DOMIDE CAPSULES 50mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Thalidomide

Available from:

PHARM-D SINGAPORE PRIVATE LIMITED

ATC code:

L04AX02

Pharmaceutical form:

CAPSULE

Composition:

Thalidomide 50mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

TTY Biopharm Company Limited Chungli Factory

Authorization status:

ACTIVE

Authorization date:

2021-11-02

Summary of Product characteristics

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1
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DOMIDE CAPSULES 50 MG
THALIDOMIDE 50 MG
【
BOXED WARNINGS
】
SEVERE, LIFE-THREATENING HUMAN BIRTH DEFFECTS
If
Thalidomide is taken during pregnancy,
it
can cause severe birth
defects or
death to an unborn baby.
Thalidomide should never
be
used in women who are pregnant
or
who could become pregnant
while taking the drug or could become pregnant within 4 weeks after
stopping the medicine.
Even a single dose taken by a pregnant
woman during her pregnancy can cause severe birth defects. Before
starting treatment,
patients have to read and sign the Letter
of
consent
for
female/male patients
for
taking DOMIDE and must
comply with the instructions and follow physicians’
directions.
Once
treatment
has started,
if
you are unable or unwilling to comply with
the instructions or directions,
you have to stop taking DOMIDE and
inform your doctors.
VENOUS THROMBOEMBOLISM
The
use
of
Thalidomide
in
combination
with
standard
chemotherapeutic
agents
including
dexamethasone
in
multiple
myeloma results in an increased risk of
venous thromboembolism,
such as deep venous thrombosis and pulmonary embolism. Patients
and physicians
are advised to be observant
for
the signs
and
symptoms of
thromboembolism.
Instruct
patients to seek medical
care if
they develop symptoms such as shortness of
breath,
chest
pain,
or arm or leg swelling.
Consider thromboprophylaxis based on
an assessment of individual patients’ underlying risk factors.
【
INDICATION
】
_MULTIPLE MYELOMA (MM):_
-
DOMIDE in combination with melphalan and prednisone is
indicated for
the treatment
of
patients with untreated multiple
myeloma
≧
65 years or ineligible for high dose chemotherapy.
-
DOMIDE in combination with dexamethasone is indicated for
induction
therapy
prior
to
high
dose
chemotherapy
with
autologous stem cell
rescue,
for the treatment
of
patients with
untreated multiple myeloma.
【
POSOLOGY AND METHOD OF ADMINISTRATION
】
-
Drugs prescribed to women of
childbearing potential
must
be
contingent upon initial
and continued confirmed negative results