400 mg powder and liquid for infusion, solution
thiotepa
What TEPADINA is and what it is used for
TEPADINA contains the active substance thiotepa, which belongs to a group of medicines called alkylating agents.
TEPADINA is used to prepare patients for bone marrow transplantation. It works by destroying bone marrow cells. This makes it possible to transplant new bone marrow cells (hematopoietic stem cells ), which in turn enable the body to form healthy blood cells.
TEPADINA can be used by adults and children and adolescents.
What you need to know before you use TEPADINA
Do not use TEPADINA
– if you are allergic to thiotepa
– if you are pregnant or think you may be pregnant
– if you are breastfeeding
– if you receive vaccination against yellow fever, live viral and bacterial vaccines.
Warnings and precautions
You should tell your doctor if you have
- liver or kidney problems
- heart or lung problems
- seizures ( epilepsy ) or have had them in the past (if these are treated with phenytoin or fosphenytoin).
As TEPADINA destroys bone marrow cells responsible for the production of blood cells, you will regularly give blood samples during treatment to check the number of blood cells.
To prevent and treat infection, you will be given anti-infection medicine.
TEPADINA may induce another type of cancer in the future. Your doctor will discuss this risk with you.
Other medicines and TEPADINA
Tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Pregnancy, breastfeeding, and fertility
You must tell your doctor if you are pregnant or think you may be pregnant before receiving TEPADINA. You must not use TEPADINA during pregnancy.
Both women and men using TEPADINA must use effective contraception during treatment. Men should not father children during treatment with TEPADINA and for one year after stopping treatment.
It is unknown if this drug is excreted in breast milk. As a precaution, women should not breastfeed during treatment with TEPADINA.
TEPADINA can impair fertility in men and women. Male patients should seek advice on sperm conservation before starting treatment.
Driving ability and use of machinery
Likely, certain side effects of thiotepa such as dizziness, headache, and blurred vision can affect the ability to drive vehicles and use machines. If you experience any side effects, do not drive or use machines.
TEPADINA contains sodium
This medicine contains 1418 mg (61.6 mmol) of sodium (the main ingredient in common/table salt) in each sachet. This corresponds to 70.9% of the recommended maximum daily intake of sodium for adults.
How to use TEPADINA
Your doctor will calculate the dose according to your body surface area or weight and your disease.
How TEPADINA is given
TEPADINA is given by qualified healthcare professionals as an intravenous infusion (drip into a vein) after diluting the solution for injection. Each infusion lasts 2–4 hours.
Frequency of administration
You will receive your infusions every 12 or 24 hours. The treatment can last up to 5 days. How often the infusions are given and how long the treatment depends on your illness.
Possible side effects
Like all medicines, TEPADINA can cause side effects, although not everybody gets them.
The most serious side effects of treatment with TEPADINA or of the transplant may include:
- decreased number of circulating blood cells (intended effect of the drug to prepare you for your transplant infusion)
- infection
- liver dysfunction including blockage of a vein in the liver
- the graft attacks your body ( graft -versus-host reaction)
- respiratory complications.
Your doctor will regularly check your blood levels and liver enzymes to detect and treat these side effects.
Side effects of TEPADINA may occur in certain frequencies, which are defined as follows:
Very common side effects (may affect more than 1 in 10 users)
- increased susceptibility to infection
- blood poisoning (inflammatory condition throughout the body; sepsis )
- reduced number of white blood cells, platelets, and red blood cells ( anemia )
- the transplanted cells attack your body ( graft -versus-host reaction)
- dizziness, headache, blurred vision
- uncontrolled shaking of the body (seizures)
- a tingling, tingling, or numbness sensation ( paresthesia )
- partial loss of mobility
- cardiac arrest
- nausea, vomiting, diarrhea
- inflammation of the oral mucosa ( mucositis )
- irritated stomach, esophagus, intestine
- inflammation of the colon
- anorexia decreased appetite
- high blood sugar level
- skin rash, itching, scaling of the skin
- changed skin color (not to be confused with jaundice – see below)
- skin redness ( erythema )
- hair loss
- back and abdominal pain, pain
- muscle and joint pain
- abnormal electrical activity in the heart ( arrhythmia )
- inflammation of the lung tissue
- enlarged liver
- altered organ function
- blockage of a vein in the liver (hepatic venous occlusive disease, VOD)
- yellowing of the skin and eyes (jaundice)
- impaired hearing
- clogging of lymphatic vessels
- high blood pressure
- elevated levels of liver, kidney, and digestive enzymes
- abnormal amounts of electrolytes in the blood
- weight gain
- fever, general weakness, chills
- bleeding
- nosebleeds
- general swelling due to fluid retention ( edema )
- pain or inflammation at the injection site
- eye infection ( conjunctivitis )
- decreased sperm count
- bleeding from the vagina
- missed periods ( amenorrhea )
- memory loss
- delayed weight gain and height growth
- bladder dysfunction
- too low production of testosterone
- insufficient production of thyroid hormone
- insufficient activity of the pituitary gland
- state of confusion.
Common side effects (may affect up to 1 in 10 users)
- worry, confusion
- abnormal bulging of one of the arteries in the brain ( intracranial aneurysm )
- elevated creatinine level
- allergic reactions
- blood clot (clogging of a blood vessel; embolism)
- disturbances in the heart rhythm
- failure of the heart
- dysfunction of the cardiovascular system
- lack of oxygen
- fluid accumulation in the lungs ( pulmonary edema)
- pulmonary hemorrhages
- respiratory arrest
- blood in the urine ( hematuria ) and moderate deterioration of kidney function
- inflammation of the bladder
- discomfort when urinating and decreased urine volume ( dysuria and oliguria )
- the increased amount of nitrogen components in the bloodstream (increased BUN)
- cataracts _ _
- liver failure
- cerebral hemorrhage
- cough
- constipation and stomach upset
- blockage of the intestine
- perforation of the stomach
- altered muscle tension
- greatly reduced coordination of muscle movements
- bruising due to low platelet count
- menopausal symptoms
- cancer
- abnormal brain function
- male and female infertility.
Uncommon side effects (may affect up to 1 in 100 users)
- skin inflammation and scaling of the skin (erythrodermic psoriasis )
- delirium, nervousness, hallucinations, agitation
- stomach/intestinal ulcers
- inflammation of the muscle tissue of the heart ( myocarditis )
- heart disease ( cardiomyopathy ).
Frequency not known (frequency cannot be calculated from available data)
- increased blood pressure in the arteries (blood vessels) in the lungs ( pulmonary arterial hypertension )
- serious skin damage (e.g. severe lesions, large blisters, etc.) potentially covering the entire body surface which may be life-threatening
- damage to a part of the brain (the so-called white brain matter) which can even be life-threatening (leukoencephalopathy).
How to store TEPADINA
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton, the label on the aluminum wrapper, and the bag after EXP.DAT. The expiration date is the last day of the specified month.
Store and transport cold (2 °C–8 °C).
Do not freeze.
Keep the bag in the aluminum wrapper to protect it from activation.
After activation and preparation, the product must be used immediately.
Unused medicines and waste must be disposed of according to current instructions.
Contents of the packaging and other information
Contents declaration
- The active substance is thiotepa. One bag contains 400 mg of thiotepa. After reconstitution with the liquid, each ml of solution contains 1 mg of thiotepa
- The other ingredients are sodium chloride and water for injections (see section 2 “TEPADINA contains sodium ).
Appearance and package sizes of the medicine
TEPADINA is supplied in a double chamber bag containing 400 mg thiotepa and 400 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
After preparation, the bag contains a clear and colorless solution for infusion.
Each bag is packed in an aluminum wrapper.
ADRIENNE Srl
Via Galileo Galilei, 19
20867 Caponago (MB) Italy
Tel. +39-02 40700445
adienne@adienne.com
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