Lofexidinedosage

The usual LUCEMYRA dosage is three 0.18 mg tablets taken orally 4 times daily at 5- to 6-hour intervals. LUCEMYRA treatment may be continued for up to 14 days with dosing guided by symptoms. Discontinue LUCEMYRA with a gradual dose reduction over 2 to 4 days.

Hepatic or Renal Impairment: Dosage adjustments are recommended based on degree of impairment.

2.1 Dosing Information

The usual LUCEMYRA starting dosage is three 0.18 mg tablets taken orally 4 times daily during the period of peak withdrawal symptoms (generally the first 5 to 7 days following last use of opioid) with dosing guided by symptoms and side effects. There should be 5 to 6 hours between each dose. The total daily dosage of LUCEMYRA should not exceed 2.88 mg (16 tablets) and no single dose should exceed 0.72 mg (4 tablets). LUCEMYRA treatment may be continued for up to 14 days with dosing guided by symptoms. Discontinue LUCEMYRA with a gradual dose reduction over a 2- to 4-day period to mitigate LUCEMYRA withdrawal symptoms (e.g., reducing by 1 tablet per dose every 1 to 2 days). The LUCEMYRA dose should be reduced, held, or discontinued for individuals who demonstrate a greater sensitivity to LUCEMYRA side effects. Lower doses may be appropriate as opioid withdrawal symptoms wane. LUCEMYRA can be administered in the presence or absence of food.

2.2 Dosage Recommendations for

Patients with Hepatic Impairment Recommended dosage adjustments based on the degree of hepatic impairment are shown in Table 1..

Table 1: Dosage Recommendations in Patients with Hepatic Impairment Mild Impairment Moderate Impairment Severe Impairment Child-Pugh score 5-6 7-9 > 9 Recommended dose 3 tablets 4 times daily (2.16 mg per day) 2 tablets 4 times daily (1.44 mg per day) 1 tablet 4 times daily (0.72 mg per day)

2.3 Dosage Recommendations for

Patients with Renal Impairment Recommended dosage adjustments based on the degree of renal impairment are shown in Table 2. LUCEMYRA may be administered without regard to the timing of dialysis.

Table 2: Dosage Recommendations in Patients with Renal Impairment Moderate Impairment Severe Impairment, End-Stage Renal Disease, or on Dialysis Estimated GFR, mL/min/1.73 m 2 30-89.9 < 30 Recommended dose 2 tablets 4 times daily (1.44 mg per day) 1 tablet 4 times daily (0.72 mg per day)