Beromun

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

tasonermin

Available from:

Belpharma s.a.

ATC code:

L03AX11

INN (International Name):

tasonermin

Therapeutic group:

Immunostimulants,

Therapeutic area:

Sarcoma

Therapeutic indications:

Beromun is indicated in adults as an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft-tissue sarcoma of the limbs, used in combination with melphalan via mild hyperthermic isolated-limb perfusion (ILP).

Product summary:

Revision: 15

Authorization status:

Authorised

Authorization date:

1999-04-12

Patient Information leaflet

20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
BEROMUN 1 MG POWDER FOR SOLUTION FOR INFUSION
Tasonermin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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 IS IN THIS LEAFLET:
1.
What Beromun is and what it is used for
2.
What you need to know before you use Beromun
3.
How to use Beromun
4.
Possible side effects
5.
How to store Beromun
6.
Contents of the pack and other information
1.
WHAT BEROMUN IS AND WHAT IT IS USED FOR
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BEROMUN
DO NOT USE BEROMUN
-
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 cer

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Beromun 1 mg powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 mg tasonermin*, corresponding to 3.0-6.0 x 10
7
IU (International Units).
*tumor necrosis factor alfa-1a (TNFα-1a) produced by recombinant DNA
technology in
_E. coli_
.
Excipient(s) with known effect:
_ _
Each vial contains 20.12 mg (0.87 mmol) sodium. After reconstitution
in 0.9 % physiological sodium
chloride solution the amount is 37.82 mg (1.64 mmol) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion (powder for infusion).
The powder is white to off-white.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Beromun is indicated in adults. as an adjunct to surgery for
subsequent removal of the tumour so as to
prevent or delay amputation, or in the palliative situation, for
irresectable soft tissue sarcoma of the
limbs, used in combination with melphalan via mild hyperthermic
isolated limb perfusion (ILP).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This treatment should be undertaken in specialised centres by surgical
teams experienced in the
management of limb sarcomas and ILP procedure, with an intensive care
unit readily available and
with the facilities for continuous monitoring for medicinal product
leakage into the systemic
circulation.
Posology
_Beromun: _
Upper limb: 3 mg total dose by ILP
Lower limb: 4 mg total dose by ILP
_Melphalan: _
Melphalan dose should be calculated according to the litre-volume
method of Wieberdink
(Wieberdink J, Benckhuysen C, Braat RP, van Slooten EA, Olthius GAA.
Dosimetry in isolation
perfusion of the limbs by assessments of perfused tissue volume and
grading of toxic tissue reactions.
_Eur J Cancer Clin Oncol_
1982; 18: 905-910.), to a maximum dose of 150 mg.
13 mg/l perfused upper limb volume
10 mg/l perfused lower limb volume
_Paediatric population_
The safety and efficacy of Beromun in children under 18 years have not
bee