A PHYSICALLY ACTIVE PATIENT
At age 52, he needs to do physically demanding work—so he must break the
frustrating cycle of failing patches
Construction job is 50 hours a week
He's used to working through pain at work, but now he needs relief from PHN that hurts when he moves—pain that gets much worse at work in hot weather.
Other patches let him down
OTC 4% patches didn't work (even with the maximum number of patches), and prescription 5% patches didn't adhere (peeling with every move).
Osteoarthritis in the left knee was diagnosed 2 years ago
First shingles outbreak 3 weeks ago
PHN (right upper back) diagnosed 1 week ago
Rated pain as significant; disrupting normal daily function and sleep
His OTC NSAIDs for osteoarthritis did not work for PHN
Tried OTC lidocaine patches, but they did not help either
His physician prescribed Lidoderm® 5% patches, which provided pain relief after 2 days at home—but would detach at work when he sweats, even with tape
Tried Tegaderm™ instead of tape; became too expensive
Disappointed, inconvenienced, and over-expensed by OTC and prescription patches
Wants a therapy that directly targets the site of pain
Needs a lidocaine patch he can trust to move with him and stay with him
WHO IS ON MULTIMODAL THERAPY
At age 48, she needs pain relief that works around her comorbidities and safety concerns
Complicating a complex case
She already struggles with several issues and a delicate balance of medications—and intense PHN on her mid-back adds to her burden.
Will not take opioids for pain
As a school bus driver, she's worried about any medications that would impair her work—and she's particularly scared by stories about opioid addiction.
Hypertensive (hydrochlorothiazide 50 mg/day)
GERD (omeprazole 20 mg/day)
Type 2 diabetes (metformin 500 mg, BID)
After a stressful period of family problems, she was diagnosed with shingles
Once the rash resolved, diagnosed with PHN after several months of pain (mid-left back area)
Also experiencing allodynia and hyperalgesia
Persistent pain between 4 and 8 (on 11-point scale); worsens with work-related movement
Her physician put her on multimodal treatment: prescription lidocaine patch 5% while titrating oral gabapentin
Gabapentin 300 mg TID provided partial relief; 600 mg TID provided relief but made her drowsy (pill burden had also become significant)
Lidocaine 5% patch also ineffective (even with 2 patches for 12 hours); wouldn't stay adhered over the pain site
Is interested in going back to lower dose of gabapentin with a different lidocaine patch
WHO HAS AGE-RELATED CONSIDERATIONS
At age 75, she wants a patch that keeps up with her and balances safety and efficacy
She works hard to stay independent
Elle struggles with her weight, but stays active with exercise classes despite various health issues. PHN makes it difficult to confidently manage her health—especially as intense pain affects her routine.
Her conditions complicate treatment
She lives with high blood pressure and hyperlipidemia, and she is also a breast cancer survivor. She also takes several medications, such as metoprolol, lisinopril, and tamoxifen.
Despite being vaccinated (live vaccine) at age 65, acute herpes zoster reactivated recently after she went through chemotherapy for breast cancer
Had rash (resolved in 4 weeks) and persistent PHN in mid-thoracic area
Experienced severe symptoms of prodromal syndrome
Stopped gabapentin after 16 days due to peripheral edema (bilateral lower extremity)
Pregabalin worked, but she discontinued due to dizziness and somnolence
Frustrated by the prescription lidocaine patches (5%) that her physician recommended, as they came loose during normal daily movement (and in exercise class)
Cannot use tape on her sensitive, frail skin—which is also sensitive to the cold, clammy feeling of patches
Increasingly frustrated with demands of PHN, after weeks of titrating anti-epileptics, which ended in treatment failure
Important Safety Information
ZTLIDO is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.
Warnings and Precautions
Accidental exposure can occur even after a ZTLIDO patch has been used. Small children or pets could suffer serious adverse effects from chewing or ingesting a new or used ZTLIDO patch. Store and dispose of patches properly and keep out of reach of children and pets.
Excessive dosing or overexposure to lidocaine can occur. Longer duration of application, application of more than the recommended number of patches, smaller patients, or impaired elimination may all contribute to increased blood concentration levels of lidocaine. If lidocaine overdose is suspected, check drug blood concentration. Management of overdose includes close monitoring, supportive care, and symptomatic treatment.
Cases of methemoglobinemia have been reported with local anesthetic use, although patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, or concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. Signs and symptoms include cyanotic skin discoloration and/or abnormal coloration of the blood and may occur immediately or may be delayed after exposure. Methemoglobin levels may continue to rise leading to more serious central nervous system and cardiovascular adverse effects. Discontinue ZTLIDO and any other oxidizing agents. Depending on severity of the symptoms, patients may respond to supportive care or may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.
Application site reactions can occur during or immediately after treatment with ZTLIDO. This may include development of blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours. Inform patients of these potential reactions and that severe skin irritation may occur with ZTLIDO if applied for a longer period than instructed.
Hypersensitivity cross-reactions may be possible for patients allergic to PABA derivatives. Manage hypersensitivity reactions by conventional means.
Eye exposure with ZTLIDO should be avoided. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye (eg, eye glasses/eye wear) until sensation returns.
Side effects of ZTLIDO include application site reactions such as, irritation, erythema, and pruritus. These are not all of the adverse reactions that may occur. Please see full Prescribing Information for more information.
Use in Specific Populations
Use of ZTLIDO during lactation should be used with caution as lidocaine is excreted into breast milk. The limited human data with lidocaine in pregnant women are not sufficient to inform drug-associated risk for major birth defects and miscarriage.
To report SUSPECTED ADVERSE REACTIONS, contact SCILEX Pharmaceuticals Inc. at 1-866-SCILEX3 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
Important Safety Information
ZTLIDO is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.Read More