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Lyrica, Pregabalin (generic): Frequently Asked Questions

What is the pharmacokinetic profile of LYRICA?

LYRICA pharmacokinetic profile in healthy volunteers 12 LYRICA has predictable, linear pharmacokinetics, with proportionate absorption across the dose range. The oral bioavailability of LYRICA is ≥90% and is independent of dose. With LYRICA you can have confidence that, regardless of dose, absorption is consistent and predictable. (BACK TO TOP) Clinical Studies (1 Question & Answer)
Source: www.pfizerpro.com
LYRICA pharmacokinetic profile in healthy volunteers 4 LYRICA was given divided TID under fasting conditions. LYRICA has predictable, linear pharmacokinetics, with proportionate absorption across the dose range. The oral bioavailability of LYRICA is ≥90% and is independent of dose. With LYRICA, you can have confidence that, regardless of dose, your patients will absorb what you have prescribed. (BACK TO TOP) Clinical Studies (1 Question & Answer)
Source: www.pfizerpro.com

How does LYRICA work?

In animal models, LYRICA was found to selectively bind to the alpha 2 -delta (A2D) subunit of voltage-gated calcium channels. In vitro , LYRICA reduced the excessive release of several neurotransmitters, possibly by modulation of calcium channel influx. It is active only in hyperexcited neurons. LYRICA is not a vascular calcium channel blocker and does not significantly affect blood pressure or cardiac function. 12
Source: www.pfizerpro.com
In animal models, LYRICA appears to selectively bind to the alpha 2 -delta (A2D) subunit of voltage-gated calcium channels. In vitro , LYRICA reduced the excessive release of several neurotransmitters, possibly by modulation of calcium channel influx. 8 It is active only in hyperexcited neurons. LYRICA is not a vascular calcium channel blocker and does not significantly affect vascular or cardiac function.
Source: www.pfizerpro.com
The central nervous system is made up of millions of nerve cells. In people with nerve pain, some cells are over-excited because they are damaged. This causes the cells to fire too many signals throughout the body, resulting in pain. LYRICA works by attaching to part of the over-firing nerve cells. This is thought to help to reduce the pain signals that cause the symptoms of diabetic nerve pain. LYRICA may reduce the nerve pain that can prevent the enjoyment of everyday activities. Watch a video that shows how LYRICA works. ...
Source: www.depressionforums.org

Does LYRICA affect GABA?

LYRICA has no effect on GABA. It does not bind to GABA A or GABA B receptors and therefore is not an agonist or an antagonist. LYRICA is not metabolically converted to GABA and does not alter GABA uptake or degradation at nerve terminals. Studies with a rat model show that high doses of LYRICA do not alter whole-brain GABA concentrations.
Source: www.pfizerpro.com

What are the most common side effects with LYRICA?

Most common adverse events in controlled Diabetic Peripheral Neuropathy and Postherpetic Neuralgia studies 12
Source: www.pfizerpro.com
In clinical trials, the most common side effects were: * dizziness * sleepiness * dry mouth * swelling of hands and feet * blurry vision * weight gain * trouble concentrating These side effects were often mild to moderate, and few people in clinical trials stopped taking LYRICA because of the side effects. Some side effects went away after a few weeks of treatment. Tell your doctor about any side effect that bothers you or that does not go away. ...
Source: www.depressionforums.org

What is the FDA-approved indication for LYRICA?

LYRICA is approved for the management of two of the most common neuropathic pain conditions: diabetic peripheral neuropathy (DPN) postherpetic neuralgia (PHN) LYRICA is also indicated for the management of Fibromyalgia and is approved for adjunctive treatment of partial onset seizures in adults.
Source: www.pfizerpro.com

What are the FDA-approved indications for LYRICA?

LYRICA is indicated as adjunctive therapy for adults with partial onset seizures. LYRICA is also indicated for the management of: Fibromyalgia Neuropathic pain associated with diabetic peripheral neuropathy (DPN) Postherpetic neuralgia (PHN)
Source: www.pfizerpro.com

How does LYRICA differ from NSAIDs and COX-2 inhibitors?

LYRICA does not affect the arachadonic acid pathways, the pathways affected by NSAIDs and COX-2 inhibitors. While there is strong evidence to suggest that NSAIDs, via inhibition of prostanoids, are effective in nociceptive pain, their efficacy in the treatment of neuropathic pain has not been established. NSAIDs and COX-2 inhibitors are not indicated for the treatment of neuropathic pain.
Source: www.pfizerpro.com
LYRICA has no direct effect on the arachadonic acid pathways, the pathways affected by NSAIDs and COX-2 inhibitors. While there is strong evidence to suggest that NSAIDs, via inhibition of prostanoids, are effective in nociceptive pain, their efficacy in the treatment of neuropathic pain has not been established. NSAIDs and COX-2 inhibitors are not indicated for the treatment of neuropathic pain.
Source: www.pfizerpro.com

Does LYRICA have a new mechanism of action?

LYRICA binds to the A2D subunit of voltage-gated calcium channels. Gabapentin is the only other marketed drug known to bind to the A2D subunit. LYRICA has a different chemical structure (shown below), which may account for its pharmacological properties, which are different from those of gabapentin. The chemical structure of LYRICA differs from that of gabapentin. It is neither an isomer of gabapentin nor is it a reformulation. LYRICA is approved for both painful DPN and PHN, while gabapentin is approved for PHN only. ...
Source: www.pfizerpro.com
LYRICA binds to the A2D subunit of voltage-gated calcium channels. Gabapentin is the only other marketed drug known to bind to the A2D subunit. LYRICA has a different chemical structure (shown below), which may account for its pharmacological properties, which are different from those of gabapentin. The chemical structure of LYRICA differs from that of gabapentin. It is neither an isomer of gabapentin nor is it a reformulation. LYRICA is approved for both painful DPN and PHN, while gabapentin is approved for PHN only. ...
Source: www.pfizerpro.com

What kinds of seizures does LYRICA treat?

LYRICA is indicated for the adjunctive treatment of partial onset seizures in adults. Partial onset seizures represent 57% of all seizures. 1 Partial onset seizures can manifest in limited motor, sensory or psychological changes.
Source: www.pfizerpro.com

How is LYRICA different from calcium channel blockers?

LYRICA binds to the A2D subunit of voltage-gated calcium channels in central nervous system tissues. These channels allow the selective permeability of calcium ions across presynaptic plasma membranes in response to a presynaptic action potential. The A2D subunit is not a part of the calcium channel pore, but is an associated protein that modulates calcium channel activity. LYRICA does not completely inhibit calcium channel function or completely reduce neurotransmitter release, even at high concentrations. ...
Source: www.pfizerpro.com

Does LYRICA affect sodium or calcium channels?

LYRICA does not block sodium or calcium channels. Based on in vitro evidence, it is hypothesized that the reduction in calcium-dependent release of several neurotransmitters seen with LYRICA results from possible modulation of calcium channel function. LYRICA is not a vascular calcium channel blocker and does not significantly affect blood pressure or cardiac function.
Source: www.pfizerpro.com

How refractory were patients in LYRICA epilepsy trials?

Patients in each of the 3 add-on trials were refractory and not adequately controlled on 1 to 3 concomitant AED treatments. Approximately half of all study participants were taking 2 concurrent AEDs at baseline.
Source: www.pfizerpro.com

Is routine blood monitoring required for my patients on LYRICA?

No blood monitoring is required for patients who are taking LYRICA. LYRICA is not protein bound and is renally excreted as unchanged drug. (BACK TO TOP) Dosing (1 Question & Answer)
Source: www.pfizerpro.com
No routine blood monitoring is required with LYRICA. (BACK TO TOP) Dosing (1 Question & Answer)
Source: www.pfizerpro.com

What sort of treatment response should I expect from LYRICA?

LYRICA treatment was associated with a robust patient response: 43% to 51% of patients taking LYRICA 600 mg daily experienced ≥50% fewer seizures. LYRICA significantly reduced seizure frequency by 50% or more across the dose range of 150 mg-600 mg daily in a significant number of patients. (BACK TO TOP) Safety (3 Questions & Answers)
Source: www.pfizerpro.com

In PHN, what was the longest LYRICA pivotal trial in which efficacy was sustained?

LYRICA demonstrated sustained efficacy at each week up to 13 weeks in a PHN study. Mean pain reduction * from baseline in a 13-week Postherpetic Neuralgia study 12
Source: www.pfizerpro.com

How quickly after they begin taking LYRICA can my patients expect pain relief?

Pain relief can begin in some patients as early as one week after starting LYRICA. The following chart is an example of mean pain reduction * from baseline in an 8-week Diabetic Peripheral Neuropathy Study 12,17 Mean pain reduction * from baseline in an 8-week Postherpetic Neuralgia study 12 LYRICA 300 mg/day (given 150 mg BID) significantly reduced mean pain score from 6.7 at baseline to 5.0 at endpoint (vs 6.9 to 6.1 for placebo, P =.0003). 12
Source: www.pfizerpro.com

How many clinical studies have evaluated the efficacy and safety of LYRICA as adjunctive therapy for partial onset seizures?

LYRICA has been studied in three 12-week, double-blind, placebo-controlled, multicenter clinical studies involving 1,052 adults with partial onset seizures. A highly refractory patient population was included in all LYRICA epilepsy studies. Patients who were enrolled had partial onset seizures with or without secondary generalization and were not adequately controlled on 1 to 3 concomitant antiepileptic drugs (AEDs). ...
Source: www.pfizerpro.com

What is LYRICA?

LYRICA is the first medication approved by the US Food and Drug Administration (FDA) to treat the pain that occurs with both diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN)—two of the most common forms of nerve pain. LYRICA is also approved as adjunctive treatment for partial onset seizures in adults.
Source: www.depressionforums.org

I understand that LYRICA and gabapentin are believed to have the same mechanism of action. How are the drugs different?

LYRICA binds to the A2D subunit of voltage-gated calcium channels. Gabapentin is the only other marketed drug known to bind to the A2D subunit. LYRICA has a different chemical structure (shown below), which may account for its pharmacological properties which are different from those of gabapentin. The chemical structure of LYRICA differs from that of gabapentin. It is neither an isomer of gabapentin, nor is it a reformulation. LYRICA is approved for both painful DPN and PHN, while gabapentin is approved for PHN only. ...
Source: www.pfizerpro.com
LYRICA binds to the A2D subunit of voltage-gated calcium channels. Gabapentin is the only other marketed drug known to bind to the A2D subunit. LYRICA has a different chemical structure (shown below), which may account for its pharmacological properties, which are different from those of gabapentin. The chemical structure of LYRICA differs from that of gabapentin. It is neither an isomer of gabapentin, nor is it a reformulation. LYRICA is approved for both painful DPN and PHN, while gabapentin is approved for PHN only. ...
Source: www.pfizerpro.com

Who should not take LYRICA?

Do not take LYRICA if you are allergic to pregabalin or any other ingredient in LYRICA. Pregabalin is the main ingredient in LYRICA. Ask your doctor or pharmacist for a list of ingredients.
Source: www.depressionforums.org

How do I take LYRICA?

LYRICA comes in 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsules. Your doctor will tell you how much you need to take and when to take it. * Take LYRICA 2 or 3 times a day, depending on what your doctor tells you * You can take LYRICA with or without food * Keep taking LYRICA, even after you start feeling relief from your pain * Do not suddenly stop taking LYRICA. Talk to your doctor first * Plan ahead to have a refill so you don’t run out
Source: www.depressionforums.org
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