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Label Changes for:

Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) 200 mg/25 mg /300 mg fixed dose combination (FDC) tablets

January 2013

Changes have been made to the CONTRAINDICATIONS, 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)


January 2013


  • added ..... proton pump inhibitors, such as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole


5.5 Depressive Disorders
  • ... Suicidal ideation was reported in 4 subjects in each arm while suicide attempt was reported in 2 subjects in the rilpivirine arm...
5.6  Hepatotoxicity (new section added)
  • Hepatic adverse events have been reported in patients receiving a rilpivirine containing regimen. Patients with underlying hepatitis B or C, or marked elevations in serum liver biochemistries prior to treatment may be .....


6.1 Adverse Reactions from Clinical Trials Experience
  • Studies C209 and C215 – Treatment-Emergent Adverse Drug Reactions
  • multiple section changes with data from week 96 pooled data
6.2 Postmarketing Experience
  • Rilpivirine: Renal and Urinary Disorders, nephrotic syndrome


8. Nursing Mothers
  • Emtricitabine: Samples of breast milk obtained from five HIV-1 infected mothers show that emtricitabine is secreted in human milk. Breastfeeding infants whose mothers are being treated with emtricitabine may be at risk for developing viral resistance to emtricitabine. Other emtricitabine-associated risks in infants breastfed by mothers being treated with emtricitabine are unknown.
  • Rilpivirine: Studies in lactating rats and their offspring indicate that rilpivirine was present in rat milk. It is not known whether rilpivirine is secreted in human milk.
  • Tenofovir Disoproxil Fumarate: Samples of breast milk obtained from five HIV-1 infected mothers in the first post-partum week show that tenofovir is excreted in human milk. The impact of this exposure in breastfed infants is unknown.


Information for Patients
  • Patients should be advised not to breastfeed because at least two of the drugs contained in COMPLERA can be passed to the baby in breast milk. It is not known whether this could harm the baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in breast milk.
  • Patients should be informed that hepatotoxicity has been reported with COMPLERA [See Warnings and Precautions (5.6)].
  • COMPLERA should not be coadministered with ATRIPLA, Edurant,  EMTRIVA, STRIBILD, TRUVADA, or VIREAD; or with drugs containing lamivudine, including Combivir, Epivir or Epivir-HBV, Epzicom, or Trizivir; or with HEPSERA [See Warnings and Precautions (5.8)]. 


August 2012



Immune Reconstitution Syndrome