusion
- problems in the nerves in the arms and legs with symptoms such as numbness decreased or increased sensitivity, tingling, burning pain ( peripheral sensory neuropathy )
- bruising, low blood pressure
- fluid around the lungs, inflammation of the throat, inflammation or pain in the larynx, cough, hiccups
- bleeding in the mouth, a feeling of bloating, pain in the esophagus or stomach, dry mouth
- liver damage
- a type of rash with red dots and sometimes with areas that may be purple or have blisters in the center (erythema multiforme), acne, rash, heavy sweating
- chest pain, pain
Has been reported (occurring in an unknown number of users)
- a life-threatening condition associated with blood poisoning ( septic shock )
- other cancer caused by chemotherapy (secondary malignancy )
- increased acidity in the blood, abnormal blood sugar level, abnormal level of electrolytes in the blood (salts in the blood)
- restlessness
- abnormal brain function ( encephalopathy ); cerebral hemorrhage; restless, repetitive, or involuntary movements and rapid speech (extrapyramidal disorder); fainting; a crawling, tingling, or numbing sensation ( paresthesia )
- dry eyes
- the heart does not pump enough blood for the body’s needs ( heart failure ), heart attack, fluid in the pericardium
- blood clot, bleeding
- sore throat, reduced oxygen supply to a tissue ( hypoxia ), hoarseness
- bleeding in the gastrointestinal tract, inflammation of the large intestine, inflammation of the esophagus, inflammation of the rectal opening, mouth ulcers
- liver failure, enlarged liver, liver pain
- skin redness (generalized erythema ), skin inflammation ( dermatitis ), dead skin tissue, skin ulcers, bronze-colored skin, dry skin
- muscle weakness
- kidney failure, inflammation of the bladder ( cystitis ), pain when urinating
- pain or inflammation at the injection site, feeling cold
- increased level of creatinine (a substance normally removed by the kidneys and excreted in the urine) in the blood, increased level of lactate dehydrogenase (a substance that indicates tissue or cell damage) in the blood
Children and young people
All other side effects are listed below according to how common they are.
Very common (may affect more than 1 in 10 users)
- inflammation of the mucous membranes, especially in the mouth (with ulcers), diarrhea, nausea, vomiting, stomach pain
- itching
- fever
Common (may affect up to 1 in 10 users)
- sore throat, nosebleed
- difficulty swallowing, pain in the mouth
- reddening and peeling of much of the skin on the body (exfoliative dermatitis ), a type of rash with flat or raised red bumps on the skin (maculopapular rash), rash, skin redness, skin pain, bronzed skin, hair loss
- increase in liver enzymes increased level of bilirubin (a pigment in the liver which is often a sign of liver problems) in the blood
Has been reported (occurring in an unknown number of users)
- other cancer caused by chemotherapy (secondary malignancy )
- decreased number of white blood cells with fever (febrile neutropenia )
- less acid than normal in the blood ( alkalosis ), abnormal level of electrolytes in the blood, reduced level of magnesium in the blood
- headache; a crawling, tingling, or numbness sensation ( paresthesia ); convulsions
- eye bleeding, dry eyes
- fluid leakage from the capillaries (small blood vessels), high blood pressure, low blood pressure
- reduced oxygen supply to parts of the body ( hypoxia )
- inflammation of the colon, inflammation of the rectal opening, stomach upset, inflammation of the rectal mucosa, pain in the gastrointestinal tract, constipation
- enlarged liver, liver damage
- skin sores, a type of rash with red dots and sometimes with areas that may be purple or have blisters in the center (erythema multiforme), hives, a skin condition with fluid-filled blisters ( dermatitis bullous ), acne, hand-foot syndrome (the palms of the hands or soles of the feet get tingling, numbness, becomes swollen and painful, or becomes red), diaper rash with sores in the area around the anus
- pain in arms or legs
- impaired kidney function, kidney failure, inflammation of the bladder ( cystitis )
- skin redness on the scrotum
- chills, fatigue, pain
- increased level of a liver enzyme (gamma-glutamyltransferase) in the blood
How Trecondi should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label and carton after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Storage instructions for the medicine after preparation can be found in the section below for healthcare professionals.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is treosulfan. This medicine has no other ingredients.
Trecondi 1 g powder for infusion, solution
1 vial contains 1 g of treosulfan.
Trecondi 5 g powder for infusion, solution
1 vial contains 5 g of treosulfan.
After reconstitution, 1 ml of the solution contains 50 mg of treosulfan.
Appearance and package sizes of the medicine
White crystalline powder in a glass vial with a rubber stopper and an aluminum cap.
Trecondi is available in packs containing 1 or 5 vials (type I glass).
Not all pack sizes may be marketed.
medac
Gesellschaft für klinische Spezialpräparate mbH
Theater. 6
22880 Wedel
Germany
Tel.: +49 4103 8006-0
Fax: +49 4103 8006-100
Email: contact@medac.de