HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciTofa safely and effectively. See full prescribing information for LuciTofa.

INDICATIONS AND USAGE

LuciTofa is a Janus kinase (JAK) inhibitor.

Rheumatoid Arthritis: LuciTofa 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 nonbiologic disease-modifying antirheumatic drugs (DMARDs).

○  Limitations of Use: Use of LuciTofa in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Psoriatic Arthritis: LuciTofa 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).

○  Limitations of Use: Use of LuciTofa in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended.  

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

○  Limitations of Use: Use of LuciTofa in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

DOSAGE AND ADMINISTRATION

Administration Instructions

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

Recommended Dosage

Rheumatoid Arthritis

LuciTofa 5 mg twice daily.

Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is LuciTofa 5 mg once daily.

Psoriatic Arthritis (in combination with nonbiologic DMARDs)

LuciTofa 5 mg twice daily.

Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is LuciTofa 5 mg once daily.

Ulcerative Colitis

LuciTofa 10 mg twice daily for at least 8 weeks; then 5 or 10 mg twice daily. Discontinue after 16 weeks of 10 mg twice daily, if adequate therapeutic benefit is not achieved. Use the lowest effective dose to maintain response.

Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment: half the total daily dosage recommended for patients with normal renal and hepatic function.

Dosage Adjustment

See the full prescribing information for dosage adjustments by indication for patients receiving CYP2C19 and/or CYP3A4 inhibitors; in patients with moderate or severe renal impairment or moderate hepatic impairment; and patients with lymphopenia, neutropenia, or anemia.

Use of LuciTofa in patients with severe hepatic impairment is not recommended in any patient population.

DOSAGE FORMS AND STRENGTHS

Tablets: 5 mg×30 tablets

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

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

· Gastrointestinal Perforations: Use with caution in patients that may be at increased risk.

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

· Immunizations: Live vaccines: Avoid use with LuciTofa.

ADVERSE REACTIONS

Most common adverse reactions are:

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

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

DRUG INTERACTIONS

See full prescribing information for clinically relevant drug interactions.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.

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.