THALOMID thalidomide 100 mg hard capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

thalidomide, Quantity: 100 mg

Available from:

Celgene Pty Ltd

INN (International Name):

Thalidomide

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: magnesium stearate; pregelatinised maize starch; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; Gelatin; sodium lauryl sulfate

Administration route:

Oral

Units in package:

28 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

MULTIPLE MYELOMA - Thalomid in combination with melphalan and prednisone is indicated for the treatment of patients with untreated multiple myeloma aged 65 years and over or ineligible for high dose chemotherapy. Thalomid 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. Thalomid, as monotherapy, is indicated for the treatment of multiple myeloma after failure of standard therapies. ERYTHEMA NODOSUM LEPROSUM (ENL). Thalomid is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). Thalomid is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis. Thalomid is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. Thalomid is prescribed and dispensed through the Thalidomide Risk Management Programme. MULTIPLE MYELOMA - Thalomid in combination with melphalan and prednisone is indicated for the treatment of patients with untreated multiple myeloma aged 65 years and over or ineligible for high dose chemotherapy. Thalomid 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. Thalomid, as monotherapy, is indicated for the treatment of multiple myeloma after failure of standard therapies. ERYTHEMA NODOSUM LEPROSUM (ENL). Thalomid is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). Thalomid is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis. Thalomid is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.

Product summary:

Visual Identification: Tan, opaque capsule shells imprinted with "BMS" and "100 mg" on the body with a "Do not get pregnant" symbol in black ink on the cap; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-12-22

Patient Information leaflet

THALOMID
® CAPSULES
_thalidomide_
CONSUMER MEDICINE INFORMATION
WARNING:
THALIDOMIDE HAS CAUSED SEVERE LIFE-THREATENING HUMAN BIRTH DEFECTS
(DEFORMED BABIES) AND DEATH TO AN UNBORN BABY
IF TAKEN DURING PREGNANCY. IF THALOMID IS TAKEN DURING PREGNANCY, IT
MAY CAUSE BIRTH DEFECTS OR DEATH TO AN UNBORN
BABY. DO NOT TAKE THALOMID IF YOU ARE PREGNANT, OR THINK THAT YOU ARE
PREGNANT.
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Thalomid.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Thalomid
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THALOMID IS
USED FOR
Thalomid contains an active
substance called thalidomide.
Thalomid belongs to a group of
medicines known as immuno-
modulating agents that work by
acting on the cells involved in the
body's immune system. The immune
system is part of the body's defence
which helps to fight illness and
infection.
_TREATMENT OF MULTIPLE_
_MYELOMA_
Thalomid is used to treat multiple
myeloma, a cancer of the bone
marrow.
It is used in combination with other
medicines, melphalan and
prednisone, for the treatment of
newly diagnosed multiple myeloma
in patients aged over 65 years or
patients who cannot receive high
dose chemotherapy. It is also used in
combination with dexamethasone at
the start of high dose chemotherapy
treatment or a bone marrow
transplant. To find out more about
these medicines, please ask your
doctor.
Thalomid may also be used for the
treatment of multiple myeloma after
other treatments have failed.
_TREATMENT OF SKIN_
_SYMPTOMS ASSOCIATED WITH_
_SEVERE ERYTHEMA NODOSUM_
_LEPROSUM (ENL)_
Thalomid is also used for the
treatment of the skin symptoms
associated with moderate to severe
erythema nodosum leprosum (ENL

Summary of Product characteristics

Thalomid
®
(thalidomide) capsules – AU Product Information
Celgene V4.0 – 21 April 2022 (CCDS V11)
AUSTRALIAN PRODUCT INFORMATION
THALOMID
® (THALIDOMIDE) CAPSULES
TERATOGENIC EFFECTS:
THALIDOMIDE HAS CAUSED SEVERE BIRTH DEFECTS WHEN TAKEN DURING
PREGNANCY. THALIDOMIDE SHOULD
NEVER BE USED BY WOMEN WHO ARE PREGNANT OR WHO COULD BECOME PREGNANT
WHILST TAKING THE
MEDICINE OR COULD BECOME PREGNANT WITHIN 4 WEEKS AFTER STOPPING THE
MEDICINE. EVEN A SINGLE DOSE
CAN CAUSE BIRTH DEFECTS
.
1.
NAME OF THE MEDICINE
Thalidomide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50 mg capsule contains 50 mg of thalidomide.
Each 100 mg capsule contains 100 mg of thalidomide.
Each 150 mg capsule contains 150 mg of thalidomide.
Each 200 mg capsule contains 200 mg of thalidomide.
For the full list of excipients, see section 6.1 (List of excipients).
3.
PHARMACEUTICAL FORM
Thalomid 50 mg capsules: White, opaque capsule shells imprinted with
“Celgene 50 mg” with a “Do not
get pregnant” symbol in black ink (SW-9008/SW-9009). The capsule
shell contains gelatin and titanium
dioxide (E171).
Thalomid 100 mg capsules: Tan, opaque capsule shells imprinted with
“Celgene 100 mg” with a “Do not
get pregnant” symbol in black ink (SW-9008/SW-9009). The capsule
shell contains gelatin, titanium
dioxide (E171) and colourants black iron oxide and yellow iron oxide.
Thalomid 150 mg capsules: Tan, opaque body capsule shells imprinted
with “Celgene 150 mg” in black
ink (SW-9008/SW-9009), and a blue, opaque cap with a “Do not get
pregnant” symbol in white ink (S-1-
7085). The capsule shell contains gelatin, titanium dioxide (E171) and
colourants blue #2, black iron
oxide and yellow iron oxide.
Thalomid 200 mg capsules: Blue, opaque capsule shells imprinted with
“Celgene 200 mg” with a “Do not
get pregnant” symbol in white ink (S-1-7085). The capsule shell
contains gelatin, titanium dioxide (E171)
and colourant blue #2.
Description
Thalidomide has an empirical formula of C
13
H
10
N
2
O
4
and a relative molecular ma