TAVALISSE 100 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

FOSTAMATINIB AS DISODIUM HEXAHYDRATE

متاح من:

MEDISON PHARMA LTD

ATC رمز:

B02BX09

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

FOSTAMATINIB AS DISODIUM HEXAHYDRATE 100 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

RIGEL PHARMACEUTICALS, INC., USA

المجال العلاجي:

FOSTAMATINIB

الخصائص العلاجية:

TAVALISSE is indicated for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments.

تاريخ الترخيص:

2021-08-04

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( - 1986
This medicine is dispensed
with a physician’s prescription only
TAVALISSE 100 MG
TAVALISSE 150 MG
FILM-COATED TABLETS
THE ACTIVE INGREDIENT AND ITS QUANTITY:
Each film-coated tablet of Tavalisse 100 mg and 150
mg contains: 100 mg and 150 mg of FOSTAMATINIB )AS
DISODIUM HEXAHYDRATE( RESPECTIVELY
For a list of inactive and allergenic ingredients in the
preparation, see section 6 ”FURTHER INFORMATION“.
See also ”IMPORTANT INFORMATION ABOUT SOME OF THE
MEDICINE’S INGREDIENTS“ in section 2.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THE MEDICINE. This leaflet contains concise
information about the medicine. If you have any further
questions, consult the physician 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.
1. WHAT IS THE MEDICINE INTENDED FOR?
Tavalisse is indicated for the treatment of chronic
immune thrombocytopenia (ITP) in adult patients who
are refractory to other treatments.
THERAPEUTIC GROUP -
The medicine belongs to the group of spleen tyrosine
kinase (Syk) inhibitors
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You are sensitive )allergic( to the active ingredient
(FOSTAMATINIB) or to any of the additional ingredients
that the medicine contains (see section 6 ”FURTHER
INFORMATION“(.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
Before treatment with Tavalisse, tell the physician if:
•
You suffer from:
o
High blood pressure
o
Liver problems
• You are pregnant or are planning to get pregnant.
Tavalisse may cause harm to the fetus.
o
The physician will check if you are pregnant before
starting treatment
o
If you are of childbearing age, you must use
effective means of contraception during treatment
with Tavalisse until at least a month after taking the
last dose.
• You are breastfeeding or are planning to breastfeed.
Do not breastfeed durin

خصائص المنتج

PHYSICIAN’S PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
TAVALISSE 100 mg
TAVALISSE 150 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TAVALISSE 100 mg film-coated tablets
Each film-coated tablet contains 126.2 mg of fostamatinib disodium
hexahydrate equivalent to 100 mg
fostamatinib
_Excipient(s) with known effect _
Each 100 mg tablet contains 23 mg sodium (from excipients and
fostamatinib disodium hexahydrate).
TAVALISSE 150 mg film-coated tablets
Each film-coated tablet contains 189.3 mg of fostamatinib disodium
hexahydrate equivalent to 150 mg
fostamatinib.
_Excipient(s) with known effect _
Each 150 mg tablet contains 34 mg sodium (from excipients and
fostamatinib disodium hexahydrate). For
the full list of excipients, see section 11
3.
THERAPEUTIC INDICATIONS
TAVALISSE is indicated for the treatment of chronic immune
thrombocytopenia (ITP) in adult patients who
are refractory to other treatments.
4
DOSAGE AND ADMINISTRATION
4.1
RECOMMENDED DOSAGE
Initiate TAVALISSE at a dose of 100 mg taken orally twice daily. After
a month, if platelet count has not
increased to at least 50 × 10
9
/L, increase TAVALISSE dose to 150 mg twice daily.
Use the lowest dose of TAVALISSE to achieve and maintain a platelet
count at least 50 × 10
9
/L as
necessary to reduce the risk of bleeding.
TAVALISSE may be taken with or without food. In the case of a missed
dose of TAVALISSE, instruct
patients to take their next dose at its regularly scheduled time.
4.2
MONITORING
After obtaining baseline assessments:
Monitor CBCs, including platelet counts, monthly until a stable
platelet count (at least 50 × 10
9
/L) is
achieved. Thereafter, continue to monitor CBCs, including neutrophils,
regularly.
Monitor liver function tests (LFTs) (e.g., ALT, AST, and bilirubin)
monthly.
Monitor blood pressure every 2 weeks until establishment of a stable
dose, then monthly thereafter.
4.3
DOSE MODIFICATION FOR ADVERSE REACTIONS
TAVALISSE dose modification is recommended based on individual safety
and tolerability.
Management of some adv