Lyrica

LYRICA- pregabalin capsule
LYRICA- pregabalin solution
Viatris Specialty LLC

1 INDICATIONS AND USAGE

LYRICA is indicated for:

Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial‑onset seizures in patients 1 month of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

LYRICA is given orally with or without food.

When discontinuing LYRICA, taper gradually over a minimum of 1 week [see Warnings and Precautions (5.6)].

Because LYRICA is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function [see Dosage and Administration (2.7)].

2.2 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy in Adults

The maximum recommended dose of LYRICA is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability.

Although LYRICA was also studied at 600 mg/day, there is no evidence that this dose confers additional significant benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 300 mg/day is not recommended [see Adverse Reactions (6.1)].

2.3 Postherpetic Neuralgia in Adults

The recommended dose of LYRICA is 75 to 150 mg two times a day, or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 75 mg two times a day, or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability.

Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day, and who are able to tolerate LYRICA, may be treated with up to 300 mg two times a day, or 200 mg three times a day (600 mg/day). In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, reserve dosing above 300 mg/day for those patients who have on-going pain and are tolerating 300 mg daily [see Adverse Reactions (6.1)].

2.4 Adjunctive Therapy for Partial-Onset Seizures in Patients 1 Month of Age and Older

The recommended dosages for adults and pediatric patients 1 month of age and older are included in Table 1. Administer the total daily dosage orally in two or three divided doses as indicated in Table 1. In pediatric patients, the recommended dosing regimen is dependent upon body weight. Based on clinical response and tolerability, dosage may be increased, approximately weekly.

Table 1. Recommended Dosage for Adults and Pediatric Patients 1 Month and Older

Age and Body Weight

Recommended Initial Dosage

Recommended Maximum Dosage

Frequency of Administration

Adults (17 years and older)

150 mg/day

600 mg/day

2 or 3 divided doses

Pediatric patients weighing 30 kg or more

2.5 mg/kg/day

10 mg/kg/day

(not to exceed 600 mg/day)

2 or 3 divided doses

Pediatric patients weighing less than 30 kg

3.5 mg/kg/day

14 mg/kg/day

1 month to less than 4 years of age:

3 divided doses

4 years of age and older:

2 or 3 divided doses

Both the efficacy and adverse event profiles of LYRICA have been shown to be dose-related.

The effect of dose escalation rate on the tolerability of LYRICA has not been formally studied.

The efficacy of adjunctive LYRICA in patients taking gabapentin has not been evaluated in controlled trials. Consequently, dosing recommendations for the use of LYRICA with gabapentin cannot be offered.

2.5 Management of Fibromyalgia in Adults

The recommended dose of LYRICA for fibromyalgia is 300 to 450 mg/day. Begin dosing at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). Although LYRICA was also studied at 600 mg/day, there is no evidence that this dose confers additional benefit and this dose was less well tolerated. In view of the dose‑dependent adverse reactions, treatment with doses above 450 mg/day is not recommended [see Adverse Reactions (6.1)].

2.6 Neuropathic Pain Associated with Spinal Cord Injury in Adults

The recommended dose range of LYRICA for the treatment of neuropathic pain associated with spinal cord injury is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate LYRICA may be treated with up to 300 mg two times a day [see Clinical Studies (14.5)].

2.7 Dosing for Adult Patients with Renal Impairment

In view of dose-dependent adverse reactions and since LYRICA is eliminated primarily by renal excretion, adjust the dose in adult patients with reduced renal function. The use of LYRICA in pediatric patients with compromised renal function has not been studied.

Base the dose adjustment in patients with renal impairment on creatinine clearance (CLcr), as indicated in Table 2. To use this dosing table, an estimate of the patient’s CLcr in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the Cockcroft and Gault equation:

Cockcroft and Gault Equation
(click image for full-size original)

Next, refer to the Dosage and Administration section to determine the recommended total daily dose based on indication, for a patient with normal renal function (CLcr greater than or equal to 60 mL/min). Then refer to Table 2 to determine the corresponding renal adjusted dose.

(For example: A patient initiating LYRICA therapy for postherpetic neuralgia with normal renal function (CLcr greater than or equal to 60 mL/min), receives a total daily dose of 150 mg/day pregabalin. Therefore, a renal impaired patient with a CLcr of 50 mL/min would receive a total daily dose of 75 mg/day pregabalin administered in two or three divided doses.)

For patients undergoing hemodialysis, adjust the pregabalin daily dose based on renal function. In addition to the daily dose adjustment, administer a supplemental dose immediately following every 4-hour hemodialysis treatment (see Table 2).

Table 2. Pregabalin Dosage Adjustment Based on Renal Function

TID = Three divided doses; BID = Two divided doses; QD = Single daily dose.

*
Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose.
Supplementary dose is a single additional dose.

Creatinine Clearance (CLcr)(mL/min)

Total Pregabalin Daily Dose(mg/day) *

Dose Regimen

Greater than or equal to 60

150

300

450

600

BID or TID

30-60

75

150

225

300

BID or TID

15-30

25-50

75

100-150

150

QD or BID

Less than 15

25

25-50

50-75

75

QD

Supplementary dosage following hemodialysis (mg)

Patients on the 25 mg QD regimen: take one supplemental dose of 25 mg or 50 mg

Patients on the 25-50 mg QD regimen: take one supplemental dose of 50 mg or 75 mg

Patients on the 50-75 mg QD regimen: take one supplemental dose of 75 mg or 100 mg

Patients on the 75 mg QD regimen: take one supplemental dose of 100 mg or 150 mg

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