ROMIPLATE POWDER FOR SOLUTION FOR INJECTION 250 μgvial

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ROMIPLOSTIM 375 μg/vial

Available from:

KYOWA KIRIN ASIA PACIFIC PTE. LTD.

ATC code:

B02BX04

Dosage:

Romiplostim 375μg/vial (deliverable amt 250μg/vial)

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

ROMIPLOSTIM 375 μg/vial 250 μg/vial (deliverable amount)

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Patheon Italia S.p.A Monza Operations

Authorization status:

ACTIVE

Authorization date:

2014-12-03

Patient Information leaflet

Page 1 of 15(FINAL PI_SIN9HUVLRQGUDIWB1RY)
1. NAME OF THE MEDICINAL PRODUCT
Romiplate
Š
250μg, SRZGHUIRUVROXWLRQIRUInjection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250 μg of romiplostim. After
reconstitution, a deliverable volume of 0.5 mL 
solution contains 250 μg of romiplostim (500 μg/mL). An
additional overfill is included in each vial 
to ensure that 250 μg of romiplostim can be delivered.
Romiplostim is
produced by recombinant DNA technology in _Escherichia
coli_ (_E. coli_). 
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for solution for injection.
This powder is white.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS 
Romiplate
Š
is indicated for adult chronic immune (idiopathic) thrombocytopenic
purpura 
(ITP) splenectomised patients who are refractory to other treatments
(e.g. 
corticosteroids, immunoglobulins).
Romiplate
Š
may be considered as second line treatment for
adult non-splenectomised
patients where surgery is contra-indicated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should remain under the supervision of a physician
who is experienced in the treatment 
of haematological diseases.
Posology
Romiplate
Š
should be administered once weekly as a subcutaneous 
injection.
Initial dose
The initial dose of romiplostim is 1 μg/kg based on actual
body weight.
_Dose calculation_
Initial or subsequent once 
weekly dose: 
Weight* in kg x Dose in μg/kg = Individual patient dose
in μg 
Volume to administer: 
Dose in μg x 1 mL
.
500 μg        = Amount to inject in mL
Example
75 kg patient is initiated at 1 μg/kg of romiplostim.
The individual patient dose =
75 kg x 1 μg/kg or 75 μg
The corresponding amount of Romiplate
Š
solution to inject 
=  75 μg x 1 mL
= 0.15 mL
500 μg
*Actual body weight at initiation of treatment should always be
used when calcula

Summary of Product characteristics

Page 1 of 21
XXXXXX
ROMIPLATE
® 250ΜG
POWDER FOR SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINAL PRODUCT
Romiplate
®
250 µg, powder for solution for Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250 µg of romiplostim. After reconstitution, a
deliverable volume of 0.5
mL
solution contains 250 µg of romiplostim (500 µg/mL). An additional
overfill is included
in each vial to
ensure that 250 µg of romiplostim can be delivered.
Romiplostim is produced by recombinant DNA technology in
_Escherichia coli _
(
_E. _
_coli_
).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection (powder for injection).
The powder is white.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Chronic immune (idiopathic) thrombocytopenic purpura (ITP) _
Romiplate
®
is indicated for adult chronic immune (idiopathic) thrombocytopenic
purpura
(ITP)
splenectomised patients who are refractory to other treatments (e.g.
corticosteroids,
immunoglobulins) (see sections 4.2 and 5.1).
Romiplate
®
may be considered as second line treatment for adult
non-splenectomised patients
where
surgery is contraindicated.
_Aplastic anaemia _
Romiplate
®
is indicated for adults with moderate to severe aplastic anaemia
refractory to
conventional therapies.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should remain under the supervision of a physician who is
experienced in the
treatment of
haematological diseases.
Posology
Romiplate
®
should be administered once weekly as a subcutaneous injection.
Page 2 of 21
_Initial dose_
_Chronic immune (idiopathic) thrombocytopenic purpura (ITP) _
The initial dose of romiplostim is 1 µg/kg based on actual body
weight.
_Aplastic anaemia _
Usually administer an initial dose of 10 μg/kg subcutaneously as
romiplostim (genetical
recombination) for adults. After initiation of treatment, the dose may
be adjusted based on the
patient’s condition, and administer once weekly. The maximum weekly
dose is 20 µg/kg.
_Dose calculation _
The