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POST TIME: 8 February, 2016 00:00 00 AM
FDA approves Zepatier

FDA approves Zepatier

The U.S. FDA has approved Zepatier (elbasvir and grazoprevir), a once-daily NS5A inhibitor and NS3/4A protease inhibitor fixed-dose combination for the treatment of adult patients with chronic hepatitis C virus (HCV) genotypes 1 and 4 infections.
What is Zepatier?
Zepatier is a prescription medicine used with or without ribavirin to treat chronic (long-lasting) hepatitis C virus (HCV) genotypes 1 or 4 infection in adults.
It is not known if Zepatier is safe or effective in children under 18 years old, people awaiting a liver transplant, or people who have had a liver transplant.
Before taking Zepatier, tell your healthcare provider if you:
have liver problems other than hepatitis C
have ever taken any medicine for hepatitis C
have HIV
have had or are waiting for a liver transplant
have any other medical conditions
are pregnant or trying to get pregnant. Zepatier has not been studied in pregnant women and it is not known if it will harm your baby while you are pregnant.
Males and females who take Zepatier and ribavirin should also read the ribavirin Medication Guide for important pregnancy, contraception, and infertility information.
are breastfeeding or plan to breastfeed. It is not known if Zepatier passes into breast milk and if it can be passed on to your baby.
Talk to your healthcare provider about the best way to feed your baby during treatment with Zepatier.
Tell your healthcare provider about all of the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements. Zepatier may affect the way other medicines work, and vice versa. Some medicines cannot be taken with Zepatier. Your healthcare provider can tell you if it is safe to take Zepatier with other medicines.
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
You can ask your healthcare provider or pharmacist for a list of medicines that interact with this medicine. Do not start taking a new medicine without telling your healthcare provider.
Zepatier side effects
Zepatier may cause serious side effects including:
Signs of liver problems. Zepatier may cause increases in your liver-related blood tests.
This could be a sign of serious liver problems. Your healthcare provider will do blood tests to check your liver before and during treatment with. Tell your healthcare provider right away if you get any of the following symptoms or if they get worse during treatment:
loss of appetite
nausea and vomiting
feeling tired or weak
yellowing of your skin or eyes
color changes in your stool
Common side effects of Zepatier when used without ribavirin include:
feeling tired
headache
nausea
trouble sleeping
diarrhoea
Common side effects of Zepatier when used with ribavirin include:
low red blood cell counts (anemia)
headache
feeling tired
shortness of breath
rash or itching
feeling irritable
stomach pain
depression
joint pain
If you have any side effect that bothers you or that does not go away, tell your healthcare provider.
There may be other side effects that are not listed. Call your doctor for medical advice about side effects.
Source: drugs.com