POMALYST pomalidomide 1 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Buy It Now

Patient Information leaflet (PIL)

13-10-2022

Summary of Product characteristics (SPC)

13-10-2022

Public Assessment Report (PAR)

26-11-2017

Active ingredient:

pomalidomide, Quantity: 1 mg

Available from:

Celgene Pty Ltd

INN (International Name):

pomalidomide

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: sodium stearylfumarate; mannitol; pregelatinised maize starch; titanium dioxide; indigo carmine; iron oxide yellow; Shellac; simethicone; propylene glycol; strong ammonia solution; isopropyl alcohol; butan-1-ol; ethanol absolute; iron oxide black; Gelatin

Administration route:

Oral

Units in package:

21 capsules, 14 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Pomalyst, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalyst, in combination with dexamethasone, is indicated for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

Product summary:

Visual Identification: Dark blue/yellow size 3 gelatin capsules marked POML in white ink and 1 mg in black ink.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-07-01

Patient Information leaflet

POMALYST
® CAPSULES
_pomalidomide_
CONSUMER MEDICINE INFORMATION
WARNING:
POMALYST (POMALIDOMIDE) IS STRUCTURALLY RELATED TO ‘THALIDOMIDE’,
WHICH IS KNOWN TO CAUSE SEVERE LIFE-THREATENING
HUMAN BIRTH DEFECTS (DEFORMED BABIES) AND DEATH TO AN UNBORN BABY IF
TAKEN DURING PREGNANCY. IF POMALYST IS TAKEN
DURING PREGNANCY, IT MAY CAUSE BIRTH DEFECTS OR DEATH TO AN UNBORN
BABY. DO NOT TAKE POMALYST IF YOU ARE PREGNANT,
OR THINK THAT YOU ARE PREGNANT.
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Pomalyst.
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 Pomalyst
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 POMALYST IS
USED FOR
Pomalyst contains an active
substance called pomalidomide.
Pomalyst belongs to a group of
medicines called immunomodulating
agents.
Pomalyst is used in combination with
another medicine called
'dexamethasone' (steroid medicine) to
treat adult patients diagnosed with
Multiple Myeloma (MM) (a cancer
of the bone marrow). It is prescribed
for patients whose disease has
progressed after two prior therapies.
Pomalyst is also used in combination
with dexamethasone and another
medicine called ‘bortezomib’ to treat
adult MM patients whose disease has
progressed after one therapy.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT HOW POMALYST
WORKS OR WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
Pomalyst will only be prescribed to
you by a doctor who has experience
in medicines to treat cancers of the
blood.
BEFORE YOU TAKE
POMALYST
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE POMALYST IF YOU HAVE
AN ALLERGY TO POMALIDOMIDE OR ANY
OF THE INGREDIENTS LISTED AT THE

Read the complete document

Summary of Product characteristics

POMALYST
®
(pomalidomide) capsules – Product Information
Celgene V4.0 – 6 May 2022 (CCDS V12)
1
AUSTRALIAN PRODUCT INFORMATION – POMALYST
(POMALIDOMIDE) CAPSULES
TERATOGENIC EFFECTS:
POMALYST (POMALIDOMIDE) IS A THALIDOMIDE ANALOGUE. THALIDOMIDE IS A
KNOWN HUMAN TERATOGEN
THAT CAUSES SEVERE LIFE-THREATENING HUMAN BIRTH DEFECTS. IF
POMALIDOMIDE IS TAKEN DURING
PREGNANCY, IT MAY CAUSE BIRTH DEFECTS OR DEATH TO AN UNBORN BABY.
WOMEN SHOULD BE ADVISED TO
AVOID PREGNANCY WHILST TAKING POMALYST (POMALIDOMIDE), DURING DOSE
INTERRUPTIONS, AND FOR
4 WEEKS AFTER STOPPING THE MEDICINE.
1
NAME OF THE MEDICINE
Pomalidomide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mg capsule contains 1 mg pomalidomide.
Each 2 mg capsule contains 2 mg pomalidomide.
Each 3 mg capsule contains 3 mg pomalidomide.
Each 4 mg capsule contains 4 mg pomalidomide.
For the full list of excipients, see Section 6.1 [List of Excipients].
Description
Pomalidomide is a yellow solid powder. It is practically insoluble in
water over the pH range 1.2-6.8
and is slightly soluble (eg. acetone, methylene chloride) to
practically insoluble (eg. heptanes,
ethanol) in organic solvents. Pomalidomide has a chiral carbon atom
and exists as a racemic mixture
of the R(+) and S(-) enantiomers.
3
PHARMACEUTICAL FORM
Pomalyst (pomalidomide) 1 mg capsules: dark blue/yellow size 3 gelatin
capsules marked “POML” in
white ink and “1 mg” in black ink. Each 1 mg capsule contains 1 mg
of pomalidomide.
Pomalyst (pomalidomide) 2 mg capsules: dark blue/orange size 1 gelatin
capsules marked “POML 2
mg” in white ink. Each 2 mg capsule contains 2 mg of pomalidomide.
Pomalyst (pomalidomide) 3 mg capsules: dark blue/green size 1 gelatin
capsules marked “POML 3
mg” in white ink. Each 3 mg capsule contains 3 mg of pomalidomide.
Pomalyst (pomalidomide) 4 mg capsules: dark blue/blue size 1 gelatin
capsules marked “POML 4
mg” in white ink. Each 4 mg capsule contains 4 mg of pomalidomide.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Pomalyst, in combinat

Read the complete document