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LYRICA® (pregabalin) CV Questions | What Is LYRICA® | Safety Info | Diabetic Nerve Pain

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Frequently Asked Questions

This page answers common questions patients may have when taking LYRICA. If you have just started taking LYRICA, you may be interested in LYRICA ANSWERS. As you begin your treatment, LYRICA ANSWERS will help you know what to expect and how to best partner with your doctor. LYRICA ANSWERS is a resource designed specifically to give new patients like you the right information at the right time.
What is LYRICA?

LYRICA (LEER-i-kah) 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. LYRICA is also indicated to treat partial onset seizures in adults with epilepsy who take 1 or more drugs for seizures.


In clinical studies, LYRICA was proven effective in 2 difficult-to-treat nerve pain conditions—diabetic nerve pain and pain after shingles—and fibromyalgia. LYRICA was proven to provide significant relief from pain associated with these 3 conditions for patients who took LYRICA compared with those who took a placebo.* LYRICA can also provide significant relief from spinal cord injury nerve pain.*


In clinical studies, LYRICA was also proven as an add-on therapy to significantly reduce the frequency of partial onset seizures in adults with epilepsy compared with a placebo.*

How is LYRICA believed to work?

LYRICA is believed to work within your body to calm the damaged or overactive nerves that cause pain. Although the exact mechanism of action is unknown, results from animal studies suggest that LYRICA works by calming damaged or overactive nerves that cause pain or seizures. The implication of these studies in humans is not known.

For what uses is LYRICA approved by the FDA?

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). It is also used to treat 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 adults with epilepsy.

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 you next dose, just skip the missed dose. Take the next dose at your regular time. Do not take two 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 of LYRICA?

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

Other side effects in these studies include dry mouth, swelling of the hands and feet, blurred vision, weight gain, trouble concentrating, and feeling “high.” 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 as early as one week. For others it took longer.*

If you aren't 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. If you become pregnant while taking LYRICA, talk to your doctor 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. Even if you do not have epilepsy, it is still important to participate. Your input may help women with epilepsy who are also having children

  • Are breast-feeding

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

Can I take LYRICA with other medicines or alcohol?

LYRICA has a low potential for interaction with other 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 narcotic pain medicine (such as oxycodone), tranquilizers or medicines for anxiety (such as lorazepam): Taking these with LYRICA may increase the chance for dizziness and sleepiness

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.

What are the approved doses of 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:

 Number of times
per day to take LYRICA
Recommended total
starting dosage
Recommended total
ongoing dosage

Fibromyalgia

2150 mg/day300 mg/day to
450 mg/day

Diabetic nerve pain

3150 mg/day300 mg/day

Spinal cord injury nerve pain

2150 mg/day150 mg/day to
600 mg/day*

Pain after shingles

2 or 3
(depending on the dose)
150 mg/day150 mg/day to
600 mg/day

Partial onset seizures in adults with epilepsy

2 or 3
(depending on the dose)
150 mg/day150 mg/day to
600 mg/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 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.

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.

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 9 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 version of LYRICA?

No. There is no FDA-approved generic version of LYRICA.

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 such as oxycodone, which is a narcotic that falls under Schedule II.

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IMPORTANT SAFETY INFORMATION & INDICATIONS

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 or 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.

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.

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, or if you are pregnant, plan to become pregnant, or are breast-feeding. 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, but not in rats. 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.

INDICATIONS

LYRICA is indicated to treat fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain, and pain after shingles. LYRICA is also indicated to treat partial onset seizures in adults with epilepsy who take 1 or more drugs for seizures.

View the Medication Guide
View the Full Prescribing Information

 
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