Lucius Version of Filgotinib: Dosage and Administration, Indications, Precautions

Lucius Version of Filgotinib: Dosage and Administration, Indications, Precautions

Indications

Rheumatoid Arthritis

LuciFilgo is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to or intolerance of one or more disease-modifying antirheumatic drugs (DMARDs). LuciFilgo can be used as monotherapy or in combination with methotrexate (MTX).

Ulcerative Colitis

LuciFilgo is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or are intolerant to conventional therapies or biologics.

Dosage and Administration

Treatment with LuciFilgo should be under the guidance of a physician experienced in the treatment of rheumatoid arthritis or ulcerative colitis.

Rheumatoid Arthritis

The recommended dose of LuciFilgo 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 is 100 mg once daily; if disease control is inadequate, the dose may be increased to 200 mg once daily. For long-term treatment, the lowest effective dose should be used.

Ulcerative Colitis

Induction Therapy

The recommended dose for induction therapy is 200 mg once daily. For patients with ulcerative colitis who do not show a sufficient therapeutic effect within the first 10 weeks of treatment, an additional 12 weeks of LuciFilgo induction therapy may further relieve symptoms. Patients who show no therapeutic effect after 22 weeks of treatment should discontinue LuciFilgo.

Use in Specific Populations

Women of Childbearing Potential/Contraception

Women of childbearing potential must use effective contraception during treatment with LuciFilgo and for at least 1 week after discontinuation.

Pregnancy

Data on the use of LuciFilgo in pregnant women are limited. Animal studies have demonstrated reproductive toxicity. Based on animal experimental results, LuciFilgo may cause harm to the fetus and is therefore contraindicated during pregnancy.

Lactation

It is not known whether LuciFilgo is excreted into human breast milk. The risk to breastfed newborns/infants cannot be excluded. Therefore, LuciFilgo should not be used during breastfeeding.

Warnings and Precautions

LuciFilgo should only be used when no suitable alternative treatments are available for patients in the following groups:

Patients aged 65 years and above;

Patients with a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (e.g., current or past long-term smokers);

Patients with risk factors for malignancy (e.g., current malignancy or history of malignancy).

Drug Interactions

Effects of Other Drugs on LuciFilgo

LuciFilgo is mainly metabolized by carboxylesterase 2 (CES2) and can be inhibited in vitro by drugs such as fenofibrate, carvedilol, diltiazem, or simvastatin. The clinical relevance of this interaction is unclear.

Effects of LuciFilgo on Other Drugs

LuciFilgo is not a clinically relevant inhibitor or inducer of most enzymes or transporters typically involved in drug interactions, such as cytochrome P450 (CYP) enzymes and UDP-glucuronosyltransferases (UGT). In vitro studies on the potential of LuciFilgo to induce CYP2B6 are inconclusive, and induction cannot be ruled out.

In vitro studies on the potential of LuciFilgo to induce or inhibit CYP1A2 are inconclusive. No clinical studies have been conducted to investigate interactions with CYP1A2 substrates, so the potential in vivo effects of LuciFilgo to both induce and inhibit CYP1A2 are unknown. Caution is recommended when LuciFilgo is co-administered with CYP1A2 substrates with a narrow therapeutic index.

In a clinical pharmacology study, co-administration with LuciFilgo had no effect on the pharmacokinetics of the combined oral contraceptives containing ethinylestradiol and levonorgestrel; therefore, no adjustment of the oral contraceptive dose is required.

Adverse Reactions

Rheumatoid Arthritis

The most common adverse reactions of LuciFilgo in patients with rheumatoid arthritis are nausea (3.5%), upper respiratory tract infection (URTI, 3.3%), urinary tract infection (UTI, 1.7%), dizziness (1.2%), and lymphopenia (1.0%).

Ulcerative Colitis

The overall safety profile observed in patients with ulcerative colitis treated with LuciFilgo is generally consistent with that observed in patients with rheumatoid arthritis.

Contraindications

None identified.

Dosage Form

Tablets.

Storage Conditions

Store at 20°C to 25°C (68°F to 77°F); short-term transportation is permitted within a temperature range of 15°C to 30°C (59°F to 86°F).