Provayblue

Last updated on RxList: 6/11/2021
Provayblue Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Provayblue?

Provayblue (methylene blue) injection is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.

What Are Side Effects of Provayblue?

Common side effects of Provayblue include:

  • pain in extremities
  • changes in urine color
  • changes in taste
  • feeling hot
  • dizziness
  • sweating
  • nausea
  • skin
  • discoloration, and
  • headache

Dosage for Provayblue

Provayblue is administered in a dose of 1 mg/kg intravenously over 5-30 minutes.

What Drugs, Substances, or Supplements Interact with Provayblue?

Provayblue may interact with SSRIs (selective serotonin reuptake inhibitors), MAO inhibitors, bupropion, buspirone, clomipramine, mirtazapine, venlafaxine, digoxin, warfarin, phenytoin, alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Tell your doctor all medications and supplements you use.

Provayblue During Pregnancy or Breastfeeding

During pregnancy, Provayblue should be used only if prescribed; it may harm a fetus. It is unknown if Provayblue passes into breast milk or if it would affect a nursing infant. Provayblue is not recommended for use while breastfeeding, and nursing mothers should discontinue breastfeeding for up to 8 days after treatment.

Additional Information

Our Provayblue (methylene blue) injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

What is hemophilia? See Answer
Provayblue Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have:

  • confusion or weakness;
  • pale or yellowed skin;
  • dark colored urine;
  • fever; or
  • high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Common side effects may include:

  • pain in your arms or legs;
  • blue or green urine;
  • altered sense of taste;
  • headache, dizziness;
  • sweating, skin discoloration;
  • nausea; or
  • feeling hot.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Provayblue (Methylene Blue for Intravenous Administration)

SLIDESHOW

Anemia Symptoms and Signs, Types, Treatment and Causes See Slideshow
Provayblue Professional Information

SIDE EFFECTS

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]
  • Anaphylaxis [see WARNINGS AND PRECAUTIONS]
  • Lack of Effectiveness [see WARNINGS AND PRECAUTIONS]
  • Hemolytic Anemia [see WARNINGS AND PRECAUTIONS]
  • Interference with In-Vivo Monitoring Devices [see WARNINGS AND PRECAUTIONS]
  • Effects on Ability to Drive and Operate Machinery [see WARNINGS AND PRECAUTIONS]
  • Interference with Laboratory Tests [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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®.

Table 1: Adverse Reactions Following Infusion of PROVAYBLUE® 2 mg/kg

Adverse Reaction Any Grade TEAE
(n=82)
Moderate-Severe TEAE
(n=82)
Pain in extremity 69 84% 46 56%
Chromaturia 61 74% 0
Dysgeusia 16 20% 1 1%
Feeling hot 14 17% 5 6%
Dizziness 13 16% 4 5%
Hyperhidrosis 11 13% 2 2%
Nausea 11 13% 2 2%
Skin discoloration 11 13% 0
Headache 8 10% 6 7%
Musculoskeletal pain 7 9% 0
Paresthesia oral 7 9% 0
Paresthesia 7 9% 0
Infusion site pain 5 6% 1 1%
Feeling cold 5 6% 0
Pallor 4 5% 0
Dermatitis contact 4 5% 0
Syncope 3 4% 3 4%
Influenza like illness 3 4% 1 1%
Pruritus 3 4% 1 1%
Anxiety 3 4% 0
Decreased appetite 3 4% 0
Chest discomfort 3 4% 0
Back pain 2 2% 2 2%
Cold sweat 2 2% 1 1%
Dizziness postural 2 2% 1 1%
Muscle spasms 2 2% 1 1%
Presyncope 2 2% 1 1%
Vomiting 2 2% 1 1%
Arthralgia 2 2% 1 1%
Chills 2 2% 0
Diarrhea 2 2% 0
Discomfort 2 2% 0
Dyspnea 2 2% 0
Erythema 2 2% 0
Hypoesthesia oral 2 2% 0
Infusion site discomfort 2 2% 0
Limb discomfort 2 2% 0
Oral discomfort 2 2% 0
Catheter site pain 2 2% 0
Ecchymosis 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

DRUG INTERACTIONS

Serotonergic Drugs

Avoid concomitant use of PROVAYBLUE®with medicinal products that enhance serotonergic transmission including SSRIs (selective serotonin reuptake inhibitors), MAO inhibitors, bupropion, buspirone, clomipramine, mirtazapine and venlafaxine; because of the potential for serious CNS reactions, including potentially fatal serotonin syndrome. Although the mechanism is not clearly understood, literature reports suggest inhibition of MAO by methylene blue may be involved. If the intravenous use of PROVAYBLUE® cannot be avoided in patients treated with serotonergic medicinal products, choose the lowest possible dose and observe closely the patient for CNS effects for up to 4 hours after administration [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Provayblue (Methylene Blue for Intravenous Administration)

© Provayblue Patient Information is supplied by Cerner Multum, Inc. and Provayblue Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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