OTEZLA TABLET STARTER PACK

Država: Singapur

Jezik: angleščina

Source: HSA (Health Sciences Authority)

Aktivna sestavina:

APREMILAST (in Beige Tablet); APREMILAST (in Brown Tablet); APREMILAST (in Pink Tablet)

Dostopno od:

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

Koda artikla:

L04AA32

Farmacevtska oblika:

TABLET, FILM COATED

Sestava:

APREMILAST (in Beige Tablet) 30 mg; APREMILAST (in Brown Tablet) 20 mg; APREMILAST (in Pink Tablet) 10 mg

Pot uporabe:

ORAL

Tip zastaranja:

Prescription Only

Izdeluje:

Celgene International Sarl

Status dovoljenje:

ACTIVE

Datum dovoljenje:

2017-03-29

Navodilo za uporabo

1
OTEZLA
®
(APREMILAST)
TABLETS
PATIENT INFORMATION LEAFLET
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 this medicine is expected to 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:
•
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), if
you cannot use another type of medicine called ‘Disease-Modifying
Antirheumatic Drugs
(DMARDs) or when you have tried one of these treatments and it did not
work.
•
Mouth ulcers associated with Behçet’s disease (a rare type of
inflammatory disease which
affects many parts of the body, the most common problem is mouth
ulcers).
Psoriasis, psoriatic arthritis and Behçet’s disease 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, psoriatic
arthritis and Behçet’s disease. 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.
In Behçet’s disease, treatment with Otezla ca

Lastnosti izdelka

1
OTEZLA
® (APREMILAST) TABLETS
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:
•
Otezla, alone or in combination with a disease-modifying
anti-rheumatic drug (DMARD), is
indicated for the treatment of signs and symptoms of active psoriatic
arthritis in adult patients
who have had an inadequate response, intolerance, or contraindication
to a prior DMARD
therapy.
•
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
Behçet’s Disease who are
candidates for systemic therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage (dose and interval)
For psoriasis, psoriatic arthritis and Behçet’s Disease, treatment
with Otezla should be initiated by
physicians experienced in the diagnosis and treatment of these
diseases.
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.
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
2
Otezla tablets should be swallowed whole, either with or without food.
The tablets should not be
crushed, split or chewed.