POMOLIDE pomalidomide 4 mg hard gelatin capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pomalidomide, Quantity: 4 mg

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: pregelatinised starch; mannitol; sodium stearylfumarate; croscarmellose sodium; titanium dioxide; indigo carmine; purified water; Gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; Shellac; ethanol absolute; ammonia; potassium hydroxide

Administration route:

Oral

Units in package:

14 capsules, 21 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Pomalidomide, 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, 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: Size 2 hard gelatin capsules with dark blue cap and a blue body printed with 'NAT' in white ink on the cap and '4 mg' in white ink on the body of the capsules.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-05-18

Patient Information leaflet

Pomolide capsules
1
POMOLIDE CAPSULES
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about taking this medicine, speak to your doctor or
pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before taking this medicine.
1.
WHY AM I TAKING POMOLIDE?
Pomolide contains the active ingredient pomalidomide. Pomolide 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.
Pomolide is also used in combination with dexamethasone and another
medicine called 'bortezomib' to treat adult MM
patients whose disease has progressed after one therapy.
For more information, see Section 1. Why am I taking Pomolide?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE POMOLIDE?
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
Pomolide?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Pomolide 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 POMOLIDE?
Your doctor will tell you how much Pomolide to take and for how long
you will need to take it, will monitor your progress and
may adjust your dose or stop your treatment based on the results of
your blood tests and on your general condition. Follow
the instructions provided and use Pomolide until your doctor tells you
to stop.
Swallow the capsules whole with a full glass of water, once a day as
directed by your doctor.
Pomolide can be taken with or

Summary of Product characteristics

Pomolide
Australian product information
POMOLIDE (pomalidomide) capsules – Product Information
1
AUSTRALIAN PRODUCT INFORMATION –
POMOLIDE (POMALIDOMIDE) CAPSULES
TERATOGENIC EFFECTS:
POMOLIDE (POMOLIDOMIDE) 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 POMOLIDE (POMALIDOMIDE), DURING DOSE
INTERRUPTIONS, AND FOR 4
WEEKS AFTER STOPPING THE MEDICINE.
1
NAME OF THE MEDICINE
Australian Approved Name: 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.
3
PHARMACEUTICAL FORM
Pomolide (pomalidomide) 1 mg capsules Size 4 hard gelatin capsules
with dark blue cap and a yellow
body printed with 'NAT' in white ink on the cap and '1 mg' in black
ink on the body of the capsules.
Each 1 mg capsule contains 1 mg of pomalidomide.
Pomolide (pomalidomide) 2 mg capsules: Size 2 hard gelatin capsules
with dark blue cap and an orange
body printed with 'NAT' in white ink on the cap and '2 mg' in white
ink on the body of the capsules.
Each 2 mg capsule contains 2 mg of pomalidomide.
Pomolide (pomalidomide) 3 mg capsules: Size 2 hard gelatin capsules
with dark blue cap and a green
body printed with 'NAT' in white ink on the cap and '3 mg' in white
ink on the body of the capsules.
Each 3 mg capsule contains 3 mg of pomalidomide.
Pomolide (pomalidomide) 4 mg capsules: Size 2 hard gelatin capsules
with dark blue cap and a blue
body printed with 'NAT' in white ink on the cap and '4 mg' in white
ink on the body of the capsules.
Each 4 mg capsule contains 4 mg of pomalidomide.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pomolide, in combination with bortezomib and dexamet