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What is LYRICA?

LYRICA is a prescription medicine approved by the US Food and Drug Administration (FDA) to treat fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain, and pain after shingles in adult patients. LYRICA (pregabalin) is also indicated to treat partial onset seizures in patients 1 month of age and older with epilepsy who take 1 or more drugs for seizures.

What conditions does LYRICA treat?

LYRICA is a prescription medicine approved by the US Food and Drug Administration (FDA) and is used in adults to manage fibromyalgia (chronic pain all over your body), diabetic nerve pain, or pain associated with diabetic peripheral neuropathy (pain in the feet and hands from damaged nerves caused by diabetes), spinal cord injury nerve pain, and pain after shingles. In addition, it is used together with other seizure medicines to treat partial onset seizures in patients 1 month of age and older with epilepsy.

What is the most important information I should know about LYRICA?

LYRICA may cause serious side effects including:

  • serious, even life-threatening, allergic reactions
  • suicidal thoughts or actions
  • serious breathing problems
  • swelling of your hands, legs and feet
  • dizziness and sleepiness

These serious side effects are described below:

  • Serious, even life-threatening, allergic reactions.
    Stop taking LYRICA and call your healthcare provider right away if you have any of these signs of a serious allergic reaction:
    • swelling of your face, mouth, lips, gums, tongue, throat or neck
    • trouble breathing
    • rash, hives (raised bumps) or blisters

How is LYRICA believed to work?

LYRICA is believed to work on damaged nerves, or calm overactive nerves, depending on your condition. It is unknown exactly how LYRICA works in the body. However, certain studies suggest that LYRICA reduces “extra” electrical signals sent out by damaged nerves in the body. The implication of these studies in humans is not known.

How do I take LYRICA?

Take LYRICA every day as prescribed by your doctor. Here are a few ways to help make sure you take LYRICA the right way:

  • Try to take LYRICA at the same times each day
  • Consider taking LYRICA in combination with other daily activities, such as eating meals or brushing your teeth
  • You can take LYRICA with or without food
  • Do not stop taking LYRICA without talking to your doctor. If you stop taking LYRICA suddenly, you may have headaches, nausea, diarrhea, trouble sleeping, increased sweating, or you may feel anxious. If you have epilepsy and stop taking LYRICA suddenly, you may have seizures more often. If you and your doctor do decide you need to stop taking LYRICA, he or she will help you stop gradually.

LYRICA may cause serious, even life-threatening, allergic reactions. Stop taking LYRICA and call your doctor right away if you have any signs of a serious allergic reaction. Some signs are swelling of your face, mouth, lips, gums, tongue, throat or neck or if you have any trouble breathing, or have a rash, hives or blisters.

LYRICA is available in multiple strengths. Your doctor can adjust your dose to help you get the most from treatment. So it’s important to discuss your progress and any side effects you may feel with your doctor, especially in the first few weeks. Your healthcare provider may change your dose. Do not change your dose without talking to your doctor.

  • If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time
  • If you take too much LYRICA, call your healthcare provider or poison control center, or go to the nearest emergency room right away

What are the most common side effects?

The 2 most common side effects of LYRICA are dizziness and sleepiness. Across all clinical studies, dizziness occurred in 30% of LYRICA patients, compared with 8% of patients taking a placebo. Sleepiness occurred in 23% of LYRICA patients, compared with 8% of patients taking a placebo. For some people, dizziness and sleepiness went away over time. For others, these lasted throughout the course of the studies.

Two Most Common Side Effects with LYRICA in Clinical Studies

Indication How long dizziness lasted on average How long sleepiness lasted on average
Fibromyalgia About 2.5 Weeks About 5 Weeks
Diabetic Nerve Pain 1 to 2 Weeks 4 to 6 Weeks
Spinal Cord Injury Nerve Pain About 1.5 Weeks Over 10 Weeks
Pain After shingles 1 to 7 Weeks 3 to 8 Weeks
Partial Onset Seizures in Adults with Epilepsy 2 to 4 Weeks 4 to 8 Weeks

Other side effects in these studies include dry mouth, swelling of the hands and feet, blurred vision, weight gain, trouble concentrating. These side effects were generally mild to moderate.

LYRICA may also cause serious, even life-threatening, allergic reactions. Stop taking LYRICA and call your doctor right away if you have any signs of a serious allergic reaction. Some signs are swelling of your face, mouth, lips, gums, tongue, throat or neck or if you have any trouble breathing, or have a rash, hives or blisters.

If you stop taking LYRICA suddenly, you may have headaches, nausea, diarrhea, or trouble sleeping. If you have epilepsy and you stop taking LYRICA suddenly, you may have seizures more often. If you and your doctor do decide you need to stop taking LYRICA, he or she will help you stop gradually.

Please see additional Important Safety Information below.

How long does LYRICA take to work?

It may take time for LYRICA to work. In clinical studies in fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain, and pain after shingles, some patients experienced a decrease in pain in as early as 1 week. For others it took longer.*

If you are not feeling the pain relief you expect, there may be things your doctor can do to help. Talk to your doctor to find out if adjusting your dose may be right for you.
*Individual results may vary.

What should I tell my doctor before I start taking LYRICA?

It’s important to give your doctor your full medical history. This will make sure you have the best possible experience with LYRICA. Before taking LYRICA, tell your doctor about all your medical conditions, including if you:

  • Have or have had depression, mood problems, or suicidal thoughts or behavior
  • Have kidney problems or get kidney dialysis
  • Have heart problems, including heart failure
  • Have a bleeding problem or a low blood platelet count
  • Have abused prescription medicines, street drugs, or alcohol in the past
  • Have ever had swelling of your face, mouth, tongue, lips, gums, neck, or throat (angioedema)
  • Plan to father a child
  • Are pregnant or plan to become pregnant. It is not known if LYRICA will harm your unborn baby. You and your healthcare provider will decide if you should take LYRICA while you are pregnant. If you become pregnant while taking LYRICA, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. Information about the registry can also be found at the website, http://www.aedpregnancyregistry.org/
  • Are breastfeeding or plan to breastfeed. LYRICA passes into your breast milk. It is not known if LYRICA can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take LYRICA. Breastfeeding is not recommended while taking LYRICA

Tell your doctor about all the medicines, vitamins, or herbal supplements you take, especially medicines that make you sleepy or any medicines mentioned below:

Any angiotensin-converting enzyme (ACE) inhibitor, used to treat many conditions such as high blood pressure: Taking this with LYRICA may increase the chance for swelling and hives.

Avandia (rosiglitazone), Avandamet (contains rosiglitazone and metformin), or Actos (pioglitazone) used for diabetes: Taking these with LYRICA may increase the chance of weight gain or swelling of your hands or feet.

Any opioids (such as oxycodone), tranquilizers, or medicines for anxiety (such as lorazepam): Taking these with LYRICA may increase the chance for dizziness and sleepiness.

Opioids (narcotic) pain medicines: Taking LYRICA in combination with these medications may reduce central nervous system activity that could lead to death.

Can I take LYRICA with other medicines or alcohol?

LYRICA has a low potential for drug interaction, but does interact with some medicines. Tell your doctor about all the medicines, vitamins, or herbal supplements you take, especially medicines that make you sleepy or any medicines mentioned below:

  • Any angiotensin-converting enzyme (ACE) inhibitor, used to treat many conditions such as high blood pressure: Taking this with LYRICA may increase the chance for swelling and hives
  • Avandia (rosiglitazone), Avandamet (contains rosiglitazone and metformin), or Actos (pioglitazone) used for diabetes: Taking these with LYRICA may increase the chance of weight gain or swelling of your hands or feet
  • Any opioids (such as oxycodone), tranquilizers, or medicines for anxiety (such as lorazepam): Taking these with LYRICA may increase the chance for dizziness and sleepiness
  • Opioids (narcotic) pain medicines: Taking LYRICA in combination with these medications may reduce central nervous system activity that could lead to death

Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your doctor.

Do not drink alcohol while taking LYRICA. LYRICA and alcohol can affect each other and increase side effects such as sleepiness and dizziness.

What are the approved doses for LYRICA?

Your doctor will decide what dose is appropriate for you. Everyone is unique and may respond to LYRICA differently. LYRICA is available in multiple strengths. Your doctor can adjust your dose to help you get the most from treatment. So it’s important to discuss your progress and any side effects you may feel with your doctor, especially in the first few weeks.

The approved doses for the different indications of LYRICA are as follows:

Indication Number of times per day to take LYRICA Recommended total starting dosage Recommended total ongoing dose based on efficacy and tolerability
Fibromyalgia 2 150 mg/day 300 mg/day to 450 mg/day*
Diabetic nerve pain 3 150 mg/day 300 mg/day
Spinal cord injury nerve pain 2 150 mg/day 150 mg/day to 600 mg/day
Pain after shingles 2 or 3 150 mg/day 150 mg/day to 600 mg/day
Add-on treatment for patient onset seizures in adult patients with epilepsy 2 or 3 150 mg/day 150 mg/day to 600 mg/day
Add-on treatment for patient onset seizures in pediatric patients with epilepsy weighing over 30 kg or more 2 or 3 2.5 mg/kg/day 10 mg/kg/day not to exceed 600 mg/day
Add-on treatment for patient onset seizures in pediatric patients with epilepsy weighing less than 30 kg or more 1 month to less than 4 years of age: 3 divided doses 4 years of age and older: 2 or 3 divided doses 3.5 mg/kg/day 14 mg/kg/day

Your doctor may make adjustments according to your needs. If you have problems with kidney function, your doctor may prescribe a lower dose of LYRICA.

*Patients who do not experience sufficient pain relief with 300 mg/day may be further increased to 450 mg/day.

Patients who do not experience sufficient pain relief following 2 to 3 weeks of treatment with 300 mg per day, and who are able to tolerate LYRICA, may be treated with up to 600 mg per day.

Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg per day, and who are able to tolerate LYRICA, may be treated with up to 600 mg per day.

What if I miss a dose?

If you miss a dose by a few hours, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take LYRICA at your next regular time. Do not take 2 doses at the same time.

What if I take too much LYRICA?

If you take too much LYRICA, call your doctor or poison control center, or go to the nearest emergency room right away.

Can I discontinue LYRICA treatment?

Do not stop taking LYRICA without talking to your healthcare provider. If you stop taking LYRICA suddenly, you may have headaches, nausea, diarrhea, trouble sleeping, increased sweating, or you may feel anxious. If you have epilepsy and you stop taking LYRICA suddenly, you may have seizures more often. If you and your doctor do decide you need to stop taking LYRICA, he or she will help you stop gradually.

How many people have been prescribed LYRICA?

Over 16 million people have been prescribed LYRICA in the United States since its approval in 2005. LYRICA is not appropriate for everyone.

Is LYRICA an antidepressant?

No. LYRICA is not an antidepressant. Be sure to tell your doctor about all the medicines you are taking.

Is LYRICA a narcotic?

No. LYRICA is not a narcotic. But if you have had a drug or alcohol problem, you may be more likely to misuse LYRICA.

Is there a generic form of LYRICA?

Yes, however, Pfizer’s brand-name LYRICA is still available for patients who prefer the brand they know since its launch in 2005.

Why is LYRICA classified as a controlled substance?

The US government regulates the manufacture, possession, and use of certain drugs and chemicals. The Drug Enforcement Administration (DEA) maintains 5 schedules (or lists) of these controlled substances. The higher the schedule number, the lower the potential there is for abuse. For instance, LYRICA is a Schedule V medicine. This means it has a lower potential for abuse than a pain medicine that falls under Schedule II to IV.

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IMPORTANT SAFETY INFORMATION

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LYRICA is not for everyone. LYRICA may cause serious, even life-threatening, allergic reactions. Stop taking LYRICA and call your doctor right away if you have any signs of a serious allergic reaction. Some signs are swelling of your face, mouth, lips, gums, tongue, throat or neck, if you have any trouble breathing, or have a rash, hives, or blisters.

Drugs used to treat seizures increase the risk of suicidal thoughts or behavior. LYRICA may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Patients, family members, or caregivers should call the doctor right away if they notice suicidal thoughts or actions, thoughts of self-harm, or any unusual changes in mood or behavior. These changes may include new or worsening depression, anxiety, restlessness, trouble sleeping, panic attacks, anger, irritability, agitation, aggression, dangerous impulses or violence, or extreme increases in activity or talking. If you have suicidal thoughts or actions, do not stop LYRICA without first talking to your doctor.

Serious breathing problems can occur when LYRICA is taken with other medicines that can cause severe sleepiness or decreased awareness, or when it is taken by someone who already has breathing problems. Watch for increased sleepiness or decreased breathing when starting LYRICA or when the dose is increased. Get help right away if breathing problems occur.

LYRICA may cause swelling of your hands, legs, and feet, which can be serious for people with heart problems. LYRICA may cause dizziness and sleepiness. You should not drive or work with machines until you know how LYRICA affects you. Also, tell your doctor right away about muscle pain or problems along with feeling sick and feverish, or any changes in your eyesight, including blurry vision or if you have any kidney problems or get dialysis.

Tell your doctor immediately if you are taking opioid painkillers (such as oxycodone), or medicines for anxiety (such as lorazepam) or insomnia (such as zolpidem). You may have a higher chance for dizziness, sleepiness or serious breathing problems if these medicines are taken with LYRICA. Taking LYRICA with opioid pain medicines may lead to death.

Some of the most common side effects of LYRICA are dizziness, blurry vision, weight gain, sleepiness, trouble concentrating, swelling of your hands and feet, dry mouth, and feeling “high.” If you have diabetes, tell your doctor about any skin sores.

You may have a higher chance for swelling and hives if you are also taking angiotensin-converting enzyme (ACE) inhibitors, so tell your doctor if you are taking these medications. You may have a higher chance of swelling of your hands or feet or gaining weight if you are also taking certain diabetes medicines. Do not drink alcohol while on LYRICA. You may have a higher chance for dizziness and sleepiness if you take LYRICA with alcohol, narcotic pain medicines, or medicines for anxiety.

Before you start LYRICA, tell your doctor if you are planning to father a child, if you are pregnant, or plan to become pregnant. Breastfeeding is not recommended while taking LYRICA. If you have had a drug or alcohol problem, you may be more likely to misuse LYRICA.

In studies, a specific type of blood vessel tumor was seen in mice. The meaning of these findings in humans is not known.

Do not stop taking LYRICA 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.

LYRICA is available in doses ranging from 25 mg to 300 mg and as a 20 mg/mL oral solution.

INDICATIONS

LYRICA is indicated to treat fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain, and pain after shingles in adult patients. LYRICA is also indicated to treat partial-onset seizures in patients 1 month of age and older with epilepsy who take 1 or more other drugs for seizures.

Please see full Prescribing Information and Medication Guide.