Giselleca 100 mg (Filgotinib Maleate)

Adult dose

The recommended dose of this medicine for adult patients with rheumatoid arthritis is 200 mg once daily. For adults at increased risk of venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and malignancy, the recommended dose of this medicine is 100mg once daily; if disease control is inadequate, the dose may be increased to 200mg once daily. If this medicine is used long term, the lowest effective dose should be used. The recommended induction dose is 200 mg once daily. For patients with ulcerative colitis who do not show adequate therapeutic benefit during the first 10 weeks of induction therapy, an additional 12 weeks of induction therapy (200 mg once daily) may be given to provide further relief of symptoms. If no therapeutic benefit is observed after 22 weeks of treatment, this medicine should be discontinued. The recommended maintenance dose is 200 mg once daily. For adults at increased risk of venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and malignancy, the recommended maintenance dose is 100mg once daily; if the disease worsens, the dose may be increased to 200mg once daily. If this medicine is used long term, the lowest effective dose should be used. Do not initiate treatment if ANC is <1 × 109 cells/L; discontinue treatment if the patient is receiving it. Treatment may be resumed when ANC recovers to at least this level. Do not initiate treatment if ALC is <0.5 × 109 cells/L; discontinue treatment if the patient is receiving it. Treatment may be resumed when ALC recovers to at least this level. Do not initiate treatment if Hb is <8 g/dL; discontinue treatment if the patient is receiving it. Treatment may be resumed when Hb recovers to at least this level. Before treatment initiation and thereafter, follow routine patient management. Starting 12 weeks after treatment initiation, follow international clinical guidelines for hyperlipidemia. If the patient develops a serious infection, treatment should be interrupted until the infection is controlled. The recommended dose for patients aged 65 years and older with rheumatoid arthritis is 100mg once daily; if disease control is inadequate, the dose may be increased to 200mg once daily. If this medicine is used long term, the lowest effective dose should be used. For patients aged 65 years and older with ulcerative colitis, the recommended induction dose is 200 mg once daily, and the recommended maintenance dose is 100 mg once daily. If the disease worsens, the dose may be increased to 200mg once daily. If this medicine is used long term, the lowest effective dose should be used. There is no experience with administration in patients aged 75 years and older. No dose adjustment is necessary in patients with mild renal impairment (creatinine clearance [CrCl] 60 mL/min or greater). For patients with moderate or severe renal impairment (CrCl 15 mL/min or greater and less than 60 mL/min), administration of this medicine 100 mg once daily is recommended. This medicine has not been studied in patients with end-stage renal disease (CrCl less than 15 mL/min); therefore, its use is not recommended in patients with end-stage renal disease. No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child‑Pugh A or B). This medicine has not been studied in patients with severe hepatic impairment (Child‑Pugh C); therefore, its use is not recommended in patients with severe hepatic impairment. This medicine is administered orally with or without food. Whether this medicine can be chewed, crushed, or divided has not been studied; swallowing it whole is recommended.

Child dose

The safety and efficacy of this medicine have not been established in children under 18 years of age.

This medicine poses a risk of serious infections, hence careful evaluation is necessary before administration to patients with a history of chronic infections or tuberculosis, or those with underlying conditions that make them susceptible to infections. Symptoms of infection should be closely monitored during and after treatment, and if an infection occurs, drug administration may be temporarily suspended along with appropriate treatment. Elderly patients and those with diabetes should be particularly vigilant as they are at higher risk of infections. This medicine may increase the mortality and risk of cardiovascular adverse reactions in patients with cardiovascular risks; thus, it should be used cautiously in patients aged 65 and older or with cardiovascular risk factors. Tuberculosis testing should be performed before starting treatment, and appropriate anti-tuberculosis therapy should be received if latent tuberculosis is present. Monitoring for viral reactivation, especially the risk of herpes zoster, is necessary, including tests for viral hepatitis. There is also a risk of malignancies; therefore, patients with a history of skin cancer or risk factors for malignancies require regular check-ups and careful evaluations. Hematological abnormalities may occur, so regular monitoring of neutrophil count, lymphocyte count, and hemoglobin levels is necessary, with discontinuation of treatment in cases of abnormalities. Live vaccine administration is not recommended during treatment or immediately before, and it is advisable to complete necessary vaccinations prior to starting treatment. There is a risk of thrombosis, so caution should be exercised in elderly, obese, or patients with a history of thrombosis, and treatment should be immediately stopped and assessed if thrombotic symptoms appear. As this medicine has immunosuppressive effects, combining it with other immunosuppressants or biological agents is not recommended. Women who are pregnant or may become pregnant, and nursing mothers should not use this medicine, and fertile women should use effective contraception for at least one week during and after treatment. Safety and efficacy in children under 18 years of age have not been established. This medicine may increase lipid levels, so lipid profiles should be monitored regularly and appropriate treatments should be undertaken as needed. Dizziness and lightheadedness may occur, so caution is needed when driving or operating machinery. In cases of overdose, vital signs and clinical status should be closely monitored, as there is no specific antidote, so supportive therapy should be relied upon. This medicine should be stored out of reach of children and not be transferred to other containers.

• Pneumonia
• tuberculosis
• esophageal candidiasis
• cryptococcosis
• herpes virus reactivation
• shingles
• malignant tumors
• non-melanoma skin cancer
• lymphoma
• lung cancer

This medicine must be stored in a tightly closed container to prevent air and moisture exposure, and should be kept at room temperature between 1°C and 30°C. Therefore, it should be kept away from extremes of heat or cold, and in a cool place that is not exposed to direct sunlight.

Appearance

Beige film-coated tablet, oblong, with “GSI” engraved on one side and “100” engraved on the other side.

Package unit

30 tablets/bottle, 14 tablets/box [(14 tablets/blister x 1)]