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IMPORTANT SAFETY INFORMATION

VEPPANU can cause serious side effects, including:

Heart rhythm problems (QTc interval prolongation). VEPPANU can cause changes in the electrical activity of your heart and may increase your risk of abnormal heart rhythm problems, and sudden death. Your healthcare provider will check your heart with a test called an electrocardiogram (ECG) and check your blood potassium and magnesium levels before and as needed during treatment with VEPPANU. Get emergency medical help right away if you get any signs and symptoms of abnormal heart rhythm, including:

feeling lightheaded or faint
dizziness

feeling that your heart is pounding or beating fast (heart palpitations)

shortness of breath
chest pain

Before taking VEPPANU, tell your healthcare provider about all of your medical conditions, including if you:

have heart failure or heart rhythm problems, including QTc prolongation, and long QTc syndrome
have low blood levels of potassium or magnesium
are pregnant or plan to become pregnant. VEPPANU can harm your unborn baby.

Females who are able to become pregnant:

Your healthcare provider may do a pregnancy test before you start treatment with VEPPANU.
Use effective birth control (contraception) during treatment with VEPPANU and for 2 weeks after the last dose.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with VEPPANU.

Males with female partners who are able to become pregnant:

Use effective birth control (contraception) during treatment with VEPPANU and for 2 weeks after the last dose.

are breastfeeding or plan to breastfeed. It is not known if VEPPANU passes into your breast milk. Do not breastfeed during treatment with VEPPANU and for 2 weeks after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. VEPPANU and other medicines may affect the way each other works and may cause serious side effects.

What should I avoid while taking VEPPANU?

Avoid taking St. John’s wort, eating grapefruit, or drinking grapefruit juice during treatment with VEPPANU.

The most common side effects of VEPPANU include:

decreased white blood cell counts
increased liver function tests
muscle and bone pain
tiredness

decreased red blood cell counts
nausea
decreased potassium levels in your blood
decreased appetite

abnormal electrocardiogram (QT prolonged)
decreased platelet counts
constipation

Your healthcare provider may decrease your dose, temporarily stop, or completely stop treatment with VEPPANU, if you develop certain side effects.

VEPPANU may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of VEPPANU. Call your doctor for medical advice about side effects. You may report side effects to FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Click here for Full Prescribing Information, including Patient Information.

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