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All price changes →Filgotin
Rx100 mg • Tablet
More from Filgotin
Other strengths and forms by Ziska Pharmaceuticals Ltd.
Indications & Uses
For rheumatoid arthritis, Filgotin is used in adults with moderate to severe active disease who have not responded well enough to one or more disease-modifying anti-rheumatic drugs (DMARDs), or who can't tolerate them. It can be taken on its own as monotherapy or together with methotrexate (MTX). For ulcerative colitis, Filgotin is used in adults with moderately to severely active disease. This applies to people who had an inadequate response to either conventional therapy or a biologic agent, lost response to it, or could not tolerate it.
Pharmacology
Filgotinib is an adenosine triphosphate (ATP)-competitive and reversible inhibitor of the JAK family. JAKs are enzymes inside the cell that pass on signals coming from cytokine or growth factor-receptor interactions on the cell membrane. JAK1 is important in mediating inflammatory cytokine signals, JAK2 in mediating myelopoiesis and erythropoiesis, and JAK3 plays critical roles in immune homeostasis and lymphopoiesis. Along this signalling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs), which modulate activity inside the cell, including gene expression. Filgotinib modulates these pathways by preventing the phosphorylation and activation of STATs. In biochemical assays, filgotinib preferentially inhibited the activity of JAK1, and it showed >5-fold higher potency for JAK1 over JAK2, JAK3 and TYK2.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
For rheumatoid arthritis, the recommended dose of Filgotinib is one 200 mg tablet once a day. For ulcerative colitis, the recommended dose is also 200 mg once daily. If a patient has shown no therapeutic benefit after 22 weeks of treatment, Filgotinibib should be stopped. Adults at higher risk of venous thromboembolism, major adverse cardiovascular events and malignancy should take 100 mg once daily as maintenance treatment. If the disease flares, the dose may be raised to 200 mg once daily. For long term treatment, use the lowest effective dose.
Side Effects
People taking Filgotinib Maleate most often report nausea, upper respiratory tract infection (URTI), urinary tract infection (UTI) and dizziness, among others.
Cautions & Contraindications
Warnings & Precautions
Filgotinib should not be combined with other potent immunosuppressants such as azathioprine, ciclosporin, tacrolimus, biologic DMARDs (bDMARDs) or other Janus kinase (JAK) inhibitors, because a risk of additive immunosuppression cannot be excluded. Infections, including serious infections, have been reported in patients taking filgotinib. Pneumonia was the most frequent serious infection. Among opportunistic infections, TB, oesophageal candidiasis and cryptococcosis were reported. Viral reactivation was also seen in clinical studies, including herpes virus reactivation (e.g., herpes zoster). If a patient develops herpes zoster, filgotinib treatment should be interrupted temporarily until the episode resolves. Before starting treatment and during it, screening for viral hepatitis and monitoring for reactivation should be done in line with clinical guidelines. On malignancy, the risk of malignancies is increased in patients with rheumatoid arthritis, and immunomodulatory medicinal products may increase the risk of malignancies too. On fertility, animal studies showed decreased fertility, impaired spermatogenesis and histopathological effects on male reproductive organs. For vaccinations, live vaccines are not recommended during filgotinib treatment or immediately before it. Filgotinib was linked with a dose-dependent increase in lipid parameters, including total cholesterol and high-density lipoprotein (HDL) levels, while low-density lipoprotein (LDL) levels were slightly increased. For venous thromboembolism, consider the risks and benefits before treating patients who may be at increased risk of thrombosis. Patients with symptoms of thrombosis should be evaluated promptly and treated appropriately.
Pregnancy & Breastfeeding
Use in pregnancy: There's little or no data on the use of filgotinib in pregnant women. Studies in animals have shown reproductive toxicity. Going by those animal findings, filgotinib may cause fetal harm, so it is contraindicated during pregnancy.
Women of childbearing potential / Contraception: Women who could become pregnant have to use effective contraception during treatment with filgotinib and for at least 1 week after stopping it.
Lactation: It is unknown whether filgotinib passes into human milk. A risk to breastfed newborns and infants can't be ruled out, so filgotinib should not be used during breast-feeding.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Elderly, rheumatoid arthritis
In patients with rheumatoid arthritis who are 65 years of age and older, the recommended dose of filgotinib is 100 mg once daily. If the disease isn't controlled well enough, the dose may be raised to 200 mg once daily. For long term treatment, the lowest effective dose should be used.
Ulcerative colitis
In patients with ulcerative colitis who are 65 years of age and older, the recommended dose is 200 mg once daily for induction treatment and 100 mg once daily for maintenance treatment. If the disease flares, the dose may be raised to 200 mg once daily. For long term treatment, the lowest effective dose should be used. Filgotin is not recommended in patients aged 75 years and older, because there is no data in this population.
Renal impairment
Patients with mild renal impairment need no dose adjustment. For patients with moderate or severe renal impairment, a dose of 100 mg of filgotinib once daily is recommended.
Hepatic impairment
No dose adjustment is required in patients with mild or moderate hepatic impairment.
Overdose
Filgotin has been given in clinical studies as a single dose and as once daily doses of up to 450 mg, and no dose-limiting toxicity was seen. The adverse reactions were comparable to those at lower doses, and no specific toxicities were identified. After a single 100 mg dose of filgotinib in healthy subjects, the pharmacokinetic data show that about 50% of the dose is eliminated within 24 hours and 90% within 72 hours.
If an overdose happens, the patient should be monitored for signs and symptoms of adverse reactions. Treatment of filgotinib overdose consists of general supportive measures, including monitoring of vital signs and observation of the patient's clinical status. It is not known whether dialysis can remove filgotinib.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store Filgotinib Maleate at a temperature not above 25°C, and keep it away from light. Keep it out of reach of children.
Drug Interactions
Common questions about Filgotin 100 mg
What is Filgotin 100 mg Tablet?
Filgotin 100 mg Tablet is a medicine that contains Filgotinib Maleate. It is made by Ziska Pharmaceuticals Ltd. It belongs to the Adenosine triphosphate (ATP)-competitive and reversible inhibitor group of medicines.
What is Filgotin used for?
For rheumatoid arthritis, Filgotin is used in adults with moderate to severe active disease who have not responded well enough to one or more disease-modifying anti-rheumatic drugs (DMARDs), or who can't tolerate them. It can be taken on its own as monotherapy or together with methotrexate (MTX).
What are the side effects of Filgotin?
People taking Filgotinib Maleate most often report nausea, upper respiratory tract infection (URTI), urinary tract infection (UTI) and dizziness, among others.
Can I take Filgotin during pregnancy or while breastfeeding?
Use in pregnancy: There's little or no data on the use of filgotinib in pregnant women. Studies in animals have shown reproductive toxicity. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Filgotin?
Filgotin has been given in clinical studies as a single dose and as once daily doses of up to 450 mg, and no dose-limiting toxicity was seen. The adverse reactions were comparable to those at lower doses, and no specific toxicities were identified. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Filgotin?
Store Filgotinib Maleate at a temperature not above 25°C, and keep it away from light. Keep it out of reach of children.
Can I take other medicines with Filgotin?
Some medicines can interact with Filgotinib Maleate, for example: Diltiazem Hydrochloride, Fenofibrate, Carvedilol, Simvastatin. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Filgotin is already among the lowest-priced brands of Filgotinib Maleate at this strength.
Do I need a prescription for Filgotin?
Filgotin is a prescription (Rx) medicine. Take it as your doctor advises.