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| HIGHLIGHTS OF PRESCRIBING INFORMATION |
| These highlights do not include all the
information needed to use lyrica safely and
effectively. See full prescribing information for lyrica. |
lyrica (pregabalin) capsule for
oral use - CV
Initial U.S.
Approval: 2004
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INDICATIONS AND USAGE
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LYRICA is indicated for:
- Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1.1)
- Post herpetic neuralgia (PHN) ( 1.2)
- Adjunctive therapy for adult patients with partial onset seizures ( 1.3)
- Fibromyalgia ( 1.4)
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DOSAGE AND ADMINISTRATION
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DPN Pain ( 2.1):
- Administer in 3 divided doses per day
- Begin dosing at 150 mg/day
- May be increased to a maximum of 300 mg/day
within 1 week.
PHN ( 2.2):
- Administer in 2 or 3 divided doses per day
- Begin dosing at 150 mg/day
- May be increased to 300 mg/day within 1 week
- Maximum dose of 600 mg/day.
Adjunctive Therapy for Adult Patients with
Partial
Onset Seizures ( 2.3):
- Administer in 2 or 3 divided doses per day
- Begin dosing at 150 mg/day
- Maximum dose of 600 mg/day.
FIBROMYALGIA ( 2.4):
- Administer in 2 divided doses per day
- Begin dosing at 150 mg/day
- May be increased to 300 mg/day within 1 week
- Maximum dose of 450 mg/day.
Dose should be adjusted in patients with reduced renal function. ( 2.5)
| |
DOSAGE FORMS AND STRENGTHS
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- Capsules: 25mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg.
( 3)
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CONTRAINDICATIONS
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- Known hypersensitivity to pregabalin or any of its components. ( 4)
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WARNINGS AND PRECAUTIONS
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- Angioedema (e.g. swelling of the throat, head and neck) can occur, and may
be associated with life-threatening respiratory compromise requiring emergency
treatment. LYRICA should be discontinued immediately in these cases. ( 5.1)
- Hypersensitivity reactions (e.g. hives, dyspnea, and wheezing) can occur.
LYRICA should be discontinued immediately in these patients. ( 5.2)
- Increased seizure frequency may occur in patients with seizure disorders if
LYRICA is rapidly discontinued. Withdraw LYRICA gradually over a minimum of 1
week. ( 5.3)
- LYRICA may cause peripheral edema. Exercise caution when co-administering
LYRICA and thiazolidinedione antidiabetic agents. (
5.4)
- LYRICA may cause dizziness and somnolence and impair patients' ability to
drive or operate machinery.( 5.5)
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ADVERSE REACTIONS
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Most common adverse reactions (≥ 5% and twice placebo) are
dizziness, somnolence, dry mouth, edema, blurred vision, weight gain and
thinking abnormal (primarily difficulty with concentration/attention). ( 6.1)
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To report SUSPECTED ADVERSE
REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
|
See 17 for
PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
|
Revised:
07/2007 | |
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
LYRICA is indicated for:
1.1 Management of neuropathic pain associated with diabetic peripheral
neuropathy
1.2 Management of postherpetic neuralgia
1.3 Adjunctive therapy for adult patients with partial onset seizures
1.4 Management of fibromyalgia
2 DOSAGE AND ADMINISTRATION
Lyrica is given orally with or without food.
When discontinuing LYRICA, taper gradually over a minimum of 1 week.
2.1 Neuropathic pain associated with diabetic peripheral neuropathy
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.
Dosing should begin at 50 mg three times a day (150 mg/day) and may be increased
to 300 mg/day within 1 week based on efficacy and tolerability. Because LYRICA
is eliminated primarily by renal excretion, the dose should be adjusted for
patients with reduced renal function [see Dosage and Administration (2.5)].
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)].
2.2 Postherpetic neuralgia
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. Dosing should begin at 75 mg two
times a day, or 50 mg three times a day (150 mg/day) and may be increased to 300
mg/day within 1 week based on efficacy and tolerability. Because LYRICA is
eliminated primarily by renal excretion, the dose should be adjusted for
patients with reduced renal function [see Dosage and Administration (2.5)].
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, dosing above 300 mg/day
should be reserved only for those patients who have on-going pain and are
tolerating 300 mg daily [see Adverse
Reactions (6.1)].
2.3 Adjunctive therapy for adult patients with partial onset seizures
LYRICA at doses of 150 to 600 mg/day has been shown to be
effective as adjunctive therapy in the treatment of partial onset seizures in
adults. The total daily dose should be divided and given either two or three
times daily. Both the efficacy and adverse event profiles of LYRICA have been
shown to be dose-related. In general, it is recommended that patients be started
on a total daily dose no greater than 150 mg/day (75 mg two times a day, or 50
mg three times a day). Based on individual patient response and tolerability,
the dose may be increased to a maximum dose of 600 mg/day.
Because LYRICA is eliminated primarily by renal excretion, the dose should be
adjusted for patients with reduced renal function [see Dosage and Administration (2.5)].
The effect of dose escalation rate on the tolerability of LYRICA has not been
formally studied.
The efficacy of add-on 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.
2.4 Management of Fibromyalgia
The recommended dose of LYRICA for fibromyalgia is 300 to 450
mg/day. Dosing should begin at 75 mg two times a day (150 mg/day) and 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)]. Because LYRICA is eliminated primarily by renal excretion,
the dose should be adjusted for patients with reduced renal function (creatinine
clearance less than 60 mL/min - see Patients with Renal Impairment) [see Dosage and Administration
(2.5)].
2.5 Patients with Renal Impairment
In view of dose-dependent adverse reactions and since LYRICA is
eliminated primarily by renal excretion, the dose should be adjusted in patients
with reduced renal function. Dosage adjustment in patients with renal impairment
should be based on creatinine clearance (CLcr), as indicated in Table 1. 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:
For patients undergoing hemodialysis, pregabalin daily dose should be
adjusted based on renal function. In addition to the daily dose adjustment, a
supplemental dose should be given immediately following every 4-hour
hemodialysis treatment (see Table 1).
Table 1. Pregabalin Dosage Adjustment Based on Renal Function
Creatinine Clearance (CLcr)
(mL/min) |
Total Pregabalin Daily
Dose (mg/day)* |
Dose
Regimen |
| TID= Three divided doses; BID = Two divided doses; QD =
Single daily dose. |
|
|
| .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 |
| <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 |
3 DOSAGE FORMS AND STRENGTHS
Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg,
and 300 mg [see Description (11)
and How Supplied/Storage and Handling
(16)].
4 CONTRAINDICATIONS
LYRICA is contraindicated in patients with known hypersensitivity
to pregabalin or any of its other components.
5 WARNINGS AND PRECAUTIONS
5.1 Angioedema
There have been postmarketing reports of angioedema in patients
during initial and chronic treatment with LYRICA. Specific symptoms included
swelling of the face, mouth (tongue, lips, and gums), and neck (throat and
larynx). There were reports of life-threatening angioedema with respiratory
compromise requiring emergency treatment. LYRICA should be discontinued
immediately in patients with these symptoms.
Caution should be exercised when prescribing LYRICA to patients who have had
a previous episode of angioedema. In addition, patients who are taking other
drugs associated with angioedema (e.g., angiotensin converting enzyme inhibitors
[ACE-inhibitors]) may be at increased risk of developing angioedema.
5.2 Hypersensitivity
There have been postmarketing reports of hypersensitivity in
patients shortly after initiation of treatment with LYRICA. Adverse reactions
included skin redness, blisters, hives, rash, dyspnea, and wheezing. LYRICA
should be discontinued immediately in patients with these symptoms.
5.3 Withdrawal of Antiepileptic Drugs (AEDs)
As with all AEDs, LYRICA should be withdrawn gradually to
minimize the potential of increased seizure frequency in patients with seizure
disorders. If LYRICA is discontinued this should be done gradually over a
minimum of 1 week.
5.4 Peripheral Edema
LYRICA treatment may cause peripheral edema. In short-term trials
of patients without clinically significant heart or peripheral vascular disease,
there was no apparent association between peripheral edema and cardiovascular
complications such as hypertension or congestive heart failure. Peripheral edema
was not associated with laboratory changes suggestive of deterioration in renal
or hepatic function.
In controlled clinical trials the incidence of peripheral edema was 6% in the
LYRICA group compared with 2% in the placebo group. In controlled clinical
trials, 0.5% of LYRICA patients and 0.2% placebo patients withdrew due to
peripheral edema.
Higher frequencies of weight gain and peripheral edema were observed in
patients taking both LYRICA and a thiazolidinedione antidiabetic agent compared
to patients taking either drug alone. The majority of patients using
thiazolidinedione antidiabetic agents in the overall safety database were
participants in studies of pain associated with diabetic peripheral neuropathy.
In this population, peripheral edema was reported in 3% (2/60) of patients who
were using thiazolidinedione antidiabetic agents only, 8% (69/859) of patients
who were treated with LYRICA only, and 19% (23/120) of patients who were on both
LYRICA and thiazolidinedione antidiabetic agents. Similarly, weight gain was
reported in 0% (0/60) of patients on thiazolidinediones only; 4% (35/859) of
patients on LYRICA only; and 7.5% (9/120) of patients on both drugs.
As the thiazolidinedione class of antidiabetic drugs can cause weight gain
and/or fluid retention, possibly exacerbating or leading to heart failure, care
should be taken when co-administering LYRICA and these agents.
Because there are limited data on congestive heart failure patients with New
York Heart Association (NYHA) Class III or IV cardiac status, LYRICA should be
used with caution in these patients.
5.5 Dizziness and Somnolence
LYRICA may cause dizziness and somnolence. Patients should be
informed that LYRICA-related dizziness and somnolence may impair their ability
to perform tasks such as driving or operating machinery [see
Patient Counseling Information (17.4)].