Label Changes for:
Truvada (emtricitabine/tenofovir disoproxil fumarate tablets
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
5 WARNINGS AND PRECAUTIONS
5.5 Decreases in Bone Mineral Density
- Assessment of bone mineral density (BMD) should be considered for HIV-1 infected adults and pediatric patients 12 years of age and older...
- In a clinical trial of HIV-1 infected pediatric subjects 12 years...
WARNINGS AND PRECAUTIONS
New Onset or Worsening Renal Impairment
- Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed.. including patients who have previously experienced renal events while receiving Hepsera.
- 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.
What are the possible side effects of TRUVADA?
- Changes in bone mineral density (thinning bones). Some HIV patients treated with tenofovir developed thinning of the bones (osteopenia) which could lead to fractures.