ODOMZO 200 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SONIDEGIB AS DIPHOSPHATE

Available from:

TARO INTERNATIONAL LTD, ISRAEL

ATC code:

L01XX48

Pharmaceutical form:

HARD CAPSULE

Composition:

SONIDEGIB AS DIPHOSPHATE 200 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

PATHEON INC., CANADA

Therapeutic area:

SONIDEGIB

Therapeutic indications:

Odomzo 200 mg is indicated for the treatment of adult patients with locally advanced basal cell carcinoma which cannot be treated with curative surgery or radiation therapy

Authorization date:

2016-06-09

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS)
- 1986
This medicine is dispensed with a doctor’s prescription only
ODOMZO
® 200 MG
HARD CAPSULES
ACTIVE INGREDIENT:
Each capsule contains: sonidegib diphosphate 280.80 mg (equivalent to
sonidegib 200 mg)
See list of inactive ingredients and allergens in this medicine in
section 6 “Additional
information” and in section 2 under “Important information about
some of this medicine’s
ingredients”.
READ THE ENTIRE PATIENT LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
This leaflet contains
concise information about this medicine. If you have any further
questions, ask your doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may
harm them, even if it seems to you that their illness is similar to
yours.
THIS MEDICINE IS NOT INTENDED FOR CHILDREN AND ADOLESCENTS UNDER 18
YEARS OLD.
PATIENT SAFETY INFORMATION CARD
In addition to the patient leaflet, Odomzo has a patient safety
information card about possible
harm to your unborn baby. This card contains important safety
information that you need to
know before starting treatment and during treatment with Odomzo.
Carefully read the patient
safety information card and package insert before using this medicine.
Keep the card and
package insert in case you need to read them again.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Odomzo is intended to treat adults with a type of skin cancer called
basal cell carcinoma
(BCC). It is used when the cancer has spread locally and cannot be
treated with surgery or
radiation.
The normal growth of cells is controlled by various chemical signals.
In patients with basal
cell carcinoma, changes occur in genes that control a part of this
process known as the
“hedgehog pathway”. This pathway switches on signals that make the
cancer cells grow out
of control. Odomzo works by blocking this pathway, blocking the
signals, and thereby
stopping cancer cells from growing and making new cells.
THERAPE

Summary of Product characteristics

Page 1 of 21
Dec 2020
1.
NAME OF THE MEDICINAL PRODUCT
Odomzo 200 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains sonidegib diphosphate 280.80 mg
(corresponding to sonidegib
200 mg)
Excipient with known effect
Each hard capsule contains 38.6 mg lactose monohydrate.
Each hard capsule contains 0.53 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Opaque pink hard gelatin capsule containing white to practically white
powder with granules,
with “NVR” imprinted in black ink (radial, rectified) on the cap
and “SONIDEGIB 200MG”
imprinted in black ink (radial, rectified) on the body.
The size of the capsule is “Size #00”, Coni-snap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Odomzo 200 mg is indicated for the treatment of adult patients with
locally advanced basal
cell carcinoma which cannot be treated with curative surgery or
radiation therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Odomzo 200 mg 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.
Page 2 of 21
Notification 12.2020
_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.
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