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INCIVEK Warnings and Precautions

People who have anemia or a weakened immune system may not be able to safely take INCIVEK. Other warnings and precautions involve talking to your healthcare provider before using this product if you are pregnant or breastfeeding, and discussing possible drug interactions that may affect you. Understanding these safety issues before using this medicine can help ensure a safe treatment process.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking INCIVEK® (telaprevir) if you have:
 
  • Blood cell problems, such as anemia
  • A weakened immune system, due to human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or any other cause
  • Liver disease (other than hepatitis C), such as hepatitis B, cirrhosis, or liver failure
  • A history of gout or high blood levels of uric acid
  • Ever had an organ transplant
  • An upcoming surgery
  • Any allergies, including to foods, dyes, or preservatives.
 
Also, let your healthcare provider know if you are:
 
  • Pregnant, thinking of becoming pregnant, or have a female partner who is pregnant
  • 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 With INCIVEK

Some warnings and precautions to be aware of prior to taking this drug include the following:
 
  • INCIVEK should only be used as part of a triple-combination treatment, consisting of INCIVEK, peginterferon alfa (Pegasys®, PEG-Intron®), and ribavirin (Copegus®, Rebetol®, Ribapak®, Ribasphere®). If you cannot take peginterferon alfa or ribavirin, then you cannot take INCIVEK.
 
  • INCIVEK may cause skin reactions, including a potentially life-threatening skin rash called Stevens-Johnson syndrome (SJS). If you notice any skin rash while taking this medication, contact your healthcare provider right away. He or she will tell you if you need to stop taking INCIVEK.
 
  • INCIVEK can cause severe anemia or other blood cell problems. Your healthcare provider will monitor you regularly (at least once a month) while you are taking INCIVEK, by doing some simple blood tests. If you develop severe anemia, your healthcare provider may instruct you to stop taking the medication. If you stop taking INCIVEK because of severe anemia, you should not start taking the medicine again, even if your anemia improves.
 
  • Make sure to keep all of your appointments with your healthcare provider. You will need regular monitoring during treatment to make sure the medication is working, and to check for potentially serious side effects.
 
 
  • Although INCIVEK is a pregnancy Category B medication, it is always used in combination with ribavirin, which is a pregnancy Category X medication. This means that this medicine should not be used in pregnant women. Women must use two forms of birth control during treatment. The medications should also not be used in men who have a pregnant partner (see INCIVEK and Pregnancy).
 
  • It is unknown if INCIVEK passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see INCIVEK and Breastfeeding).
 

INCIVEK Drug Information

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