Efavirenz & Emtricitabine & Tenofovir

Efavirenz/emtricitabine/tenofovir is a prescription medication used to treat HIV and AIDS in adults. This medication comes as a single tablet containing three different medications; efavirenz, emtricitabine, and tenofovir. Efavirenz belongs to a group of drugs called non-nucleoside reverse transcriptase inhibitors, while emtricitabine and tenofovir belong to a group of drugs called nucleoside reverse transcriptase inhibitors. Both classes of drugs decrease the presence of HIV in the blood. 

This medication comes in tablet form and is taken once a day on an empty stomach at bedtime.

Some of the common side effects of efavirenz/emtricitabine/tenofovir include dizziness, headache, difficulty sleeping, and drowsiness.

Efavirenz/emtricitabine/tenofovir is used alone or in combination with other anti-HIV-1 medicines to treat people with HIV-1 infection. Efavirenz/emtricitabine/tenofovir is for adults age 18 and over. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Efavirenz & Emtricitabine & Tenofovir may be found in some form under the following brand names:

• Atripla

Efavirenz/emtricitabine/tenofovir may cause the following serious side effects:

• Lactic acidosis (buildup of an acid in the blood)
• Serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly) and fat in the liver (steatosis)
• "Flare-ups" of hepatitis B virus (HBV) infection
• Serious psychiatric problems
• Kidney problems (including decline or failure of kidney function)
• Changes in bone mineral density (thinning bones)

Common side effects:

• dizziness
• headache
• trouble sleeping
• drowsiness
• trouble concentrating
• unusual dreams 
• rash 
• tiredness
• upset stomach 
• vomiting
• gas
• diarrhea
• changes in body fat
• skin discoloration (small spots or freckles)
• symptoms of infection
• inflammation of the pancreas
• allergic reaction (including swelling of the face, lips, tongue, or throat), shortness of breath, pain, stomach pain, weakness and indigestion

This is not a complete list of efavirenz/emtricitabine/tenofovir drug interactions. Ask your doctor or pharmacist for more information.

The following medicines may cause serious and life-threatening side effects when taken with efavirenz/emtricitabine/tenofovir. You should not take any of these medicines while taking efavirenz/emtricitabine/tenofovir:

• Hepsera (aclefovir)
• Vascor (bepridil)
• Propulsid (cisapride)
• Versed (midazolam)
• Orap (pimozide)
• Halcion (triazolam)
• ergot medications such as Wigraine and Cafergot
• Vfend (voriconazole)
• St. John's wort (Hypericum perforatum)

Efavirenz/emtricitabine/tenofovir also should not be used with the following medications because one or more of these are components of the 3 medications found in efavirenz/emtricitabine/tenofovir:

• Combivir (lamivudine/zidovudine)
• Emtriva, Epivir
• Epivir-HBV (lamivudine)
• Epzicom (abacavir sulfate/lamivudine)
• Trizivir (abacavir sulfate/lamivudine/zidovudine)
• Sustiva
• Truvada
• Viread

The following medicines may need to be replaced with another medicine when taken with efavirenz/emtricitabine/tenofovir:

• Calcium channel blockers such as Cardizem or Tiazac (diltiazem)
• Covera HS or Isoptin (verapamil) and others
• Crixivan (indinavir)
• Selzentry (maraviroc) 
• the immunosuppressant medicines such as cyclosporine (Gengraf, Neoral, Sandimmune, and others)
• Prograf (tacrolimus)
• Rapamune (sirolimus)
• Methadone
• Mycobutin (rifabutin)
• Rifampin 
• cholesterol-lowering medicines such as Lipitor (atorvastatin), Pravachol (pravastatin sodium), and Zocor (simvastatin) 
• Zoloft (sertraline)
• Videx, Videx EC (didanosine) 
• tenofovir DF (a component of efavirenz/emtricitabine/tenofovir) 
• Reyataz (atazanavir sulfate) or Kaletra (lopinavir/ritonavir)
• Medicine for seizures [for example, Dilantin (phenytoin), Tegretol (carbamazepine), or phenobarbital]

This is not a complete list of efavirenz/emtricitabine/tenofovir drug interactions. Ask your doctor or pharmacist for more information.

Efavirenz/emtricitabine/tenofovir does not cure HIV infection. You can still spread HIV infection while taking efavirenz/emtricitabine/tenofovir. It is important to take precautions such as practicing safer sex and not sharing needles.

Some people who have taken medicine like efavirenz/emtricitabine/tenofovir (which contains nucleoside analogs) have developed a serious condition called lactic acidosis (build up of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your doctor right away if you get the following signs or symptoms of lactic acidosis:

• You feel very weak or tired.
• You have unusual (not normal) muscle pain.
• You have trouble breathing.
• You have stomach pain with nausea and vomiting.
• You feel cold, especially in your arms and legs.
• You feel dizzy or lightheaded.
• You have a fast or irregular heartbeat.

Some people who have taken medicines like efavirenz/emtricitabine/tenofovir have developed serious liver problems. Call your doctor right away if you get the following signs or symptoms of liver problems:

• Your skin or the white part of your eyes turns yellow (jaundice).
• Your urine turns dark.
• Your bowel movements (stools) turn light in color.
• You don't feel like eating food for several days or longer.
• You feel sick to your stomach (nausea).
• You have lower stomach area (abdominal) pain.

You may be more likely to get lactic acidosis or liver problems if you are female, very overweight (obese), or have been taking nucleoside analog-containing medicines, like efavirenz/emtricitabine/tenofovir, for a long time. If you also have hepatitis B virus (HBV) infection and you stop taking efavirenz/emtricitabine/tenofovir, you may get a "flare-up" of your hepatitis. A "flare-up" is when the disease suddenly returns in a worse way than before. Patients with HBV who stop taking efavirenz/emtricitabine/tenofovir need close medical follow-up for several months, including medical exams and blood tests to check for hepatitis that could be getting worse. Efavirenz/emtricitabine/tenofovir is not approved for the treatment of HBV, so you must discuss your HBV therapy with your doctor.

Do not take efavirenz/emtricitabine/tenofovir if you are allergic to efavirenz/emtricitabine/tenofovir or any of its ingredients. The active ingredients of efavirenz/emtricitabine/tenofovir are efavirenz, emtricitabine, and tenofovir DF.

• Women should not become pregnant while taking efavirenz/emtricitabine/tenofovir and for 12 weeks after stopping it. Serious birth defects have been seen in the babies of animals and women treated with efavirenz (a component of efavirenz/emtricitabine/tenofovir) during pregnancy. It is not known whether efavirenz caused these defects.
• Women should not rely only on hormone-based birth control, such as pills, injections, or implants, because efavirenz/emtricitabine/tenofovir may make these contraceptives ineffective. Women must use a reliable form of barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control. Efavirenz, a component of efavirenz/emtricitabine/tenofovir, may remain in your blood for a time after therapy is stopped. Therefore, you should continue to use contraceptive measures for 12 weeks after you stop taking efavirenz/emtricitabine/tenofovir.
• Do not breast-feed if you are taking efavirenz/emtricitabine/tenofovir. The Centers for Disease Control and Prevention recommend that mothers with HIV not breast-feed because they can pass the HIV through their milk to the baby. Also, efavirenz/emtricitabine/tenofovir may pass through breast milk and cause serious harm to the baby. 
• Taking efavirenz/emtricitabine/tenofovir with alcohol or other medicines causing similar side effects as efavirenz/emtricitabine/tenofovir, such as drowsiness, may increase those side effects.
• Do not take any other medicines, including prescription and nonprescription medicines and herbal products, without checking with your doctor.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of efavirenz/emtricitabine/tenofovir there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving efavirenz/emtricitabine/tenofovir, tell your doctor about all of your medical conditions including if you:

• Have kidney problems or are undergoing kidney dialysis treatment.
• Have bone problems.
• Have liver problems, including hepatitis B virus infection. Your healthcare provider may want to do tests to check your liver while you take efavirenz/emtricitabine/tenofovir or may switch you to another medicine.
• Have ever had mental illness or are using drugs or alcohol.
• Have ever had seizures or are taking medicine for seizures. 

Tell your doctor if you are pregnant or breastfeeding.

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. Women should not become pregnant while taking efavirenz/emtricitabine/tenofovir and for 12 weeks after stopping it. It is not known if efavirenz/emtricitabine/tenofovir will cause birth defects. Women should not rely only on hormone-based birth control, such as pills, injections, or implants, because efavirenz/emtricitabine/tenofovir may cause these contraceptives to become ineffective. Use of a condom or diaphragm (barrier contraception) is recommended even if other methods of birth control are used. Continue to use barrier method of contraception for at least 12 weeks after you stop taking efavirenz/emtricitabine/tenofovir.

Do not breastfeed if you are taking efavirenz/emtricitabine/tenofovir. Efavirenz/emtricitabine/tenofovir may pass through the breast milk and cause serious harm to your baby. Also, it is known that the HIV can pass through the breast milk, therefore breastfeeding while on efavirenz/emtricitabine/tenofovir is not recommended.

• Efavirenz/emtricitabine/tenofovir comes as a tablet to be taken by mouth on an empty stomach.
• Take efavirenz/emtricitabine/tenofovir with water at bedtime.
• Do not miss a dose of efavirenz/emtricitabine/tenofovir. If you forget to take efavirenz/emtricitabine/tenofovir, take the missed dose right away, unless it is almost time for your next dose. Do not double the next dose.
• Take efavirenz/emtricitabine/tenofovir every day. The amount of virus in your blood may increase if the medicine is stopped for even a short time.

The dose of efavirenz/emtricitabine/tenofovir is one tablet by mouth once daily taken on an empty stomach at bedtime. Take the exact amount of efavirenz/emtricitabine/tenofovir your doctor prescribes. Never change the dose on your own. Do not stop this medicine unless your doctor tells you to stop.

If you take too much efavirenz/emtricitabine/tenofovir call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If efavirenz/emtricitabine/tenofovir is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep efavirenz/emtricitabine/tenofovir and all other medicines out of reach of children.
• Store efavirenz/emtricitabine/tenofovir at room temperature.
• Keep efavirenz/emtricitabine/tenofovir in its original container and keep the container tightly closed.
• Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away make sure that children will not find them.

WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST-TREATMENT EXACERBATION OF HEPATITIS B