Label Changes for:

Viread (tenofovir disoproxil fumarate) tablets

October 2009

Changes have been made to the WARNINGS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) --

 

October 2010

 

ADVERSE REACTIONS

Clinical Trial in Adult Subjects with Chronic Hepatitis B and Decompensated Liver Disease
  • In a small randomized, double-blind, active-controlled trial (0108), subjects with CHB and decompensated liver disease received treatment with Viread or other antiviral drugs for up to 48 weeks [see Clinical Studies (14.2)]. Among the 45 subjects receiving Viread, the most frequently reported treatment-emergent adverse reactions of any severity were abdominal pain (22%), nausea (20%), insomnia (18%), pruritus (16%), vomiting (13%), dizziness (13%), and pyrexia (11%). Two of 45(4%) subjects died through Week 48 of the study due to progression of liver disease. Three of 45 (7%) subjects discontinued treatment due to an adverse event. Four of 45 (9%) subjects experienced a confirmed increase in serum creatinine of 0.5 mg/dL (1 subject also had a confirmed serum phosphorus < 2mg/dL through Week 48). Three of these subjects (each of whom had a Child-Pugh score ≥ 10 and MELD score ≥ 14 at entry) developed renal failure. Because both Viread and decompensated liver disease may have an impact on renal function, the contribution of Viread to renal impairment in this population is difficult to ascertain.
  • One of 45 subjects experienced an on-treatment hepatic flare during the 48 Week study.

 

October 2009

 

WARNINGS

New Onset or Worsening Renal Impairment
  • Routine monitoring of calculated creatinine clearance...including patients who have previously experienced renal events while receiving Hepsera.

ADVERSE REACTIONS

Clinical Trials Experience
  • Nucleoside-Experienced Patients:  No new adverse reactions to tenofovir disoproxil fumarate were identified in those patients in Studies 0102, 0103, and 0106 who had been previously treated with HEPSERA, lamivudine or other nucleoside analogs (n=352).
  • Nucleoside-Experienced Patients:  Increased serum lipase (4/352;1%) was the only additional Grade 3/4 laboratory abnormality occurring in  ≥1 % of those patients in Studies 0102, 0103, and 0106 who had been previously treated with Hepsera, lamivudine or other nucleoside analogs (n=352).

Postmarketing Experience

  • Immune System Disorders:...including angioedema

PATIENT COUNSELING INFORMATION

Information for Patients
  • Patients should be advised to continue to practice safer sex and to use latex or polyurethane condoms to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions or blood.  Patients should be advised never to re-use or share needles

FDA-Approved Patient Labeling 

What is the most important information I should know about VIREAD?
  • Some people who have taken medicine like VIREAD (nucleoside analogs) have developed a serious condition called lactic acidosis (build up of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your healthcare provider right away if you get the following signs or symptoms of lactic acidosis. -You feel very weak or tired. -You have unusual (not normal) muscle pain. -You have trouble breathing. -You have stomach pain with nausea and vomiting. You feel cold, especially in your arms and legs. You feel dizzy or lightheaded. You have a fast or irregular heartbeat.
  • Some people who have taken medicines like VIREAD have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare provider right away if you get the following signs or symptoms of liver problem: Your skin or the white part of your eyes turns yellow (jaundice). Your urine turns dark. Your bowel movements (stools) turn light in color. You don’t feel like eating food for several days or longer. You feel sick to your stomach (nausea). You have lower stomach area (abdominal) pain.
  • You may be more likely to get lactic acidosis or liver problems if you are female, very overweight (obese), or have been taking nucleoside analog medicines, like Viread, for a long time.
  • If you are infected with the Hepatitis B Virus (HBV)...
Who should not take VIREAD?
  • you are currently taking Hepsera
What should I tell my healthcare provider before taking VIREAD?
  • ...You and your healthcare provider will need to decide if Viread is right for you. If you use VIREAD while you are pregnant, talk to your healthcare provider about how you can be on the Viread Antiviral Pregnancy Registry.
  • It is not known whether Viread is passed to the infant in breast milk; and whether it could harm your baby.
  • Talk with your healthcare provider about the best way to feed your baby.
What are the possible side effects of VIREAD?
  • Some HIV patients treated with Viread developed thinning of the bones (osteopenia) which could lead to fractures
  • After stopping treatment with Viread, some patients with HBV have had symptoms or blood tests showing that their hepatitis has gotten worse (“flare-ups”). Therefore, your doctor should check your health, which may include blood tests, for at least several months after stopping treatment with Viread. Tell your doctor right away about any new or unusual symptoms that you notice after stopping treatment.

 

 

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