Dosage and Administration

• Ensure patent venous access prior to administration of PROVAYBLUE®. Do not administer PROVAYBLUE® subcutaneously.
• Monitor vital signs, electrocardiogram and methemoglobin levels during treatment with PROVAYBLUE® and through resolution of methemoglobinemia.
• Administer PROVAYBLUE® 1 mg/kg intravenously over 5-30 minutes.
• If the methemoglobin level remains greater than 30% or if clinical signs and symptoms persist, a repeat dose of PROVAYBLUE® 1 mg/kg may be given one hour after the first dose.
• If methemoglobinemia does not resolve after 2 doses of PROVAYBLUE®, consider initiating alternative interventions for treatment of methemoglobinemia.

Recommended Dosage for Renal Impairment

• The recommended dosage of PROVAYBLUE® in patients with moderate or severe renal impairment (eGFR 15-59 mL/min/1.73 m2) is a single dose of 1 mg/kg.
• If the methemoglobin level remains greater than 30% or if the clinical symptoms persist 1 hour after dosing, consider initiating alternative interventions for the treatment of methemoglobinemia.

Preparation and Storage

Each mL of PROVAYBLUE ® contains 5 mg methylene blue.

Each 10 mL ampule and vial of PROVAYBLUE ® contains 50 mg methylene blue. Each 2 mL ampule and vial of PROVAYBLUE® contains 10 mg methylene blue.

PROVAYBLUE ® is hypotonic and may be diluted before use in a solution of 50 mL 5% Dextrose Injection in order to avoid local pain, particularly in the pediatric population. Use the diluted solution immediately after preparation.

Avoid diluting with sodium chloride solutions, because it has been demonstrated that chloride reduces the solubility of methylene blue.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Keep the ampule and the vial in the original package to protect from light.

Discard unused portion.