Treatment with PROVAYBLUE ® may cause confusion, dizziness and disturbances in vision [see Adverse Reactions ( 6)] . 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.
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.
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Serotonin Syndrome with Concomitant Use of Serotonergic Drugs [see Warnings and Precautions ( 5.1)]
- Anaphylaxis [see Warnings and Precautions ( 5.2)]
- Lack of Effectiveness [see Warnings and Precautions ( 5.3)]
- Hemolytic Anemia [see Warnings and Precautions ( 5.4)]
- Interference with In-Vivo Monitoring Devices [see Warnings and Precautions ( 5.5)]
- Effects on Ability to Drive and Operate Machinery [see Warnings and Precautions ( 5.6)]
- Interference with Laboratory Tests [see Warnings and Precautions ( 5.7)]
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of PROVAYBLUE ® was determined in 82 healthy adults of median age of 36 years (range, 19-55 years); 54% were male, and 68% were white. Each individual in the safety population received a single dose of PROVAYBLUE ® 2 mg/kg intravenously. There was one serious adverse reaction reported (syncope due to sinus pauses of 3-14 seconds). The most common (≥2%) moderate or severe adverse reactions were pain in the extremity (56%), headache (7%), feeling hot (6%), syncope (4%), back pain (2%), hyperhidrosis (2%) and nausea (2%). Table 1 lists the adverse reactions of any severity that occurred in at least 2% of individuals who received PROVAYBLUE ®.
|Adverse Reaction||Any Grade TEAE (n=82)||Moderate- Severe TEAE (n=82)|
|Pain in extremity||69||84%||46||56%|
|Infusion site pain||5||6%||1||1%|
|Influenza like illness||3||4%||1||1%|
|Infusion site discomfort||2||2%||0|
|Catheter site pain||2||2%||0|
Other adverse reactions reported to occur following administration of methylene blue class products include the following:
Blood and lymphatic system disorders: hemolytic anemia, hemolysis, hyperbilirubinemia, methemoglobinemia
Cardiac disorders: palpitations, tachycardia
Eye disorders: eye pruritus, ocular hyperemia, vision blurred
Gastrointestinal disorders: abdominal pain lower, dry mouth, flatulence, glossodynia, tongue eruption
General disorders and administration site conditions: death, infusion site extravasation, infusion site induration, infusion site pruritus, infusion site swelling, infusion site urticaria, peripheral swelling, thirst
Investigations: elevated liver enzymes
Musculoskeletal and connective tissue disorders: myalgia
Renal and urinary disorders: dysuria
Respiratory, thoracic and mediastinal disorders: nasal congestion, oropharyngeal pain, rhinorrhea, sneezing
Skin and subcutaneous tissue disorders: necrotic ulcer, papule, phototoxicity
Vascular disorders: hypertension
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