LYSODREN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MITOTANE

Available from:

CTS LTD

ATC code:

L01XX23

Pharmaceutical form:

TABLETS

Composition:

MITOTANE 500 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

HRA PHARMA RARE DISEASES, FRANCE

Therapeutic area:

MITOTANE

Therapeutic indications:

Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma (ACC).

Authorization date:

2021-01-19

Patient Information leaflet

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
LYSODREN
500 MG TABLETS
THE ACTIVE INGREDIENT AND ITS AMOUNT:
Each tablet contains 500 mg of mitotane.
Inactive and allergenic ingredients in the preparation - see Section 6
“Further
Information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have further
questions, consult
the doctor or pharmacist.
This medicine has been prescribed to treat your ailment. Do not pass
it on to others. It
may harm them even if it seems to you that their ailment is similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the symptomatic treatment of advanced
(unresectable,
metastatic or relapsed) adrenal cortical carcinoma (ACC).
THERAPEUTIC GROUP: Antineoplastic agents.
2.
BEFORE USING THE MEDICINE
X DO NOT USE THE MEDICINE IF:
-
You are sensitive (allergic) to mitotane or to any of the other
ingredients
contained in the medicine (see section 6).
-
You are breastfeeding. You must not breastfeed during treatment with
Lysodren.
-
You are being treated with medicines containing spironolactone (see
“Drug
interactions”).
! SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH THIS MEDICINE, TELL THE DOCTOR IF:
-
You have an injury (shock, severe trauma), an infection or illness
while you are
taking Lysodren. Tell the doctor immediately, who may decide to
temporarily
stop treatment.
-
You have liver problems: Tell the doctor if you develop any of the
following signs
and symptoms indicating liver problems during Lysodren treatment:
itching,
yellow eyes or skin, dark urine, pain or discomfort in the right upper
abdomen
area. The doctor should do blood tests to check your liver function
before and
during treatment with Lysodren, and as clinically needed.
-
You have severe kidney problems.
-
You are using any of the medicines mentioned below (see “D

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Lysodren
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 Authorisation Holder or its local represen