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Questions often asked about SYNERA®

What is SYNERA®?

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 EMLA®.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®.4

What does SYNERA® look like?

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.

How big is the SYNERA® patch?

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.

How does SYNERA® work?

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

Is SYNERA® effective?

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

How does SYNERA® compare to other topical numbing creams like EMLA®?

SYNERA® works at least twice as fast and is more convenient to use than EMLA®.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®, and at 30 minutes, 95% of subjects reported no pain with SYNERA® vs 65% with EMLA®.3 SYNERA® is more convenient to use–it takes just 20-30 minutes to work vs at least 1 hour for EMLA®.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.

How long does it take SYNERA® to work?

Once applied, SYNERA® takes just 20-30 minutes to work.1

How is SYNERA® applied?

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.

Will it hurt to apply or take off the SYNERA® patch?

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.

What happens once the SYNERA® patch is removed?

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.

What side effects are associated with SYNERA®?

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.

How is SYNERA® available?

SYNERA® topical patch is available in cartons of 10. Each carton contains 10 individually packaged SYNERA® patches.

How can I purchase SYNERA® for use in my practice?

SYNERA® is available through most major wholesalers. For your ordering convenience, SYNERA® is available as the following:

  • NDC10885-002-10 box of 10 individually packaged SYNERA® patches

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.

Can I write a prescription for SYNERA® for my patients?

Yes, but SYNERA® is not widely available in retail pharmacies. For that reason, Galen has set up SNAP, the SYNERA® NOW Access Program. The special pharmacy coordinators at SNAP 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 SNAP enrollment forms that can be downloaded.

Is SYNERA® reimbursable if used in my practice?

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.

Is SYNERA® covered by insurance?

Yes. SYNERA® currently has national coverage on major managed care plans including:

  • Aetna
  • Cigna
  • Express Scripts
  • Humana
  • Medical Mutual

Specific coverage details will need to be verified with each insurance plan. Call the SYNERA® NOW Access Program customer service line at 1-844-GALENRX (1-844-425-3679) to discuss specific insurance plan coverage.

Is SYNERA® covered by Medicaid and Medicare?

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.

Where can I get more information about SYNERA®?

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 medicalinformation@synera.com

SYNERA® works at least twice as fast and is more convenient to use than EMLA®.1,2,3

View Study Results

SYNERA(R) Patch

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

References

  1. SYNERA® Prescribing Information. Galen US Inc., Souderton, PA; March 2014.
  2. EMLA® Cream 5% Prescribing Information. Akorn Inc., Lake Forest, IL; April 2012.
  3. Sawyer J, Febbraro S, Masud S, Ashburn MA, Campbell JC. Heated lidocaine/tetracaine patch (SYNERA®, Rapydan) compared with lidocaine/prilocaine cream (EMLA) for topical anaesthesia before vascular access. Br J Anaesth. 2009;102(2):210-215.
  4. Wallace MS, Kopecky EA, Ma T, Brophy F, Campbell JC. Evaluation of the depth and duration of anesthesia from heated lidocaine/tetracaine (SYNERA®) patches compared with placebo patches applied to healthy adult volunteers. Reg Anesth Pain Med. 2010;35(6):507-513.
  5. Sethna NF, Verghese ST, Hannallah RS, Solodiuk JC, Zurakowski D, Berde CB. A randomized controlled trial to evaluate S-Caine patch for reducing pain associated with vascular access in children. Anesthesiology. 2005;102(2):403-408.
  6. Masud S, Wasnich RD, Ruckle JL, et al. Contribution of a heating element to topical anesthesia patch efficacy prior to vascular access: results from two randomized, double-blind studies. J Pain Symptom Manage. 2010;40(4):510-519.
  7. Data on file. Galen US Inc. Souderton, PA; 2015.
  8. LMX4- lidocaine cream. DailyMed website. http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f0e7c92f-8b0b-4045-b659-af9f6e81260f. Updated June 2014. Accessed March 19, 2015.
  9. Miller KA, Balakrishnan G, Eichbauer G, Betley K. 1% lidocaine injection, EMLA cream, or “numby stuff” for topical analgesia associated with peripheral intravenous cannulation. AANA J. 2001;69(3):185-187.
  10. Page DE, Taylor DM. Vapocoolant spray vs subcutaneous lidocaine injection for reducing the pain of intravenous cannulation: a randomized, controlled, clinical trial. Br J Anaesth. 2010;105(4):519-525.
  11. Manabat ER, Pujol LA, Hunt P, Wang D. Judging pain sensitivity with subcutaneous lidocaine injections. Pain Med. 2011;12(4):668-672.
  12. Why use Gebauer’s Pain Ease for emergency procedures [patient brochure]. Cleveland, OH: Gebauer Company; 2008. http://cdn2.hubspot.net/hubfs/150313/docs/Pain_Ease/PE_Frequently_Asked_Questions.pdf. Accessed October 19, 2015.
  13. Gebauer’s Ethyl Chloride [package insert]. Gebauer Company. http://cdn2.hubspot.net/hubfs/150313/docs/Ethyl_Chloride/Application/EC_English_IFU.pdf. Accessed October 19, 2015.
  14. Benefits of J-Tip Needle-Free Injection System. J-Tip Needle-Free Injection System website. http://www.jtip.com/index.html#2. Accessed March 19, 2015.
  15. FAQ. J-TIP Needle-Free Injection System website. http://www.jtip.com/faq.html. Accessed March 19, 2015.

Indication

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).

Important Safety Information

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.

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.

SYNERA® should be used with caution in patients with a history of methemoglobinemia (refer to Full Prescribing Information).

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 or 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®.