Emtricitabine-Tenofovir Treatment Report

Precautions

Instructions

Side Effects

Interactions

You should not take this medication if you are allergic to emtricitabine or tenofovir.

Do not take this medication with other medicines that also contain emtricitabine or tenofovir (Atripla, Emtriva, Viread), or lamivudine (Combivir, Epivir, Epzicom, or Trizivir).

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take emtricitabine and tenofovir, tell your doctor if you have:

• liver disease;
• kidney disease;
• osteopenia (low bone mineral density); or
• if you also have hepatitis B infection.

FDA pregnancy category B. Emtricitabine and tenofovir is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

HIV can be passed to the baby if the mother is not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Your name may need to be listed on an pregnancy registry if you become pregnant while using this medication. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether emtricitabine and tenofovir had any effect on the baby.

You should not breast-feed while you are using emtricitabine and tenofovir. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

Some people have developed a life-threatening condition called lactic acidosis while taking emtricitabine and tenofovir. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken certain HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.

Do not give this medicine to anyone under 18 without the advice of a doctor.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

• muscle pain or weakness;
• numb or cold feeling in your arms and legs;
• trouble breathing;
• feeling dizzy, light-headed, tired, or very weak;
• stomach pain, nausea with vomiting; or
• slow or uneven heart rate.

Call your doctor at once if you have any of these other serious side effects:

• signs of liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• increased thirst and urination, loss of appetite, weakness, constipation;
• urinating less than usual or not at all; or
• signs of infection such as fever, chills, skin lesions, or cough with yellow or green mucus.

Less serious side effects may include:

• dizziness, anxiety, depressed mood;
• headache, tired feeling;
• sleep problems (insomnia), strange dreams;
• mild nausea, vomiting, diarrhea, upset stomach;
• mild itching or skin rash;
• darkened skin on the palms of your hands or the soles of your feet;
• joint pain, back pain;
• numbness or tingly feeling;
• runny or stuffy nose, cough; or
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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This medication can be harmful to the kidneys, and this effect is increased when emtricitabine and tenofovir is used together with other medicines that can harm the kidneys. Before taking this medication, tell your doctor if you have recently used:

• lithium (Lithobid);
• methotrexate (Rheumatrex, Trexall);
• pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Cataflam, Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others;
• medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);
• IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);
• antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or
• cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).

You may need dose adjustments or special tests when taking any of these medications together with emtricitabine and tenofovir.

Other medications that can affect emtricitabine and tenofovir include:

• the herpes medications acyclovir (Zovirax) or valacyclovir (Valtrex);
• medications to treat cytomegalovirus (CMV) such as cidofovir (Vistide), ganciclovir (Cytovene) or valganciclovir (Valcyte); or
• certain other HIV medicines such as atazanavir (Reyataz), didanosine (Videx), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), or ritonavir (Norvir).

This list is not complete and there may be other drugs that can interact with emtricitabine and tenofovir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Truvada, emtricitabine-tenofovir, and tenofovir-emtricitabine

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