Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Incivek.
Abnormal heart rhythms: Incivek can cause abnormal heart rhythms. Certain medications (e.g., Sotalol, quinidine, thioridazine, Chlorpromazine, droperidol, pimozide, gatifloxacin, moxifloxacin, Mefloquine, pentamidine, Dolasetron, Tacrolimus) can increase the risk of a type of an abnormal heart rhythm called QT prolongation, and should not be used in combination with telaprevir. You are more at risk for this type of abnormal heart rhythm and its complications if you:
- are female
- are older than 65 years of age
- have a family history of sudden cardiac death
- have a history of heart disease or abnormal heart rhythms
- have a slow heart rate
- have congenital prolongation of the QT interval
- have Diabetes
- have had a Stroke
- have low potassium, magnesium, or calcium levels
- have nutritional deficiencies
If you have heart disease, an abnormal heart rhythm, or are taking certain medications that may increase your risk of QT prolongation, discuss with your doctor how Incivek may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Incivek, and whether any special monitoring is needed.
Anemia: Telaprevir may cause low levels of red blood cells, a condition called anemia. If you experience symptoms of anemia, such as dizziness, shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.
Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.
Birth Control: Telaprevir must be used with ribavirin and peginterferon alfa. Treatment with ribavirin can cause severe birth defects to an unborn child. Both partners should use a reliable form of birth control while taking Incivek and for 6 months afterwards (the time it takes for ribavirin to be cleared from the body). For women, your doctor will not give you telaprevir until you have had a negative pregnancy test. Your doctor should have you continue to do monthly pregnancy tests to ensure that you do not become pregnant while using Incivek.
Methods of birth control that use hormones, such as a birth control pill, patch or injection, may not be fully reliable as telaprevir interacts with many medications and may change the way that your body uses the hormones. At least 2 forms of non-hormonal birth control (condom, diaphragm) must be used while you are taking Incivek.
Infection with HIV or hepatitis B: The safety and effectiveness of treatment with telaprevir have not been established for people who also have human immunodeficiency virus (HIV) or hepatitis B virus (HBV).
Kidney function: The safety and effectiveness of using telaprevir have not been established for people with severely reduced kidney function. If you have decreased kidney function, discuss with your doctor how Incivek may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Incivek, and whether any special monitoring is needed.
Liver function: Telaprevir is not recommended for people with active, worsening liver disease, or moderate to severely reduced liver function. If you have a history of reduced liver function, discuss with your doctor how Incivek may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Incivek, and whether any special monitoring is needed.
Organ Transplantation: The safety and effectiveness of treatment with telaprevir have not been established for people with liver or other organ transplants. Telaprevir may interact with medications used to prevent rejection of the transplanted organ.
Skin reactions: Telaprevir may cause skin rash or itchiness with or without a rash. Rarely, people taking telaprevir experience a severe skin reaction that can be life-threatening. If you experience mouth sores or ulcers, red or inflamed eyes (such as "pink eye"), a rash that gets worse, or develops into blisters, covers a large area of the body, or is associated with a fever, get immediate medical attention.
Pregnancy: Telaprevir has not been studied for use by pregnant women and it must be taken with peginterferon alfa and ribavirin. Ribavirin has been shown to cause serious problems in the developing fetus. As a result, telaprevir (plus peginterferon alfa and ribavirin) should not be used by pregnant women or by men whose partners are pregnant. Both partners should use a reliable form of birth control while taking Incivek and for 6 months afterwards. Tell your doctor immediately if you become pregnant while using Incivek.
Breast-feeding: It is not known if telaprevir passes into breast milk. If you are a breast-feeding mother and are taking Incivek, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children and adolescents: The safety and effectiveness of using Incivek have not been established for children and adolescents less than 18 years of age.
Seniors: Seniors may be more likely to experience side effects when taking telaprevir.
