HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LuciFilgo safely and effectively. See full prescribing information for LuciFilgo.
INDICATIONS AND USAGE
Rheumatoid arthritis
LuciFilgo is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). LuciFilgo may 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 with, lost response to, or were intolerant to either conventional therapy or a biologic agent.
DOSAGE AND ADMINISTRATION
Treatment with LuciFilgo should be initiated by a physician experienced in the treatment of rheumatoid arthritis or ulcerative colitis.
Rheumatoid arthritis
The recommended dose of LuciFilgo for adult patients is 200 mg once daily.
In adults at increased risk of VTE, MACE and malignancy, the recommended dose is 100 mg once daily and may be escalated to 200 mg once daily in case of insufficient disease control.
For long term treatment, the lowest effective dose should be used.
Ulcerative colitis
Induction treatment
The recommended dose for induction treatment is 200 mg once daily.
For patients with ulcerative colitis who do not show an adequate therapeutic benefit during the initial 10 weeks of treatment, 12 additional weeks of induction treatment with LuciFilgo 200 mg once daily may provide additional relief of symptoms. Patients who have not shown any therapeutic benefit after 22 weeks of treatment should discontinue LuciFilgo.
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg×30 tablets
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Active tuberculosis (TB) or active serious infections.
Pregnancy.
WARNINGS AND PRECAUTIONS
LuciFilgo should only be used if no suitable treatment alternatives are available in patients:
-65 years of age and older;
-patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers);
-patients with malignancy risk factors (e.g. current malignancy or history of malignancy).
ADVERSE REACTIONS
Rheumatoid arthritis
The most frequently reported adverse reactions 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
In general, the overall safety profile observed in LuciFilgo-treated patients with ulcerative colitis was generally consistent with the safety profile observed in patients with rheumatoid arthritis.
DRUG INTERACTIONS
Effect of other medicinal products on LuciFilgo
LuciFilgo is primarily metabolised by carboxylesterase 2 (CES2), which can be inhibited in vitro by medicinal products such as fenofibrate, carvedilol, diltiazem or simvastatin. The clinical relevance of this interaction is unknown.
Effect of LuciFilgo on other medicinal products
LuciFilgo is not a clinically relevant inhibitor or inducer of most enzymes or transporters commonly involved in interactions such as cytochrome P450 (CYP) enzymes and UDP-glucuronosyltransferases (UGT).
In vitro studies are inconclusive regarding the potential of LuciFilgo to induce CYP2B6. In vivoinduction cannot be excluded.
In vitro studies are inconclusive regarding the potential of LuciFilgo to induce or inhibit CYP1A2. No clinical studies have been performed to investigate interactions with CYP1A2 substrates and therefore the potential in vivo effect of concomitant induction and inhibition of CYP1A2 by LuciFilgo is unknown. Caution is recommended when LuciFilgo is co-administered with CYP1A2 substrates with a narrow therapeutic index.
In a clinical pharmacology study, there was no effect on the pharmacokinetics of the combined contraceptive ethinyl estradiol and levonorgestrel when co-administered with LuciFilgo; thus no dose adjustment of oral contraceptives is required.
USE IN SPECIFIC POPULATIONS
Women of childbearing potential / Contraception
Women of childbearing potential have to use effective contraception during and for at least 1 week after cessation of LuciFilgo treatment.
Pregnancy
There are no or limited amount of data from the use of LuciFilgo in pregnant women. Studies in animals have shown reproductive toxicity.Based on findings in animals, LuciFilgo may cause foetal harm and is therefore contraindicated during pregnancy .
Breast-feeding
It is unknown whether LuciFilgo is excreted in human milk. A risk to breastfed newborns/infants cannot be excluded. Therefore, LuciFilgo should not be used during breast-feeding.
Storage
Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.