Jyseleca - Filgotinib uses, dose and side effects

Jelena is used to treat adults with rheumatoid arthritis, a disease that causes inflammation in the joints. It can be used if previous treatment has not worked well enough or has not been tolerated. Jelena can be used alone or in combination with another arthritis medicine, methotrexate.

Jyseleca reduces inflammation in the body. It helps reduce pain, fatigue, stiffness, and swelling in the joints, and slows down damage to bones and cartilage in the joints. These effects can make it easier for you to perform your normal daily activities and improve your quality of life.

What you need to know before using Jyseleca

Do not use Jyseleca

if you are allergic to filgotinib or any of the other ingredients of this medicine (listed in section 6).

if you have active tuberculosis ( TB ).

if you have an active serious infection (see section “Warnings and precautions”).

if you are pregnant or think you may be pregnant.

→ If any of these apply to you, do not take Jyseleca and talk to a doctor immediately.

Warnings and cautions

Talk to your doctor or pharmacist before taking Jyseleca:

if you have an infection or if you get infection often . Tell your doctor if you get sick (especially if you get a fever or chills, shortness of breath, persistent cough or fatigue) while taking Jyseleca. Jyseleca may reduce your body’s ability to fight infections . It can aggravate an ongoing infection or increase the risk of getting a new infection . You are more likely to get a serious infection if you are 75 years or older.
if you have or have ever had tuberculosis ( TB ) or have come in contact with someone with tuberculosis . You may need to provide samples to check if you have tuberculosis before and during treatment with Jyseleca.
If you have had a herpes zoster infection ( shingles ) before, Jyseleca can make that infection come back. Tell your doctor if you get painful rashes with blisters during treatment with Jyseleca. This may be a sign of shingles .
if you have or have had hepatitis B or C before .
if you have cancer. Your doctor will need to decide if you should be treated with Jyseleca.
If you are at high risk of developing skin cancer , your doctor may recommend preventative measures such as regular skin examinations while you are taking Jyseleca. Talk to your doctor if you develop a new skin change or get any change in the appearance of your skin. Some patients who have been treated with Jyseleca have developed skin cancer.
if you are a man , Jyseleca may reduce your fertility (reduce the ability to have children) or cause infertility (inability to have children). See also the section “Male fertility”.
if you have recently been vaccinated or are about to do so. Some types of vaccines (live vaccines) are not recommended when using Jyseleca. Talk to your doctor or pharmacist before taking Jyseleca. They may want to make sure your vaccinations are up to date.
if you have heart problems, high blood pressure or high cholesterol .
if you have previously had blood clots in the veins of your legs (deep vein thrombosis ) or lungs ( pulmonary embolism ). Tell your doctor if you have pain in one leg and swelling, or chest pain or shortness of breath. This may be a sign of blood clots in the veins.

Children and young people

Do not give this medicine to children and adolescents under 18 years of age. The drug has not been studied in this age group

Other medicines and Jyseleca

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially if you are taking medicines that affect your immune system (such as azathioprine, ciclosporin, and tacrolimus).

It is also very important to talk to your doctor or pharmacist if you are taking any of the following:

medicines to treat heart failure , heart disease or high blood pressure (such as diltiazem , carvedilol or valsartan)
drugs for the treatment of high cholesterol (such as fenofibrate or statins including atorvastatin, pravastatin or simvastatin )

Pregnancy, contraception, breastfeeding and male fertility

Pregnancy

Jyseleca must not be used during pregnancy. Do not take this medicine if you are pregnant, think you may be pregnant, or are planning to have a baby. Talk to your doctor before using this medicine.

Contraceptive

Avoid getting pregnant while taking Jyseleca. You should use an effective contraceptive while you are taking Jyseleca, and for at least one week after taking your last dose of Jyseleca. If you become pregnant while taking Jyseleca, stop taking the tablets and tell your doctor immediately.

Breast-feeding

You should not breastfeed while taking Jyseleca. It is not known if the active substance is transferred to breast milk.

Male fertility

If you are a man taking Jyseleca, it is possible that this medicine may affect your sperm production and may reduce your fertility (impair the ability to have children) or lead to infertility (inability to have children). It is not known whether these effects may be temporary or permanent. Talk to your doctor if you have any questions or concerns about this.

Driving and using machines

Jelena can cause dizziness. If you feel dizzy while taking Jyseleca, do not drive or use any tools or machines.

Jyseleca contains lactose

Each Jyseleca 100 mg film-coated tablet contains 76 mg of lactose and each Jyseleca 200 mg film-coated tablet contains 152 mg of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to use Jyseleca

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is one 200 mg tablet once a day.

If you are older than 75 years or if you have kidney problems, your doctor may recommend a dose of a 100 mg tablet once a day. Talk to your doctor if you have severe liver problems, as Jyseleca is not recommended for you.

Swallow the tablet with a glass of water. Do not split, crush or chew the tablet before swallowing, as it may alter the amount of medicine entering the body. You can take Jyseleca with food or between meals. The desiccant should not be swallowed.

Take Jyseleca at the same time each day. This will help you remember to take the tablets.

Your doctor may interrupt treatment temporarily or permanently if blood tests show a low number of white or red blood cells.

If you take more Jyseleca than you should

If you take more tablets than you should, contact a doctor immediately.

If you forget to take Jyseleca

If you forget to take a dose , take it as soon as you remember.
If a full day (24 hours) has passed without you taking a dose , skip the missed dose and only take one dose at the time you usually take your dose .
Do not take a double dose to make up for a forgotten tablet.

If you stop taking Jyseleca

If you stop taking Jyseleca, tell your doctor straight away.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects are

Talk to a doctor or seek medical attention immediately if you get any signs of a serious infection such as:

fever and symptoms of urinary tract infection (urination more often than usual, pain or discomfort when urinating or back pain). Urinary tract infections are common (may affect up to 1 in 10 people), and some of them can be serious.
pneumonia: symptoms may include persistent cough, fever, shortness of breath and fatigue. This is less common (may affect up to 1 in 100 people).
Shingles ( herpes zoster): the symptoms may be painful skin rashes with blisters. This is less common (may affect up to 1 in 100 people).

Other side effects are

Talk to your doctor if you notice any of the following side effects:

Common (may affect up to 1 in 10 people)

infection you in the nose and throat
dizziness
nausea.

Uncommon (may affect up to 1 in 100 people)

Blood tests may show:

low white blood cell count ( neutrophils )
an increase in a muscle enzyme called creatine phosphokinase
increased levels of blood fats ( cholesterol ).

How to store Jyseleca

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

Do not use this medicine after the expiry date which is stated on the carton and can after EXP. The expiration date is the last day of the specified month.

Store in the original package. Moisture sensitive. Close the jar tightly. Do not use this medicine if you find that the seal on the jar is broken or missing.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is filgotinib. One film-coated tablet contains 100 or 200 mg of filgotinib (as filgotinib maleate).
Other ingredients are:

Tablet core: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, colloidal silica, fumaric acid, magnesium stearate

Film coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), red iron oxide (E172)

What the medicine looks like and contents of the pack

Jelena 100 mg film-coated tablets are beige, 12 mm × 7 mm, capsule-shaped with “GSI” on one side and “100” on the other.

Jelena 200 mg film-coated tablets are beige, 17 mm × 8 mm, capsule-shaped with “GSI” on one side and “200” on the other.

Jelena 100 mg and 200 mg are available in 30 tablet cans and in packs of 3 cans, each containing 30 tablets. Each jar contains a desiccant with silica gel that must be kept in the jar to protect the tablets. The desiccant with silica gel is in a separate bag or container and should not be swallowed.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer