USE OF VIREAD1
VIREAD? (tenofovir disoproxil fumarate) is a type of medicine called a nucleotide analog reverse transcriptase and hepatitis B virus (HBV) polymerase inhibitor (NRTI). VIREAD is used to treat chronic hepatitis B (an infection with HBV) in adults age 18 years and older. VIREAD works by interfering with the normal working of an enzyme (HBV DNA polymerase) that is essential for the HBV to reproduce itself. VIREAD may help lower the amount of hepatitis B virus in your body by lowering the ability of the virus to multiply and infect new liver cells.
VIREAD is also a treatment for Human Immunodeficiency Virus 1 (HIV-1) infection in adults age 18 years and older. VIREAD is always used in combination with other anti-HIV-1 medicines to treat people with HIV-1 infection.
VIREAD does not cure HIV-1 infection or AIDS, or reduce the risk of passing HIV-1 or HBV to others. The long-term effects of VIREAD are not known at this time.
Do not take VIREAD if you are allergic to VIREAD or any of its ingredients. VIREAD should not be used with TRUVADA? (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) or ATRIPLA? (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) because VIREAD is one of the active ingredients in TRUVADA AND ATRIPLA. VIREAD should not be used with HEPSERA? (adefovir dipivoxil).
The usual dose of VIREAD is one 300-mg tablet once a day. If you have kidney problems, your healthcare provider may recommend that you take VIREAD less frequently. Stay under a healthcare provider?s care when taking VIREAD.
IMPORTANT SAFETY INFORMATION1
Contact your healthcare provider right away if you experience any of the following side effects or conditions while taking VIREAD:
* Nausea, vomiting, unusual or unexpected stomach discomfort, and weakness. These may be signs of a buildup of lactic acid in the blood (lactic acidosis), which is a serious medical condition
* Light colored stools, dark colored urine, and/or if your skin or the whites of your eyes turn yellow. These may be signs of serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly), and fat in the liver (steatosis)
* If you have HBV infection or HIV-1 and HBV infection together and you stop taking VIREAD, you may have a ?flare-up? of hepatitis B and your liver disease may suddenly get worse. Do not stop taking VIREAD without your healthcare provider?s advice. After you stop taking VIREAD, your healthcare provider will need to check your health and take blood tests to check your liver for several months.
* Some patients treated with VIREAD have had kidney problems. If you have had kidney problems or take other medicines that can cause kidney problems, your healthcare provider may need to perform additional blood tests
* Lab tests show changes in the bones of patients treated with VIREAD. If you have had bone problems in the past, your healthcare provider may need to perform additional tests or suggest additional medication. Also, bone pain and softening of the bone (which may contribute to fractures) may occur as a consequence of kidney problems.
Changes in body fat have been seen in some people taking VIREAD and other anti-HIV-1 medicines.
If you notice any symptoms of infection soon after you start HIV-1 treatment, talk to your healthcare provider right away.
Studies in patients with chronic hepatitis B: The most common side effect of VIREAD is nausea. Less common side effects include abdominal pain, diarrhea, headache, dizziness, fatigue, nasopharyngitis, back pain, and skin rash.
Studies in patients with HIV-1: The most common side effects of VIREAD are rash, headache, pain, diarrhea, depression, weakness, and nausea. Less common side effects include vomiting, dizziness, and intestinal gas.
Discuss all medicines you take with your healthcare provider and be aware: Your healthcare provider may need to follow you more closely or adjust your therapy if you are taking Videx? or Videx EC? (didanosine), Reyataz? (atazanavir sulfate), or Kaletra? (lopinavir/ritonavir) with VIREAD.
