Efavirenz, lamivudine, and tenofovir

Efavirenz, lamivudine, and tenofovir is a combination antiviral medicine that treats human immunodeficiency virus (HIV). HIV is the virus that may lead to acquired immunodeficiency syndrome (AIDS). Efavirenz, lamivudine, and tenofovir is not a cure for HIV or AIDS.

Symfi is for adults and children who weigh at least 88 pounds (40 kilograms).

Symfi Lo is for adults and children who weigh at least 77 pounds (35 kilograms).

Efavirenz, lamivudine, and tenofovir may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Efavirenz, lamivudine, and tenofovir is a complete regimen and is not for use with other antiviral medications.

Take this medicine on an empty stomach at bedtime.

You will need frequent medical tests.

Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store this medicine in the original container at room temperature, away from moisture and heat.

If you've ever had hepatitis B, this virus may become active or get worse in the months after you stop using this medicine. You may need frequent liver function tests for several months after your last dose.

If you have ever had hepatitis B, it could become active or worsen after you stop taking this medicine. You may need regular liver function tests for several months.

Do not change your dose or stop taking this medicine without your doctor's advice.

You should not use this medicine if:

• you also take elbasvir and grazoprevir (for hepatitis C); or
• you are allergic to any antiviral combination medicine that contains efavirenz, lamivudine, or tenofovir.

Tell your doctor if you have ever had:

• liver disease (especially hepatitis B or C); or
• kidney disease (or if you are on dialysis);
• heart problems;
• long QT syndrome (in you or a family member);
• drug or alcohol addiction;
• a seizure; or
• fractures or other problems with your bones.

You may develop lactic acidosis, which is a dangerous build-up of lactic acid in your blood. This may be more likely if you are overweight or if you are a woman. Ask your doctor about your risk.

You may need to have a negative pregnancy test before starting this treatment.

Do not use this medicine if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 12 weeks after your last dose.

Use two forms of birth control to prevent pregnancy, including a barrier form such as a condom, diaphragm, cervical cap, or contraceptive sponge.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of this medicine on the baby.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Efavirenz, lamivudine, and tenofovir may cause serious side effects. Call your doctor right away if you have:

• severe dizziness or drowsiness, trouble concentrating, strange dreams;
• confusion, thinking problems, seeing or hearing things that are not real (may occur months to years after you start taking this medicine);
• fast or pounding heartbeats, fluttering in your chest, and sudden dizziness (like you might pass out);
• problems with balance or coordination;
• new or worsening bone pain;
• pain in your arms, legs, hands, or feet;
• lactic acidosis--unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired;
• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting;
• unusual thoughts--fear, paranoia, feeling sad or hopeless, thoughts of hurting yourself or others; or
• liver problems--swelling around your midsection, upper stomach pain, unusual tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Symfi affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of efavirenz, lamivudine, and tenofovir may include:

• headache, dizziness;
• depression, thinking problems;
• nausea, diarrhea;
• sleep problems (insomnia);
• pain;
• weakness, tiredness;
• cough, stuffy nose, sinus pain;
• rash; 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.

Usual Adult Dose for HIV Infection:

1 tablet orally once a dayUse: As a complete regimen for the treatment of HIV-1 infection

Usual Pediatric Dose for HIV Infection:

1 tablet orally once a dayComments:-Symfi Lo(TM) is approved for patients weighing at least 35 kg.-Symfi(TM) is approved for patients weighing at least 40 kg.-Recommended for pediatric patients who can swallow a solid tabletUse: As a complete regimen for the treatment of HIV-1 infection

Take the medicine as soon as you can, but if it’s almost time for your next dose, skip the missed dose. Do not take two doses at the same time.

Make sure to get your prescription refilled before you run out of medicine completely.

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

• Avoid eating or drinking anything that contains sorbitol (an artificial sweetener).

• Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Sometimes, it is not safe to take certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medications less effective.

Many drugs can affect efavirenz, lamivudine, and tenofovir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are included here. Inform your doctor about all your current medicines and any medicine you begin or stop using.

• What is the difference between HIV treatments Symfi and Symfi Lo?
• What drugs are contained in the HIV treatment Symfi Lo?