OTEZLA TITRATION PACK apremilast tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
27-01-2021
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
apremilast, Quantity: 30 mg
Available from:
Amgen Australia Pty Ltd
INN (International Name):
apremilast
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide
Administration route:
Oral
Units in package:
4 x 10 mg plus 4 x 20 mg plus 19 x 30 mg Starter Pack, 4 x 10 mg plus 4 x 20 mg plus 19 x 30 mg Titration pack
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Otezla is indicated for: ? The treatment of signs and symptoms of active psoriatic arthritis in adult patients. ? The treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. ? The treatment of adult patients with oral ulcers associated with Beh?et?s Disease who are candidates for systemic therapy.
Product summary:
Visual Identification: Beige, diamond shaped 30 mg film-coated tablet with 'APR' engraved on one side and '30' on the opposite side; Container Type: Blister Pack; Container Material: PVC-coated Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2015-03-19
Patient Information leaflet
OTEZLA
®
_apremilast_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Otezla. 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 Otezla against
the benefits they expect it will 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 OTEZLA IS USED
FOR
Otezla is used to treat adults with the
following conditions:
•
Moderate to severe plaque
psoriasis (an inflammatory
disease of the skin, which can
cause red, scaly, thick, itchy,
painful patches on your skin, and
can also affect your scalp and
nails)
•
Psoriatic arthritis (an
inflammatory disease of the
joints, often accompanied by
psoriasis)
Psoriasis and psoriatic arthritis are
usually lifelong conditions and there
is currently no cure. Otezla works by
reducing the activity of a natural
substance in the body’s cells called
‘phosphodiesterase 4’. This helps
regulate the immune response
associated with psoriasis and
psoriatic arthritis. By regulating the
immune response, Otezla can help to
control the signs and symptoms of
these conditions.
In psoriasis, treatment with Otezla
results in a reduction in psoriatic skin
plaques and other signs and
symptoms of the disease.
In psoriatic arthritis, treatment with
Otezla results in an improvement in
swollen and painful joints, and can
improve your general physical
function.
Otezla has also been shown to
improve the quality of life in patients
with psoriasis or psoriatic arthritis.
This means that the impact of your
condition on daily activities,
relationships and other factors should
be less than it was before.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT HOW OTEZLA WORKS,
OR WHY THIS MEDICINE HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine
Read the complete document
Summary of Product characteristics
PRODUCT INFORMATION – OTEZLA
®
PAGE 1 OF 28
AUSTRALIAN PRODUCT INFORMATION – OTEZLA
®
(APREMILAST)
1.
NAME OF THE MEDICINE
Apremilast
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Refer to Section 6.1 – List of excipients.
Excipients with known effect
Sugars (as lactose).
3.
PHARMACEUTICAL FORM
Otezla 10 mg Tablets: Pink, diamond shaped 10 mg film-coated tablet
with “APR”
engraved on one side and “10” on the opposite side.
Otezla 20 mg Tablets: Brown, diamond shaped 20 mg film-coated tablet
with “APR”
engraved on one side and “20” on the opposite side.
Otezla 30 mg Tablets: Beige, diamond shaped 30 mg film-coated tablet
with “APR”
engraved on one side and “30” on the opposite side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Otezla is indicated for:
•
The treatment of signs and symptoms of active psoriatic arthritis in
adult patients.
•
The treatment of adult patients with moderate to severe plaque
psoriasis who are
candidates for phototherapy or systemic therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage (dose and interval)
Treatment with Otezla should be initiated by specialists experienced
in the diagnosis and
treatment of psoriasis or psoriatic arthritis.
The recommended dose of Otezla is 30 mg twice daily taken orally
approximately
12 hours apart. An initial titration schedule is required as shown
below in Table 1. No
re-titration is required after initial titration.
PRODUCT INFORMATION – OTEZLA
®
PAGE 2 OF 28
TABLE 1:
DOSE TITRATION SCHEDULE
DAY 1
DAY2
DAY 3
DAY 4
DAY 5
DAY 6 &
THEREAFTER
AM
AM
PM
AM
PM
AM
PM
AM
PM
AM
PM
10 mg
10 mg
10 mg
10 mg
20 mg
20 mg
20 mg
20 mg
30 mg
30 mg
30 mg
Method of administration
Otezla tablets should be swallowed whole, either with or without food.
The tablets
should not be crushed, split or chewed.
If patients miss a dose, the next dose should be taken as soon as
possible. If it is close
to the time for their next dose, the missed dose should not be taken
and the next dose
should be taken at the regular time.
Dosage adjustment
Read the complete document
