LYRICA is indicated for the management of Fibromyalgia, neuropathic pain associated with Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, and as adjunctive therapy for adults with Partial Onset Seizures.
LYRICA is contraindicated in patients with known hypersensitivity to pregabalin or any of its components.
The most common adverse reactions occurring during Fibromyalgia and/or other controlled clinical trials for patients taking LYRICA vs those taking a placebo were dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, constipation, euphoric mood, balance disorder, increased appetite, and thinking abnormal (primarily difficulty with concentration/attention).
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. LYRICA should be discontinued immediately in patients with these symptoms.
There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with LYRICA. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. LYRICA should be discontinued immediately in patients with these symptoms.
Patients taking LYRICA should be counseled that dizziness and somnolence may impair their ability to perform potentially hazardous tasks such as driving or operating complex machinery until they have sufficient experience with LYRICA to determine its effect on cognitive and motor function.
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. More frequent assessment should be considered for patients who are already routinely monitored for ocular conditions.
Higher frequency of weight gain and edema was observed in patients taking both LYRICA and thiazolidinedione antidiabetic drugs. Caution should be exercised when coadministering these drugs.
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. LYRICA should be used with caution in patients who have had a previous episode of angioedema.
LYRICA may exacerbate the effects of oxycodone, lorazepam, or ethanol on cognitive and gross motor functioning.
In controlled clinical studies of LYRICA in Fibromyalgia, 106 patients were 65 years of age or older. Although the adverse reaction profile was similar between the 2 age groups, the following neurological adverse reactions were more frequent in patients 65 years of age or older: dizziness, vision blurred, balance disorder, tremor, confusional state, coordination abnormal, and lethargy.
In standard, preclinical in vivo lifetime carcinogenicity studies of LYRICA, an unexpectedly high incidence of hemangiosarcoma was identified in 2 different strains of mice. The clinical significance of this finding is unknown. Clinical experience during LYRICA's premarketing development provides no direct means to assess its potential for inducing tumors in humans.
In clinical studies across various patient populations comprising 6396 patient-years of exposure in patients >12 years of age, new or worsening preexisting 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 whether the incidence seen in these cohorts is or is not affected by treatment.
A dose-dependent increase in the incidence of hemangiosarcomas was observed in 2 strains of mice given LYRICA for 2 years. Plasma LYRICA exposure (AUC) in mice receiving the lowest dose that increased hemangiosarcomas was approximately equal to the human exposure of 600 mg/day. A no-effect dose for induction of hemangiosarcomas in mice was not established. No evidence of carcinogenicity was seen in 2 studies in Wistar rats following dietary administration of LYRICA for 2 years at doses that were associated with plasma exposures up to 24 times human exposure.
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.
LYRICA should be discontinued gradually over a minimum of 1 week.
As with all antiepileptic drugs (AEDs), if LYRICA is discontinued it should be withdrawn gradually over a minimum of 1 week to lessen the potential of increased seizure frequency in patients with seizure disorders.
Patients with a history of drug or alcohol abuse may have a higher chance of misuse or abuse of LYRICA.
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