GET THE MOST FROM YOUR LYRICA TREATMENT - Pfizer for Professionals
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GET THE
MOST FROM
YOUR LYRICA®
TREATMENT
Answers and information to help you
GET STARTED on LYRICA.
SEE PAGE 16 FOR POSSIBLE SAVINGS ON
YOUR PRESCRIPTION
Please see accompanying Full Prescribing Information, including
Medication Guide starting on page 17, and additional Important
Safety Information throughout the PDF.
Welcome to LYRICA
Getting started with LYRICA
LYRICA is a proven pain reliever for diabetic nerve pain,
fibromyalgia pain, spinal cord injury nerve pain, and pain after
shingles. LYRICA may provide patients like you with consistent
and sustained relief.
What can I expect when I start taking LYRICA?
During clinical trials, some patients with these conditions who
took LYRICA felt less pain in as early as 1 week.* But everyone is
unique, and you may respond differently. That’s why it’s important
to talk with your doctor about your progress and any side effects
that you may have while taking LYRICA. Talk to your doctor to find
out if adjusting your dose may help you get the most from LYRICA.
*Individual results may vary.
Getting started with once-daily LYRICA® CR
(pregabalin) extended release tablets
If you have diabetic nerve pain or postherpetic neuralgia pain,
your doctor may have prescribed LYRICA CR. LYRICA CR is only
taken once daily after the evening meal.
For more information about LYRICA CR, see pages 10-15.
Indications Important Safety Information
LYRICA is indicated to treat fibromyalgia, diabetic nerve pain, LYRICA and LYRICA CR are not for everyone.
spinal cord injury nerve pain, and pain after shingles in adult LYRICA and LYRICA CR may cause serious, even life-
patients. LYRICA is also indicated to treat partial onset seizures threatening, allergic reactions. Stop taking LYRICA or LYRICA
in patients 4 years of age and older with epilepsy who take 1 or CR and call your doctor right away if you have any signs of a
more other drugs for seizures. serious allergic reaction. Some signs are swelling of your face,
LYRICA CR is indicated to treat pain from damaged nerves mouth, lips, gums, tongue, throat, or neck or if you have any
(neuropathic pain) that happens with diabetes or that follows trouble breathing, or have a rash, hives, blisters, or skin redness.
healing of shingles.
It is not known if LYRICA CR is safe and effective in children.
It is not known if LYRICA CR is effective when used for the
treatment of fibromyalgia or when taken with other seizure
medicines for adults with partial onset seizures.
Please see accompanying Full Prescribing Information,
including Medication Guide starting on page 17, and
2 additional Important Safety Information throughout the PDF. 3
Getting started with LYRICA
Why did my doctor prescribe LYRICA? SPINAL CORD INJURY NERVE PAIN
When you injure your spinal cord, some of your nerves may
LYRICA is proven effective in treating 4 painful conditions become damaged in the process. The burning and throbbing of
spinal cord injury pain may be hard to treat, but LYRICA may be
DIABETIC NERVE PAIN able to help. For some patients, even those who’ve had spinal
cord injury nerve pain for several years, LYRICA provided
Diabetic nerve pain feels like shooting, burning, or pins and
significant relief.
needles pain in the feet and hands. People living with diabetes
can have elevated blood sugar levels, which can cause this
type of nerve damage. For some patients, LYRICA can provide
PAIN AFTER SHINGLES
significant relief from diabetic nerve pain. Also known as postherpetic neuralgia, this is the burning,
stabbing, and shooting pain from damaged nerves (neuropathic
FIBROMYALGIA PAIN pain) that persists following healing of shingles. In a clinical study,
LYRICA was shown to provide significant relief for some patients.
Fibromyalgia is a chronic, widespread pain condition that is often
accompanied by tenderness. It can make it difficult to perform
everyday tasks. For some patients, LYRICA may significantly
relieve fibromyalgia pain and improve physical function.
Important Safety Information Important Safety Information
LYRICA and LYRICA CR may cause suicidal thoughts or actions LYRICA and LYRICA CR may cause swelling of your hands, legs,
in a very small number of people, about 1 in 500. Patients, and feet, which can be serious for people with heart problems.
family members, or caregivers should call the doctor right LYRICA and LYRICA CR may cause dizziness and sleepiness.
away if they notice suicidal thoughts or actions, thoughts of You should not drive or work with machines until you know how
self-harm, or any unusual changes in mood or behavior. These LYRICA or LYRICA CR affects you. Also, tell your doctor right
changes may include new or worsening depression, anxiety, away about muscle pain or problems along with feeling sick and
restlessness, trouble sleeping, panic attacks, anger, irritability, feverish or any changes in your eyesight, including blurry vision
agitation, aggression, dangerous impulses or violence, or or if you have any kidney problems or get dialysis.
extreme increases in activity or talking. If you have suicidal
thoughts or actions, do not stop LYRICA or LYRICA CR without
first talking to your doctor.
Please see accompanying Full Prescribing Information,
including Medication Guide starting on page 17, and
4 additional Important Safety Information throughout the PDF. 5
This chart shows the approved dosages of LYRICA for each condition:
NUMBER OF TIMES
STARTING DOSE RECOMMENDED
PER DAY TO
(DAILY TOTAL) ONGOING DOSE
TAKE LYRICA
Up to
DIABETIC NERVE PAIN 3 150 mg/day
300 mg/day*
300 mg/day to
FIBROMYALGIA 2 150 mg/day
450 mg/day
Working with your doctor to reach the SPINAL CORD INJURY
NERVE PAIN
2 150 mg/day
300 mg/day to
600 mg/day
RIGHT DOSE FOR YOU
300 mg/day to
PAIN AFTER SHINGLES 2 or 3 150 mg/day
600 mg/day
What dose is recommended for my condition?
*300 mg/day is the maximum recommended dose for diabetic nerve pain.
If you have problems with kidney function, your doctor may prescribe
The total daily starting dose of LYRICA is 150 mg. Then, after talking a lower dose of LYRICA.
with your doctor about how LYRICA is working for you, he or she may
adjust your dose.
It’s important to talk with your doctor.
Dose adjustments may improve your relief. You may feel side effects before you start to feel better. If you do
experience side effects, your doctor may be able to help.
LYRICA is available in multiple strengths. Your doctor can adjust
your dose to help you get the most from treatment. So it’s important It’s important that you talk to your doctor first if you want to stop
to discuss your progress and any side effects you may feel with your treatment. Do not stop taking LYRICA on your own. Your doctor can
doctor, especially in the first few weeks. Your healthcare provider help you minimize potential side effects when stopping LYRICA.
may change your dose. Do not change your dose without talking to
your doctor.
Important Safety Information Important Safety Information
Some of the most common side effects of LYRICA are dizziness, You may have a higher chance for swelling and hives if you are
blurry vision, weight gain, sleepiness, trouble concentrating, also taking angiotensin-converting enzyme (ACE) inhibitors, so
swelling of your hands and feet, dry mouth, and feeling “high.” tell your doctor if you are taking these medications. You may
Some of the most common side effects of LYRICA CR are have a higher chance of swelling of your hands or feet or gaining
dizziness, blurry vision, weight gain, sleepiness, tiredness, weight if you are also taking Avandia (rosiglitazone), Avandamet
swelling of hands and feet, dry mouth, and nausea. (contains rosiglitazone and metformin), or Actos (pioglitazone).
Do not drink alcohol while on LYRICA or LYRICA CR. You may
If you have diabetes, tell your doctor about any sores or have a higher chance for dizziness and sleepiness if you take
skin problems. LYRICA or LYRICA CR with alcohol, narcotic pain medicines, or
medicines for anxiety.
Please see accompanying Full Prescribing Information,
including Medication Guide starting on page 17, and
6 additional Important Safety Information throughout the PDF. 7
HOW LONG DIZZINESS HOW LONG SLEEPINESS
LASTED ON AVERAGE LASTED ON AVERAGE
DIABETIC NERVE PAIN 1-2 weeks 4-6 weeks
FIBROMYALGIA About 2.5 weeks About 5 weeks
SPINAL CORD INJURY
About 1.5 weeks About 10 weeks
NERVE PAIN
Understanding potential side effects PAIN AFTER SHINGLES 1-7 weeks 3-8 weeks
can help you STAY ON TRACK What are other common side effects of LYRICA?
Other common side effects, which were generally mild to
What are the most common side effects of LYRICA? moderate, included:
• Dry mouth • Swelling of the hands and feet
• Blurred vision • Weight gain
When LYRICA was studied in clinical trials, side effects were
generally mild to moderate. • Trouble concentrating • Feeling “high”
The 2 most common side effects of LYRICA were dizziness and In controlled LYRICA trials of up to 14 weeks, 9% of patients
sleepiness. Across all clinical studies, dizziness occurred in taking LYRICA gained weight, compared with 2% of patients
30% of patients taking LYRICA, compared with 8% of patients taking a placebo.
taking a placebo. Sleepiness occurred in 23% of patients taking
For more information on serious potential side effects, see
LYRICA, compared with 8% of patients taking a placebo. For some
Important Safety Information throughout this PDF.
patients, these side effects went away over time. For others,
these lasted throughout their treatment.
Important Safety Information Important Safety Information
Before you start LYRICA or LYRICA CR, tell your doctor if you are LYRICA and LYRICA CR are not for everyone.
planning to father a child, if you are pregnant, or plan to become LYRICA and LYRICA CR may cause serious, even life-
pregnant. Breastfeeding is not recommended while taking threatening, allergic reactions. Stop taking LYRICA or LYRICA
LYRICA or LYRICA CR. If you have had a drug or alcohol problem, CR and call your doctor right away if you have any signs of a
you may be more likely to misuse LYRICA or LYRICA CR. serious allergic reaction. Some signs are swelling of your face,
In studies, a specific type of blood vessel tumor was seen in mouth, lips, gums, tongue, throat, or neck or if you have any
mice. The meaning of these findings in humans is not known. trouble breathing, or have a rash, hives, blisters, or skin redness.
Do not stop taking LYRICA or LYRICA CR without talking to your
doctor. If you stop suddenly, you may have headaches, nausea,
diarrhea, trouble sleeping, increased sweating, or you may feel
anxious. If you have epilepsy, you may have seizures more often.
Please see accompanying Full Prescribing Information,
including Medication Guide starting on page 17, and
8 additional Important Safety Information throughout the PDF. 9
Getting started with once-daily
LYRICA CR
Why did my doctor prescribe LYRICA CR?
LYRICA CR is proven effective in treating 2 painful conditions
DIABETIC NERVE PAIN
Diabetic nerve pain feels like shooting, burning, or pins and
needles pain in the feet and hands. People living with diabetes
can have elevated blood sugar levels, which can cause this type
of nerve damage. For some patients, LYRICA CR can provide
significant relief from diabetic nerve pain.
PAIN AFTER SHINGLES
Also known as postherpetic neuralgia, this is the burning, stabbing,
and shooting pain from damaged nerves (neuropathic pain) that
persists following healing of shingles. In a clinical study, LYRICA CR
was shown to provide significant relief for some patients.
Important Safety Information Important Safety Information
LYRICA and LYRICA CR may cause suicidal thoughts or actions LYRICA and LYRICA CR may cause swelling of your hands, legs,
in a very small number of people, about 1 in 500. Patients, and feet, which can be serious for people with heart problems.
family members, or caregivers should call the doctor right away LYRICA and LYRICA CR may cause dizziness and sleepiness.
if they notice suicidal thoughts or actions, thoughts of self-harm, You should not drive or work with machines until you know how
or any unusual changes in mood or behavior. These changes may LYRICA or LYRICA CR affects you. Also, tell your doctor right
include new or worsening depression, anxiety, restlessness, away about muscle pain or problems along with feeling sick and
trouble sleeping, panic attacks, anger, irritability, agitation, feverish or any changes in your eyesight, including blurry vision
aggression, dangerous impulses or violence, or extreme or if you have any kidney problems or get dialysis.
increases in activity or talking. If you have suicidal thoughts or
actions, do not stop LYRICA or LYRICA CR without first talking to
your doctor.
Please see accompanying Full Prescribing Information,
including Medication Guide starting on page 17, and
10 additional Important Safety Information throughout the PDF. 11
Working with your
doctor to reach the
RIGHT LYRICA CR DOSE
FOR YOU
Dose adjustments may improve your relief.
What dose is recommended for my condition? LYRICA CR is available in multiple strengths. Your doctor can
adjust your dose to help you get the most from treatment. So
Your doctor may have chosen once-daily LYRICA CR as a treatment it’s important to discuss your progress and any side effects you
for your diabetic nerve or postherpetic neuralgia pain. Once-daily may feel with your doctor, especially in the first few weeks. Your
dosages begin at 165 mg per day and can be changed by your doctor healthcare provider may change your dose. Do not change your
to better fit your needs. LYRICA CR is only taken once daily after dose without talking to your doctor.
an evening meal.
Be sure to talk to your doctor if stopping treatment.
This chart shows the approved dosages of LYRICA CR for
each condition: You may feel side effects before you start to feel better. If you do
NUMBER OF TIMES RECOMMENDED experience side effects, your doctor may be able to help.
STARTING DOSE
PER DAY TO ONGOING DOSE
TAKE LYRICA CR
(DAILY TOTAL)
(DAILY TOTAL) Talking to your doctor is very important if you choose to stop
treatment. Do not stop taking LYRICA CR on your own. Your doctor
can help you minimize potential side effects when stopping
DIABETIC NERVE PAIN Once daily 165 mg/day 330 mg/day
LYRICA CR.
330 mg/day to
PAIN AFTER SHINGLES Once daily 165 mg/day
660 mg/day
Important Safety Information Important Safety Information
Some of the most common side effects of LYRICA are dizziness, You may have a higher chance for swelling and hives if you are
blurry vision, weight gain, sleepiness, trouble concentrating, also taking angiotensin-converting enzyme (ACE) inhibitors, so
swelling of your hands and feet, dry mouth, and feeling “high.” tell your doctor if you are taking these medications. You may
Some of the most common side effects of LYRICA CR are have a higher chance of swelling of your hands or feet or gaining
dizziness, blurry vision, weight gain, sleepiness, tiredness, weight if you are also taking Avandia (rosiglitazone), Avandamet
swelling of hands and feet, dry mouth, and nausea. (contains rosiglitazone and metformin), or Actos (pioglitazone).
Do not drink alcohol while on LYRICA or LYRICA CR. You may have
If you have diabetes, tell your doctor about any sores or a higher chance for dizziness and sleepiness if you take LYRICA
skin problems. or LYRICA CR with alcohol, narcotic pain medicines, or medicines
for anxiety.
Please see accompanying Full Prescribing Information,
including Medication Guide starting on page 17, and
12 additional Important Safety Information throughout the PDF. 13
Understanding potential side effects
can help you STAY ON TRACK
What are the most common side effects
of LYRICA CR?
In the LYRICA CR controlled trials, the 2 most common side effects
of LYRICA CR were dizziness and sleepiness. Dizziness was
experienced by 24% of LYRICA CR patients. Sleepiness was
experienced by 16% of LYRICA CR patients. For some patients,
these side effects went away over time. For others, these lasted
throughout their treatment.
What are other common side effects of LYRICA CR?
Other common side effects, which were generally mild to
moderate, included:
• Headache • Fatigue
• Blurred vision • Weight gain
• Nausea • Dry mouth
In controlled LYRICA CR trials of up to 14 weeks, 4% of patients
taking LYRICA CR gained weight, compared with 1% of patients
taking a placebo.
For more information on serious potential side effects, see
Important Safety Information throughout this PDF.
Important Safety Information Indications
Before you start LYRICA or LYRICA CR, tell your doctor if you are LYRICA is indicated to treat fibromyalgia, diabetic nerve pain,
planning to father a child, if you are pregnant, or plan to become spinal cord injury nerve pain, and pain after shingles in adult
pregnant. Breastfeeding is not recommended while taking patients. LYRICA is also indicated to treat partial onset seizures in
LYRICA or LYRICA CR. If you have had a drug or alcohol problem, patients 4 years of age and older with epilepsy who take 1 or more
you may be more likely to misuse LYRICA or LYRICA CR. other drugs for seizures.
In studies, a specific type of blood vessel tumor was seen in LYRICA CR is indicated to treat pain from damaged nerves
mice. The meaning of these findings in humans is not known. (neuropathic pain) that happens with diabetes or that follows
Do not stop taking LYRICA or LYRICA CR without talking to your healing of shingles.
doctor. If you stop suddenly, you may have headaches, nausea, It is not known if LYRICA CR is safe and effective in children.
diarrhea, trouble sleeping, increased sweating, or you may feel It is not known if LYRICA CR is effective when used for the
anxious. If you have epilepsy, you may have seizures more often. treatment of fibromyalgia or when taken with other seizure
medicines for adults with partial onset seizures.
Please see accompanying Full Prescribing Information,
including Medication Guide starting on page 17, and
14 additional Important Safety Information throughout the PDF. 15Save on your prescription with
the Co-Pay Savings Card
Eligible patients pay as little as $4 per Rx
Maximum savings up to $175 per Rx*
Three ways to access savings:
1 Visit LYRICA.com to download a card
2 Text “LSAVINGS” to LYRICA (597422)
to enroll via text†
See terms and conditions below.
3 Call 1-800-578-7076 to activate a card
SAVE EVERY MONTH FOR 12 MONTHS*
*Terms and conditions apply.
†
Mobile terms and conditions apply. Message and data rates may apply. Message frequency varies and
patients may receive up to 5 messages to enroll and recurring messages per month. For mobile and email
terms and conditions, please visit www.lyrica.com/xmt. Text HELP for info, STOP to opt out.
TERMS AND CONDITIONS
Offer Terms & Conditions: By using the Co-Pay Savings Card, you acknowledge that you currently meet
the eligibility criteria and will comply with the following terms and conditions: Patients are not eligible to
use this card or participate in this program if they are enrolled in a state or federally funded insurance
program, including but not limited to Medicare, Medicaid, TRICARE, Veteran Affairs health care, a state
prescription drug assistance program, or the Government Health Insurance Plan available in Puerto
Rico (formerly known as “La Reforma de Salud”). Patient must have private insurance. Offer is not valid
for cash paying patients. The value of this card is limited to $175 per month per prescription (“offering
period”) or the amount of your co-pay, whichever is less (Maximum annual savings of $2100). This
program is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your
private insurance plan or other private health or pharmacy benefit programs. You must deduct the value
received under this program from any reimbursement request submitted to your private insurance plan,
either directly by you or on your behalf. You are responsible for reporting use of this program to any
private insurer, health plan, or other third party who pays for or reimburses any part of the prescription
filled using the program, as may be required. You should not use the program if your insurer or health
plan prohibits use of manufacturer co-pay cards. You must be 18 years of age or older to accept this offer.
This offer is not valid where prohibited by law.
For Massachusetts residents: This co-pay offer is not valid if an A/B generic is available for
Massachusetts residents whose prescriptions are covered in whole or in part by third-party insurance.
For California residents: This co-pay offer is not valid if a generic is available for California residents
whose prescriptions are covered in whole or in part by third-party insurance.
Please check with your healthcare professional or insurer to confirm eligibility. This offer cannot be
combined with any other savings, free trial or similar offer for the specified prescription. The co-pay
card will be accepted only at participating pharmacies. The co-pay card is not
health insurance. Offer good only in the U.S. and Puerto Rico. The co-pay card is limited to one per person
during this offering period and is not transferable. A co-pay card may not be redeemed more than once
per offering period per patient. No other purchase is necessary. Data related to your redemption of the
co-pay card may be collected, analyzed, and shared with Pfizer, for market research and other purposes
related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will
be combined with data related to other co-pay card redemptions and will not identify you. Pfizer reserves
the right to rescind, revoke or amend this offer without notice. No membership fee. For more information,
visit our website www.lyrica.com, call 1-866-954-1475, or contact us at 2250 Perimeter Park Drive, Suite
300, Morrisville, NC 27560. Offer expires 12/31/2020.
For reimbursement when using a nonparticipating pharmacy/mail order: Pay for prescription, and mail
copy of original pharmacy receipt (cash register receipt NOT valid) with product name, date, and amount
circled to: Co-Pay Savings Card, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560. Be sure to
include a copy of the front of your activated Co-Pay Savings Card, your name and mailing address.
Please see accompanying Full Prescribing Information, including
Medication Guide starting on page 17, and additional Important
Safety Information throughout the PDF.
PP-LYR-USA-2916 © 2018 Pfizer Inc. All rights reserved. December 2018HIGHLIGHTS OF PRESCRIBING INFORMATION --------------------------------DOSAGE FORMS AND STRENGTHS--------------------------------
These highlights do not include all the information needed to use LYRICA safely and • Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg. (3)
effectively. See full prescribing information for LYRICA. • Oral Solution: 20 mg/mL. (3)
LYRICA (pregabalin) Capsules, CV ----------------------------------------CONTRAINDICATIONS----------------------------------------
LYRICA (pregabalin) Oral Solution, CV • Known hypersensitivity to pregabalin or any of its components. (4)
Initial U.S. Approval: 2004 ----------------------------------WARNINGS AND PRECAUTIONS----------------------------------
-------------------------------------RECENT MAJOR CHANGES------------------------------------ • Angioedema (e.g., swelling of the throat, head and neck) can occur, and may be associated
Indications and Usage (1) 5/2018 with life-threatening respiratory compromise requiring emergency treatment.
Dosage and Administration, Adjunctive Therapy for Partial Onset Discontinue LYRICA immediately in these cases. (5.1)
Seizures in Patients 4 Years of Age and Older (2.4) 5/2018 • Hypersensitivity reactions (e.g., hives, dyspnea, and wheezing) can occur. Discontinue
Dosage and Administration, Dosing for Adult Patients with LYRICA immediately in these patients. (5.2)
Renal Impairment (2.7) 5/2018 • Increased seizure frequency or other adverse reactions may occur if LYRICA is rapidly
discontinued. Withdraw LYRICA gradually over a minimum of 1 week. (5.3)
-------------------------------------INDICATIONS AND USAGE-------------------------------------
• Antiepileptic drugs, including LYRICA, increase the risk of suicidal thoughts or behavior.
LYRICA is indicated for: (5.4)
• Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1) • LYRICA may cause peripheral edema. Exercise caution when co-administering LYRICA
• Postherpetic neuralgia (PHN) (1) and thiazolidinedione antidiabetic agents. (5.5)
• Adjunctive therapy for the treatment of partial onset seizures in patients 4 years of age • LYRICA may cause dizziness and somnolence and impair patients’ ability to drive or
and older (1) operate machinery. (5.6)
• Fibromyalgia (1)
• Neuropathic pain associated with spinal cord injury (1) ----------------------------------------ADVERSE REACTIONS----------------------------------------
Most common adverse reactions (greater than or equal to 5% and twice placebo) in adults
----------------------------------DOSAGE AND ADMINISTRATION--------------------------------- are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and thinking
• For adult indications, begin dosing at 150 mg/day. For partial onset seizure dosing in abnormal (primarily difficulty with concentration/attention). (6.1)
pediatric patients 4 years of age and older, refer to section 2.4. (2.2, 2.3, 2.4, 2.5, 2.6)
Most common adverse reactions (greater than or equal to 5% and twice placebo) in
• Dosing recommendations:
pediatric patients for the treatment of partial onset seizures are increased weight and
INDICATION Dosing Maximum Dose increased appetite. (6.1)
Regimen
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at (800) 438-1985 or FDA
DPN Pain (2.2) 3 divided doses 300 mg/day within 1 week at 1-800-FDA-1088 or www.fda.gov/medwatch.
per day
----------------------------------USE IN SPECIFIC POPULATIONS----------------------------------
PHN (2.3) 2 or 3 divided doses 300 mg/day within 1 week. • Pregnancy: May cause fetal harm. Advise of potential risk to the fetus. (8.1)
per day Maximum dose of 600 mg/day.
• Lactation: Breastfeeding is not recommended. (8.2)
Adjunctive Therapy for Partial 2 or 3 divided doses Maximum dose of 600 mg/day.
Onset Seizures in Patients per day See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
4 Years of Age and Older (2.4)
Revised: 5/2018
Fibromyalgia (2.5) 2 divided doses 300 mg/day within 1 week.
per day Maximum dose of 450 mg/day.
Neuropathic Pain Associated 2 divided doses 300 mg/day within 1 week.
with Spinal Cord Injury (2.6) per day Maximum dose of 600 mg/day.
• Dose should be adjusted in adult patients with reduced renal function. (2.7)
FULL PRESCRIBING INFORMATION: CONTENTS* 8 USE IN SPECIFIC POPULATIONS
1 INDICATIONS AND USAGE 8.1 Pregnancy
2 DOSAGE AND ADMINISTRATION 8.2 Lactation
2.1 Important Administration Instructions 8.3 Females and Males of Reproductive Potential
2.2 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy 8.4 Pediatric Use
2.3 Postherpetic Neuralgia 8.5 Geriatric Use
2.4 Adjunctive Therapy for Partial Onset Seizures 8.6 Renal Impairment
in Patients 4 Years of Age and Older 9 DRUG ABUSE AND DEPENDENCE
2.5 Management of Fibromyalgia 9.1 Controlled Substance
2.6 Neuropathic Pain Associated with Spinal Cord Injury 9.2 Abuse
2.7 Dosing for Adult Patients with Renal Impairment 9.3 Dependence
3 DOSAGE FORMS AND STRENGTHS 10 OVERDOSAGE
4 CONTRAINDICATIONS 11 DESCRIPTION
5 WARNINGS AND PRECAUTIONS 12 CLINICAL PHARMACOLOGY
5.1 Angioedema 12.1 Mechanism of Action
5.2 Hypersensitivity 12.3 Pharmacokinetics
5.3 Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation 13 NONCLINICAL TOXICOLOGY
5.4 Suicidal Behavior and Ideation 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
5.5 Peripheral Edema 13.2 Animal Toxicology and/or Pharmacology
5.6 Dizziness and Somnolence 14 CLINICAL STUDIES
5.7 Weight Gain 14.1 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy
5.8 Tumorigenic Potential 14.2 Postherpetic Neuralgia
5.9 Ophthalmological Effects 14.3 Adjunctive Therapy for Partial Onset Seizures
5.10 Creatine Kinase Elevations in Patients 4 Years of Age and Older
5.11 Decreased Platelet Count 14.4 Management of Fibromyalgia
5.12 PR Interval Prolongation 14.5 Neuropathic Pain Associated with Spinal Cord Injury
6 ADVERSE REACTIONS 16 HOW SUPPLIED/STORAGE AND HANDLING
6.1 Clinical Trial Experience 17 PATIENT COUNSELING INFORMATION
6.2 Postmarketing Experience * Sections or subsections omitted from the full prescribing information are not listed.
7 DRUG INTERACTIONSFULL PRESCRIBING INFORMATION 2.7 Dosing for Adult Patients with Renal Impairment
1 INDICATIONS AND USAGE 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 is indicated for:
LYRICA in pediatric patients with compromised renal function has not been studied.
• Management of neuropathic pain associated with diabetic peripheral
neuropathy 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
• Management of postherpetic neuralgia in mL/min is needed. CLcr in mL/min may be estimated from serum creatinine (mg/dL)
• Adjunctive therapy for the treatment of partial onset seizures in patients determination using the Cockcroft and Gault equation:
4 years of age and older
• Management of fibromyalgia [140 - age (years)] x weight (kg)
CLCr = (x 0.85 for female patients)
• Management of neuropathic pain associated with spinal cord injury 72 x serum creatinine (mg/dL)
Next, refer to the Dosage and Administration section to determine the recommended
2 DOSAGE AND ADMINISTRATION
total daily dose based on indication, for a patient with normal renal function (CLcr greater
2.1 Important Administration Instructions than or equal to 60 mL/min). Then refer to Table 2 to determine the corresponding renal
LYRICA is given orally with or without food. adjusted dose.
When discontinuing LYRICA, taper gradually over a minimum of 1 week [see Warnings (For example: A patient initiating LYRICA therapy for postherpetic neuralgia with normal
and Precautions (5.3)]. renal function (CLcr greater than or equal to 60 mL/min), receives a total daily dose of
Because LYRICA is eliminated primarily by renal excretion, adjust the dose in adult 150 mg/day pregabalin. Therefore, a renal impaired patient with a CLcr of 50 mL/min
patients with reduced renal function [see Dosage and Administration (2.7)]. would receive a total daily dose of 75 mg/day pregabalin administered in two or three
divided doses.)
2.2 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy
For patients undergoing hemodialysis, adjust the pregabalin daily dose based on renal
The maximum recommended dose of LYRICA is 100 mg three times a day (300 mg/day)
function. In addition to the daily dose adjustment, administer a supplemental dose
in patients with creatinine clearance of at least 60 mL/min. Begin dosing at 50 mg three
immediately following every 4-hour hemodialysis treatment (see Table 2).
times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week
based on efficacy and tolerability. Table 2. Pregabalin Dosage Adjustment Based on Renal Function
Although LYRICA was also studied at 600 mg/day, there is no evidence that this dose Creatinine Clearance Total Pregabalin Daily Dose
confers additional significant benefit and this dose was less well tolerated. In view of Dose Regimen
(CLcr) (mL/min) (mg/day)*
the dose-dependent adverse reactions, treatment with doses above 300 mg/day is not
recommended [see Adverse Reactions (6.1)]. Greater than or equal to 60 150 300 450 600 BID or TID
2.3 Postherpetic Neuralgia 30–60 75 150 225 300 BID or TID
The recommended dose of LYRICA is 75 to 150 mg two times a day, or 50 to 100 mg 15–30 25–50 75 100–150 150 QD or BID
three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least Less than 15 25 25–50 50–75 75 QD
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 Supplementary dosage following hemodialysis (mg)†
efficacy and tolerability. Patients on the 25 mg QD regimen: take one supplemental dose of 25 mg or 50 mg
Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment Patients on the 25–50 mg QD regimen: take one supplemental dose of 50 mg or 75 mg
with 300 mg/day, and who are able to tolerate LYRICA, may be treated with up to Patients on the 50–75 mg QD regimen: take one supplemental dose of 75 mg or 100 mg
300 mg two times a day, or 200 mg three times a day (600 mg/day). In view of the Patients on the 75 mg QD regimen: take one supplemental dose of 100 mg or 150 mg
dose-dependent adverse reactions and the higher rate of treatment discontinuation due TID = Three divided doses; BID = Two divided doses; QD = Single daily dose.
to adverse reactions, reserve dosing above 300 mg/day for those patients who have * Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose.
on-going pain and are tolerating 300 mg daily [see Adverse Reactions (6.1)]. †
Supplementary dose is a single additional dose.
2.4 Adjunctive Therapy for Partial Onset Seizures in Patients 4 Years of Age and Older
3 DOSAGE FORMS AND STRENGTHS
The recommended dosage for adults and pediatric patients 4 years of age and older
is included in Table 1. Administer the total daily dosage orally in two or three divided Capsules: 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg
doses. In pediatric patients 4 years of age and older, the recommended dosing regimen is Oral Solution: 20 mg/mL
dependent upon body weight. Based on clinical response and tolerability, dosage may be [see Description (11) and How Supplied/Storage and Handling (16)]
increased, approximately weekly. 4 CONTRAINDICATIONS
Table 1: Recommended Dosage for Adults and Pediatric Patients 4 Years and Older LYRICA is contraindicated in patients with known hypersensitivity to pregabalin or any
Age and Body Weight Recommended Initial Dosage Recommended Maximum of its components. Angioedema and hypersensitivity reactions have occurred in patients
(administer in two or three Dosage (administer in two receiving pregabalin therapy [see Warnings and Precautions (5.2)].
divided doses) or three divided doses) 5 WARNINGS AND PRECAUTIONS
Adults (17 years and older) 150 mg/day 600 mg/day 5.1 Angioedema
Pediatric patients weighing 10 mg/kg/day There have been postmarketing reports of angioedema in patients during initial and
2.5 mg/kg/day
30 kg or more (not to exceed 600 mg/day) chronic treatment with LYRICA. Specific symptoms included swelling of the face,
Pediatric patients weighing mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of
3.5 mg/kg/day 14 mg/kg/day life-threatening angioedema with respiratory compromise requiring emergency treatment.
11 kg to less than 30 kg
Discontinue LYRICA immediately in patients with these symptoms.
Both the efficacy and adverse event profiles of LYRICA have been shown to be dose-related.
Exercise caution when prescribing LYRICA to patients who have had a previous episode
The effect of dose escalation rate on the tolerability of LYRICA has not been formally of angioedema. In addition, patients who are taking other drugs associated with
studied. angioedema (e.g., angiotensin converting enzyme inhibitors [ACE-inhibitors]) may
The efficacy of add-on LYRICA in patients taking gabapentin has not been evaluated in be at increased risk of developing angioedema.
controlled trials. Consequently, dosing recommendations for the use of LYRICA with
5.2 Hypersensitivity
gabapentin cannot be offered.
There have been postmarketing reports of hypersensitivity in patients shortly after
2.5 Management of Fibromyalgia initiation of treatment with LYRICA. Adverse reactions included skin redness, blisters,
The recommended dose of LYRICA for fibromyalgia is 300 to 450 mg/day. Begin dosing hives, rash, dyspnea, and wheezing. Discontinue LYRICA immediately in patients with
at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times these symptoms.
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 5.3 Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation
times a day (450 mg/day). Although LYRICA was also studied at 600 mg/day, there is no As with all antiepileptic drugs (AEDs), withdraw LYRICA gradually to minimize the
evidence that this dose confers additional benefit and this dose was less well tolerated. In potential of increased seizure frequency in patients with seizure disorders.
view of the dose-dependent adverse reactions, treatment with doses above 450 mg/day is Following abrupt or rapid discontinuation of LYRICA, some patients reported symptoms
not recommended [see Adverse Reactions (6.1)]. including insomnia, nausea, headache, anxiety, hyperhidrosis, and diarrhea.
2.6 Neuropathic Pain Associated with Spinal Cord Injury If LYRICA is discontinued, taper the drug gradually over a minimum of 1 week rather than
The recommended dose range of LYRICA for the treatment of neuropathic pain discontinue the drug abruptly.
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 5.4 Suicidal Behavior and Ideation
two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients Antiepileptic drugs (AEDs), including LYRICA, increase the risk of suicidal thoughts
who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg or behavior in patients taking these drugs for any indication. Monitor patients treated
two times a day and who tolerate LYRICA may be treated with up to 300 mg two times a with any AED for any indication for the emergence or worsening of depression, suicidal
day [see Clinical Studies (14.5)]. thoughts or behavior, and/or any unusual changes in mood or behavior.Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) In the LYRICA controlled trial in pediatric patients for the treatment of partial onset
of 11 different AEDs showed that patients randomized to one of the AEDs had approx- seizures, somnolence was experienced by 21% of LYRICA-treated patients compared to
imately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking 14% of placebo-treated patients, and occurred more frequently at higher doses.
or behavior compared to patients randomized to placebo. In these trials, which had a 5.7 Weight Gain
median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior
or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among LYRICA treatment may cause weight gain. In LYRICA controlled clinical trials in adult
16,029 placebo-treated patients, representing an increase of approximately one case of patients of up to 14 weeks, a gain of 7% or more over baseline weight was observed
suicidal thinking or behavior for every 530 patients treated. There were four suicides in in 9% of LYRICA-treated patients and 2% of placebo-treated patients. Few patients
drug-treated patients in the trials and none in placebo-treated patients, but the number is treated with LYRICA (0.3%) withdrew from controlled trials due to weight gain. LYRICA
too small to allow any conclusion about drug effect on suicide. associated weight gain was related to dose and duration of exposure, but did not appear
The increased risk of suicidal thoughts or behavior with AEDs was observed as early to be associated with baseline BMI, gender, or age. Weight gain was not limited to
as one week after starting drug treatment with AEDs and persisted for the duration of patients with edema [see Warnings and Precautions (5.5)].
treatment assessed. Because most trials included in the analysis did not extend beyond Although weight gain was not associated with clinically important changes in blood
24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be pressure in short-term controlled studies, the long-term cardiovascular effects of
assessed. LYRICA-associated weight gain are unknown.
The risk of suicidal thoughts or behavior was generally consistent among drugs in the Among diabetic patients, LYRICA-treated patients gained an average of 1.6 kg
data analyzed. The finding of increased risk with AEDs of varying mechanisms of action (range: -16 to 16 kg), compared to an average 0.3 kg (range: -10 to 9 kg) weight gain
and across a range of indications suggests that the risk applies to all AEDs used for any in placebo patients. In a cohort of 333 diabetic patients who received LYRICA for at
indication. The risk did not vary substantially by age (5-100 years) in the clinical trials least 2 years, the average weight gain was 5.2 kg.
analyzed. While the effects of LYRICA-associated weight gain on glycemic control have not been
Table 3 shows absolute and relative risk by indication for all evaluated AEDs. systematically assessed, in controlled and longer-term open label clinical trials with
Table 3. Risk by Indication for Antiepileptic Drugs in the Pooled Analysis diabetic patients, LYRICA treatment did not appear to be associated with loss of glycemic
control (as measured by HbA1C).
Indication Placebo Drug Patients Relative Risk: Risk Difference:
5.8 Tumorigenic Potential
Patients with with Events Per Incidence of Events Additional Drug
Events Per 1000 Patients in Drug Patients/ Patients with In standard preclinical in vivo lifetime carcinogenicity studies of LYRICA, an unexpectedly
1000 Patients Incidence in Placebo Events Per high incidence of hemangiosarcoma was identified in two different strains of mice
Patients 1000 Patients [see Nonclinical Toxicology (13.1)]. The clinical significance of this finding is unknown.
Clinical experience during LYRICA’s premarketing development provides no direct means
Epilepsy 1.0 3.4 3.5 2.4 to assess its potential for inducing tumors in humans.
Psychiatric 5.7 8.5 1.5 2.9 In clinical studies across various patient populations, comprising 6396 patient-years
Other 1.0 1.8 1.9 0.9 of exposure in patients greater than 12 years of age, new or worsening-preexisting
Total 2.4 4.3 1.8 1.9 tumors were reported in 57 patients. Without knowledge of the background incidence
and recurrence in similar populations not treated with LYRICA, it is impossible to know
The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy whether the incidence seen in these cohorts is or is not affected by treatment.
than in clinical trials for psychiatric or other conditions, but the absolute risk differences
5.9 Ophthalmological Effects
were similar for the epilepsy and psychiatric indications.
In controlled studies in adult patients, a higher proportion of patients treated with LYRICA
Anyone considering prescribing LYRICA or any other AED must balance the risk of
reported blurred vision (7%) than did patients treated with placebo (2%), which resolved
suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many
in a majority of cases with continued dosing. Less than 1% of patients discontinued
other illnesses for which AEDs are prescribed are themselves associated with morbidity
and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal LYRICA treatment due to vision-related events (primarily blurred vision).
thoughts and behavior emerge during treatment, the prescriber needs to consider Prospectively planned ophthalmologic testing, including visual acuity testing, formal
whether the emergence of these symptoms in any given patient may be related to the visual field testing and dilated funduscopic examination, was performed in over
illness being treated. 3600 patients. In these patients, visual acuity was reduced in 7% of patients treated
with LYRICA, and 5% of placebo-treated patients. Visual field changes were detected
5.5 Peripheral Edema
in 13% of LYRICA-treated, and 12% of placebo-treated patients. Funduscopic changes
LYRICA treatment may cause peripheral edema. In short-term trials of patients without were observed in 2% of LYRICA-treated and 2% of placebo-treated patients.
clinically significant heart or peripheral vascular disease, there was no apparent
Although the clinical significance of the ophthalmologic findings is unknown, inform
association between peripheral edema and cardiovascular complications such as
patients to notify their physician if changes in vision occur. If visual disturbance
hypertension or congestive heart failure. Peripheral edema was not associated with
laboratory changes suggestive of deterioration in renal or hepatic function. persists, consider further assessment. Consider more frequent assessment for patients
who are already routinely monitored for ocular conditions [see Patient Counseling
In controlled clinical trials in adult patients, the incidence of peripheral edema was 6% in Information (17)].
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. 5.10 Creatine Kinase Elevations
Higher frequencies of weight gain and peripheral edema were observed in patients taking LYRICA treatment was associated with creatine kinase elevations. Mean changes in
both LYRICA and a thiazolidinedione antidiabetic agent compared to patients taking creatine kinase from baseline to the maximum value were 60 U/L for LYRICA-treated
either drug alone. The majority of patients using thiazolidinedione antidiabetic agents in patients and 28 U/L for the placebo patients. In all controlled trials in adult patients
the overall safety database were participants in studies of pain associated with diabetic across multiple patient populations, 1.5% of patients on LYRICA and 0.7% of placebo
peripheral neuropathy. In this population, peripheral edema was reported in 3% (2/60) patients had a value of creatine kinase at least three times the upper limit of normal.
of patients who were using thiazolidinedione antidiabetic agents only, 8% (69/859) of Three LYRICA treated subjects had events reported as rhabdomyolysis in premarketing
patients who were treated with LYRICA only, and 19% (23/120) of patients who were on clinical trials. The relationship between these myopathy events and LYRICA is not
both LYRICA and thiazolidinedione antidiabetic agents. Similarly, weight gain was reported completely understood because the cases had documented factors that may have caused
in 0% (0/60) of patients on thiazolidinediones only; 4% (35/859) of patients on LYRICA or contributed to these events. Instruct patients to promptly report unexplained muscle
only; and 7.5% (9/120) of patients on both drugs. pain, tenderness, or weakness, particularly if these muscle symptoms are accompanied
As the thiazolidinedione class of antidiabetic drugs can cause weight gain and/or by malaise or fever. Discontinue treatment with LYRICA if myopathy is diagnosed or
fluid retention, possibly exacerbating or leading to heart failure, exercise caution when suspected or if markedly elevated creatine kinase levels occur.
co-administering LYRICA and these agents. 5.11 Decreased Platelet Count
Because there are limited data on congestive heart failure patients with New York Heart LYRICA treatment was associated with a decrease in platelet count. LYRICA-treated
Association (NYHA) Class III or IV cardiac status, exercise caution when using LYRICA subjects experienced a mean maximal decrease in platelet count of 20 × 103/μL,
in these patients. compared to 11 × 103/μL in placebo patients. In the overall database of controlled trials
5.6 Dizziness and Somnolence in adult patients, 2% of placebo patients and 3% of LYRICA patients experienced a
LYRICA may cause dizziness and somnolence. Inform patients that LYRICA-related potentially clinically significant decrease in platelets, defined as 20% below baseline
dizziness and somnolence may impair their ability to perform tasks such as driving or value and less than 150 × 103/μL. A single LYRICA treated subject developed severe
operating machinery [see Patient Counseling Information (17)]. thrombocytopenia with a platelet count less than 20 × 103/μL. In randomized controlled
trials, LYRICA was not associated with an increase in bleeding-related adverse reactions.
In the LYRICA controlled trials in adult patients, dizziness was experienced by 30% of
LYRICA-treated patients compared to 8% of placebo-treated patients; somnolence was 5.12 PR Interval Prolongation
experienced by 23% of LYRICA-treated patients compared to 8% of placebo-treated LYRICA treatment was associated with PR interval prolongation. In analyses of clinical
patients. Dizziness and somnolence generally began shortly after the initiation of LYRICA trial ECG data in adult patients, the mean PR interval increase was 3–6 msec at LYRICA
therapy and occurred more frequently at higher doses. Dizziness and somnolence were doses greater than or equal to 300 mg/day. This mean change difference was not
the adverse reactions most frequently leading to withdrawal (4% each) from controlled associated with an increased risk of PR increase greater than or equal to 25% from
studies. In LYRICA-treated patients reporting these adverse reactions in short-term, baseline, an increased percentage of subjects with on-treatment PR greater than
controlled studies, dizziness persisted until the last dose in 30% and somnolence 200 msec, or an increased risk of adverse reactions of second or third degree AV block.
persisted until the last dose in 42% of patients [see Drug Interactions (7)].Subgroup analyses did not identify an increased risk of PR prolongation in patients Table 4. Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain
with baseline PR prolongation or in patients taking other PR prolonging medications. Associated with Diabetic Peripheral Neuropathy
However, these analyses cannot be considered definitive because of the limited
Body system 75 150 300 600 All PGB* Placebo
number of patients in these categories.
Preferred term mg/day mg/day mg/day mg/day
6 ADVERSE REACTIONS [N=77] [N=212] [N=321] [N=369] [N=979] [N=459]
The following serious adverse reactions are described elsewhere in the labeling: % % % % % %
• Angioedema [see Warnings and Precautions (5.1)] Body as a whole
• Hypersensitivity [see Warnings and Precautions (5.2)] Asthenia 4 2 4 7 5 2
• Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation Accidental injury 5 2 2 6 4 3
[see Warnings and Precautions (5.3)]
Back pain 0 2 1 2 2 0
• Suicidal Behavior and Ideation [see Warnings and Precautions (5.4)]
• Peripheral Edema [see Warnings and Precautions (5.5)] Chest pain 4 1 1 2 2 1
• Dizziness and Somnolence [see Warnings and Precautions (5.6)] Face edema 0 1 1 2 1 0
• Weight Gain [see Warnings and Precautions (5.7)] Digestive system
• Tumorigenic Potential [see Warnings and Precautions (5.8)] Dry mouth 3 2 5 7 5 1
• Ophthalmological Effects [see Warnings and Precautions (5.9)]
Constipation 0 2 4 6 4 2
• Creatine Kinase Elevations [see Warnings and Precautions (5.10)]
Flatulence 3 0 2 3 2 1
• Decreased Platelet Count [see Warnings and Precautions (5.11)]
• PR Interval Prolongation [see Warnings and Precautions (5.12)] Metabolic and nutritional disorders
6.1 Clinical Trials Experience Peripheral edema 4 6 9 12 9 2
Because clinical trials are conducted under widely varying conditions, adverse reaction Weight gain 0 4 4 6 4 0
rates observed in the clinical trials of a drug cannot be directly compared to rates in the Edema 0 2 4 2 2 0
clinical trials of another drug and may not reflect the rates observed in practice. Hypoglycemia 1 3 2 1 2 1
In all controlled and uncontrolled trials across various patient populations during the
Nervous system
premarketing development of LYRICA, more than 10,000 patients have received LYRICA.
Approximately 5000 patients were treated for 6 months or more, over 3100 patients were Dizziness 8 9 23 29 21 5
treated for 1 year or longer, and over 1400 patients were treated for at least 2 years. Somnolence 4 6 13 16 12 3
Adverse Reactions Most Commonly Leading to Discontinuation in All Premarketing Neuropathy 9 2 2 5 4 3
Controlled Clinical Studies
Ataxia 6 1 2 4 3 1
In premarketing controlled trials of all adult populations combined, 14% of patients
treated with LYRICA and 7% of patients treated with placebo discontinued prematurely Vertigo 1 2 2 4 3 1
due to adverse reactions. In the LYRICA treatment group, the adverse reactions most Confusion 0 1 2 3 2 1
frequently leading to discontinuation were dizziness (4%) and somnolence (4%). Euphoria 0 0 3 2 2 0
In the placebo group, 1% of patients withdrew due to dizziness and less than 1% withdrew
due to somnolence. Other adverse reactions that led to discontinuation from controlled Incoordination 1 0 2 2 2 0
trials more frequently in the LYRICA group compared to the placebo group were ataxia, Thinking abnormal† 1 0 1 3 2 0
confusion, asthenia, thinking abnormal, blurred vision, incoordination, and peripheral Tremor 1 1 1 2 1 0
edema (1% each).
Abnormal gait 1 0 1 3 1 0
Most Common Adverse Reactions in All Controlled Clinical Studies in Adults
Amnesia 3 1 0 2 1 0
In premarketing controlled trials of all adult patient populations combined (including
DPN, PHN, and adult patients with partial onset seizures), dizziness, somnolence, dry Nervousness 0 1 1 1 1 0
mouth, edema, blurred vision, weight gain, and “thinking abnormal” (primarily difficulty Respiratory system
with concentration/attention) were more commonly reported by subjects treated with
Dyspnea 3 0 2 2 2 1
LYRICA than by subjects treated with placebo (greater than or equal to 5% and twice the
rate of that seen in placebo). Special senses
Controlled Studies with Neuropathic Pain Associated with Diabetic Peripheral Blurry vision‡ 3 1 3 6 4 2
Neuropathy Abnormal vision 1 0 1 1 1 0
Adverse Reactions Leading to Discontinuation * PGB: pregabalin
In clinical trials in patients with neuropathic pain associated with diabetic peripheral
†
Thinking abnormal primarily consists of events related to difficulty with concentration/attention
but also includes events related to cognition and language problems and slowed thinking.
neuropathy, 9% of patients treated with LYRICA and 4% of patients treated with placebo ‡
Investigator term; summary level term is amblyopia
discontinued prematurely due to adverse reactions. In the LYRICA treatment group, the
most common reasons for discontinuation due to adverse reactions were dizziness (3%) Controlled Studies in Postherpetic Neuralgia
and somnolence (2%). In comparison, less than 1% of placebo patients withdrew due to
dizziness and somnolence. Other reasons for discontinuation from the trials, occurring Adverse Reactions Leading to Discontinuation
with greater frequency in the LYRICA group than in the placebo group, were asthenia, In clinical trials in patients with postherpetic neuralgia, 14% of patients treated with
confusion, and peripheral edema. Each of these events led to withdrawal in approximately LYRICA and 7% of patients treated with placebo discontinued prematurely due to adverse
1% of patients. reactions. In the LYRICA treatment group, the most common reasons for discontinuation
due to adverse reactions were dizziness (4%) and somnolence (3%). In comparison, less
Most Common Adverse Reactions
than 1% of placebo patients withdrew due to dizziness and somnolence. Other reasons
Table 4 lists all adverse reactions, regardless of causality, occurring in greater than or for discontinuation from the trials, occurring in greater frequency in the LYRICA group
equal to 1% of patients with neuropathic pain associated with diabetic neuropathy in the than in the placebo group, were confusion (2%), as well as peripheral edema, asthenia,
combined LYRICA group for which the incidence was greater in this combined LYRICA ataxia, and abnormal gait (1% each).
group than in the placebo group. A majority of pregabalin-treated patients in clinical
studies had adverse reactions with a maximum intensity of “mild” or “moderate”. Most Common Adverse Reactions
Table 5 lists all adverse reactions, regardless of causality, occurring in greater than or
equal to 1% of patients with neuropathic pain associated with postherpetic neuralgia
in the combined LYRICA group for which the incidence was greater in this combined
LYRICA group than in the placebo group. In addition, an event is included, even if the
incidence in the all LYRICA group is not greater than in the placebo group, if the incidence
of the event in the 600 mg/day group is more than twice that in the placebo group.
A majority of pregabalin-treated patients in clinical studies had adverse reactions with
a maximum intensity of “mild” or “moderate”. Overall, 12.4% of all pregabalin-treated
patients and 9.0% of all placebo-treated patients had at least one severe event while
8% of pregabalin-treated patients and 4.3% of placebo-treated patients had at least one
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