Consumer medicine information

1. Why am I using Enbrel?

Enbrel contains the active ingredient etanercept. Enbrel is used to treat specific types of joint inflammation and skin conditions, namely rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis (nr-AxSpA), psoriatic arthritis and plaque psoriasis.
For more information, see Section 1. Why am I using Enbrel? in the full CMI.

2. What should I know before I use Enbrel?

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

3. What if I am taking other medicines?

Some medicines may interfere with Enbrel 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 Enbrel?

• Enbrel is given in adults either once a week as a 50 mg dose, or as two separate 25 mg doses 3-4 days apart. In children, the dose and frequency depend on weight and the disease.

• Enbrel is injected under the skin and is for single use in one patient only. Refer to Instructions for Use provided in the pack.

• Enbrel dose-dispenser cartridges are intended for use with the SmartClic injection device.

5. What should I know while using Enbrel?

6. Are there any side effects?

Common side effects include a mild reaction in the area of injection, infections and inflammation, allergic reactions, rash, itching, fever, headache and raised liver enzymes.
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

Etanercept.

2 Qualitative and Quantitative Composition

Powder for injection. Each vial of Enbrel powder for injection contains 25 mg of the active ingredient, etanercept. The content of the diluent syringe is 1 mL of sterile water for injections.
Pre-filled syringe (solution for injection). Each syringe of Enbrel solution for injection contains either 25 mg* (in 0.5 mL) or 50 mg (in 1 mL) of etanercept.
Dose-dispenser cartridge (solution for injection). Each dose-dispenser cartridge of Enbrel solution for injection contains either 25 mg (in 0.5 mL) or 50 mg (in 1 mL) of etanercept.
Auto-injector (solution for injection). The Enbrel prefilled auto-injector contains 50 mg of etanercept.
* Not all presentations may be marketed.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for solution for injection. Following reconstitution with water for injections, Enbrel is a colourless to slightly yellow or pale brown and clear to slightly opalescent solution, with a pH of 7.1-7.7.
Solution for injection. Enbrel solution for injection in the pre-filled syringe, auto-injector and dose-dispenser cartridge is a clear to opalescent, colourless to yellow or pale brown solution with a pH of 6.1-6.5. The liquid may contain trace levels of translucent to white amorphous particles.
Enbrel 25 mg and 50 mg solution for injection in the single-use dose-dispenser cartridge is for use in a Multi-Use Single-Patient device (MUSP).

4 Clinical Particulars

4.9 Overdose

The maximum tolerated dose of Enbrel has not been established in humans. Repeat dose studies have been performed in cynomolgus monkeys at doses resulting in AUC based systemic exposure levels of etanercept that were over 13-fold higher than in humans at the highest proposed therapeutic dose of 50 mg and have revealed no dose limiting or target organ toxicity. No dose limiting toxicities were observed during clinical trials of RA patients. The highest dose level evaluated has been an IV loading dose of 32 mg/m² followed by SC doses of 16 mg/m² administered twice weekly. One RA patient mistakenly self administered 62 mg Enbrel SC twice weekly for three weeks without experiencing unexpected side effects. Single IV doses up to 60 mg/m² (approximately twice the recommended dose) have been administered to healthy volunteers in an endotoxaemia study without evidence of dose limiting toxicities.
There is no known antidote to Enbrel. For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Genotoxicity studies showed no evidence of gene mutations or chromosomal damage.
Carcinogenicity. Long-term animal studies have not been conducted to evaluate the carcinogenic potential of Enbrel (see Section 4.4 Special Warnings and Precautions for Use).

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system. Etanercept is a dimer of a protein genetically engineered by fusing the extracellular ligand-binding domain of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1. This Fc component contains the hinge, CH₂ and CH₃ regions but not the CH₁ region of IgG1. Etanercept contains 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. Etanercept is now manufactured using a serum-free process..
CAS number. 185243-69-0.

7 Medicine Schedule (Poisons Standard)

S4, Prescription only medicine.

Summary Table of Changes

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