Consumer medicine information

Taltz 80 mg/mL Solution for injection

Ixekizumab

BRAND INFORMATION

Brand name

Taltz

Active ingredient

Ixekizumab

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Taltz 80 mg/mL Solution for injection.

1. Why am I using TALTZ?


TALTZ contains the active ingredient ixekizumab. TALTZ is used to treat plaque psoriasis, psoriatic arthritis, ankylosing spondylitis (also known as radiographic axial spondyloarthritis) and non-radiographic axial spondyloarthritis.
For more information, see Section 1. Why am I using TALTZ? in the full CMI.

2. What should I know before I use TALTZ?


Do not use if you have ever had an allergic reaction to TALTZ or any of the ingredients listed at the end of the CMI.
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 TALTZ? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with TALTZ and affect how it works.
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 TALTZ?

  • TALTZ is given as an injection under your skin, known as a subcutaneous injection. Your first dose will be given by a doctor, nurse or pharmacist.
  • Each autoinjector or syringe contains one dose of TALTZ (80mg). The first dose of TALTZ for plaque psoriasis and psoriatic arthritis is 160 mg (two 80mg injections). The dose of TALTZ for radiographic and non-radiographic axial spondyloarthritis is 80 mg (one injection).

More instructions can be found in Section 4. How do I use TALTZ? in the full CMI.

5. What should I know while using TALTZ?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using TALTZ.
  • Keep all of your doctor's appointments so that your progress can be checked.
  • If you need to get vaccinated, tell your doctor you are taking TALTZ before you have the vaccination.
Things you should not do
  • Do not stop using TALTZ unless your doctor tells you to.
  • Do not use TALTZ if you think it has been frozen or exposed to excessive heat.
  • Do not use TALTZ if you notice that the autoinjector or syringe is damaged, or the medicine is cloudy, distinctly brown or has particles in it.
Looking after your medicine
  • TALTZ autoinjector or syringe is single use only.
  • Keep your unused TALTZ autoinjector or syringe in a fridge between 2°C to 8°C. Do not freeze or shake.
  • Keep TALTZ in the original package in order to protect it from light.

For more information, see Section 5. What should I know while using TALTZ? in the full CMI.

6. Are there any side effects?


Side effects include injection site reactions (e.g. red skin or pain); stomach pain or diarrhoea due to inflammatory bowel disease; upper respiratory tract infections with symptoms such as sore throat and stuffy nose. More serious side effects include allergic reactions; severe itching of the skin, with red rash or raised bumps.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Taltz

Active ingredient

Ixekizumab

Schedule

S4

 

1 Name of Medicine

Ixekizumab (rch).

2 Qualitative and Quantitative Composition

Each prefilled pen (autoinjector) or prefilled syringe contains ixekizumab 80 mg/mL.
Taltz (ixekizumab (rch)) is a humanised immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralising activity against interleukin-17A (IL-17A). Taltz is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Taltz is supplied as a solution for injection.
The Taltz solution is sterile, preservative free, clear and colourless to slightly yellow. The Taltz solution has a pH of 5.3 to 6.1. Taltz is administered as a subcutaneous (SC) injection. Taltz is for single use, therefore contains no antimicrobial preservative.
Taltz is available as a 1 mL single-dose prefilled pen (autoinjector) or a 1 mL single dose prefilled syringe. Each autoinjector or prefilled syringe is composed of ixekizumab (80 mg/mL).
The autoinjector and prefilled syringe each contain a 1 mL glass syringe with a fixed needle. The Taltz autoinjector and prefilled syringe are manufactured to deliver 80 mg of ixekizumab. Taltz is latex-free.

4 Clinical Particulars

4.9 Overdose

Doses up to 180 mg have been administered subcutaneously in clinical trials without dose-limiting toxicity. Overdoses up to 240 mg have been reported without any serious adverse events. In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. The genotoxic potential of ixekizumab has not been studied.
Carcinogenicity. Non-clinical studies have not been conducted to evaluate the carcinogenic potential of ixekizumab.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Ixekizumab has a molecular weight of 146,158 Daltons for the protein backbone of the molecule.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSIXEKIZ.gif CAS number. CAS registry number 1143503-69-8.

7 Medicine Schedule (Poisons Standard)

Prescription Medicine - Schedule 4.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/TALTZST.gif