Buy Jyseleca (filgotinib)

What is Jyseleca (filgotinib) for?

Jyseleca (filgotinib) is a Janus kinase 1 (JAK1) inhibitor indicated for the treatment of adults with moderate to severe active rheumatoid arthritis (RA).^[1]

It is indicated for patients who do not respond or are intolerant to other anti-rheumatic medicines.^[1]

It can be used on its own (monotherapy) or together with another anti-rheumatic medicine, methotrexate (MTX).^[1]

Jyseleca (filgotinib) is available as 200 mg tablets.^[1]

How does Jyseleca (filgotinib) work?

RA is a disease in which the body’s immune system attacks healthy tissue to cause inflammation and pain in joints.^[2]

The active substance in Jyseleca, filgotinib, acts on enzymes known as Janus kinases (JAK). Filgotinib is designed to block the action of the specific subtype JAK1. These enzymes play an important role in the process of inflammation that is seen in rheumatoid arthritis.^[2]

By blocking JAK1’s action, filgotinib helps reduce the inflammation and other symptoms of RA. It helps in reducing pain, tiredness, stiffness and swelling in the joints. It can slow down damage to the bone and cartilage in the joints.^[1,2]

Where has Jyseleca (filgotinib) been approved?

Jyseleca (filgotinib) was approved for the acute treatment of adults with migraine by:

• The European Medicines Agency (EMA), Europe, on September 24, 2020.^[3]
• The Pharmaceuticals and Medical Devices Agency (PMDA), Japan, on September 25, 2020.^[4]

In August 2020, the Food and Drug Administration (FDA), US. expressed concerns of testicular toxicity previously associated with high doses of filgotinib. In December 2020, Gilead and Galapagos announced that Gilead will not advance Jyseleca for RA treatment in the US.^[5]

Filgotinib is being studied for the treatment of multiple inflammatory diseases, including Ulcerative colitis (UC), Crohn’s disease (CD), Psoriatic arthritis (PsA) and Ankylosing spondylitis (AS).^[6]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Jyseleca (filgotinib) taken?

The standard dosage is:^[1]

• 200 mg (tablet) taken by mouth once daily

A patient can only start with Jyseleca (filgotinib) treatment if blood levels of haemoglobin and of certain white blood cells are above a set limit. Treatment may be interrupted if blood levels fall below this limit.^[1]

Treatment should be started by a doctor that is experienced in treating RA.^[1]

Complete information about Jyseleca (filgotinib) dosage and administration can be found in the official prescribing information listed in our references section.^[1]

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Jyseleca (filgotinib)?

Common adverse reactions

The most common side effects (1-10% of patients) listed in the prescribing information include:^[1]

• Nausea (feeling sick)
• Upper respiratory tract infection (nose and throat infection)
• Urinary tract infection
• Dizziness

Serious adverse reactions

The serious side effects listed in the prescribing information include:^[1]

• Increased risk of serious infections

In August 2020, the Food and Drug Administration (FDA), US. expressed concerns of testicular toxicity previously associated with 200 mg doses of filgotinib.^[5]

Use in a specific population

Women who are able to bear a child (fertile) have to use effective contraception during and for at least 1 week after the end of filgotinib treatment.^[1]

Jyseleca (filgotinib) can cause fetal harm when administered to a pregnant woman, it is advised to avoid pregnancies and breastfeeding.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Full prescribing information [EMA]: Jyseleca (filgotinib) [PDF] Galapagos, Sept 24, 2020

2. The effect of JAK1/JAK2 inhibition in rheumatoid arthritis: efficacy and safety of baricitinib [PDF] Choy EHS, Clinical and Experimental Rheumatology, 2019 vol 37

3. European Commission Grants Marketing Authorization for Jyseleca (Filgotinib) for the Treatment of Adults With Moderate to Severe Active Rheumatoid Arthritis
Gilead press release, Sept 25, 2020

4. Jyseleca® (Filgotinib) Approved in Japan for Rheumatoid Arthritis
Gilead press release, Sept 25, 2020

5. Gilead and Galapagos announce New Commercialization and Development Agreement for Jyseleca® (filgotinib)
Galapagos press release, Dec 15, 2020

6. Filgotinib in inflammation
Galapagos annual report 2019, cited on Nov 13, 2020