Jyseleca

Monotherapy or in combination w/ MTX for moderate to severe active RA in adult patients who have inadequate response to or who are intolerant to ≥1 DMARDs. Adult patients w/ moderately to severely active ulcerative colitis who have inadequate response w/, lost response to or were intolerant to either conventional therapy or biologic agent.

RA Adult 200 mg once daily. Adult w/ increased risk of VTE, major adverse CV events (MACE) & malignancy; elderly ≥65 yr 100 mg once daily, may be escalated to 200 mg once daily in case of insufficient disease control. Ulcerative colitis Adult Induction: 200 mg once daily. Patient who does not show adequate therapeutic benefit during initial 10 wk Additional 12 wk of induction treatment may provide additional symptomatic relief. Maintenance: 200 mg once daily. Adult w/ increased risk of VTE, MACE & malignancy Maintenance: 100 mg once daily, may be escalated to 200 mg once daily in case of disease flare. Elderly ≥65 yr Induction: 200 mg once daily. Maintenance: 100 mg once daily, may be escalated to 200 mg once daily in case of disease flare. Moderate or severe renal impairment (CrCl 15 to <60 mL/min) 100 mg once daily.

May be taken with or without food: Swallow whole.

Hypersensitivity. Active TB or serious infections. Pregnancy.

Use only if no suitable treatment alternatives in patients ≥65 yr; w/ history of atherosclerotic CV disease or other CV risk factors (eg, current or past long-time smokers); w/ malignancy risk factors (eg, current or history of malignancy). Not recommended in combination w/ other immunosuppressants (eg, ciclosporin, tacrolimus, biologics or other Janus kinase inhibitors). Possible infections including serious infections. Consider risks & benefits prior to treatment initiation in patients w/ chronic or recurrent infection; who have been exposed to TB; w/ history of serious or opportunistic infection; who have resided or travelled in areas of endemic TB or mycoses; w/ underlying conditions that may predispose to infection. Closely monitor for development of signs & symptoms of infections during & after treatment. Temporarily interrupt treatment if patient is unresponsive to standard antimicrobial therapy. Higher incidence of infections in elderly & diabetic patients. Screen for TB before treatment initiation; not to be administered to patients w/ active TB. Initiate standard antimycobacterial therapy before administrating filgotinib. Monitor for development of TB signs & symptoms including patients who tested -ve for latent TB prior to treatment initiation. Possible viral reactivation including herpes virus reactivation (eg, herpes zoster). Higher risk of herpes zoster in females, Asians, patients ≥50 yr, w/ medical history of herpes zoster or chronic lung disease & those treated w/ filgotinib 200 mg once daily. Temporarily interrupt treatment if patient develops herpes zoster until episode resolves. Screen for viral hepatitis & monitor for reactivation before starting & during treatment. Possible lymphoma & other malignancies. Possible non-melanoma skin cancer; perform periodic skin exam for all patients particularly those who are at increased risk of skin cancer. Do not initiate or temporarily interrupt treatment in patients w/ ANC <1 x 10⁹ cells/L, ALC <0.5 x 10⁹ cells/L or Hb <8 g/dL. Not recommended to use live vaccines during or immediately prior to treatment. Update immunisations including prophylactic zoster vaccinations prior to treatment initiation. Possible dose-dependent increased in lipid parameters including total cholesterol & HDL levels; slightly increased LDL levels. Possible MACE; DVT & pulmonary embolism. Patients w/ known VTE risk factors other than CV or malignancy risk factors. Periodically re-evaluate during treatment to assess for changes in VTE risk. Promptly evaluate patients w/ signs & symptoms of VTE & discontinue use in those w/ suspected VTE regardless of dose. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Consider benefits & risks for individual patient prior to initiating or continuing therapy. Possible GI perforation; patients who may be at increased risk of GI perforation (eg, those w/ history of diverticulitis, concomitant use of corticosteroids &/or NSAIDs). Promptly evaluate patients presenting w/ new onset abdominal signs & symptoms for early identification of GI perforation. Minor influence on ability to drive & use machines; possible dizziness & vertigo. Not recommended for use in patients w/ ESRD (CrCl <15 mL/min) or severe hepatic impairment (Child-Pugh C). Advise women of childbearing potential to use effective contraception during & for at least 1 wk after treatment cessation. Not to be used during breast-feeding. Childn <18 yr.

UTI, URTI; lymphopenia; dizziness; nausea.

May be inhibited in vitro by fenofibrate, carvedilol, diltiazem or simvastatin. Co-administration w/ CYP1A2 substrate w/ narrow therapeutic index.

Immunosuppressants

L04AF04 - filgotinib ; Belongs to the class of Janus-associated kinase (JAK) inhibitors. Used as immunosuppressants.

POM