Lysodren

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Mitotane

Available from:

HRA Pharma Rare Diseases

ATC code:

L01XX23

INN (International Name):

mitotane

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Adrenal Cortex Neoplasms

Therapeutic indications:

Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma. The effect of Lysodren on non-functional adrenal cortical carcinoma is not established.

Product summary:

Revision: 18

Authorization status:

Authorised

Authorization date:

2004-04-28

Patient Information leaflet

18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET: INFORMATION FOR THE USER
LYSODREN 500 MG TABLETS
mitotane
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
ALWAYS KEEP WITH YOU THE
LYSODREN PATIENT CARD INCLUDED AT THE END OF THIS LEAFLET.
WHAT IS IN THIS LEAFLET
:
1.
What Lysodren is and what it is used for
2.
What you need to know before you take Lysodren
3.
How to take Lysodren
4.
Possible side effects
5.
How to store Lysodren
6.
Contents of the pack and other information
1.
WHAT LYSODREN IS AND WHAT IT IS USED FOR
Lysodren is an antitumoral medicine.
This medicine is used for the treatment of symptoms of advanced non
operable, metastatic or recurrent
malignant tumours of the adrenal glands.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LYSODREN
DO NOT TAKE LYSODREN
-
if you are allergic to mitotane or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are breast-feeding. You must not breast-feed while taking
Lysodren.
-
if you are being treated with medicines containing spironolactone (see
"Other medicines and
Lysodren").
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Lysodren.
You should tell your doctor if any of the following applies to you:
-
if you have an injury (shock, severe trauma), an infection or if you
have any illness while you
are taking Lysodren. Tell your doctor immediately, who may decide to
temporarily stop
treatment.
-
if you have liver problems: Tell your doctor if you develop any of the
following signs and
symptoms of liver problems during Lysodren treatment: itc

Summary of Product characteristics

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lysodren 500 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of mitotane.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, biconvex, round, scored tablets.
They are bisected on one side and impressed "BL" over "L1" on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of advanced (unresectable, metastatic or
relapsed) adrenal cortical carcinoma
(ACC).
The effect of Lysodren on non functional adrenal cortical carcinoma is
not established.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and followed by a suitably experienced
specialist.
_ _
Posology
Treatment in adults should be started with 2 - 3 g mitotane per day
and increased progressively (e.g. at
two-week intervals) until mitotane plasma levels reach the therapeutic
window 14 – 20 mg/L.
If it is urgent to control Cushing’s symptoms in highly symptomatic
patients, higher starting doses
between 4 - 6 g per day could be necessary and daily dose increased
more rapidly (e.g. every week). A
starting dose higher than 6 g/day is generally not recommended.
_Dose adjustments, monitoring and discontinuation_
Dose adjustment is aimed to reach a therapeutic window (mitotane
plasma levels 14 - 20 mg/L) which
ensures optimal use of Lysodren with acceptable safety. Indeed,
neurologic toxicity has been
associated with levels above 20 mg/L and therefore this threshold
should not be reached. There are
some data suggesting that mitotane plasma above 14 mg/L may result in
enhanced efficacy (see
section 5.1). Mitotane plasma levels higher than 20 mg/L may be
associated with severe undesirable
effects and offer no further benefit in terms of efficacy. Mitotane
plasma levels should therefore be
monitored in order to adjust the Lysodren dose and to avoid reaching
toxic levels. For further
information on the sample testing please contact the Marketing
Authorisatio