Doptelet

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

avatrombopag maleate

Διαθέσιμο από:

Swedish Orphan Biovitrum AB (publ)

Φαρμακολογική κατηγορία (ATC):

B02BX

INN (Διεθνής Όνομα):

avatrombopag

Θεραπευτική ομάδα:

Antihemorrhagics

Θεραπευτική περιοχή:

Thrombocytopenia

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Revision: 5

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2019-06-20

Φύλλο οδηγιών χρήσης

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOPTELET 20 MG FILM-COATED TABLETS
avatrombopag
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 Doptelet is and what it is used for
2.
What you need to know before you take Doptelet
3.
How to take Doptelet
4.
Possible side effects
5.
How to store Doptelet
6.
Contents of the pack and other information
1.
WHAT DOPTELET IS AND WHAT IT IS USED FOR
Doptelet contains an active substance called avatrombopag. It belongs
to a group of medicines called
thrombopoietin receptor agonists.
Doptelet is used in adults with chronic liver disease to treat low
platelet count (called
thrombocytopenia) before having a medical procedure where there is a
risk of bleeding.
Doptelet is used to treat adults with low platelet counts due to
primary chronic immune
thrombocytopenia (ITP) when a prior treatment for ITP (such as
corticosteroids or immunoglobulins)
has not worked well enough.
Doptelet works by helping to increase the number of platelets in the
blood. Platelets are blood cells
that help the blood to clot and so reduce or prevent bleeding.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOPTELET
_ _
DO NOT TAKE DOPTELET
-
if you are allergic to avatrombopag or any of the other ingredients of
this medicine (listed in
section 6). If you are not sure, talk to your doctor or pharmacist
before taking Doptelet.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Doptelet if:
•
you are at risk of blood clots in your veins or arteries,

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Doptelet 20 mg film-coated tablets
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
Doptelet is indicated for the treatment of severe thrombocytopenia in
adult patients with chronic liver
disease who are scheduled to undergo an invasive procedure.
Doptelet 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. Doptelet 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 Doptelet
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.
3
TABLE 1: DAILY DOSE RECOMMENDATION FOR AVATROMBOPAG
PLATELET COUNT (×10
9
/L)
ONCE-DAILY DOSE
DURATION OF DOSING
< 40
60 mg (Three 20 mg tablets)
5 days
≥ 40 to < 50
40 mg