Methemoglobinemia due to aryl amines or sulfa drugs may not resolve or may rebound after response to treatment with ProvayBlue
.
or if methemoglobinemia rebounds after a response consider additional treatment options.
to its active form. ProvayBlue
may not be effective in patients with G6PD deficiency.
Hemolytic Anemia
Hemolysis can occur during treatment of methemoglobinemia with ProvayBlue
®. Use the lowest effective number of doses of ProvayBlue
® to treat methemoglobinemia. Discontinue ProvayBlue
® and consider alternative treatments of methemoglobinemia if severe hemolysis occurs.
Treatment of patients with G6PD deficiency with ProvayBlue
® may result in severe hemolysis and severe anemia. ProvayBlue
® is contraindicated for use in patients with G6PD deficiency.
Interference with In Vivo Monitoring Devices
The presence of methylene blue in the blood may result in an underestimation of the oxygen saturation reading by pulse oximetry.
A fall in the Bispectral Index (BIS) has been reported following administration of methylene blue class products. If ProvayBlue® is administered during surgery, alternative methods for assessing the depth of anesthesia should be employed.
Effects on Ability to Drive and Operate Machinery
Treatment with ProvayBlue® may cause confusion, dizziness and disturbances in vision. Advise patients to refrain from driving or engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery until such adverse reactions to ProvayBlue® have resolved.
Interference with Laboratory Tests
ProvayBlue® is a blue dye which passes freely into the urine and may interfere with the interpretation of any urine test which relies on a blue indicator, such as the dipstick test for leucocyte esterase.
ADVERSE REACTIONS
The safety of ProvayBlue® was determined in 82 healthy adults 19-55 years of age, with a median age of 36 years. Each individual in the safety population received a single dose of ProvayBlue® 2 mg/kg intravenously.
The most commonly reported adverse reactions (≥10%) are pain in extremity, chromaturia, dysgeusia, feeling hot, dizziness, hyperhidrosis, nausea, skin discoloration and headache. There was one serious adverse reaction reported (syncope due to sinus pauses of 3-14 seconds).
Other adverse reactions reported to occur following administration of methylene blue class products include, but are not limited to, the following: hemolytic anemia, hemolysis, hyperbilirubinemia, methemoglobinemia; palpitations, tachycardia; eye pruritus, ocular hyperemia, vision blurred; abdominal pain lower, dry mouth, flatulence, glossodynia, tongue eruption; death, infusion site extravasation, infusion site induration, infusion site pruritus, infusion site swelling, infusion site urticaria, peripheral swelling, thirst; elevated liver enzymes; myalgia; dysuria; nasal congestion, oropharyngeal pain, rhinorrhea, sneezing; necrotic ulcer, papule, phototoxicity; and hypertension.
USE IN SPECIFIC POPULATIONS
Pregnancy and Lactation
ProvayBlue® may cause fetal harm when administered to a pregnant woman. Intra-amniotic injection of pregnant women with a methylene blue class product during the second trimester was associated with neonatal intestinal atresia and fetal death. Advise pregnant women of the potential risk to the fetus.
There is no information regarding the presence of methylene blue in human milk. Because of the potential for serious adverse reactions, including genotoxicity discontinue breast-feeding during and for up to 8 days after treatment with ProvayBlue®.
Renal Impairment
Methylene blue concentrations increased in subjects with renal impairment (eGFR 15 to 89 mL/min/1.73 m2). Adjust ProvayBlue® dosage in patients with moderate or severe renal impairment (eGFR 15 to 59 mL/min/1.73 m2). No dose adjustment is recommended in patients with mild renal impairment.
Hepatic Impairment
Methylene blue is extensively metabolized in the liver. Monitor patients with any hepatic impairment for toxicities and potential drug interactions for an extended period of time following treatment with ProvayBlue®.
OVERDOSAGE
In case of overdose of ProvayBlue®, maintain the patient under observation until signs and symptoms have resolved, monitor for cardiopulmonary, hematologic and neurologic toxicities, and institute supportive measures.
For additional safety information, including BOXED WARNING, please see Full Prescribing Information.
You are encouraged to report Adverse Drug Events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.
REF-0131 12/2021