FDA Approves Zingo
The U.S. Food and Drug Administration (FDA) has approved Zingo (lidocaine hydrochloride monohydrate) powder intradermal injection system, which provides rapid, topical, local analgesia to reduce the pain associated with venous access procedures, such as IV insertions or blood draws, in children three to 18 years of age.
Zingo is a ready-to-use, easy-to-administer, single-use, needle-free system that delivers sterile lidocaine powder into the epidermis of the skin. Zingo provides topical local analgesia in one to three minutes after administration allowing uninterrupted care during intravenous line placement or venipuncture procedures.
Guidelines and recommendations from the American Academy of Pediatrics, the American Pain Society and the Infusion Nurses Society all call for the use of topical anesthetics prior to venous access procedures.
Venous access procedures, like IV insertions and blood draws, are among the most common interventions performed at a hospital, with more than 18 million pediatric venous access procedures and 400 million total procedures per year in the U.S. Needlesticks are also a source of deep anxiety. An Impulse Research survey conducted last year by Anesiva found that 70 percent of children experience fear and stress during a visit to the doctor or hospital that involves a needlestick procedure, and more than half of all children -- even those older than seven -- cry during these procedures. The problem is compounded in children with chronic illnesses who must undergo frequent IV insertions.
Data from two pivotal, placebo-controlled, Phase 3 clinical studies, which collectively enrolled 1,109 patients across 15 U.S. clinical centers, demonstrated that Zingo provided statistically significant pain relief in children ages three to 18 undergoing venous access procedures, such as IV line placements. These data indicated that treatment with Zingo quickly and effectively reduced pain when given just one to three minutes prior to the venous access procedure. Zingo was well-tolerated. The most common adverse reactions were redness (erythema), red dots (petechiae) and swelling (edema) at the site of administration.
Highlights of Zingo Prescribing Information
(lidocaine hydrochloride monohydrate)
powder intradermal injection system
These highlights do not include all the information needed to use Zingo safely and effectively.
Zingo Indications and Usage
- Zingo is an amide local anesthetic indicated for use on intact skin to provide local analgesia prior to venipuncture or peripheral intravenous cannulation in children 3-18 years of age.
Important Limitations:
- For use on intact skin only
- For external use only
Zingo Dosage and Administration
- Apply one Zingo (0.5 mg lidocaine hydrochloride monohydrate) to the site planned for venipuncture or intravenous cannulation, one to three minutes prior to needle insertion.
- Perform the procedure within 10 minutes after Zingo administration.
- Use Zingo only on intact skin.
Dosage Forms and Strengths
Zingo is a sterile, single-use, powder intradermal injection system containing 0.5 mg lidocaine hydrochloride monohydrate.
Zingo utilizes a helium-powered delivery system.
Zingo Contraindications
Zingo is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type.
Zingo Warnings and Precautions
- Use on intact skin only
- Avoid contact with the eye
- Do not use if device is dropped or the pouch is damaged or torn
- Patients with bleeding tendencies or platelet disorders could have a higher risk of superficial dermal bleeding
Zingo Adverse Reactions
The most common adverse reactions (>5%) are skin reactions at the site of administration: erythema, petechiae, edema.
To report Suspected Adverse Reactions, contact Anesiva, Inc. at 1-650-624-9600 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Instructions for Use
- Prepare the Treatment Site and Device: Examine the treatment site to ensure that the skin is intact. Clean the site, according to standard practice. Visually inspect the pouch. Do not use if the pouch has been torn, or damaged or if the device has been dropped. Tear open the pouch using the notch provided. Remove Zingo from the pouch, being careful not to touch the purple outlet (open end) to avoid contamination.
- Position Zingo: Grip Zingo and place on the application site, with one hand, or with both hands. Ensure that the patient?s treatment site is supported to prevent movement. Seal the purple Zingo outlet against the patient?s skin. Hold the device perpendicular to the skin, making sure that your thumb can reach the green start button. Avoid gaps between the skin and the Zingo outlet as gaps will impede drug delivery.
- Release the Safety Interlock: Apply adequate downward pressure to release the safety interlock, while maintaining the seal between Zingo and the skin. Zingo is ready for administration when the green start button has moved into the upward position. Zingo cannot be actuated without releasing the internal safety interlock.
- Administer Zingo: While maintaining downward pressure, administer the dose by pressing the green start button. Do not move Zingo during administration. Actuation is accompanied by a "popping" sound, indicating that the dose has been discharged.
- Remove Zingo: Remove Zingo from the application site and dispose.
- Begin Procedure: Start the venipuncture or intravenous cannulation procedure 1?3 minutes after Zingo administration.
How Supplied / Storage and Handling
Zingo (lidocaine hydrochloride monohydrate) powder intradermal injection system contains 0.5 mg of sterile lidocaine hydrochloride monohydrate. Zingo is a singleuse device packaged in an individual foil/clear pouch placed inside a bubble-wrap sleeve. Twelve sleeves are placed in labeled cartons. Cartons are stored at controlled room temperature (15?30?C, 59?86?F).
Patient Counseling Information
Patients should be made aware that a sound similar to that of a popping balloon is emitted at the time Zingo is actuated. Patients should be informed that skin reactions including erythema, petechiae and edema may occur.
Manufactured for:
Anesiva, Inc.
South San Francisco, CA 94080
