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Precautions and Warnings With Emtricitabine/Rilpivirine/Tenofovir

To help ensure a safe and effective HIV and AIDS treatment, it is important to fully understand the safety precautions and warnings with emtricitabine/rilpivirine/tenofovir. For example, people with hepatitis B, kidney disease, or bone problems may not be able to safely use emtricitabine/rilpivirine/tenofovir. In addition, make sure your healthcare provider is aware of any allergies you may have and whether you are pregnant or breastfeeding.

What Should I Tell My Healthcare Provider Before Taking Emtricitabine/Rilpivirine/Tenofovir?

You should talk with your healthcare provider prior to taking emtricitabine/rilpivirine/tenofovir disoproxil fumarate (Complera™) if you have:
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Emtricitabine/Rilpivirine/Tenofovir Precautions and Warnings

Some warnings and precautions to be aware of before taking this medicine include the following:
  • Emtricitabine/rilpivirine/tenofovir can make a hepatitis B infection worse. If you have hepatitis B, you may need to be monitored more closely to make sure your infection is not getting worse.
  • In rare cases, this medicine can cause a condition called lactic acidosis and hepatic steatosis. This condition is caused by damage to the liver and can be quite dangerous. People with liver disease have a greater risk for developing this complication.
  • If you have hepatitis B or C, or if you already have high liver enzymes (found using a standard blood test), you might be at higher risk for liver problems due to this medication. Close monitoring of your liver function will be required. 
  • Emtricitabine/rilpivirine/tenofovir can change the distribution of fat on your body. You may gain fat in areas that are not typical for you, such as in the abdomen (stomach) or at the back of the neck (a "buffalo hump"), and may lose weight in other areas.
  • In clinical studies, emtricitabine/rilpivirine/tenofovir was associated with depression or other similar mood disorders. Make sure your healthcare provider knows if you have a history of mental illness, and be watchful for any undesired changes in mood or behavior.
  • People with kidney problems may be at a higher risk for kidney damage due to this drug. Make sure your healthcare provider knows if you have any kidney problems before starting treatment with this medicine, as you may need a lower emtricitabine/rilpivirine/tenofovir dosage.
  • Emtricitabine/rilpivirine/tenofovir can decrease bone density, which increases the risk for osteoporosis and broken bones. Your healthcare provider should check your bone density while taking emtricitabine/rilpivirine/tenofovir, especially if you have had a broken bone in the past. Ask your healthcare provider if you should take calcium and vitamin D, as this may help strengthen your bones.
  • This medicine is not a cure for HIV or AIDS. If you have HIV or AIDS, you should always use safer sex practices, regardless of whether you are taking medications.
  • As with all HIV medications, it is important that you take emtricitabine/rilpivirine/tenofovir exactly as prescribed. Missing doses may increase the chance of the virus becoming resistant to HIV medications.
  • Emtricitabine/rilpivirine/tenofovir is a pregnancy Category B medication. This means that it is probably safe for use during pregnancy, although the full risks are unknown (see Complera and Pregnancy).
  • At least two of the active ingredients in this medication pass through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider before taking the drug (see Complera and Breastfeeding). It is important to understand that the HIV virus can be transmitted through breast milk and that breastfeeding is usually not recommended in women with HIV or AIDS.

Emtricitabine/Rilpivirine/Tenofovir Information

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