emtricitabine and tenofovir

Generic Name: emtricitabine and tenofovir (em trye SYE ta been and ten OF oh vir)
Brand Names: AccessPak for HIV PEP Basic, Truvada

What is emtricitabine and tenofovir?

Emtricitabine and tenofovir are antiviral drugs that work by preventing HIV (human immunodeficiency virus) cells from multiplying in the body.

The combination of emtricitabine and tenofovir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Emtricitabine and tenofovir is not a cure for HIV or AIDS.

Emtricitabine and tenofovir may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about emtricitabine and tenofovir?

You should not take this medication if you are allergic to emtricitabine (Emtriva) or tenofovir (Viread).

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

Some people develop lactic acidosis while taking emtricitabine and tenofovir. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired. Emtricitabine and tenofovir can cause severe or fatal liver problems. Call your doctor at once if you have symptoms such as nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

What should I discuss with my healthcare provider before taking emtricitabine and tenofovir?

You should not take this medication if you are allergic to emtricitabine (Emtriva) or tenofovir (Viread). 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 any of these other conditions, you may need an emtricitabine and tenofovir dose adjustment or special tests:

• liver or kidney disease;

• osteopenia (low bone mineral density); or

• if you also have hepatitis B infection.

Some people develop 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 HIV or AIDS medications for a long time. Talk with your doctor about your individual risk. 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 your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of emtricitabine and tenofovir on the baby.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk. Do not give this medicine to anyone under 18 without the advice of a doctor.

How should I take emtricitabine and tenofovir?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You may take this medication with or without food.

Use emtricitabine and tenofovir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your kidney and liver function or bone density may also need to be tested. Visit your doctor regularly.

If you have hepatitis B you may develop liver symptoms after you stop taking emtricitabine and tenofovir, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop using the medicine. Do not miss any follow-up visits to your doctor.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet of moisture-absorbing preservative that comes with emtricitabine and tenofovir.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking emtricitabine and tenofovir?

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

Emtricitabine and tenofovir side effects

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

• fast 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, urinating more or less than usual or not at all;

• swelling, rapid weight gain, feeling short of breath; or

• signs of infection such as fever, chills, skin lesions, or cough with yellow or green mucus.

Less serious side effects may include:

• diarrhea, mild nausea;

• headache, tired feeling;

• dizziness, depressed mood;

• sleep problems (insomnia), strange dreams;

• mild itching or skin rash;

• 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.

See also: emtricitabine and tenofovir side effects (in more detail)

Emtricitabine and tenofovir Dosing Information

Usual Adult Dose for HIV Infection:

1 tablet orally once every 24 hours

Usual Adult Dose for Nonoccupational Exposure:

1 tablet orally once every 24 hours plus efavirenz
Prophylaxis should be initiated as soon as possible, within 72 hours of exposure.
Duration: 28 days

Usual Pediatric Dose for HIV Infection:

12 years or older with body weight 35 kg or more: 1 tablet orally once every 24 hours

What other drugs will affect emtricitabine and tenofovir?

Emtricitabine and tenofovir can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests 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);

• an IV antibiotic such as gentamicin (Garamycin), vancomycin (Vancocin, Vancoled), and others;

• 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 other drugs may interact with emtricitabine and tenofovir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about emtricitabine and tenofovir.