Sirturo Warnings and Precautions

A number of warnings and precautions are associated with Sirturo, so it is important that your healthcare provider is aware of any medical conditions you might have and any drugs you are taking. This tuberculosis medicine can increase the risk for certain complications, including serious heart rhythm problems, liver damage, and even death. Talk to your healthcare provider about the risks that may apply to you.

 

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking Sirturo™ (bedaquiline) if you have:
 
  • Ever had an abnormal heart rhythm (arrhythmia)
  • A heart problem known as QT prolongation or congenital long QT syndrome, or if you have a family history of these problems
  • Heart failure
  • Hypothyroidism (an underactive thyroid)
  • Been told you have low blood levels of calcium, magnesium, or potassium
  • Had a recent heart attack
  • Human immunodeficiency virus (HIV) infection
  • Liver disease, such as hepatitis, cirrhosis, or liver failure
  • Kidney disease, such as kidney failure (renal failure)
  • Any allergies, including to foods, dyes, or preservatives.
 
Also, let your healthcare provider know if you:
 
  • Drink alcohol
  • Are pregnant or thinking of becoming pregnant
  • Are breastfeeding.
 
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
 

Specific Precautions and Warnings for Sirturo

Some warnings and precautions to be aware of prior to taking this drug include the following:
 
  • In one clinical study, people given Sirturo were more likely to die than people given a placebo (a "sugar pill" with no active ingredient). Researchers do not know why Sirturo increased the risk for death. However, because of this risk, the medication should only be used in people who do not have other treatment options.
 
  • This medication may cause a serious heart rhythm problem known as QT prolongation. You may have a higher risk for this complication if you have certain other medical problems, such as hypothyroidism or congenital long QT syndrome, or if you take other medicines that may cause QT prolongation (see Sirturo Drug Interactions).

    Your healthcare provider will monitor your heart rhythm with an electrocardiogram (ECG) before treatment and at least 2, 12, and 24 weeks after treatment begins. Because low blood levels of calcium, magnesium, or potassium can also increase the risk for QT prolongation, your healthcare provider will do blood tests to check your levels of these electrolytes before starting treatment.
 
  • Sirturo may cause liver damage. Your healthcare provider will monitor your liver function with a blood test before treatment begins and at least monthly during treatment. Let your healthcare provider know if you experience signs of liver problems, such as:
    • Fatigue or excessive tiredness
    • Loss of appetite
    • Nausea and vomiting
    • Upper-right abdominal (stomach) pain
    • Dark urine
    • Yellowing of the skin or whites of the eyes (jaundice).
 
  • Drinking alcohol during treatment can increase your risk for liver damage. Do not drink alcohol while you are taking Sirturo.
 
  • There is very little information available on the use of this medication in people who also have HIV. If you have HIV, your healthcare provider will determine whether this is the best medication to treat your tuberculosis
 
  • It is recommended that this medication be given by directly observed therapy (DOT), which means you will need to take your dose in front of a trained healthcare provider or other person. DOT helps ensure tuberculosis medications are taken as prescribed.

    This is important because missing doses or failing to complete the entire course of treatment may increase the chance that your tuberculosis is not adequately treated and that you spread the infection to others. It may also increase the likelihood that the bacteria will become resistant to Sirturo or other tuberculosis medications in the future. 
 
  • This medication should be used with caution in people with severe liver disease. It should also be used with caution in people with severe kidney disease or people on dialysis.
   
  • Sirturo is a pregnancy Category B medication, which means it is likely safe for use in women who are pregnant (see Sirturo and Pregnancy).
 
  • It is unknown if Sirturo passes through breast milk in humans. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Sirturo and Breastfeeding).
 

Sirturo Medication Information

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