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SYNERA® is a technological advance to help prevent needle-stick pain in patients. SYNERA® combines two commonly used local anesthetic agents (lidocaine and tetracaine) with warming technology in a simple-to-use peel-and-stick patch to reduce pain associated with certain procedures that require a needle stick. SYNERA® works at least twice as fast and is more convenient to use than lidocaine 2.5%/prilocaine 2.5% cream (formerly EMLA® Cream).1,2,3 The unique warming technology in SYNERA® has been proven to enhance the anesthetic effect with a depth of anesthesia of almost 7 mm at 30 minutes, increasing to greater than 8 mm even after patch removal, greater than has been shown in separate published studies with EMLA® (lidocaine 2.5%/prilocaine 2.5% cream).4
SYNERA® is an oval-shaped patch that is similar in appearance to an adhesive bandage. Around the edges of the patch, you will see the following words printed into the patch: SYNERA®, LIDOCAINE and TETRACAINE. The center of the SYNERA® patch is raised slightly and has 6 small holes. This is the area where the medications and gentle warming pod are located.
The SYNERA® topical patch is oval-shaped and is approximately 3-1/4 inches wide and 2-3/8 inches tall. The total surface of the SYNERA® patch is 50 cm2. Only 10 cm2 contains the active medications.
Once removed from the pouch and exposed to air, the advanced, yet gentle, warming technology begins and SYNERA® starts warming. When applied, SYNERA® increases skin temperature by up to approximately 5°C/9°F to enhance the anesthetic effect by promoting faster dermal absorption of lidocaine and tetracaine.1 The maximum skin temperature will not exceed 40°C/104°F.1
SYNERA® is proven to help prevent needle-stick pain with effective local analgesia within 20 to 30 minutes.1 In a randomized, double-blind, placebo-controlled crossover study conducted among 24 healthy volunteers, SYNERA® produced local analgesia to a depth of almost 7 mm after 30 minutes.4 The analgesia continued to deepen for an additional hour after the patch was removed to a depth of >8 mm (8.2 mm).4 The mean pain depth (depth at which pain was first felt) was significantly deeper for SYNERA® than for a placebo patch at each time point.4
SYNERA® is proven to help prevent needle-stick pain in children.5 In a randomized trial in patients aged 3 to 17 years, 59% of patients reported no pain upon venipuncture vs placebo.1,5 SYNERA® was proven safe and effective in children as young as 3 years of age.5 Safe use of SYNERA® in infants 4 to 6 months of age was documented in one study.1
SYNERA® works at least twice as fast and is more convenient to use than lidocaine 2.5%/prilocaine 2.5% cream (formerly EMLA® Cream).1,2,3 In a study of adults, significantly more subjects reported no pain with SYNERA® after 20 and 30 minutes.3 At just 20 minutes, 90% of subjects reported no pain with SYNERA® vs 60% with EMLA® (lidocaine 2.5%/prilocaine 2.5% cream) and at 30 minutes, 95% of subjects reported no pain with SYNERA® vs 65% with EMLA® (lidocaine 2.5%/prilocaine 2.5% cream).3 SYNERA® is more convenient to use—it takes just 20-30 minutes to work vs at least 1 hour for lidocaine 2.5%/prilocaine 2.5% cream (formerly EMLA® Cream).1,2 The quick and simple-to-use peel-and-stick SYNERA® patch also does not require the use of additional wraps to cover the site, making it easier and more comfortable for caregivers, patients, and parents.
Once applied, SYNERA® takes just 20-30 minutes to work.1
SYNERA® has a simple peel-and-stick application. Just open the pouch and remove the SYNERA® patch. As soon as it is exposed to oxygen, the gentle warming technology activates. Remove the backing from the SYNERA® patch and apply SYNERA® to the area directly over the vein to be accessed. The patient will experience a warm sensation in the area in which the patch is located. Remove the patch immediately if irritation or a burning sensation occurs. Leave patch in place for 20-30 minutes, then peel the patch off the skin and properly dispose of it away from pets and children prior to the procedure. Wash your hands thoroughly after handling SYNERA®. Always remove the SYNERA® patch prior to venipuncture or intravenous cannulation.
SYNERA® should not be much different from applying or removing an adhesive bandage. Remove the patch immediately if irritation or a burning sensation occurs. SYNERA® should only be applied to intact skin.
In a clinical study, SYNERA® produced local dermal analgesia to a depth of almost 7 mm.4 After removal of the patch, the analgesia continued to deepen for an additional hour to a depth of >8 mm.4 Gradually the normal feeling will return but patients should avoid any trauma (rubbing, scratching, or exposure to heat or cold) before complete feeling returns to the area. Used SYNERA® patches contain a large amount of lidocaine and tetracaine. Chewing or swallowing a new or used SYNERA® patch may result in serious adverse effects. Store and dispose of SYNERA® out of the reach of children and pets.
In clinical studies of 1449 subjects who were given SYNERA®, the most common local reactions were erythema (71%), blanching (12%) and edema (12%); these reactions were generally mild and went away on their own soon after patch removal. There were no treatment-related serious adverse events.
SYNERA® topical patch is available in cartons of 10. Each carton contains 10 individually packaged SYNERA® patches.
SYNERA® is available through most major wholesalers. For your ordering convenience, SYNERA® is available as the following:
You can also buy SYNERA® directly from Galen.
To set up an account and place an order for SYNERA®, call Galen Customer Service at 877‑900‑7358 Monday — Friday 9:00 AM — 5:00 PM CT.
Yes, but SYNERA® is not widely available in retail pharmacies. For that reason, Galen has set up the Galen Access Program. The patient advocates can help patients with insurance questions, fill your prescription, and ship SYNERA® directly to your patient’s home. See the ‘Ordering and Prescribing’ tab on this website for more information and the required enrollment forms that can be downloaded.
Yes, SYNERA® is reimbursable.
When billing for SYNERA® in the physician’s office (non-hospital use) the miscellaneous J-code, J3490 Unclassified drugs should be used on the CMS 1500 form.
Please note… For proper reimbursement, please be sure to enter the correct NDC number as it appears on the actual package used.
Yes. SYNERA® currently has national coverage on major managed care plans including:
Specific coverage details will need to be verified with each insurance plan. Call the Galen Access Program customer service line at 1-844-GALENRX (1-844-425-3679) to discuss specific insurance plan coverage.
Yes. State Medicaid coverage may be controlled or restricted by the use of prior authorization. As such, Medicaid coverage will vary from state to state. Galen participates in the Medicare Part D Coverage Gap Program. Reimbursement will vary from plan to plan with each plan making the determination to cover with or without restrictions.
If you have any medical questions about SYNERA® or using SYNERA®, please call 877‑900‑7358 Monday — Friday 9:00 AM — 5:00 PM CT. You can also e-mail firstname.lastname@example.org
EMLA® is a registered trademark of Abraxis Bioscience, Inc.
SYNERA® works at least twice as fast and is more convenient to use than lidocaine 2.5%/prilocaine 2.5% cream (formerly EMLA® Cream).1,2,3
In clinical studies involving 1,449 subjects treated with SYNERA®, the most common local reactions were redness of the skin (71%), pale skin (12%) and swelling (12%); these reactions were generally mild and resolved on their own soon after patch removal. There were no treatment related serious adverse events.1
SYNERA® (lidocaine and tetracaine) Topical Patch is indicated for use on intact skin to provide local dermal analgesia for superficial venous access (apply for 20-30 mins) and superficial dermatological procedures (apply for 30 mins).
SYNERA® is contraindicated in patients with a known history of sensitivity to lidocaine, tetracaine, local anesthetics of the amide or ester type, or any other component of the product and in patients with para-aminobenzoic acid (PABA) hypersensitivity.
Keeping a patch on longer than recommended or applying multiple patches simultaneously or sequentially could result in systemic absorption sufficient to result in serious adverse effects that are typical of drugs in this class.
Patients should not use SYNERA® if they have a history of methemoglobinemia. If SYNERA® must be used in patients who are more susceptible to developing the condition, they should be closely monitored for signs and symptoms, which may occur immediately or may be delayed some hours, and must be treated immediately. SYNERA® and any other oxidizing agents should be discontinued.
Used SYNERA® patches contain a large amount of lidocaine and tetracaine (at least 90% of the initial amount). Chewing or ingesting a new or used SYNERA® patch may result in serious adverse effects. Store and dispose of SYNERA® out of the reach of children and pets.
SYNERA® should be used with caution in patients who may be more sensitive to the systemic effects of lidocaine and tetracaine, particularly the acutely ill, the debilitated, and those with compromised hepatic function. Patients with severe hepatic disease or pseudocholinesterase deficiency are at greater risk of developing toxic plasma concentrations.
Do not use on mucous membranes or on areas with a compromised skin barrier. Application to broken or inflamed skin may result in toxic blood concentrations of lidocaine and tetracaine.
Allergic or anaphylactoid reactions (urticaria, angioedema, bronchospasm, and shock) to the active or inactive components of SYNERA® can occur and should be managed by conventional means.
Avoid contact of SYNERA® with the eyes due to potential irritation or abrasion. If contact occurs, immediately wash out the eye with water or saline, and protect it until sensation returns.
Safety and effectiveness of SYNERA® have been established in patients 3 years and older.
Simultaneous or sequential application of more than two SYNERA® patches to children is not recommended as it has not been adequately studied.
Lidocaine has been shown to inhibit viral and bacterial growth. The effect of SYNERA® on intradermal injections of live vaccines has not been determined.
The heating component contains iron powder, and the patch must be removed before magnetic resonance imaging.
SYNERA® may lead to diminished or blocked sensation in the treated skin; therefore, patients should avoid inadvertent trauma (rubbing, scratching, or exposure to heat or cold) before complete sensation returns.
SYNERA® should be used with caution in patients receiving class 1 antiarrhythmics and/or other local anesthetics, because the systemic toxic effects may be additive and potentially synergistic with lidocaine and tetracaine.
In clinical studies, the most common local reactions were erythema (71%), blanching (12%), and edema (12%); these reactions were generally mild, resolving spontaneously soon after patch removal.
Do not cut or remove the top cover of the patch as this could result in thermal injury.
Please refer to Full Prescribing Information including Instructions For Use before prescribing SYNERA®.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.