Beromun
tasonermin
Tasonermin
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor.
If you get any side effects , talk to your doctor. This includes any possible side effects not listed in this leaflet.
What Beromun is and what it is used for
What you need to know before you use Beromun
How to use Beromun
Possible side effects
How to store Beromun
Contents of the pack and other information
Beromun contains the active substance tasonermin (tumor necrosis factor alfa-1a), produced by recombinant DNA technology. It belongs to a class of medicines known as immunostimulants, which help your body’s immune system fight cancer cells.
Beromun is used, together with melphalan containing medicine, for the treatment of soft tissue sarcoma of the arms and legs. By reducing the size of the tumour, the treatment is intended to facilitate the removal of the tumor by surgery or to prevent severe damage to the surrounding healthy tissue and thus to delay or prevent the need for arm or leg amputation.
if you are allergic to tasonermin or any of the other ingredients of this medicine (listed in section 6).
if you have significant heart problems
if you have severe lung disease
if you have or have recently had a stomach ulcer
if you have too low numbers of blood cells or bleeding problems
if you have moderate to severe liver or kidney disease
if you cannot use vasopressors (used to increase low blood pressure), anticoagulants (used to prevent blood clotting) or radioactive tracers
if you are also using medicines with heart toxicity
if you have raised levels of calcium in your blood
if you have certain infections which do not respond to antibiotics
if you have severe swelling of the affected arm or leg due to local fluid build-up, or severe fluid build-up in the abdomen
if you are pregnant or planning to become pregnant.
if you are breast-feeding, you must stop for at least seven days after receiving Beromun
Beromun will be administered by a doctor who is experienced and skilled in isolated limb perfusion
(ILP). This technique ensures that Beromun is kept within the affected arm or leg. It is important that
it does not reach other parts of your body, because this so-called systemic leakage could cause serious side effects on the main organs of the body.
During the IPL and the seven to ten day period afterwards you will need to stay in hospital, your doctor will carefully monitor your blood pressure, circulation and any side effects. You may have to stay in an intensive care unit (ICU) directly after the ILP for a short time.
A condition called “compartment syndrome” may develop within the first three days after Beromun administration. Symptoms of muscle damage at the perfused limb include pain, swelling, as well as neurological symptoms (e. g. paraesthesia, paralysis), all of which should be reported immediately to the attending doctor.
Tell your doctor if you are using, have recently used or might use any other medicines. In particular, you should tell your doctor if you are using medicines to lower blood pressure (to treat hypertension).
For ILP, you will also receive other medicines to control pain, fever, blood pressure and blood clotting, as well as general anaesthesia.
You must not use Beromun if you are pregnant.
You must not breast-feed for at least seven days after treatment with Beromun.
Not relevant
This medicine contains 151.27 mg (6.58mmol) sodium in each recommended dose. This is equivalent to 7.6% of the recommended maximum daily dietary intake of sodium for an adult.
Beromun will be administered by isolated limb perfusion (ILP), together with the anti-tumour agent melphalan. This will occur whilst you are unconscious, under the influence of a general anaesthetic.
The blood flow to and from your affected limb will be stopped using a tourniquet. Blood, supplied with oxygen by a heart and lung machine, is pumped into your affected limb via a catheter in the main artery, while it is drained (pumped out) from the main vein. Beromun and then melphalan are injected into this circuit, over a total of 90 minutes the affected limb will be exposed to Beromun.
The recommended dose of Beromun depends on the affected limb, usually 3 mg for the arm and 4 mg for the leg. Beromun powder has to be dissolved before use. The resulting solution will be administered into an artery in your affected arm or leg by ILP for an initial period of 30 minutes. After that, melphalan will be added and the ILP continued for another 60 minutes.
Finally, your limb will be washed out to remove the rest of Beromun and melphalan.
ILP allows that tumour cells in your limb can be exposed to a very high dose of Beromun and melphalan, enhancing their anti-tumour effect, but without reaching the rest of the body, where they could cause serious side effects.
You will usually not receive a second ILP with Beromun. If you do, this will not be until at least six weeks after your first ILP.
As Beromun is always administered by experienced and qualified hospital doctors, accidental overdose is extremely unlikely. However, should this occur, your doctor will immediately wash out
your affected limb to remove Beromun, and the ILP will be stopped. If there is any risk of serious side effects, your doctor will immediately transfer you to an intensive care unit to closely monitor you and
start adequate treatment.
If more than 10% of your Beromun dose reaches the main part of your body, your doctor will take similar measures as in the case of overdose.
If you have any further questions on the use of this product, ask your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may be caused by Beromun, melphalan, the ILP technique or a combination of these factors. Some of the side effects can be serious, particularly if Beromun reaches other parts of your body (systemic leakage). In approximately 2% of cases, Beromun may cause tissue damage in your affected arm or leg which is severe enough to require amputation. If there is any risk of serious side effects, your doctor will immediately transfer you to an intensive care unit to closely monitor you and start adequate treatment.
The following side effects were observed during treatment with this medicine (grouped by how likely they are to happen).
Very common (may affect more than 1 in 10 people)
disturbances in your heart beat (arrhythmia)
feeling sick, vomiting
liver damage
blistering of the skin
fever (usually mild to moderate), chills
pain in the affected arm or leg
tiredness (fatigue)
Common (may affect up to 1 in 10 people)
- infections
local wound infections
reductions in numbers of certain white blood cells and platelets
hypersensitivity (allergic) reactions
nerve damage
decreased consciouness
headache
heart problems which can cause shortness of breath or ankle swelling
blood clot formation in the artery or vein of the affected arm or leg (thrombosis)
low blood pressure, shock
severe breathing problems
constipation, diarrhoea
skin necrosis (death of skin cells) in the affected arm or leg
swelling of the ankles, feet or fingers caused by fluid build up in the affected arm or leg
“compartment syndrome”, a medical condition characterised by pain, swelling and neurological symptoms, as well as muscle damage in the affected arm or leg
muscle pain
- protein in urine
night sweats
tissue necrosis (death of tissue cells) in the affected arm or leg, which is severe enough to require amputation
Uncommon (may affect up to 1 in 100 people)
blood poisoning (sepsis)
fluid in the lungs
stomach ache
inflammation of the gastric mucosa (gastritis)
temporary loss of finger or toe nails of the affected arm or leg
kidney failure
blood tests showing changes in the way the kidneys are working
narrowing or closing of limb vessels carrying blood from the heart
If you get any side effects talk to your doctor. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Upon reconstitution the product should be used immediately.
The active substance is tasonermin. Each vial contains 1 mg tasonermin. The content of one vial
of Beromun powder should be reconstituted with 5.3 ml sterile 0.9% sodium chloride solution for injection
The other ingredients (excipient(s)) are sodium dihydrogen phosphate dihydrate, disodium
phosphate dodecahydrate and human serum albumin.
Beromun is a white to off-white powder for solution for infusion (powder for infusion) supplied in a
glass vial with rubber stopper and sealed with aluminium flip-off cap. Each pack contains 4 vials of powder.
BELPHARMA s.a.
2, Rue Albert 1er
L-1117 Luxembourg
Grand Duchy of Luxembourg
Eumedica NV
Chemin de Nauwelette 1 B-7170 Manage
Belgium
For any information about this medicine, please contact the Marketing Authorisation Holder:
BELPHARMA s.a.
2, Rue Albert 1er
L-1117 Luxembourg
Grand Duchy of Luxembourg Tel : +352 27403070
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.