Provayblue (injection)

Methemoglobin is a type of hemoglobin (HEEM o glo bin). Hemoglobin is a substance in blood that carries oxygen to your tissues and organs. However, methemoglobin does not help carry oxygen.

Methemoglobin usually exists in small amounts in the blood. But when methemoglobin levels rise, the blood becomes less effective at moving oxygen around. This lack of oxygen in the body can lead to symptoms like pale or blue-colored skin.

Methemoglobinemia is a condition where there are high levels of methemoglobin in the blood. Methemoglobinemia can happen when a person is exposed to certain drugs or chemicals, such as nitrites.

Provayblue is used to treat methemoglobinemia. Provayblue works by changing methemoglobin into a more effective type of hemoglobin that can carry oxygen better throughout the body.

Provayblue may also be used for other reasons not mentioned in this medication guide.

You should not receive Provayblue if you have glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Many medications can interact with Provayblue. Inform your doctor about all the medicines you are currently taking and any you have recently discontinued, especially an antidepressant.

You should not receive Provayblue if you are allergic to it, or if you have:

• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Many medications can interact with Provayblue. Inform your doctor about all the medicines you are currently taking and any you have recently stopped using, especially:

• alfentanil, fentanyl;
• buspirone;
• digoxin, digitalis;
• dihydroergotamine, ergotamine;
• phenytoin;
• pimozide;
• quinidine;
• warfarin (Coumadin, Jantoven);
• an MAO inhibitor--isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine, and others;
• an "SSRI" antidepressant--citalopram, escitalopram, fluoxetine, paroxetine, sertraline, Prozac, Paxil, Zoloft, and others;
• an "SNRI" antidepressant--desvenlafaxine, duloxetine, levomilnacipran, milnacipran, venlafaxine, Effexor, Cymbalta, Pristiq, and others;
• other antidepressants--bupropion, clomipramine, mirtazapine; or
• medicine to prevent organ transplant rejection--cyclosporine, sirolimus, tacrolimus.

To ensure Provayblue is safe for you, inform your doctor if you have:

• liver disease; or
• kidney disease.

Using Provayblue during pregnancy may harm the unborn baby. Inform your doctor if you are pregnant.

Do not breast-feed for 8 days after receiving Provayblue. If you use a breast pump during this time, discard any milk you collect. Do not feed it to your baby.

Get emergency medical help if you have signs of an allergic reaction: hives; trouble 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 of Provayblue may include:

• pain in your arms or legs;
• blue or green urine;
• changed 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.

Provayblue is injected into a vein through an IV. A healthcare provider will give you this injection. The IV infusion can take up to 30 minutes to complete.

Your breathing, blood pressure, oxygen levels, kidney function, and other vital signs will be watched closely while you are receiving Provayblue. Your blood will also need to be tested to help your doctor determine that the medicine is working.

You may only need to receive one dose of Provayblue. If you do need a second dose, it can be given 1 hour after your first dose.

Provayblue will most likely cause your urine or stools to appear blue or green in color. This is a normal side effect of the medication and will not cause any harm. However, this effect may cause unusual results with certain urine tests.

Because you will receive Provayblue in a clinical setting, it is unlikely that you will miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include vomiting, stomach pain, chest pain or tightness, wheezing, trouble breathing, feeling like you might pass out, fast heart rate, anxiety, confusion, tremor, dilated pupils, blue-colored skin or lips, numbness, or tingling.

Provayblue may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

For at least 24 hours after treatment with Provayblue, avoid exposure to sunlight or tanning beds. This medicine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Many drugs can interact with Provayblue, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you are using and those you have recently used before you start treatment with this medicine.