LIVTENCITY maribavir 200 mg film coated tablet bottle

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

maribavir, Quantity: 200 mg

Boleh didapati daripada:

Takeda Pharmaceuticals Australia Pty Ltd

Borang farmaseutikal:

Tablet, film coated

Komposisi:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; purified talc; brilliant blue FCF aluminium lake; polyvinyl alcohol; macrogol 3350

Laluan pentadbiran:

Oral

Unit dalam pakej:

28, 56

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

Treatment of adults with post-transplant cytomegalovirus (CMV) infection and disease resistant, refractory or intolerant to one or more prior therapies (see 4.3 CONTRAINDICATIONS and, 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).

Ringkasan produk:

Visual Identification: Blue, film-coated, oval-shaped, convex tablet that is de-bossed with SHP on one side and 620 on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Status kebenaran:

Registered

Tarikh kebenaran:

2022-10-07

Risalah maklumat

LIVTENCITY
®
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1
.
1
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.
▼
This medicine is new. Please report side effects. See the full CMI for
further details.
1.
WHY AM I TAKING LIVTENCITY?
LIVTENCITY contains the active ingredient maribavir. LIVTENCITY is a
prescription medicine to treat adults with post-transplant
cytomegalovirus (CMV) infection and disease who are resistant,
refractory or intolerant to one or more prior therapies.
For more information, see Section 1. Why am I taking LIVTENCITY? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE LIVTENCITY?
Do not take if you have ever had an allergic reaction to LIVTENCITY 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
LIVTENCITY? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with LIVTENCITY 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 LIVTENCITY?
•
The recommended dosage of LIVTENCITY is 400 mg (two 200 mg tablets)
orally twice daily. LIVTENCITY can be taken with or
without food. The tablet can be taken as a whole tablet, a crushed
tablet, or a crushed tablet through nasogastric or orogastric
tube.
•
More instructions can be found in Section 4. How do I take LIVTENCITY?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING LIVTENCITY?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, or pharmacist you visit that you are
taking LIVTENCITY.
•
Take the tablets regularly, as instructed by the healthcare
professional.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking this medicine suddenly.
•
Even if you feel better, do not stop taking LIVT

Ciri produk

LIVTENCITY PI V1.0 (CCDS V1.0)
1
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
LIVTENCITY
® (MARIBAVIR) TABLETS
1
NAME OF THE MEDICINE
Maribavir
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LIVTENCITY is available in 200 mg immediate-release tablets and is
intended for oral
administration. Each film-coated tablet contains 200 mg of maribavir,
a potent, selective,
antiviral drug belonging to the benzimidazole ribosides class.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Film-coated tablets.
APPEARANCE
Blue, film-coated, oval-shaped, convex tablet that is de-bossed with
‘SHP’ on one side and
‘620’ on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of adults with post-transplant cytomegalovirus (CMV)
infection and disease
resistant, refractory or intolerant to one or more prior therapies
(see 4.3 C
ONTRAINDICATIONS
and, 4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
).
4.2
D
OSE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSAGE
The recommended dose of LIVTENCITY is 400 mg (two 200 mg tablets)
twice daily
resulting in a daily dose of 800 mg. Treatment duration may need to be
individualised based
on the clinical characteristics of each patient.
In the pivotal efficacy Study 303, 400 mg twice daily dose of
LIVTENCITY was
administered for 8 weeks (see 5.1
P
HARMACODYNAMIC
P
ROPERTIES
/C
LINICAL TRIALS
).
▼

LIVTENCITY PI V1.0 (CCDS V1.0)
2
SPECIAL PATIENT POPULATIONS
Elderly patients
No dose adjustment is required for patient over 65 years of age.
Paediatric patients
The safety and efficacy of LIVTENCITY in patients below 18 years of
age have not been
established.
Renal impairment
No dose adjustment of LIVTENCITY is needed for patients with mild,
moderate, or severe
renal impairment. Administration of LIVT