Atripla

Generic Name: efavirenz, emtricitabine, and tenofovir (ef AV ir enz, em trye SYE ta been, and ten OF oh vir)
Brand Names: Atripla

What is Atripla?

Atripla is an antiviral medication that prevents human immunodeficiency virus (HIV) from reproducing in your body. It contains a combination of 3 reverse transcriptase inhibitors. It works by slowing the growth of HIV, the virus that causes AIDS.

Atripla treats HIV, which causes acquired immunodeficiency syndrome (AIDS). Atripla is not a cure for HIV or AIDS.

Atripla may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Atripla?

Do not use Atripla while you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medication, and for at least 12 weeks after your treatment ends. Tell your doctor if you become pregnant during treatment. Do not take Atripla if you are also taking cisapride (Propulsid), midazolam (Versed), triazolam (Halcion), St. John's wort, voriconazole (Vfend), or an ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), ergotamine (Ergomar), or methylergonovine (Methergine). Do not take Atripla with other medicines that also contain efavirenz, emtricitabine, tenofovir (Sustiva, Emtriva, Truvada, or Viread), or lamivudine (Combivir, Epivir, Epzicom, or Trizivir).

There are many other medicines that can cause interactions or serious medical problems if you take them together with Atripla. 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.

Some people have developed a life-threatening condition called lactic acidosis while taking Atripla. Get emergency medical help if you have any of these symptoms of lactic acidosis: 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. Atripla 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 Atripla?

Do not use Atripla if you are taking any of the following drugs:

• cisapride (Propulsid);

• midazolam (Versed) or triazolam (Halcion);

• St. John's wort;

• voriconazole (Vfend);

• an ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), ergotamine (Ergomar), or methylergonovine (Methergine); or

• lamivudine (Combivir, Epivir, Epzicom, or Trizivir); or

• any other medicines that also contain efavirenz, emtricitabine, or tenofovir (such as Sustiva, Emtriva, Truvada, or Viread).

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

• liver or kidney disease;

• a history of mental illness, use of antipsychotic medication, or injection drug use;

• epilepsy or other seizure disorder;

• osteopenia (low bone mineral density); or

• hepatitis B or C infection.

FDA pregnancy category D. Do not use Atripla if you are pregnant. It could harm the unborn baby. Tell your doctor right away if you become pregnant during treatment. Use two forms of birth control, including an effective barrier form (such as a condom or diaphragm with spermicide gel or inserts) while taking this medication. Keep using birth control to prevent pregnancy for at least 12 weeks after you stop taking Atripla. It may take that long for the medication to completely clear from your body. 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 a pregnancy patient registry when you start using Atripla.

You should not breast-feed while you are using Atripla. 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. This medication may cause lactic acidosis (the build up of lactic acid in the body, which can be fatal). 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. Early signs of lactic acidosis generally get worse over time and this condition can be fatal.

How should I take Atripla?

Take Atripla exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results from Atripla.

Take this medication on an empty stomach at bedtime.

To be sure Atripla is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

It is important to take this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Store Atripla at room temperature away from moisture, heat, and direct light. Keep the medicine in its original bottle with the cap tightly closed.

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose can cause uncontrolled muscle movements.

What should I avoid while taking Atripla?

Avoid drinking alcohol, which can increase some of the side effects of Atripla. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking Atripla 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.

Atripla 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. Emtricitabine and tenofovir 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.

• signs of liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• urinating less than usual or not at all;

• fever, chills, body aches, flu symptoms;

• unusual thoughts or behavior, severe depression, extreme fear, thoughts of hurting yourself or others, hallucinations;

• severe blistering, peeling, and red skin rash; or

• seizure (convulsions).

Less serious Atripla side effects may include:

• dizziness, drowsiness, anxiety, depressed mood;

• headache, tired feeling, ringing in your ears, vision problems;

• sleep problems (insomnia), confusion, strange dreams, forgetfulness;

• mild nausea, vomiting, diarrhea, loss of appetite, upset stomach;

• 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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Atripla?

Before using Atripla, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Atripla.

There are many other medicines that can cause interactions or serious medical problems if you take them together with Atripla. Tell your doctor if you use any of the following:

• acyclovir (Zovirax), ganciclovir (Cytovene), valacyclovir (Valtrex), or valganciclovir (Valcyte);

• sertraline (Zoloft);

• methadone (Methadose);

• adefovir (Hepsera) or cidofovir (Vistide);

• a blood thinner such as warfarin (Coumadin);

• cholesterol medications such as atorvastatin (Lipitor), pravastatin (Pravachol), or simvastatin (Zocor);

• antibiotics such as clarithromycin (Biaxin), itraconazole (Sporanox), ketoconazole (Nizoral), rifabutin (Mycobutin), rifampin (Rifater, Rifamate);

• a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nifedipine (Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan), and others;

• seizure medicines such as carbamazepine (Tegretol, Carbatrol), phenytoin (Dilantin), phenobarbital (Luminal, Solfoton); or

• certain other HIV medicines such as atazanavir (Reyataz), didanosine (Videx), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), or ritonavir (Norvir).

This list is not complete and there may be other drugs that can interact with Atripla. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

• Your pharmacist can provide more information about Atripla.

• Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2009 Cerner Multum, Inc. Version: 2.03. Revision Date: 4/12/2009 4:46:07 PM.

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