LUCEMYRA Film-coated tablet Ref.[10120] Active ingredients: Lofexidine

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) [see Warnings & Precautions (5.5)]. The LUCEMYRA dose should be reduced, held, or discontinued for individuals who demonstrate a greater sensitivity to LUCEMYRA side effects [see Adverse Reactions (6.1), Warnings and Precautions (5.1)]. 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 [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Table 1. Dosage Recommendations in Patients with Hepatic Impairment:

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 [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

Table 2. Dosage Recommendations in Patients with Renal Impairment:

Overdose with LUCEMYRA may manifest as hypotension, bradycardia, and sedation. In the event of acute overdose, perform gastric lavage where appropriate. Dialysis will not remove a substantial portion of the drug. Initiate general symptomatic and supportive measures in cases of overdosage.

Store in original container at controlled room temperature, 25°C (77°F); with excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep LUCEMYRA away from excess heat and moisture both in the pharmacy and after dispensing. Do not remove desiccant packs from bottles until all tablets are used. Keep LUCEMYRA and all medicines out of the reach of children.