Eldixia®

What is it?

What is Eldixia^®?

Eldixia^® contains Guselkumab, a human IgG1 monoclonal antibody. Each prefilled syringe of Eldixia^® contains 100 mg of Guselkumab in 1 mL solution for subcutaneous injection.

How do Eldixia^® syringes work?

Indications

What is Eldixia^® used for?

• Eldixia^® is used to treat adults with moderate to severe “plaque psoriasis”, an inflammatory condition affecting the skin and nails.  Eldixia^® can improve the condition of the skin and the appearance of nails and reduce symptoms such as scaling, shedding, flaking, itching, pain and burning.
• Eldixia^® is also used to treat a condition called “psoriatic arthritis”, an inflammatory disease of the joints, often accompanied by plaque psoriasis.

Using Eldixia^® in psoriatic arthritis will benefit by reducing the signs and symptoms of the disease, slowing down the damage to the cartilage and bone of the joints and improving ability to do normal daily activities.

Contraindications

Who should not use Eldixia^®?

Do not use Eldixia^® if:

• You are allergic to Guselkumab or any of the other ingredients of this medicine.
• You have an active infection, including active tuberculosis.

Important information

What should you know about taking Eldixia^®?

Talk to your doctor, pharmacist or nurse before using Eldixia^®:

• If you are being treated for an infection;
• If you have an infection that does not go away or that keeps coming back;
• If you have tuberculosis or have been in close contact with someone with tuberculosis;
• If you think you have an infection or have symptoms of an infection;
• If you have recently had a vaccination or if you are due to have a vaccination during treatment with Eldixia^®;

If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Eldixia^®.

As directed by your doctor, you may need blood tests to check if you have high levels of liver enzymes before you start taking Eldixia^® and when using it.

Eldixia^® can potentially cause some side effects, including allergic reactions and infections. You must look out for signs of these conditions while you are taking Eldixia^®.

Children and Adolescents:

Eldixia^® is not recommended for children and adolescents under 18 years of age because Guselkumab has not been studied in this age group.

Pregnancy and Breastfeeding:

· Eldixia^® should not be used in pregnancy as the effects of this medicine in pregnant women are not known. If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Eldixia^® and for at least 12 weeks after the last Eldixia^® dose. Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.

· Talk to your doctor if you are breastfeeding or are planning to breastfeed. You and your doctor should decide if you will breastfeed or use Eldixia^®.

Driving and Using Machines:

Eldixia^® is unlikely to influence your ability to drive and use machines.

If you use more Eldixia^® than you should:

If you have received more Eldixia® than you should or the dose has been given sooner than prescribed, inform your doctor.

If you forget to use Eldixia^®:

If you have forgotten to inject a dose of Eldixia^®, inform your doctor.

If you stop using Eldixia^®:

You should not stop using Eldixia^® without speaking to your doctor first. If you stop treatment, symptoms of psoriasis may come back.

What other drugs could affect Eldixia^®?

Eldixia^® may interact with some of your other medicines. Tell your doctor or pharmacist:

• If you are using, have recently used or might use any other medicines.
• If you recently had or are due to have a vaccination. You should not be given certain types of vaccines (live vaccines) while using Eldixia^®.

How to use Eldixia^®?

• Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor, nurse or pharmacist if you are not sure.
• At the start, your doctor or nurse will inject Eldixia^®. However, you may decide together with your doctor to give Eldixia^® yourself in which case you will get the appropriate training on how to inject Eldixia^®. Talk to your doctor or nurse if you have any questions about giving yourself an injection. It is important not to try to inject yourself until you have been trained by your doctor or nurse.
• Eldixia^® is supplied in a prefilled syringe for subcutaneous injection.

Side Effects

What are the possible side effects of Eldixia^®?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects are all mild to moderate. If any of these side effects become severe, tell your doctor, pharmacist, or nurse immediately.

Very common side effects (may affect more than 1 in 10 people):

• Upper respiratory infections

Common side effects (may affect up to 1 in 10 people):

• Headache
• Joint pain (arthralgia)
• Diarrhea
• Redness at the injection site

For more information, please refer to the product`s leaflet.

Storage

How to store Eldixia^®?

• Store in a refrigerator (2 – 8 °C). Do not freeze.
• Keep the prefilled syringe in the outer carton in order to protect it from light.
• Do not shake.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine if you notice that the medicine is cloudy or discoloured, or contains large particles.

FAQs