IMPORTANT SAFETY INFORMATION AND INDICATION
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LYRICA CR is indicated for the management of pain associated with diabetic peripheral neuropathy and management of postherpetic neuralgia. Efficacy of LYRICA CR has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures.
LYRICA is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, management of postherpetic neuralgia, management of fibromyalgia, and management of neuropathic pain associated with spinal cord injury in adult patients, and as adjunctive therapy for the treatment of partial onset seizures in patients 1 month of age and older.
IMPORTANT SAFETY INFORMATION
LYRICA and LYRICA CR are contraindicated in patients with known hypersensitivity to pregabalin or any of the components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy.
There have been postmarketing reports of angioedema in patients during initial and chronic treatment with LYRICA. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Discontinue LYRICA or LYRICA CR immediately in patients with these symptoms. Patients who are taking other drugs associated with angioedema, such as angiotensin-converting enzyme inhibitors (ACE inhibitors), may be at increased risk of developing angioedema. Exercise caution when using LYRICA or LYRICA CR in patients who have had a previous episode of angioedema.
There have been postmarketing reports of hypersensitivity reactions in patients shortly after initiation of treatment with LYRICA. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Discontinue LYRICA or LYRICA CR immediately in patients with these symptoms.
Antiepileptic drugs (AEDs), including pregabalin, the active ingredient in LYRICA and LYRICA CR, increase the risk of suicidal thoughts or behavior in patients taking AEDs for any indication. Monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Pooled analyses showed clinical trial patients taking an AED had approximately twice the risk of suicidal thoughts or behavior than placebo-treated patients. The estimated incidence rate of suicidal thoughts or behavior among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately 1 patient for every 530 patients treated with an AED.
Inform patients taking LYRICA or LYRICA CR that dizziness and somnolence may impair their ability to perform potentially hazardous tasks, such as driving or operating machinery, until they have sufficient experience with LYRICA to determine its effect on cognitive and motor function. Concomitant use of LYRICA or LYRICA CR with other CNS depressants may exacerbate these effects.
Caution is advised when prescribing pregabalin concomitantly with opioids due to risk of CNS depression. In an observational study of opioid users, patients who took pregabalin concomitantly with an opioid had an increased risk for opioid-related death compared to opioid use alone.
In controlled studies, a higher proportion of patients treated with LYRICA reported blurred vision (7%) than did patients treated with placebo (2%), which resolved in a majority of cases with continued dosing. In controlled studies, 5% of patients treated with LYRICA CR reported blurred vision in the single-blind phase; less than 1% discontinued LYRICA CR treatment. Additionally, 1% of LYRICA CR-treated patients as compared to zero placebo-treated patients experienced blurred vision in the double-blind phase. Consider more frequent assessment for patients who are already routinely monitored for ocular conditions.
LYRICA and LYRICA CR may cause weight gain. LYRICA and LYRICA CR may cause peripheral edema in patients also taking thiazolidinedione antidiabetic drugs. Exercise caution when coadministering these drugs.
The most common adverse reactions in LYRICA CR clinical trials were dizziness, somnolence, peripheral edema, fatigue, headache, nausea, blurred vision, weight gain, and dry mouth.
The most common adverse reactions across all LYRICA clinical trials in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, constipation, euphoric mood, balance disorder, increased appetite, and thinking abnormal (primarily difficulty with concentration/attention). The most common adverse reactions in pediatric patients for the treatment of partial onset seizures were somnolence, weight gain, and increased appetite.
Advise nursing mothers that breastfeeding is not recommended during treatment with LYRICA or LYRICA CR.
LYRICA and LYRICA CR may exacerbate the effects of oxycodone, lorazepam, or ethanol on cognitive and gross motor functioning.
Carefully evaluate all patients treated with LYRICA or LYRICA CR for history of drug abuse and observe them for signs of LYRICA or LYRICA CR misuse or abuse (eg, development of tolerance, dose escalation, drug-seeking behavior).
Withdraw LYRICA or LYRICA CR gradually over a minimum of 1 week. Discontinue LYRICA or LYRICA CR immediately in patients with symptoms of hypersensitivity or angioedema.
LYRICA CR is not recommended for patients with creatinine clearance (CLcr) less than 30 mL/min or who are undergoing hemodialysis. Adjust the dose of LYRICA CR for patients with reduced renal function (CLcr ≤60 mL/min).
LYRICA-treated patients with a creatinine clearance of 30 to 60 mL/min had a greater incidence of discontinuation due to adverse reactions than patients with normal creatinine clearance. Adjust the daily dose of LYRICA for adult patients with reduced renal function (creatinine clearance ≤60 mL/min) and in those undergoing hemodialysis. Administer a supplemental dose of LYRICA immediately following every 4-hour hemodialysis treatment. The use of LYRICA in pediatric patients with compromised renal function has not been studied.
In standard, preclinical in vivo lifetime carcinogenicity studies of pregabalin, an unexpectedly high incidence of hemangiosarcoma was identified in 2 different strains of mice. The clinical significance of this finding is unknown. In clinical studies across various patient populations comprising 6396 patient-years of exposure in patients greater than 12 years of age, new or worsening preexisting tumors were reported in 57 patients.