About Kovanaze®

deviceNasal Spray Utilizing Needle-Free Technology

  • Indication: KOVANAZE is indicated for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J in adults and children who weigh 40 kg or more.
  • Patients may not experience the same sensations of numbness or tingling of the lips and cheeks associated with injectable anesthetics.
  • Kovanaze provides regional anesthesia with 96% efficacy in teeth #5-12, 64% in #4 and #13*, therefore Kovanaze offers a needle-free alternative to the majority of anterior maxillary injections.

*In a Phase 3, randomized, double-blind study comparing the efficacy and safety of KOVANAZE to placebo for providing dental anesthesia sufficient to complete a dental procedure on a single maxillary tooth (#4-13) in adults, 150 patients received either KOVANAZE (n=100) or placebo (n=50) as a dose of two or three 0.2 mL intranasal sprays. Eighty-eight percent of KOVANAZE patients were able to complete the dental procedure without the need for rescue medication compared to 28% of patients who received placebo. KOVANAZE had a lower success rate (64%) for dental procedures on the 2nd pre-molar (teeth #4 and #13) compared with 96% for more anterior teeth (#5 through #12).

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Important Safety Information

IMPORTANT SAFETY INFORMATION: Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Use in patients with uncontrolled hypertension or inadequately controlled active thyroid disease of any type is not advised. Allergic or anaphylactic reactions can occur. If an allergic reaction occurs, seek emergency help immediately. KOVANAZE® is contraindicated in patients with a history of allergy to tetracaine, benzyl alcohol, other ester local anesthetics, p-aminobenzoic acid (PABA), oxymetazoline, or any other component of the product. Some clinical trial patients experienced an increase in blood pressure, so blood pressure should be monitored. In addition, patients should be carefully monitored for dysphagia. KOVANAZE® is not recommended for use in patients with a history of frequent nose bleeds. Concomitant use of monoamine oxidase inhibitors, nonselective beta adrenergic antagonist, or tricyclic antidepressants may cause hypertension and is not recommended. Discontinue use of oxymetazoline-containing products 24 hours prior to KOVANAZE® administration. Avoid concomitant use of intranasal products. The most common adverse reactions to KOVANAZE® occurring in >10% of patients include a runny nose, nasal congestion, nasal discomfort, sore throat, and watery eyes.

Click here for full Prescribing Information: Package Insert

IMPORTANT SAFETY INFORMATION: Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Use in patients with uncontrolled hypertension or inadequately controlled active thyroid disease of any type is not advised. Allergic or anaphylactic reactions can occur. If an allergic reaction occurs, seek emergency help immediately. KOVANAZE® is contraindicated in patients with a history of allergy to tetracaine, benzyl alcohol, other ester local anesthetics, p-aminobenzoic acid (PABA), oxymetazoline, or any other component of the product. Some clinical trial patients experienced an increase in blood pressure, so blood pressure should be monitored. In addition, patients should be carefully monitored for dysphagia. KOVANAZE® is not recommended for use in patients with a history of frequent nose bleeds. Concomitant use of monoamine oxidase inhibitors, nonselective beta adrenergic antagonist, or tricyclic antidepressants may cause hypertension and is not recommended. Discontinue use of oxymetazoline-containing products 24 hours prior to KOVANAZE® administration. Avoid concomitant use of intranasal products. The most common adverse reactions to KOVANAZE® occurring in >10% of patients include a runny nose, nasal congestion, nasal discomfort, sore throat, and watery eyes.

Click here for full Prescribing Information: Package Insert