Thiotepa Riemser - tiotepa uses, dose and side effects

Thiotepa Riemser 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.

Thiotepa Riemser can be used by adults and children and adolescents.

What you need to know before you use Thiotepa Riemer

Do not use Thiotepa Riemser

– 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).

Because Thiotepa Riemser 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.

Thiotepa Riemser may induce another type of cancer in the future. Your doctor will discuss this risk with you.

Other medicines and Thiotepa Riemer

Tell your doctor if you are taking or have recently taken or might take any other medicines.

Pregnancy, breastfeeding, and fertility

You must tell your doctor if you are pregnant or think you may be pregnant before receiving Thiotepa Riemer. You must not use Thiotepa Riemser during pregnancy.

Both women and men using Thiotepa Riemser must use effective contraception during treatment. Male patients should not father children while they are being treated and the year after treatment has ended.

It is unknown if this drug is excreted in breast milk. As a precaution, women must not breastfeed during treatment with Thiotepa Riemer.

Thiotepa Riemser can impair fertility in men and women. Male patients should seek advice on saving sperm before starting treatment.

Driving ability and use of machinery

Likely, certain side effects of tiotepa such as dizziness, headache, and blurred vision can affect the ability to drive vehicles and use machines. If you notice such side effects, you should not drive or use machinery.

How to use Thiotepa Riemser

Your doctor will calculate the dose according to your body surface area or weight and your disease.

How Thiotepa Riemser is given

Thiotepa Riemser 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, Thiotepa Riemser can cause side effects, although not everybody gets them.

The most serious side effects of treatment with Thiotepa Riemser 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.

Other side effects of Thiotepa Riemser, which may occur in some frequencies, are listed below:

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
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) of 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 Thiotepa Riemser

Keep this medicine out of the sight and reach of children.

Do not use before the expiry date which is stated on the carton and the vial label after EXP. The expiration date is the last day of the specified month.

Store and transport cold (2 °C-8 °C).

Do not freeze.

After preparation, the solution is stable for 8 hours if stored at 2 °C-8 °C.

After dilution, the solution is stable for 24 hours if stored at 2 °C-8 °C and in

4 hours if stored at 25 °C. From a microbiological point of view, the product should be used immediately.

Unused medicines and waste must be disposed of according to current instructions.

Contents of the packaging and other information

Contents declaration

Thiotepa Riemser 15 mg powder for concentrate for infusion solution, solution

The active substance is thiotepa. One vial contains 15 mg of thiotepa. After reconstitution , each ml contains 10 mg thiotepa (10 mg/ml).

Thiotepa Riemser 100 mg powder for concentrate for infusion solution, solution

The active substance is thiotepa. One vial contains 100 mg of thiotepa. After reconstitution , each ml contains 10 mg thiotepa (10 mg/ml).
Thiotepa Riemser does not contain any other excipients.

Appearance and package sizes of the medicine

Thiotepa Riemser 15 mg powder for concentrate for infusion solution, solution

Thiotepa Riemser is a white crystalline powder supplied in a glass vial containing 15 mg of thiotepa.

Thiotepa Riemser 100 mg powder for concentrate for infusion solution, solution

Thiotepa Riemser is a white crystalline powder supplied in a glass vial containing 100 mg of thiotepa.

Each carton contains 1 vial.

Marketing authorization holder and manufacturer

Marketing Authorisation Holder

Esteve Pharmaceuticals GmbH

Hohenzollerndamm 150-151

14199 Berlin

Germany

Manufacturer

HWI development GmbH

Straßburger Str. 77

77767 Appenweier