Odomzo

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

sonidegib diphosphate

MAH:

Sun Pharmaceutical Industries Europe B.V.

ATC_code:

L01XJ02

INN:

sonidegib

therapeutic_group:

Antineoplastic agents

therapeutic_area:

Carcinoma, Basal Cell

therapeutic_indication:

Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.

leaflet_short:

Revision: 10

authorization_status:

Authorised

authorization_date:

2015-08-14

PIL

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ODOMZO 200 MG HARD CAPSULES
sonidegib
Odomzo may cause severe birth defects. It may lead to the death of a
baby before it is born or shortly after
being born. You must not become pregnant while taking this medicine.
You must follow the contraception
instructions contained in this leaflet.
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.
WHAT IS IN THIS LEAFLET
1.
What Odomzo is and what it is used for
2.
What you need to know before you take Odomzo
3.
How to take Odomzo
4.
Possible side effects
5.
How to store Odomzo
6.
Contents of the pack and other information
1.
WHAT ODOMZO IS AND WHAT IT IS USED FOR
WHAT ODOMZO IS
Odomzo contains the active substance sonidegib. It is an anti-cancer
medicine.
WHAT ODOMZO IS USED FOR
Odomzo is used to treat adults with a type of skin cancer called basal
cell carcinoma. It is used when the
cancer has spread locally and cannot be treated with surgery or
radiation.
HOW ODOMZO WORKS
The normal growth of cells is controlled by various chemical signals.
In patients with basal cell carcinoma,
changes occur to genes controlling a part of this process known as the
“hedgehog pathway”. This switches on
signals that make the cancer cells grow out of control. Odomzo works
by blocking this process, stopping
cancer cells from growing and making new cells.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ODOMZO
Read the specific instructions given to you by your doctor,
particularly on the effects of Odomzo on unborn
babies.
Read caref

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Odomzo 200 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 200 mg sonidegib (as phosphate).
Excipient with known effect
Each hard capsule contains 38.6 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Opaque pink hard capsule containing white to almost white powder with
granules, with “NVR” imprinted in
black ink on the cap and “SONIDEGIB 200MG” imprinted in black ink
on the body.
The size of the capsule is “Size #00” (dimensions 23.3 x 8.53 mm).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Odomzo is indicated for the treatment of adult patients with locally
advanced basal cell carcinoma (BCC)
who are not amenable to curative surgery or radiation therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Odomzo should only be prescribed by or under the supervision of a
specialist physician experienced in the
management of the approved indication.
Posology
The recommended dose is 200 mg sonidegib taken orally.
Treatment should be continued as long as clinical benefit is observed
or until unacceptable toxicity develops.
_Dose modifications for creatine phosphokinase (CK) elevations and
muscle-related adverse reactions _
Temporary dose interruption and/or dose reduction of Odomzo therapy
may be required for CK elevations
and muscle-related adverse reactions.
3
Table 1 summarises recommendations for dose interruption and/or dose
reduction of Odomzo therapy in the
management of symptomatic CK elevations and muscle-related adverse
reactions (such as myalgia,
myopathy, and/or spasm).
TABLE 1
RECOMMENDED DOSE MODIFICATIONS AND MANAGEMENT FOR SYMPTOMATIC CK
ELEVATIONS AND
MUSCLE-RELATED ADVERSE REACTIONS
SEVERITY OF CK ELEVATION
DOSE MODIFICATIONS* AND MANAGEMENT
RECOMMENDATIONS
Grade 1
[CK elevation >ULN - 2.5 x ULN]
•
Continue treatment at the same dose and
monitor CK levels weekly until resolution
to baseline level an