Jyseleca (Filgotinib)
JAK Inhibitor for Rheumatoid Arthritis and Ulcerative Colitis
Quick Facts About Jyseleca
Key Takeaways About Jyseleca
- Targeted JAK1 inhibition: Jyseleca preferentially inhibits JAK1, offering a more selective approach to reducing inflammation in rheumatoid arthritis and ulcerative colitis compared to non-selective JAK inhibitors
- Once-daily oral convenience: Taken as a single tablet once daily with or without food, providing a practical alternative to injectable biological therapies
- Infection risk: Jyseleca reduces immune function and increases susceptibility to infections, including serious infections and herpes zoster (shingles) reactivation
- Contraindicated in pregnancy: Jyseleca must not be used during pregnancy; effective contraception is required during treatment and for at least one week after the last dose
- Regular monitoring required: Blood tests are needed before and during treatment to monitor white blood cell counts, liver function, and lipid levels
What Is Jyseleca and What Is It Used For?
Jyseleca contains the active substance filgotinib, which belongs to a group of medicines called Janus kinase (JAK) inhibitors. These medicines work by targeting specific enzymes in the body’s immune signalling pathways that are responsible for driving chronic inflammation. By blocking JAK1, filgotinib interrupts the signalling cascade of multiple pro-inflammatory cytokines, thereby reducing the overactive immune response that characterises autoimmune conditions.
Rheumatoid Arthritis
Jyseleca is approved for the treatment of moderate-to-severe active rheumatoid arthritis in adults who have had an inadequate response to, or who are intolerant of, one or more disease-modifying antirheumatic drugs (DMARDs). Rheumatoid arthritis is a chronic autoimmune condition in which the body’s immune system mistakenly attacks the lining of the joints (synovium), causing persistent inflammation, pain, swelling, and progressive joint damage.
In rheumatoid arthritis, Jyseleca can be used either as monotherapy or in combination with methotrexate, the standard first-line DMARD. Clinical trials, including the FINCH programme (FINCH 1, 2, and 3), demonstrated that filgotinib significantly reduced disease activity scores, improved physical function, and inhibited the progression of structural joint damage compared to placebo. Many patients achieved clinical remission or low disease activity within the first 12 weeks of treatment.
The therapeutic effects of Jyseleca in rheumatoid arthritis include reduction in joint pain and tenderness, decreased morning stiffness, reduced joint swelling, improved physical function and quality of life, and slowed radiographic progression of joint erosion. These benefits allow many patients to resume normal daily activities that were previously limited by their disease.
Ulcerative Colitis
Jyseleca is also indicated for the treatment of moderate-to-severe active ulcerative colitis in adults who have had an inadequate response to, have lost response to, or were intolerant of conventional therapy or a biological agent. Ulcerative colitis is a chronic inflammatory bowel disease that causes inflammation and ulceration of the innermost lining of the large intestine (colon) and rectum, leading to symptoms such as bloody diarrhoea, abdominal pain, urgency, and fatigue.
The SELECTION programme of clinical trials demonstrated that filgotinib effectively induced and maintained clinical remission in patients with ulcerative colitis. Treatment with Jyseleca led to endoscopic improvement, reduced rectal bleeding, normalisation of stool frequency, and decreased need for corticosteroid therapy. The oral, once-daily formulation offers a significant convenience advantage over injectable biological therapies commonly used in ulcerative colitis management.
By reducing intestinal inflammation, Jyseleca helps to alleviate the debilitating symptoms of ulcerative colitis and improve patients’ overall quality of life. It represents an important therapeutic option for patients who have not achieved adequate disease control with other treatments, including anti-TNF agents, vedolizumab, or ustekinumab.
What Should You Know Before Taking Jyseleca?
Before initiating treatment with Jyseleca, a thorough medical evaluation is essential. Your prescribing physician will consider your complete medical history, current medications, and individual risk factors to determine whether Jyseleca is the most appropriate treatment option for you. Understanding these precautions helps ensure the safest and most effective use of this medication.
Contraindications
- You are allergic to filgotinib or any of the other ingredients in the tablets
- You have active tuberculosis (TB)
- You have a serious active infection of any kind
- You are pregnant or think you may be pregnant
Warnings and Precautions
Jyseleca suppresses certain immune functions, which means patients may be more vulnerable to infections and certain other conditions. It is critically important to inform your doctor about all aspects of your medical history before starting treatment. The following situations require particular caution and careful discussion with your healthcare provider:
Infections: Tell your doctor if you currently have an infection or if you frequently get infections. Symptoms such as fever, wounds, excessive tiredness, or dental problems could be signs of an infection. Jyseleca can reduce the body’s ability to fight infections and may worsen an existing infection or increase the risk of developing a new one. Patients with diabetes or those aged 65 years and older are at increased risk of infection during treatment.
Tuberculosis (TB): If you have a history of TB or have been in close contact with someone who has TB, you may need to be tested before and during treatment with Jyseleca. Your doctor will screen you for latent TB infection and will not start treatment until active TB has been excluded or adequately treated.
Herpes Zoster (Shingles): If you have a history of shingles, Jyseleca may cause the infection to recur. Inform your doctor immediately if you develop a painful skin rash with blisters during treatment, as this could be a sign of shingles reactivation. The European Medicines Agency (EMA) and the American College of Rheumatology (ACR) recommend considering herpes zoster vaccination prior to starting JAK inhibitor therapy.
Hepatitis B or C: Tell your doctor if you have or have had hepatitis B or C infection. Reactivation of hepatitis B virus has been reported in patients taking JAK inhibitors. Viral hepatitis screening is typically performed before treatment initiation.
Cancer: If you have or have had cancer, are a current smoker, or have previously smoked, discuss this with your doctor. JAK inhibitors as a class have been associated with an increased risk of certain malignancies, particularly in patients over 65 years of age and in those with additional risk factors. Non-melanoma skin cancers have been observed in patients taking Jyseleca, and your doctor may recommend regular dermatological examinations during treatment.
Blood Clots: If you have a history of deep vein thrombosis (DVT) or pulmonary embolism (PE), or if you have risk factors for blood clots (such as recent major surgery, use of hormonal contraceptives or hormone replacement therapy, or a known clotting disorder), inform your doctor. JAK inhibitors have been associated with venous thromboembolism. Seek immediate medical attention if you experience sudden shortness of breath, chest pain, leg swelling, or leg pain or discolouration.
Heart Problems: If you have or have had cardiovascular problems, discuss this with your doctor. Regulatory agencies have issued guidance regarding cardiovascular risk with JAK inhibitors, and your doctor will evaluate whether Jyseleca is appropriate based on your individual cardiovascular risk profile.
Vaccinations: Certain vaccines (live vaccines) are not recommended while taking Jyseleca, as the medicine suppresses immune function. Your doctor may wish to ensure all vaccinations are up to date before you begin treatment. Inactivated vaccines, including annual influenza and pneumococcal vaccines, can generally be administered during treatment.
Elderly Patients
Patients aged 65 years and older may be at increased risk of infections, heart attack, and certain types of cancer during treatment with JAK inhibitors. Your doctor may decide that Jyseleca is not suitable for you based on your age and overall health profile. Jyseleca is not recommended for patients over 75 years of age with ulcerative colitis.
Children and Adolescents
Jyseleca should not be given to children and adolescents under 18 years of age. The safety and efficacy of this medicine have not been established in this age group, and it is not authorised for paediatric use.
Pregnancy and Breastfeeding
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. Seek medical advice before using this medicine.
Contraception: Use effective contraception while taking Jyseleca and for at least one week after taking the last dose. If you become pregnant during treatment, stop the tablets immediately and inform your doctor.
Breastfeeding: Do not breastfeed while taking Jyseleca. It is not known whether the active substance passes into breast milk.
Driving and Using Machines
Jyseleca may cause dizziness and vertigo. If you feel dizzy while taking this medicine, do not drive a vehicle or operate machinery until the symptoms resolve.
Lactose Content
Jyseleca tablets contain lactose. Each 100 mg tablet contains 76 mg of lactose, and each 200 mg tablet contains 152 mg of lactose. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine.
How Does Jyseleca Interact with Other Drugs?
Drug interactions can alter the effectiveness of Jyseleca or increase the risk of side effects. It is essential to tell your doctor or pharmacist about all medications you are taking, have recently taken, or might take, including prescription medicines, over-the-counter drugs, herbal supplements, and vitamins.
Immunosuppressant Interactions
Jyseleca should not be used in combination with other potent immunosuppressants such as ciclosporin or tacrolimus. Combining Jyseleca with these medications significantly increases the level of immunosuppression, raising the risk of serious infections and other immune-related complications. Similarly, Jyseleca should not be combined with biological DMARDs (such as anti-TNF agents, IL-6 inhibitors, or other JAK inhibitors), as the combination has not been studied and could lead to excessive immune suppression.
However, Jyseleca can be safely used in combination with conventional synthetic DMARDs, most notably methotrexate, which is the standard backbone therapy for rheumatoid arthritis. Clinical trials demonstrated that the combination of filgotinib plus methotrexate provided superior efficacy compared to either agent alone in certain clinical endpoints.
Cardiovascular Drug Interactions
Certain medications used to treat heart failure, heart disease, or high blood pressure may interact with Jyseleca. In particular, diltiazem (a calcium channel blocker) and carvedilol (a beta-blocker) can affect the metabolism of filgotinib and its active metabolite. If you are taking either of these medications, your doctor may need to adjust your treatment or monitor you more closely.
Lipid-Lowering Agents
Fenofibrate, a fibrate medication used to treat high cholesterol and triglycerides, interacts with the active metabolite of filgotinib. Concurrent use may require dose adjustment or additional monitoring. Other lipid-lowering agents, such as statins, do not appear to have clinically significant interactions with Jyseleca.
| Drug | Category | Interaction | Clinical Advice |
|---|---|---|---|
| Ciclosporin | Immunosuppressant | Additive immunosuppression | Do not use together |
| Tacrolimus | Immunosuppressant | Additive immunosuppression | Do not use together |
| Methotrexate | DMARD | No significant pharmacokinetic interaction | Can be used together (approved combination) |
| Diltiazem | Calcium channel blocker | May affect filgotinib metabolism | Use with caution; monitor closely |
| Carvedilol | Beta-blocker | May affect filgotinib metabolism | Use with caution; monitor closely |
| Fenofibrate | Lipid-lowering agent | Affects active metabolite levels | Monitor; dose adjustment may be needed |
| Live vaccines | Immunisation | Risk of vaccine-strain infection | Contraindicated during treatment |
What Is the Correct Dosage of Jyseleca?
Always take Jyseleca exactly as your doctor has prescribed. Your doctor will determine the most appropriate dose based on your condition, age, kidney function, and other individual factors. Do not change your dose or stop taking the medicine without consulting your doctor first.
Adults
Standard Adult Dosage
The recommended dose is one 200 mg tablet or one 100 mg tablet taken once daily. Your doctor will select the appropriate strength based on your clinical situation. The tablet should be swallowed whole with a glass of water and should not be split, crushed, or chewed, as this may alter the amount of medicine that enters the body. Jyseleca can be taken with or without food.
| Patient Group | Indication | Recommended Dose | Notes |
|---|---|---|---|
| Adults (18–64 years) | Rheumatoid Arthritis | 200 mg once daily | May use 100 mg based on clinical judgement |
| Adults (18–74 years) | Ulcerative Colitis | 200 mg once daily | Not recommended for patients over 75 years |
| Elderly (≥65 years) | Rheumatoid Arthritis | 100 mg once daily | Reduced dose due to increased infection risk |
| Renal impairment (moderate to severe) | RA / UC | 100 mg once daily | Reduced clearance of active metabolite |
| Severe hepatic impairment | RA / UC | Not recommended | Insufficient data on safety |
| Children (<18 years) | N/A | Not approved | Safety and efficacy not established |
Elderly Patients
For patients aged 65 years and older with rheumatoid arthritis, the recommended dose is 100 mg once daily. This dose reduction reflects the increased risk of infections and other adverse events observed in older patients treated with JAK inhibitors. For ulcerative colitis, Jyseleca is not recommended in patients over 75 years of age due to limited clinical data in this population.
Kidney Impairment
If you have moderate to severe kidney problems, your doctor may recommend a dose of 100 mg once daily. The active metabolite of filgotinib (GS-829845) is primarily eliminated through the kidneys, so reduced kidney function can lead to higher drug exposure. No dose adjustment is necessary for patients with mild kidney impairment.
Liver Impairment
Jyseleca is not recommended for patients with severe liver problems (Child-Pugh C), as the medicine has not been studied in this population. No dose adjustment is needed for mild or moderate hepatic impairment. Liver function tests should be performed before starting treatment and monitored periodically during therapy.
Missed Dose
If you forget to take a dose, take it as soon as you remember. However, if an entire day (24 hours) has passed since the missed dose, skip it and take your next dose at the usual time. Do not take a double dose to make up for a forgotten tablet. Taking your medicine at the same time each day can help you remember.
Overdose
If you have taken more tablets than prescribed, contact your doctor or seek emergency medical attention immediately. In clinical studies, single doses of up to 450 mg and multiple doses of up to 300 mg daily have been administered. There is no specific antidote for filgotinib overdose, and treatment is supportive. Due to the high protein binding of filgotinib, haemodialysis is not expected to be an effective method of drug removal.
Stopping Treatment
If you stop taking Jyseleca, tell your doctor immediately. Do not stop treatment on your own, as your symptoms may return or worsen. The decision to discontinue treatment should always be made in consultation with your healthcare provider, who will consider alternative therapeutic options.
- Swallow the tablet whole – do not split, crush, or chew
- Take at the same time each day to maintain consistent drug levels
- Can be taken with or without food
- Do not swallow the desiccant (moisture-absorbing agent) found in the bottle
- Keep the bottle tightly closed to protect from moisture
What Are the Side Effects of Jyseleca?
Like all medicines, Jyseleca can cause side effects, although not everybody gets them. Most side effects are mild to moderate in severity and tend to decrease over time. However, some side effects can be serious and require prompt medical attention. It is important to be aware of the signs and symptoms of these side effects so you can seek appropriate care.
- Signs of a serious infection: persistent fever, unusual fatigue, unexplained weight loss, or signs of pneumonia (persistent cough, fever, shortness of breath)
- Signs of herpes zoster (shingles): painful skin rash with blisters, usually on one side of the body
- Signs of a blood clot: sudden shortness of breath, chest pain, leg swelling, or leg pain
- Signs of sepsis (blood infection): high fever, rapid heartbeat, confusion, or feeling very unwell
Common Side Effects
- Nasopharyngeal infections (infections of the nose and throat)
- Urinary tract infections (some of which may be serious)
- Dizziness
- Nausea
- Low lymphocyte count (shown on blood tests)
- Decreased blood phosphate levels (shown on blood tests)
Uncommon Side Effects
- Pneumonia (lung infection)
- Herpes zoster (shingles)
- Sepsis (blood infection)
- Vertigo (spinning sensation)
- Low neutrophil count (shown on blood tests)
- Elevated creatine phosphokinase (a muscle enzyme, shown on blood tests)
- Elevated blood cholesterol (shown on blood tests)
Blood Test Abnormalities
Your doctor will perform regular blood tests before and during treatment with Jyseleca to monitor for potential adverse effects on blood counts and blood chemistry. These tests are particularly important during the first few months of treatment and help your doctor detect any issues early.
White blood cell changes: Jyseleca can reduce the number of white blood cells, including lymphocytes and neutrophils, which are essential for fighting infections. Your doctor may temporarily pause or permanently discontinue treatment if your blood counts fall below certain thresholds. A lymphocyte count below 0.5 × 109/L or a neutrophil count below 1.0 × 109/L typically warrants treatment interruption.
Lipid changes: Treatment with Jyseleca may increase blood cholesterol and triglyceride levels. Your doctor will check your lipid levels approximately 12 weeks after starting treatment and will manage elevated lipid levels according to established clinical guidelines.
Liver enzymes: Although hepatotoxicity is not a commonly reported side effect of Jyseleca, periodic monitoring of liver function is recommended, particularly in patients with pre-existing liver conditions or those taking concomitant hepatotoxic medications.
Long-Term Safety Considerations
Based on long-term extension studies and post-marketing surveillance, the safety profile of Jyseleca appears consistent with that observed in pivotal clinical trials. The EMA and regulatory authorities continue to monitor the long-term safety of all JAK inhibitors, particularly regarding risks of malignancy, major adverse cardiovascular events (MACE), and venous thromboembolism (VTE). Patients should attend all scheduled follow-up appointments and report any new or worsening symptoms to their healthcare provider promptly.
It is important to report suspected side effects after a medicine has been authorised. This allows continuous monitoring of the medicine’s benefit-risk balance. Healthcare professionals and patients can report suspected adverse reactions to their national pharmacovigilance authority (e.g., the MHRA in the UK, the FDA MedWatch programme in the US, or the EMA in Europe).
How Should You Store Jyseleca?
Proper storage of Jyseleca is essential to maintain the medicine’s effectiveness and safety throughout its shelf life. Follow these storage guidelines carefully:
- Keep out of the sight and reach of children. Store the medicine in a location that is not accessible to children.
- Do not use after the expiry date printed on the carton and bottle after “EXP.” The expiry date refers to the last day of the stated month.
- Store in the original packaging to protect from moisture. Jyseleca is moisture-sensitive and should be kept in the original bottle with the cap tightly closed.
- Do not swallow the desiccant (silica gel sachet or container) found inside the bottle. It is included to protect the tablets from moisture.
- Do not use if the seal on the bottle is broken or missing when you first open it.
Do not dispose of medicines via household waste or wastewater. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment and prevent accidental exposure to others.
What Does Jyseleca Contain?
Understanding the composition of your medication is important, particularly if you have known allergies or intolerances to any pharmaceutical excipients. Below is the complete list of ingredients in Jyseleca tablets.
Active Ingredient
Each film-coated tablet contains either 100 mg or 200 mg of filgotinib (as filgotinib maleate). Filgotinib maleate is the salt form used to enhance the stability and absorption of the active substance.
Inactive Ingredients
Tablet core: Microcrystalline cellulose, lactose monohydrate, pregelatinised starch, colloidal silicon dioxide, fumaric acid, and magnesium stearate.
Film coating: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), and red iron oxide (E172).
Tablet Appearance and Pack Sizes
Jyseleca 100 mg: Beige, capsule-shaped film-coated tablets measuring 12 mm × 7 mm, debossed with “G” on one side and “100” on the other.
Jyseleca 200 mg: Beige, capsule-shaped film-coated tablets measuring 17 mm × 8 mm, debossed with “G” on one side and “200” on the other.
Both strengths are available in bottles containing 30 tablets, and in multipacks consisting of 3 bottles each containing 30 tablets (90 tablets total). Each bottle contains a silica gel desiccant to protect the tablets from moisture. Not all pack sizes may be marketed in every country.
Frequently Asked Questions About Jyseleca
Jyseleca (filgotinib) is designed to preferentially inhibit JAK1, which may offer a more targeted approach compared to non-selective JAK inhibitors like tofacitinib (Xeljanz), which inhibits JAK1 and JAK3, or baricitinib (Olumiant), which inhibits JAK1 and JAK2. This selectivity for JAK1 may theoretically reduce certain side effects associated with inhibition of other JAK family members, though all JAK inhibitors share similar class-wide safety warnings. Your doctor will determine which treatment is most appropriate based on your individual circumstances.
Some patients may notice improvement in symptoms within the first 2 to 4 weeks of treatment, but the full therapeutic effect of Jyseleca typically develops over 8 to 12 weeks. In clinical trials for rheumatoid arthritis, significant improvements in disease activity were observed as early as week 2, with maximum benefit generally achieved by week 12 to 24. For ulcerative colitis, induction treatment is typically assessed at week 10 to 12. It is important to continue taking the medicine even if you do not notice immediate improvement.
There are no specific warnings about alcohol consumption with Jyseleca in the prescribing information. However, excessive alcohol use can affect liver function and may increase the risk of gastrointestinal side effects. If you are also taking methotrexate in combination with Jyseleca, alcohol should be limited or avoided, as both methotrexate and alcohol can affect the liver. Discuss your alcohol consumption with your doctor for personalised advice.
Yes, regular blood tests are an important part of monitoring during Jyseleca treatment. Your doctor will typically check your blood counts (including lymphocytes and neutrophils), liver function tests, and kidney function before starting treatment and at regular intervals during therapy. Lipid levels (cholesterol and triglycerides) are usually checked approximately 12 weeks after starting treatment. These tests help your doctor detect any adverse effects early and adjust your treatment accordingly.
Yes, Jyseleca can be used either alone (monotherapy) or in combination with methotrexate for the treatment of rheumatoid arthritis. In clinical trials (FINCH 1 and FINCH 3), the combination of filgotinib and methotrexate demonstrated significant improvements in disease activity compared to methotrexate alone. Your rheumatologist will determine the most appropriate treatment strategy based on your disease severity, previous treatment history, and individual risk factors.
If you develop signs of an infection while taking Jyseleca – such as fever, cough, painful urination, unusual fatigue, or flu-like symptoms – contact your doctor promptly. Do not wait for the symptoms to worsen. Your doctor may temporarily pause Jyseleca treatment until the infection has been treated and resolved. For serious infections requiring hospitalisation, Jyseleca should be discontinued until the infection is fully controlled. Never restart the medicine without your doctor’s approval.
References and Sources
All information is based on peer-reviewed research and international medical guidelines. This article does not receive any commercial funding.
- European Medicines Agency (EMA). Jyseleca (filgotinib) – Summary of Product Characteristics. European Medicines Agency. Available at: ema.europa.eu/jyseleca. Accessed January 2026.
- Combe B, et al. Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial (FINCH 1). Annals of the Rheumatic Diseases. 2021;80(7):848–858. doi:10.1136/annrheumdis-2020-219214
- Genovese MC, et al. Filgotinib, a selective JAK1 inhibitor, in patients with rheumatoid arthritis: a phase 2, randomised, placebo-controlled study (DARWIN 1). Annals of the Rheumatic Diseases. 2019;78(8):1009–1015.
- Feagan BG, et al. Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double-blind, randomised, placebo-controlled trial. The Lancet. 2021;397(10292):2372–2384. doi:10.1016/S0140-6736(21)00666-8
- Smolen JS, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Annals of the Rheumatic Diseases. 2023;82(1):3–18. doi:10.1136/ard-2022-223356
- Fraenkel L, et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis & Rheumatology. 2021;73(7):1108–1123. doi:10.1002/art.41752
- Raine T, et al. ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment. Journal of Crohn’s and Colitis. 2022;16(1):2–17. doi:10.1093/ecco-jcc/jjab178
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: World Health Organization; 2023.
- Nash P, et al. Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement. Annals of the Rheumatic Diseases. 2021;80(1):71–87.
- Winthrop KL, et al. The safety and immunogenicity of vaccines in patients treated with JAK inhibitors. Expert Review of Clinical Immunology. 2022;18(3):295–306.
Editorial Team
This article has been medically reviewed and approved by the iMedic Medical Editorial Team, consisting of specialist physicians in rheumatology, gastroenterology, and clinical pharmacology.
Independent specialists in rheumatology and gastroenterology following EULAR, ACR, and ECCO guidelines
Based on systematic reviews and meta-analyses of randomised controlled trials (GRADE framework)
Last medically reviewed: . Next review scheduled within 12 months. All information is independently produced with no pharmaceutical company involvement.