Pomalyst

Country: New Zealand

Bahasa: Inggeris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Pomalidomide 3mg;  

Boleh didapati daripada:

Celgene Limited

INN (Nama Antarabangsa):

Pomalidomide 3 mg

Dos:

3 mg

Borang farmaseutikal:

Capsule

Komposisi:

Active: Pomalidomide 3mg   Excipient: Gelatin Indigo carmine Iron oxide yellow Mannitol Pregelatinised maize starch Sodium stearyl fumarate Titanium dioxide

Jenis preskripsi:

Prescription

Dikeluarkan oleh:

Lonza AG

Tanda-tanda terapeutik:

Pomalidomide, 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

Ringkasan produk:

Package - Contents - Shelf Life: Blister pack, PVC/ PCTFE (Aclar)/ Al in printed carton - 21 capsules - 48 months from date of manufacture stored at or below 25°C

Tarikh kebenaran:

2014-09-08

Risalah maklumat

Pomalyst
®
(pomalidomide) capsules – NZ CMI
Celgene V1.7.0 – 29 October 2020
1
NEW ZEALAND CONSUMER MEDICINE INFORMATION
POMALYST
® (POMALIDOMIDE) CAPSULES
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.
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.
Pomalyst
®
(pomalidomide) capsules – NZ CMI
Celgene V1.7.0 – 29 October 2020
2
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 OTHER INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
Some of the symptoms of an allergic reaction may include:
•
shortness of breath,
•
wheezing or difficulty breathing,
•
swelling of the face, lips, tongue or other parts of the body,
•
rash, itching or hives on the skin.
IF YOU THINK YOU MAY BE ALLERGIC TO POMALYST, ASK YOUR DOCTOR FOR
ADVICE.
DO NOT TAKE THIS MEDICINE IF YOU ARE PREGNANT, O

Ciri produk

POMALYST
®
(pomalidomide) capsules – NZ Data Sheet
Page 1
Celgene V3.0 – 31 January 2022 (CCDS V12)
NEW ZEALAND DATA SHEET
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
PRODUCT NAME
Pomalyst 1 mg capsules.
Pomalyst 2 mg capsules.
Pomalyst 3 mg capsules.
Pomalyst 4 mg capsules.
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.
3
PHARMACEUTICAL FORM
Presentation
Pomalyst 1 mg capsules: dark blue/yellow size 3 gelatin capsules
marked “POML” in white ink and
“1 mg” in black ink.
Pomalyst 2 mg capsules: dark blue/orange size 1 gelatin capsules
marked “POML 2 mg” in white ink.
Pomalyst 3 mg capsules: dark blue/green size 1 gelatin capsules marked
“POML 3 mg” in white ink.
Pomalyst 4 mg capsules: dark blue/blue size 1 gelatin capsules marked
“POML 4 mg” in white ink.
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.
4
CLINICAL PARTICULARS
4.1
Therapeutic Indications
Pomalidomide, 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 demo