NUBEQA darolutamide 300 mg tablet bottle

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

darolutamide, Quantity: 300 mg

Commercializzato da:

Bayer Australia Ltd

Forma farmaceutica:

Tablet, film coated

Composizione:

Excipient Ingredients: croscarmellose sodium; hypromellose; lactose monohydrate; magnesium stearate; calcium hydrogen phosphate; macrogol 3350; titanium dioxide; povidone

Via di somministrazione:

Oral

Confezione:

120 tablets

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

NUBEQA is indicated for the treatment of patients with: ? non-metastatic castration resistant prostate cancer (nmCRPC) ? metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

Dettagli prodotto:

Visual Identification: White to off-white, oval, film-coated tablets, length 16 mm, width 8 mm, marked with 300 on one side, and BAYER on the other side; Container Type: Bottle; Container Material: PE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2020-02-26

Foglio illustrativo

NUBEQA ® CMI v3.0
1
NUBEQA®
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.
This medicine is new. Please report side effects that you may
experience with this medicine. See the full CMI for further
details.
1.
WHY AM I USING NUBEQA?
NUBEQA contains the active ingredient darolutamide. NUBEQA is used to
treat prostate cancer that has not spread to other
parts of the body and no longer responds to medical or surgical
treatment that lowers testosterone.
For more information, see Section 1. Why am I using NUBEQA?
i
n the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NUBEQA?
Do not use if you have ever had an allergic reaction to NUBEQA or any
of the ingredients listed at the end of the CMI.
NUBEQA is not for use in women.
Do not use NUBEQA if you are intending to father a child. Use a highly
effective method of contraception during and for 3
months after treatment with NUBEQA.
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 use
NUBEQA?
i
n the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NUBEQA and affect how it works. Tell
your doctor or pharmacist if you are taking any
other medicines, including any medicines, vitamins or supplements that
you buy without a prescription from your pharmacy,
supermarket or health food shop.
A list of these medicines is in Section 3. What if I am taking other
medicines?
i
n the full CMI.
4.
HOW DO I USE NUBEQA?
•
THE RECOMMENDED DOSE IS two tablets two times a day. This is also the
maximum daily dose.
•
Your doctor may need to reduce your dose to one tablet two times daily
or may decide to interrupt your treatment if
necessary.
•
Take NUBEQA with food.
•
Swallow the tablets whole
More instructions can be found in Section 4. How do I use NUBEQA? in
t

Scheda tecnica

Nubeqa PI V3.0; CCDS V5
Page 1 of 15
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any suspected
adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION- NUBEQA
(DAROLUTAMIDE) TABLET
1
NAME OF THE MEDICINE
Darolutamide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 300 mg of darolutamide.
Excipients with known effect:
Contains sugars as lactose.
For a full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
White to off-white, oval, film-coated tablets with a length of 16 mm
and a width of 8 mm, marked
with “300” on one side, and “BAYER” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nubeqa is indicated for the treatment of patients with non-metastatic
castration resistant prostate
cancer (nmCRPC).
4.2
DOSE AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION _
For oral use.
_DOSAGE REGIMEN _
The recommended dose is 600 mg (two film-coated tablets of 300 mg)
darolutamide taken twice daily,
equivalent to a total daily dose of 1200 mg.
The tablets should be taken whole with food (see section 5.2
PHARMACOKINETIC PROPERTIES).
Patients receiving Nubeqa should also receive a gonadotropin-releasing
hormone (GnRH) analog
concurrently or should have had bilateral orchiectomy.
If a dose of Nubeqa is missed, the dose should be taken as soon as the
patient remembers prior to the
next scheduled dose. The patient should not take two doses together to
make up for a missed dose.
▼
Nubeqa PI V3.0; CCDS V5
Page 2 of 15
_DOSE MODIFICATION _
If a patient experiences a ≥ Grade 3 toxicity or an intolerable
adverse reaction, dosing should be
withheld or reduced to 300 mg twice daily until symptoms improve. Then
treatment may be resumed
at a dose of 600 mg twice daily.
Dose reduction below 300 mg twice daily is not recommended. The
maximum efficacious daily dose
is the recommended dos