POMALIDOMIDE SANDOZ pomalidomide 4 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pomalidomide, Quantity: 4 mg

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: microcrystalline cellulose; maltodextrin; sodium stearylfumarate; Gelatin; titanium dioxide; iron oxide yellow; iron oxide red; indigo blue; erythrosine; Shellac

Administration route:

Oral

Units in package:

14, 21

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Hard gelatin capsule, with a dark blue body and red cap, with 'PLM 4' in white ink on the body. Capsule size 2; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2022-06-02

Patient Information leaflet

Pomalidomide Sandoz®
1
POMALIDOMIDE SANDOZ®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: POMALIDOMIDE SANDOZ (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 POMALIDOMIDE
SANDOZ IS TAKEN DURING PREGNANCY, IT MAY CAUSE BIRTH DEFECTS OF DEATH
TO AN UNBORN BABY. DO NOT TAKE POMALIDOMIDE SANDOZ IF
YOU ARE PREGNANT, OR THINK THAT YOU ARE PREGNANT.
1.
WHY AM I TAKING POMALIDOMIDE SANDOZ?
Pomalidomide Sandoz contains the active ingredient pomalidomide.
Pomalidomide Sandoz is used to treat adult patients
diagnosed with Multiple Myeloma (MM) (a cancer of the bone marrow)
whose disease has progressed after prior therapies.
For more information, see Section 1. Why am I taking Pomalidomide
Sandoz? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE POMALIDOMIDE SANDOZ?
Do not use if you have ever had an allergic reaction to pomalidomide
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I take
Pomalidomide Sandoz? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Pomalidomide Sandoz and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE POMALIDOMIDE SANDOZ?
•
Swallow the capsules whole with a full glass of water, once a day as
directed by your doctor.
•
Do not open, break or chew the capsules.
More instructions can be found in Section 4. How do I take
Pomalidomide Sandoz? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING POMALIDOMIDE SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, de

Summary of Product characteristics

220602-pomalidomide sandoz-pi
Page 1 of 30
AUSTRALIAN PRODUCT INFORMATION
POMALIDOMIDE SANDOZ
® (POMALIDOMIDE) CAPSULES
1.
NAME OF THE MEDICINE
Pomalidomide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Pomalidomide Sandoz 1 mg capsule contains 1 mg pomalidomide.
Each Pomalidomide Sandoz 2 mg capsule contains 2 mg pomalidomide.
Each Pomalidomide Sandoz 3 mg capsule contains 3 mg pomalidomide.
Each Pomalidomide Sandoz 4 mg capsule contains 4 mg pomalidomide.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Pomalidomide Sandoz 1 mg capsules: Hard gelatin capsule, with a yellow
body and red cap,
with “PLM 1” in white ink on the body. Capsule size 4.
Pomalidomide Sandoz 2 mg capsules: Hard gelatin capsule, with an
orange body and red cap,
with “PLM 2” in white ink on the body. Capsule size 2.
Pomalidomide Sandoz 3 mg capsules: Hard gelatin capsule, with a
turquoise body and red cap,
with “PLM 3” in white ink on the body. Capsule size 2.
Pomalidomide Sandoz 4 mg capsules: Hard gelatin capsule, with a dark
blue body and red cap,
with “PLM 4” in white ink on the body. Capsule size 2.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Pomalidomide Sandoz, 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.
Pomalidomide Sandoz, 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.
TERATOGENIC EFFECTS:
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 pr