Otezla

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Apremilast 30mg;  

Disponible des:

Amgen New Zealand Limited

Designació comuna internacional (DCI):

Apremilast 30 mg

Dosis:

30 mg

formulario farmacéutico:

Film coated tablet

Composición:

Active: Apremilast 30mg   Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry beige 85F17424 Purified water

tipo de receta:

Prescription

Fabricat per:

Celgene Chemicals GmbH

indicaciones terapéuticas:

For the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phytotherapy or systemic therapy.

Resumen del producto:

Package - Contents - Shelf Life: Blister pack, PVC blisters with aluminium push through foil 30mg - 56 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC blisters with aluminium push through foil 30mg - 168 tablets - 36 months from date of manufacture stored at or below 30°C

Data d'autorització:

2015-06-17

Informació per a l'usuari

Otezla
®
(apremilast) film coated tablets
1
NEW ZEALAND CONSUMER MEDICINE INFORMATION
OTEZLA
® (APREMILAST) FILM COATED TABLETS
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:
•
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 PRE

Fitxa tècnica

NEW ZEALAND DATA SHEET
OTEZLA DATA SHEET
PAGE 1 OF 29
1.
PRODUCT NAME
Otezla
®
30 mg tablets
Otezla titration pack 10 mg, 20 mg, 30 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg tablet contains 10 mg apremilast.
Each 20 mg tablet contains 20 mg apremilast.
Each 30 mg tablet contains 30 mg apremilast.
For the full list of excipients, see section 6.1 List of excipients.
Excipient(s) with known effect
Otezla 10 mg, 20 mg and 30 mg tablets contain 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.
Description
Apremilast is a white to pale yellow non-hygroscopic powder with a
melting point of
approximately 156.1°C. It is practically insoluble in water, slightly
soluble in ethanol, and
soluble in acetone. Apremilast is the S-enantiomer with a specific
rotation of +28.1° in
acetonitrile at a concentration of 20 mg/mL.
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.
NEW ZEALAND DATA SHEET
OTEZLA DATA SHEET
PAGE 2 OF 29
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment with Otezla should be initiated by specialists experienced
in the diagnosis and
treatment of psoriasis or psoriatic arthritis.
Dose
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