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Drugs reference index «efavirenz, emtricitabine, and tenofovir»

efavirenz, emtricitabine, and tenofovir


efavirenz, emtricitabine, and tenofovir (Oral route)

ef-a-VYE-renz, em-trye-SYE-ta-been, ten-OF-oh-vir dye-soe-PROX-il FUE-ma-rate

Oral routeTablet
  • Lactic acidosis/severe hepatomegaly with steatosis and post treatment exacerbation of hepatitis B
    • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of efavirenz/emtricitabine/tenofovir disoproxil fumarate, in combination with other antiretrovirals.
    • Efavirenz/emtricitabine/tenofovir disoproxil fumarate is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of efavirenz/emtricitabine/tenofovir disoproxil fumarate have not been established in patients co-infected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued emtricitabine or tenofovir disoproxil fumarate which are components of efavirenz/emtricitabine/tenofovir disoproxil fumarate. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are co-infected with HIV-1 and HBV and discontinue efavirenz/emtricitabine/tenofovir disoproxil fumarate. If appropriate, initiation of anti-hepatitis B therapy may be warranted .

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues in combination with other antiretrovirals. Not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy have not been established in patients co-infected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued emtricitabine or tenofovir disoproxil fumarate. Monitor hepatic function upon discontinuation of therapy in patients co-infected with HIV-1 and HBV .

Commonly used brand name(s):

In the U.S.

  • Atripla

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Non-Nucleoside Reverse Transcriptase Inhibitor

Uses For efavirenz, emtricitabine, and tenofovir

Efavirenz, emtricitabine, and tenofovir combination is used alone or with other anti-HIV medicines to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

efavirenz, emtricitabine, and tenofovir does not cure or prevent HIV or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems that usually result from AIDS or HIV disease. It will not keep you from spreading HIV to other people. People who receive efavirenz, emtricitabine, and tenofovir may continue to have some of the problems usually related to AIDS or HIV disease.

efavirenz, emtricitabine, and tenofovir is available only with your doctor's prescription.

Before Using efavirenz, emtricitabine, and tenofovir

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For efavirenz, emtricitabine, and tenofovir, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to efavirenz, emtricitabine, and tenofovir or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of efavirenz, emtricitabine, and tenofovir combination in children younger than 18 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of efavirenz, emtricitabine, and tenofovir combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving efavirenz, emtricitabine, and tenofovir combination.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using efavirenz, emtricitabine, and tenofovir with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Astemizole
  • Bepridil
  • Cisapride
  • Dihydroergotamine
  • Ergoloid Mesylates
  • Ergonovine
  • Ergotamine
  • Methylergonovine
  • Methysergide
  • Midazolam
  • Pimozide
  • St John's Wort
  • Triazolam

Using efavirenz, emtricitabine, and tenofovir with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adefovir Dipivoxil
  • Amprenavir
  • Atazanavir
  • Cyclosporine
  • Didanosine
  • Etravirine
  • Fosamprenavir
  • Itraconazole
  • Maraviroc
  • Posaconazole
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Sirolimus
  • Tacrolimus
  • Tolvaptan
  • Voriconazole

Using efavirenz, emtricitabine, and tenofovir with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Atazanavir
  • Atorvastatin
  • Bupropion
  • Carbamazepine
  • Caspofungin
  • Clarithromycin
  • Darunavir
  • Diltiazem
  • Etonogestrel
  • Indinavir
  • Ketoconazole
  • Lopinavir
  • Methadone
  • Norgestimate
  • Pravastatin
  • Ritonavir
  • Saquinavir
  • Sertraline
  • Simvastatin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of efavirenz, emtricitabine, and tenofovir. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bone problems or
  • Kidney problems or
  • Liver disease (especially hepatitis B or C infection), history of or
  • Mental illness (severe depression) or
  • Seizure, history of—Use with caution. May make these conditions worse.
  • Hypersensitivity reaction to efavirenz (e.g., Stevens-Johnson syndrome, erythema multiforme, toxic skin eruptions), history of—Should not be used in patients with this condition.

Proper Use of efavirenz, emtricitabine, and tenofovir

Take efavirenz, emtricitabine, and tenofovir exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

efavirenz, emtricitabine, and tenofovir comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Do not change the dose or stop using efavirenz, emtricitabine, and tenofovir without checking with your doctor first. When your supply of efavirenz, emtricitabine, and tenofovir is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of efavirenz, emtricitabine, and tenofovir.

You should take efavirenz, emtricitabine, and tenofovir on an empty stomach.

Take efavirenz, emtricitabine, and tenofovir at the same time each day, preferably at bedtime.

Keep taking efavirenz, emtricitabine, and tenofovir for the full time of treatment even if you begin to feel better. It is also important that you continue taking all of the medicines that your doctor has given you for HIV infection.

Dosing

The dose of efavirenz, emtricitabine, and tenofovir will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of efavirenz, emtricitabine, and tenofovir. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For treatment of HIV infection:
    • For oral dosage form (tablets):
      • Adults—1 tablet once a day with water. Each tablet contains efavirenz 600 milligrams (mg), emtricitabine 200 mg, and tenofovir 300 mg.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of efavirenz, emtricitabine, and tenofovir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using efavirenz, emtricitabine, and tenofovir

Your doctor will want to check your progress at regular visits, especially during the first few weeks that you take efavirenz, emtricitabine, and tenofovir. Blood tests may be needed to check for any unwanted effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

You should not use any of the following medicines while you are taking efavirenz, emtricitabine, and tenofovir combination:

  • Adefovir (e.g., Hepsera®).
  • Bepridil (e.g., Vascor®).
  • Cisapride (e.g., Propulsid®).
  • Ergot medicines (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, Ergomar®, or Wigraine®).
  • Lamivudine-containing medicines (e.g., Combivir®, Epivir®, Epivir-HBV®, Epzicom™, or Trizivir®).
  • Midazolam (e.g., Versed®).
  • Other anti-HIV medicines containing efavirenz, emtricitabine, or tenofovir (e.g., Emtriva®, Sustiva®, Truvada®, or Viread®).
  • Pimozide (e.g., Orap®).
  • St. John's wort.
  • Triazolam (e.g., Halcion®).
  • Voriconazole (e.g., Vfend®).

Two rare but serious reactions to efavirenz, emtricitabine, and tenofovir are lactic acidosis (too much acid in the blood) and liver toxicity, including an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you have abdominal or stomach discomfort; cramping, nausea, vomiting, diarrhea, or a decreased appetite; muscle cramping or pain; unusual tiredness or weakness; trouble with breathing; or yellow skin or eyes.

efavirenz, emtricitabine, and tenofovir may increase your risk of having serious mental or behavioral problems. Tell your doctor if you develop mood changes, strange thoughts, or any unusual behavior while you are using efavirenz, emtricitabine, and tenofovir.

Some people who have used efavirenz, emtricitabine, and tenofovir developed serious skin problems. Tell your doctor if you notice a skin rash; blistering, peeling, or loosening of the skin; red skin lesions; sores or ulcers on the skin; or fever or chills while you are using efavirenz, emtricitabine, and tenofovir.

efavirenz, emtricitabine, and tenofovir may also increase your risk of developing fractures (broken bones). Ask your doctor about this if you have any concerns.

Using efavirenz, emtricitabine, and tenofovir while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are taking efavirenz, emtricitabine, and tenofovir and for 12 weeks after stopping it. If you think you have become pregnant while using the medicine, tell your doctor right away.

Birth control pills may not work as well while you are using efavirenz, emtricitabine, and tenofovir. To keep from getting pregnant, use another form of birth control together with your pills. Other forms include a condom, diaphragm, or contraceptive foam or jelly.

efavirenz, emtricitabine, and tenofovir does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contamination through blood. Make sure you understand and practice safe sex, even if your partner also has HIV. Avoid sharing needles with anyone.

efavirenz, emtricitabine, and tenofovir may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Be careful to limit the amount of alcohol that you drink, since alcohol can also make you drowsy. Make sure you know how you react to efavirenz, emtricitabine, and tenofovir before you drive, use machines, or do anything else that could be dangerous if you are not alert.

When you start taking HIV medicines, your immune system may get stronger. If you already have certain infections, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor.

efavirenz, emtricitabine, and tenofovir may cause you to have excess body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

efavirenz, emtricitabine, and tenofovir Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
  • Abdominal or stomach pain or tenderness
  • blistering, peeling, or loosening of the skin
  • body aches or pain
  • chills
  • clay-colored stools
  • cough
  • dark urine
  • ear congestion
  • fever
  • headache
  • itching
  • loss of voice
  • muscle aches
  • nasal congestion
  • nausea and vomiting
  • right upper abdominal pain and fullness
  • severe skin rash
  • shortness of breath
  • sneezing
  • sore throat
  • swelling of the feet or lower legs
  • tightness of the chest
  • trouble breathing
  • trouble concentrating
  • wheezing
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Diarrhea
  • dizziness
  • unusual tiredness or weakness
Less common
  • Abnormal dreams
  • decreased appetite
  • discouragement
  • feeling sad or empty
  • irritability
  • loss of appetite
  • loss of interest or pleasure
  • mild rash
  • pain or tenderness around the eyes and cheekbones
  • sleepiness
  • sleeplessness
  • stuffy or runny nose
  • trouble sleeping
  • unable to sleep
  • unusual drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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