Tremfya 100 mg solucion inyectable en jeringa precargada

Prospect: Information for the User

Tremfya 100 mg injectable solution in pre-filled syringe

Guselkumab

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect thoroughly before starting to use this medicine, because

it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed to you alone, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects that do not appear in this prospect. See section 4.

Tremfya contains the active ingredient guselkumab, which is a type of protein called monoclonal antibody.

This medication acts by blocking the activity of a protein called IL-23,which is present in greater quantities in people with psoriasis and psoriatic arthritis.

Plaque psoriasis

Tremfya is used to treat adults with “plaque psoriasis” of moderate to severe, an inflammatory disorder that affects the skin and nails.

Tremfya can improve skin disorders and the appearance of nails and reduce symptoms, such as scaling, shedding, exfoliation, itching, pain, and burning.

Psiatic arthritis

Tremfya is used to treat a disease called “psoriatic arthritis”, an inflammatory joint disease, often accompanied by psoriasis. If you have psoriatic arthritis, you will be given other medications first. If you do not respond well enough to these medications, you will be given Tremfya to reduce the signs and symptoms of your disease. Tremfya can be used alone or with another medication called methotrexate.

The use of Tremfya in psoriatic arthritis will benefit you by reducing the signs and symptoms of the disease, slowing down the damage to the cartilage and bone of the joints, and improving your ability to perform normal daily activities.

No use Tremfya

• If you are allergic to guselkumab or any of the other components of this medication

(see section 6). If you think you may be allergic, consult your doctor before using Tremfya

• If you have an active infection, including active tuberculosis

Warnings and precautions

Consult your doctor, pharmacist or nurse before using Tremfya:

• If you are receiving treatment for an infection

• If you have a persistent or recurring infection
• If you have tuberculosis or have had close contact with someone with tuberculosis
• If you think you may have an infection or symptoms of an infection (see below “Infection and allergic reaction monitoring”)
• If you have recently been vaccinated or need to receive a vaccine during treatment with Tremfya.

If you are unsure whether any of the above conditions apply to you, speak with your doctor, pharmacist or nurse before using Tremfya.

Following your doctor's instructions, before receiving Tremfya and when you are going to use it, you may need to have blood tests to check if you have elevated liver enzyme levels. Elevated liver enzyme levels may be more frequent in patients who receive Tremfya every 4weeks than in those who receive Tremfya every 8weeks (see “How to use Tremfya” in section 3).

Infection and allergic reaction monitoring

Tremfya has the potential to produce severe adverse reactions, including allergic reactions and infections. You must monitor the appearance of signs of these disorders while receiving Tremfya.

Stop using Tremfya and consult your doctor or seek medical help immediately if you observe

any sign that indicates a possible severe allergic reaction or infection.

The signs of infection may include fever or flu-like symptoms; muscle pain; cough; difficulty breathing; burning sensation while urinating or urinating more frequently than usual; blood in mucus (phlegm); weight loss; diarrhea or stomach pain; hot, red, or painful skin, or sores on the body that are different from psoriasis lesions.

Severe allergic reactions with Tremfya have occurred, which may include the following symptoms,swelling of the face, lips, mouth, tongue, or throat, difficulty swallowing or breathing, and hives (see “Severe adverse reactions” in section4).

Children and adolescents

Tremfya is not recommended for children and adolescents under 18 years of age because there are no studies in this age group.

Other medications and Tremfya

Talk to your doctor or pharmacist:

• If you are using, have used recently or may need to use any other

medication.

• If you have recently been vaccinated or need to be vaccinated. You should not receive certain types of vaccines (live organisms) while using Tremfya.

Pregnancy and breastfeeding

• Tremfya should not be used during pregnancy as the effects of this medication on pregnant women are unknown. If you are a fertile woman, it is recommended that you avoid becoming pregnant and use an appropriate contraceptive method during treatment with Tremfya and at least 12 weeks after the last dose of Tremfya.

Inform your doctor if you are pregnant, think you may be pregnant or intend to become pregnant.

• Also inform your doctor if you are breastfeeding or plan to do so. You and your doctor must decide whether you can breastfeed or use Tremfya.

Driving and operating machinery

It is unlikely that Tremfya will affect your ability to drive and operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor or nurse. In case of doubt, consult your doctor, nurse, or pharmacist.

What dose of Tremfya to administer and for how long

Your doctor will decide for how long you need to use Tremfya.

Plaque psoriasis

• The dose is 100 mg (the contents of 1 pre-filled syringe) administered by subcutaneous injection under the skin. Your doctor or nurse will probably administer this injection.
• After the first dose, you will receive the next dose 4 weeks later and then every 8 weeks.

Psoriatic arthritis

• The dose is 100 mg (the contents of 1 pre-filled syringe) administered by subcutaneous injection under the skin. Your doctor or nurse will probably administer this injection.
• After the first dose, you will receive the next dose 4 weeks later and then every 8 weeks. In some patients, after the first dose, Tremfya may be administered every 4 weeks. Your doctor will decide how often you can receive Tremfya.

Initially, your doctor or nurse will administer Tremfya. However, you and your doctor may decide that you can administer Tremfya yourself, in which case, you will receive the necessary training on how to administer Tremfya. Consult your doctor or nurse if you have any doubts about administering injections. It is essential that you do not attempt to administer the injections yourself until your doctor or nurse has taught you.

To know how to use Tremfya, read carefully the "Instructions for use" leaflet before using it, which is attached to the packaging.

If you use more Tremfya than you should

If you have received more Tremfya than you should or the dose was administered before the prescribed time, inform your doctor.

If you forget to use Tremfya

If you have forgotten to administer a dose of Tremfya, inform your doctor.

If you interrupt treatment with Tremfya

Do not stop using Tremfya without first talking to your doctor. If you suspend treatment, your symptoms may reappear.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Severe Adverse Effects

Inform your doctor or seek immediate medical help if you experience any of the following severe adverse effects:

Severe Allergic Reaction(may affect up to 1 in 100people)- symptoms may include:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• intense itching of the skin, with a red rash or swelling

Other Adverse Effects

The following adverse effects are all mild to moderate. If any of these adverse effects become severe, consult your doctor, pharmacist, or nurse immediately.

Some adverse effects are very common (may affect more than 1 in 10 people):

• respiratory tract infections

Some adverse effects are common (may affect up to 1 in 10 people):

• headache
• joint pain (arthritis)
• diarrhea
• redness, irritation, or pain at the injection site

• increased levels of liver enzymes in the blood

Some adverse effects are uncommon (may affect up to 1 in 100 people):

• allergic reaction
• skin rash
• decrease in the number of a type of white blood cell called neutrophils
• herpes simplex infection
• skin infection by fungi, for example between the toes (e.g., athlete's foot)
• gastroenteritis (stomach upset)
• hives

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly throughtheSpanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the syringe label and on the box after CAD. The expiration date is the last day of the month indicated.

Store the pre-filled syringe in the outer packaging to protect it from light.

Store in refrigerator (2°C–8°C). Do not freeze.

Do not shake.

Do not use this medication if it warns that it is cloudy or has an abnormal color, or contains large particles. Before using the medication, remove the packaging from the refrigerator and keep the pre-filled syringe in it until it reaches room temperature, waiting 30 minutes.

This medication is for single use. Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the medications that you no longer need. This will help protect the environment.

Composition of Tremfya

• The active ingredient is guselkumab. Each pre-filled syringe contains 100 mg of guselkumab in1 ml of solution.
• The other components are histidine, monohydrochloride monohydrate of histidine, polisorbate 80, sucrose, and water for injection.

Appearance of Tremfya and contents of the pack

Injectable solution (injection). Tremfya is a transparent and colourless to light yellow solution. It is presented in a carton pack containing a single-dose glass syringe

and as a multiple pack containing 2 (2packs of 1) pre-filled syringes. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Biologics B.V.

Einsteinweg 101

2333CB Leiden

Netherlands

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

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• Country of registration
  Spain
• Active substance
  Guselkumab.
• Prescription required
  Yes
• Manufacturer
  Janssen-Cilag International N.V
• Composition
  Sacarosa (83 mg mg)
• This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.

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