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

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

Indications

Rheumatoid Arthritis: Tofacitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs).

Usage Restriction: Concomitant use of LuciTofa with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Psoriatic Arthritis: Tofacitinib is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).

Usage Restriction: Concomitant use of Tofacitinib with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Ulcerative Colitis: Tofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).

Usage Restriction: Concomitant use of Tofacitinib with biologic therapies for UC or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Dosage and Administration

Do not initiate Tofacitinib if the absolute lymphocyte count is <500 cells/mm³, absolute neutrophil count (ANC) is <1000 cells/mm³, or hemoglobin is <9 g/dL.

Recommended Dosage

Rheumatoid Arthritis: Tofacitinib 5 mg twice daily. For patients with moderate to severe renal impairment or moderate hepatic impairment, the recommended dosage is Tofacitinib 5 mg once daily.

Psoriatic Arthritis (in combination with non-biologic DMARDs): Tofacitinib 5 mg twice daily. For patients with moderate to severe renal impairment or moderate hepatic impairment, the recommended dosage is Tofacitinib 5 mg once daily.

Ulcerative Colitis: Tofacitinib 10 mg twice daily for at least 8 weeks; then 5 mg or 10 mg twice daily. Discontinue treatment after 16 weeks if an adequate therapeutic response is not achieved. Use the lowest effective dosage to maintain response.

For patients with moderate to severe renal impairment or moderate hepatic impairment: Half the total daily recommended dosage for patients with normal renal and hepatic function.

Dosage Adjustment

Refer to the full prescribing information for indicated dosage adjustments in patients receiving CYP2C19 and/or CYP3A4 inhibitors; patients with moderate or severe renal impairment or moderate hepatic impairment; and patients with lymphopenia, neutropenia, or anemia. Tofacitinib is not recommended for use in patients with severe hepatic impairment in any patient population.

Use in Specific Populations

Lactation: Breastfeeding is not recommended.

Warnings and Precautions

Serious Infections: Avoid use of LuciTofa during active serious infections, including localized infections.

Gastrointestinal Perforation: Use with caution in patients at increased risk.

Laboratory Monitoring: Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids.

Immunization: Live Vaccines: Avoid concurrent use with LuciTofa.

Drug Interactions

For clinically relevant drug interactions, refer to the full prescribing information.

Adverse Reactions

Most Common Adverse Reactions

Rheumatoid Arthritis and Psoriatic Arthritis: Reported within the first 3 months of controlled clinical trials in rheumatoid arthritis, occurring in ≥2% of patients receiving LuciTofa as monotherapy or in combination with DMARDs: upper respiratory tract infection, nasopharyngitis, diarrhea, and headache.

Ulcerative Colitis: Reported in ≥5% of patients treated with LuciTofa 5 mg or 10 mg twice daily in induction or maintenance clinical trials, and ≥1% higher than in patients receiving placebo: nasopharyngitis, increased cholesterol levels, headache, upper respiratory tract infection, increased blood creatine phosphokinase, rash, diarrhea, and herpes zoster.

Contraindications

Contraindicated in patients with active infections.

Contraindicated in patients with hypoalbuminemia (<9 g/dL).

May be used in pregnant women only if the potential benefit justifies the potential risk to the fetus.

Animal studies have shown that this product is excreted in rat milk; excretion in human milk has not been determined. Lactating women should weigh the importance of the product to themselves and choose to discontinue the drug or breastfeeding.

Efficacy in pediatric patients has not been established.

Dosage Form

Tablets.

Storage Conditions.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F) for short-term transport. Protect from moisture.