Skyrizi

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Risankizumab 150 mg/mL;  

Inapatikana kutoka:

AbbVie Limited

Kipimo:

150 mg/mL

Dawa fomu:

Solution for injection

Tungo:

Active: Risankizumab 150 mg/mL   Excipient: Glacial acetic acid Polysorbate 20 Sodium acetate trihydrate Trehalose dihydrate Water for injection

Dawa ya aina:

Prescription

Matibabu dalili:

Psoriatic Arthritis: Skyrizi is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to or are intolerant to one or more disease modifying antirheumatic drugs (DMARDs). Skyrizi may be used as monotherapy or in combination with a conventional synthetic disease modifying antirheumatic drug (csDMARD).

Bidhaa muhtasari:

Package - Contents - Shelf Life: Syringe, glass, Type 1 clear, with fluoropolymer coated bromobutyl rubber stopper and needle encased in autoinjector - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours not refrigerated stored at or below 25°C protect from light. One time. If unopened and stored for less than 24hours, product may be returned to the refrigerator.

Idhini ya tarehe:

2020-09-26

Taarifa za kipeperushi

Skyrizi®
12 July 2023
Version 8
1
SKYRIZI®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING SKYRIZI?
Skyrizi contains the active ingredient risankizumab. Skyrizi is used
to treat moderate to severe plaque psoriasis and active
psoriatic arthritis in adults and moderate to severe Crohn's disease
in patients from 16 years of age.
For more information, see Section 1. Why am I using Skyrizi?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SKYRIZI?
Check the list of ingredients at the end of the CMI. Do not use
Skyrizi if you have ever had an allergic reaction to any of them.
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 use
Skyrizi?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Skyrizi and affect how it works or
Skyrizi 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 USE SKYRIZI?
•
Skyrizi is injected under the skin. More instructions can be found in
Section 4. How do I use Skyrizi? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SKYRIZI?
THINGS YOU
SHOULD DO
•
Ensure you are up to date with your immunisations before you start
therapy with Skyrizi.
•
Speak to your doctor if you think you have an infection.
•
Remind any doctor, dentist or pharmacist you visit that you are using
Skyrizi.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine or change the dose without checking
with your doctor.
DRIVING OR USING
MACHINES
•
Skyrizi is not expected to have any effect on your ability to drive or
use machines.
DRINKING
ALCOHOL
•
There is no information on the effects of using Skyrizi with alcohol.
LOOKING AFTER
YOUR MEDICINE

Tabia za bidhaa

SKYRIZI Data Sheet
Version 10
12 October 2023
1 of 38
NEW ZEALAND DATA SHEET
1
SKYRIZI
®
75mg/0.83mL solution for injection
SKYRIZI
®
150 mg/mL solution for injection
SKYRIZI
® 360 mg/2.4 mL solution for injection
SKYRIZI
® 600 mg/10.0 mL concentrate for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 75 mg/0.83 mL pre-filled syringe contains 75 mg risankizumab in
0.83 mL
solution.
Each 150 mg/mL pre-filled pen or pre-filled syringe contains 150 mg
risankizumab in
1 mL solution.
Each 360 mg/2.4 mL pre-filled cartridge contains 360 mg risankizumab
in 2.4 mL
solution.
Each 600 mg/10.0 mL single-dose vial contains 600 mg risankizumab in
10.0 mL
solution.
Skyrizi (risankizumab), an interleukin-23 blocker, is a humanised
immunoglobin G1
(IgG1) monoclonal antibody.
Risankizumab is a recombinant human monoclonal antibody produced in
Chinese
Hamster Ovary (CHO) cells using recombinant DNA technology.
Excipients with known effect
Skyrizi 75 mg/0.83 mL contains 68 mg sorbitol per 150 mg dose.
Skyrizi 150 mg/mL and Skyrizi 75 mg/0.83 mL contains less than 1 mmol
sodium
(23 mg) per 150 mg dose and is essentially sodium free.
Skyrizi 360 mg/2.4 mL contains less than 1 mmol sodium (23 mg) per 360
mg dose
and is essentially sodium free.
Skyrizi 600 mg/10.0 mL contains less than 1 mmol sodium (23 mg) per
600 mg dose
and is essentially sodium free.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
SKYRIZI Data Sheet
Version 10
12 October 2023
2 of 38
3
PHARMACEUTICAL FORM
75 mg/0.83 mL: Solution for injection in a pre-filled syringe.
The solution is colourless to slightly yellow and clear to slightly
opalescent. The
solution may contain tiny white or clear particles.
150 mg/ mL: Solution for injection in a pre-filled syringe or
pre-filled pen.
The solution is colourless to yellow and clear to slightly opalescent.
The solution
may contain tiny white or clear particles.
360 mg/2.4 mL: Solution for subcutaneous injection in a pre-filled
cartridge with an
on-body injector.
Solution is colourless to yel