DOPTELET avatrombopag (as maleate) 20 mg film-coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

avatrombopag maleate, Quantity: 23.6 mg

Available from:

Swedish Orphan Biovitrum Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; lactose monohydrate; microcrystalline cellulose; magnesium stearate; crospovidone; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

10, 30, 15

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

DOPTELET is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.,DOPTELET is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Product summary:

Visual Identification: Pale yellow, round biconvex, film-coated tablet, debossed with 'AVA' on one side and '20' on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 60 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2023-01-16

Patient Information leaflet

DOPTELET
1
DOPTELET
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING DOPTELET?
DOPTELET contains the active ingredient avatrombopag maleate. DOPTELET
is used to treat low platelet count (called
thrombocytopenia) in adults with chronic liver disease before having
an invasive medical procedure where there is a risk of
bleeding and adults with low platelet counts due to primary chronic
immune thrombocytopenia (ITP) when a prior treatment
for ITP has not worked well enough.
For more information, see Section 1. Why am I using DOPTELET? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DOPTELET?
Do not use if you have ever had an allergic reaction to avatrombopag
or to any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
DOPTELET? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DOPTELET and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE DOPTELET?
•
Take DOPTELET exactly as your doctor has told you. Your dose will
depend on your platelet counts.
•
If you have chronic liver disease and are scheduled for an invasive
medical procedure, the usual dose is either 40 mg
(2 tablets) or 60 mg (3 tablets) every day for 5 days in a row.
•
If you have chronic immune thrombocytopenia, the usual starting dose
is 20 mg (1 tablet) a day.
•
DOPTELET tablets should be swallowed whole and taken with food.
More instructions can be found in Section 4. How do I use DOPTELET? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DOPTELET?

Summary of Product characteristics

Product Information - Australia
CCDSv3
Page 1 of 14
a
This medicinal product is subject to additional monitoring in
Australia. This will allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse events at
_https://www.tga.gov.au/reporting-problems_.
AUSTRALIAN PRODUCT INFORMATION – DOPTELET
(AVATROMBOPAG) FILM COATED TABLETS
1. NAME OF THE MEDICINE
avatrombopag maleate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each DOPTELET tablet contains 23.6 mg avatrombopag maleate (equivalent
to 20 mg of avatrombopag).
Excipients with known effect: sugars as lactose.
For the full list of excipients, see _section 6.1 List of excipients_.
3. PHARMACEUTICAL FORM
Film coated tablet.
Pale yellow, round biconvex, film-coated tablet, debossed with
“AVA” on one side and “20” on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DOPTELET is indicated for the treatment of thrombocytopenia in adult
patients with chronic liver disease who are
scheduled to undergo a procedure.
DOPTELET is indicated
for
the
treatment
of
thrombocytopenia
in
adult
patients
with
chronic
immune
thrombocytopenia (ITP) who have had an insufficient response to a
previous treatment.
4.2 DOSE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSAGE FOR PATIENTS WITH CHRONIC LIVER DISEASE
Obtain a platelet count prior to administration of DOPTELET therapy
and on the day of a procedure to ensure an
adequate increase in platelet count. DOPTELET should only be used for
procedures for which an adequate platelet
count is required to reduce the risk of bleeding.
Begin DOPTELET dosing 10 to 13 days prior to the scheduled procedure.
The recommended daily dose of
DOPTELET is based on the patient’s platelet count prior to the
scheduled procedure (see Table 1). Patients should
undergo their procedure 5 to 8 days after the last dose of DOPTELET.
DOPTELET should be taken orally once daily for 5 consecutive days with
food. In the case of a missed dose,
patients should take the next dose of DOPTEL