Consumer medicine information

1. Why am I using TREMFYA?

TREMFYA contains the active ingredient guselkumab. TREMFYA is used to treat adults with moderate to severe plaque psoriasis or adults with active psoriatic arthritis.
For more information, see Section 1. Why am I using TREMFYA? in the full CMI.

2. What should I know before I use TREMFYA?

Do not use if you have ever had an allergic reaction to guselkumab 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 TREMFYA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with TREMFYA 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 TREMFYA?

• TREMFYA is given by injection under your skin (subcutaneous injection)

5. What should I know while using TREMFYA?

6. Are there any side effects?

Side effects that require urgent medical attention include: Signs of an allergic reaction, such as rash, itching or hives on the skin, shortness of breath, wheezing or difficulty breathing, a tight feeling in your chest, swelling of the face, lips, tongue or other parts of the body; signs of infection such as fever or flu-like symptoms, blood in your phlegm (mucus), muscle aches, cough, shortness of breath, weight loss, stomach flu (gastroenteritis), burning when you urinate or urinating more often than normal, warm, red, or painful skin or sores on your body different from your psoriasis.
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.

1 Name of Medicine

Guselkumab.

2 Qualitative and Quantitative Composition

Tremfya 100 mg solution for injection in pre-filled syringe. Each pre-filled syringe contains 100 mg of guselkumab per 1 mL solution.
Tremfya 100 mg solution for injection in pre-filled pen. Each pre-filled pen contains 100 mg of guselkumab per 1 mL solution.
Guselkumab is a fully human immunoglobulin G1 lambda (IgG1 lambda) monoclonal antibody (mAb) that binds selectively to the extracellular human interleukin 23 (IL-23) protein with high specificity and affinity. Guselkumab is produced in a mammalian cell line using recombinant DNA technology.
For a full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection in a prefilled syringe or a pre-filled pen (One-Press patient controlled injector).
Tremfya is a clear, colourless to light yellow solution.

4 Clinical Particulars

4.9 Overdose

Single intravenous doses of Tremfya up to 987 mg (10 mg/kg) have been administered in healthy volunteers and single subcutaneous doses of Tremfya up to 300 mg have been administered in subjects with plaque psoriasis in clinical trials without dose-limiting toxicity. In the event of overdose, monitor the patient for any signs or symptoms of adverse reactions and administer appropriate symptomatic treatment 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. Guselkumab has not been evaluated for genotoxic potential.
Carcinogenicity. Guselkumab has not been evaluated for carcinogenic potential.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSGUSELK.gif CAS number. 1350289-85-8.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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