OPTZURO

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

AVATROMBOPAG AS MALEATE

Tilgjengelig fra:

TRUEMED LTD, ISRAEL

ATC-kode:

B02BX08

Legemiddelform:

FILM COATED TABLETS

Sammensetning:

AVATROMBOPAG AS MALEATE 20 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

SWEDISH ORPHAN BIOVITRUM AB (PUBL), SWEDEN

Terapeutisk område:

AVATROMBOPAG

Indikasjoner:

for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure.For the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins)

Autorisasjon dato:

2023-07-20

Informasjon til brukeren

Page 1 of 6
Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor’s prescription onl
y
Optzuro
Film-coated tablets
Active ingredient:
Each film-coated tablet contains 20 mg avatrombopag as maleate.
Inactive ingredients and allergens in this medicine: see section 2
under ‘Important information about
some of this medicine’s ingredients’, and section 6 ‘Additional
information’.
Read the entire leaflet carefully before you start using this
medicine. This leaflet contains concise
information about this medicine. If you have any further questions,
consult 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.
1.
What is this medicine intended for?
Optzuro is used:
•
for the treatment of severe thrombocytopenia (low platelet count) in
adult patients with chronic
liver disease who are scheduled to undergo an invasive procedure.
•
for the treatment of primary chronic immune thrombocytopenia (ITP) in
adult patients who are
refractory to other treatments (e.g. steroids, immunoglobulins).
Therapeutic group: Antihaemorrhagics, other haemostatics.
2.
Before using this medicine
Do not use this medicine if:
•
You are sensitive (allergic) to the active ingredient avatrombopag or
to any of the other
ingredients in this medicine (see section 6 'Additional information').
Special warnings about using this medicine
Before using Optzuro, tell your doctor:
•
If you are at risk of blood clot formation in the veins or arteries,
or a member of your family has
had blood clots.
•
If you have another blood disease called myelodysplastic syndrome
(MDS); taking Optzuro
may worsen this syndrome.
You may be at increased risk of blood clot formation as you get older
or if:
−
you have had to stay in bed for a long time
−
you have cancer
−
you are taking contraceptive birth control pill or hormone replacement
the

Preparatomtale

1
1.
NAME OF THE MEDICINAL PRODUCT
OPTZURO
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains avatrombopag maleate equivalent to 20
mg of avatrombopag.
Excipient with known effect
Each film-coated tablet contains 120.8 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Pale yellow, round biconvex film-coated 7.6
mm tablet debossed with “AVA” on one side and “20” on
the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Optzuro is indicated for the treatment of severe thrombocytopenia in
adult patients with chronic liver
disease who are scheduled to undergo an invasive procedure.
Optzuro is indicated for the treatment of primary chronic immune
thrombocytopenia (ITP) in adult
patients who are refractory to other treatments (e.g. corticosteroids,
immunoglobulins).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment should be initiated by and remain under the supervision of a
physician who is experienced
in the treatment of haematological diseases. Optzuro should be taken
at the same time of day (e.g. in
the morning or evening) with food, including when taking the dose less
frequently than once daily.
_Chronic Liver Disease _
Obtain a platelet count prior to the administration of Optzuro therapy
and on the day of a procedure to
ensure an adequate increase in platelet count, and no unexpectedly
high increase in platelet count in
the patient populations specified in sections 4.4 and 4.5.
The recommended daily dose of avatrombopag is based on
the patient’s
platelet count (see Table 1).
Dosing should begin 10 to 13 days prior to the planned procedure. The
patient should undergo their
procedure 5 to 8 days after the last dose of avatrombopag.
2
TABLE 1: DAILY DOSE RECOMMENDATION FOR AVATROMBOPAG
PLATELET COUNT (X 10
9
/L)
ONCE-DAILY DOSE
DURATION OF DOSING
< 40
60 mg (Three 20 mg tablets)
5 days
≥
40 to < 50
40 mg (Two 20 mg tablets)
5 days
_ _
_Duration of treatment _
Due to limited informa