IMPORTANT SAFETY INFORMATION AND INDICATION
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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 is contraindicated in patients with known hypersensitivity to pregabalin or any of its other components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy.
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. Discontinue LYRICA immediately in patients with these symptoms.
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 immediately in patients with these symptoms.
Antiepileptic drugs (AEDs), including LYRICA, 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 behavior or ideation 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.
There is evidence from case reports, human studies, and animal studies associating LYRICA with serious, life-threatening, or fatal respiratory depression when co-administered with central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. When the decision is made to co-prescribe LYRICA with another CNS depressant, particularly an opioid, or to prescribe LYRICA to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating LYRICA at a low dose.
There is more limited evidence from case reports, animal studies, and human studies associating LYRICA with serious respiratory depression, without co-administered CNS depressants or without underlying respiratory impairment.
The most common adverse reactions across all LYRICA clinical trials in adults 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). The most common adverse reactions in pediatric patients for the treatment of partial-onset seizures were somnolence, weight gain, and increased appetite.
Inform patients taking LYRICA 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. Consider more frequent assessment 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. Exercise caution 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. Exercise caution when using LYRICA in patients who have had a previous episode of angioedema.
Advise nursing mothers that breastfeeding is not recommended during treatment with LYRICA.
LYRICA may exacerbate the effects of oxycodone, lorazepam, or ethanol on cognitive and gross motor functioning.
Patients with a history of drug or alcohol abuse may have a higher chance of misuse or abuse of LYRICA.
As with all antiepileptic drugs (AEDs), withdraw LYRICA gradually over a minimum of 1 week to lessen the potential of increased seizure frequency in patients with seizure disorders.
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.
Following abrupt or rapid discontinuation of LYRICA, some patients reported symptoms including insomnia, nausea, headache, anxiety, hyperhidrosis, and diarrhea.
If LYRICA is discontinued, taper the drug gradually over a minimum of 1 week rather than discontinue the drug abruptly.
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. 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.
LYRICA is available in doses ranging from 25 mg to 300 mg and as a 20 mg/mL oral solution.
By participating in the LYRICA® (pregabalin) Savings Offer Program, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
- Patients are not eligible to use this Savings Offer if they are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs healthcare, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”)
- Patients must have private insurance. This Savings Offer is not valid for cash-paying patients. The value of this Savings Offer is limited to $250 per use or the amount of your co-pay, whichever is less
- This Savings Offer is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plans or other health or pharmacy benefit programs
- You must deduct the savings received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf
- You are responsible for reporting use of this Savings Offer to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using this Savings Offer, as may be required. You should not use this Savings Offer if your insurer or health plan prohibits use of manufacturer Savings Offers
- Eligible patients may pay a minimum of $4 per monthly prescription fill. By using this Savings Offer, eligible patients may receive a savings of up to $250 per fill off their co-pay or out-of-pocket costs. This Savings Offer is available for a maximum savings of $3000 per year ($250 per month x 12 months). This Savings Offer may limit your prescription cost to $4, subject to a $250 maximum monthly benefit. Thus, if your co-pay or out-of-pocket cost is more than $250, you will save $250 off of your co-pay or total out-of-pocket costs. [Example: If your co-pay or out-of-pocket costs are $275, you will pay $25 ($275 – $250 = $25).] If your co-pay or out-of-pocket costs are no more than $250, you pay $4. For a mail-order 3-month prescription, your total maximum savings may be $750 ($250 x 3)
- This Savings Offer is not valid (i) for Massachusetts residents or (ii) for California residents whose prescriptions are covered, in whole or in part, by third-party insurance
- This Savings Offer is not valid where prohibited by law
- This Savings Offer cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription
- This Savings Offer will be accepted only at participating pharmacies
- This Savings Offer is not health insurance
- This Savings Offer may not be redeemed more than once per 30 days per patient
- This Savings Offer is good only in the U.S. and Puerto Rico
- This Savings Offer is limited to 1 per person during this offering period and is not transferable
- No other purchase is necessary
- Data related to your redemption of this Savings Offer may be collected, analyzed, and shared with Viatris for market research and other purposes related to assessing Viatris' programs. Data shared with Viatris will be aggregated and de-identified; it will be combined with data related to other Savings Offer redemptions and will not identify you
-Viatris reserves the right to rescind, revoke, or amend the program without notice
-No membership fees. This Savings Offer and Program expire on 12/31/2023
-For further information, call 1-866-954-1475, visit LYRICA.com, or write: Viatris, P.O. Box 2941, Mission, KS 66201
If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this Savings Offer. Pay for your LYRICA prescription and mail copy of original pharmacy receipt (cash register receipt NOT valid) with product name, date, and amount circled to: LYRICA Savings Offer, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560. Be sure to include a copy of the front of your LYRICA Savings Card, your name, and mailing address. Please expect up to 4 to 6 weeks for reimbursement.