Rinvoq

Pajjiż: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Upadacitinib hemihydrate 15.4mg equivalent to upadacitinib 15mg

Disponibbli minn:

AbbVie Limited

Dożaġġ:

15 mg

Għamla farmaċewtika:

Modified release tablet

Kompożizzjoni:

Active: Upadacitinib hemihydrate 15.4mg equivalent to upadacitinib 15mg Excipient: Colloidal silicon dioxide Hypromellose Magnesium stearate Mannitol Microcrystalline cellulose Opadry purple 85F100091 Tartaric acid

Tip ta 'preskrizzjoni:

Prescription

Indikazzjonijiet terapewtiċi:

Rinvoq is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis. Rinvoq may be used as monotherapy or in combination with methotrexate or other conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs).

Sommarju tal-prodott:

Package - Contents - Shelf Life: Calendar pack, PVC/PE/PTFE Blister with push through Al foil, Starter Pack - 7 tablets - 24 months from date of manufacture stored at or below 30°C protect from moisture - Calendar pack, PVC/PE/PTFE Blister with push through Al foil - 28 tablets - 24 months from date of manufacture stored at or below 30°C protect from moisture

Data ta 'l-awtorizzazzjoni:

2019-01-30

Fuljett ta 'informazzjoni

Rinvoq ®_ 03 October 2023 Version_ _12 _
_ _
1_ _
RINVOQ
®
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.
1.
WHY AM I TAKING RINVOQ?
Rinvoq contains the active ingredient upadacitinib. Rinvoq is used to
treat moderately to severely active rheumatoid arthritis,
active psoriatic arthritis, active ankylosing spondylitis, active
non-radiographic axial spondyloarthritis, moderate to severe atopic
dermatitis, moderately to severely active ulcerative colitis and
moderately to severely active Crohn's disease.
For more information, see Section 1. Why am I taking Rinvoq?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE RINVOQ?
Check the list of ingredients at the end of the CMI. Do not take
Rinvoq if you have ever had an allergic reaction to any of them.
Talk to your doctor before you take this medicine if you have any
other medical conditions, you are a current or past long-time
smoker, 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 Rinvoq?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Rinvoq and affect how it works or
Rinvoq may interfere with other medicines and affect how
they work. 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 RINVOQ?
•
The usual dose is one tablet once every day.
•
Do not split, crush, or chew the tablets. Swallow them whole with a
full glass of water with or without food.
More instructions can be found in Section 4. How do I take Rinvoq?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING RINVOQ?
THINGS YOU
SHOULD DO
•
Remind any doctor, pharmacist or dentist you visit that you are taking
Rinvoq.
•
Keep all your appointments, including blood tests.
•
Tell your doctor if you develop an infection, or pain or swelling in
the leg, or pain i

Karatteristiċi tal-prodott

Rinvoq [upadacitinib] Data Sheet
Version 16
CCDS v 16
0
7
September 2023
Page 1 of 86
NEW ZEALAND DATA SHEET
1
RINVOQ
® MODIFIED RELEASE TABLETS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rinvoq contains upadacitinib hemihydrate, equivalent to 15 mg, 30 mg
or 45 mg of upadacitinib, a
JAK inhibitor.
The tablets do not contain gluten or lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Rinvoq 15 mg modified release tablets are purple, biconvex oblong,
with dimensions of 14 x 8 mm,
and debossed with ‘a15’ on one side.
Rinvoq 30 mg modified-release tablets are red, biconvex oblong, with
dimensions of 14 x 8 mm and
debossed with ‘a30’ on one side.
Rinvoq 45 mg modified release tablets are yellow to mottled yellow,
biconvex oblong, with
dimensions of 14 x 8 mm and debossed with ‘a45’ on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid Arthritis
Rinvoq is indicated for the treatment of adults with moderately to
severely active rheumatoid arthritis.
Rinvoq may be used as monotherapy or in combination with methotrexate
or other conventional
synthetic disease-modifying anti-rheumatic drugs (csDMARDs).
Atopic Dermatitis
Rinvoq is indicated for the treatment of adults and adolescents 12
years and older with moderate
to severe atopic dermatitis who are candidates for systemic therapy.
Rinvoq [upadacitinib] Data Sheet
Version 16
CCDS v 16
0
7
September 2023
Page 2 of 86
Psoriatic arthritis
Rinvoq is indicated for the treatment of active psoriatic arthritis in
adult patients who have responded
inadequately to, or who are intolerant to one or more DMARDs.
Rinvoq may be used as monotherapy or in combination with a
non-biological DMARD.
Ankylosing spondylitis
Rinvoq is indicated for the treatment of active ankylosing spondylitis
in adult patients who have
responded inadequately to conventional therapy.
Non-radiographic Axial Spondyloarthritis
Rinvoq is indicated for the treatment of adults with active
non-radiographic axial spondyloarthritis
with