Efavirenz (ef-a-VYE-renz), Lamivudine (la-MIV-ue-deen), Tenofovir Disoproxil Fumarate (ten-OF-oh-vir dye-soe-PROX-il FUE-ma-rate)

Treats HIV infection. HIV causes AIDS. This medicine does not cure HIV or AIDS, but combinations of drugs may slow the progress of the disease.

Brand Name(s):

Symfi, Symfi Lo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take this medicine at the same time each day, preferably at bedtime. This may help lessen the side effects symptoms.
• Do not stop using this medicine without checking first with your doctor. If you stop the medicine even briefly, the virus may become harder to treat. Contact your doctor or pharmacist when your supply is running low so you do not run out.
• It is best to take this medicine on an empty stomach.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the medicine in its original container. Keep the bottle tightly closed.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with elbasvir/grazoprevir.
• Some medicines can affect how efavirenz/lamivudine/tenofovir works. Tell your doctor if you are using any of the following:
  • Acyclovir, adefovir, boceprevir, cidofovir, cyclosporine, ganciclovir, ledipasvir/sofosbuvir, methadone, pibrentasvir/glecaprevir, rifabutin, rifampin, simeprevir, sirolimus, sorbitol, St John's wort, tacrolimus, trimethoprim, valacyclovir, valganciclovir, velpatasvir/sofosbuvir, velpatasvir/sofosbuvir/ voxilaprevir
  • Birth control pills and implants
  • Blood pressure medicine (including diltiazem, felodipine, nicardipine, nifedipine, verapamil)
  • Blood thinner (including warfarin)
  • Medicine to treat depression (including bupropion, sertraline)
  • Medicine to treat an infection (including clarithromycin, gentamicin, itraconazole, ketoconazole, posaconazole)
  • Medicine to treat malaria (artemether/lumefantrine, atovaquone/proguanil)
  • Medicine to treat seizures (including carbamazepine, phenobarbital, phenytoin)
  • NSAID or pain reliever medicine
  • Statin medicine (including atorvastatin, pravastatin, simvastatin)
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Use 2 forms of birth control during treatment with this medicine and for at least 12 weeks after your last dose. Use a barrier method plus another type, such as birth control pills. Talk with your doctor about what choice is best for you.
• Tell your doctor if you have kidney disease, liver disease (including hepatitis B or C), high cholesterol, heart rhythm problems, or a history of bone problems (including osteoporosis), pancreas problems, seizures, mental illness, or drug abuse. Tell your doctor if you drink alcohol.
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may cause the following problems:
  • Lactic acidosis (too much acid in the blood)
  • Liver problems
  • Worsening of hepatitis B infection (if the medicine is stopped)
  • New or worsening kidney problem
  • Changes in mood or behavior
  • Serious skin reactions
  • Pancreatitis (swelling of the pancreas)
  • Seizures
  • Lower bone mineral density
  • Changes in heart rhythm
• Your immune system may get stronger when you start taking HIV medicines. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health.
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Always practice safe sex, even if your partner also has HIV. If you stop taking this medicine or do not take it as prescribed, you may spread HIV to others. Do not reuse or share needles, or other items, that may have blood or body fluids on them.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, anger, aggression, depression, seeing or hearing things that are not there, thoughts of hurting yourself or others
• Behavior or mood changes, paranoid or manic behavior
• Blistering, peeling, red skin rash
• Bone, joint, or muscle pain
• Change in how much or how often you urinate
• Confusion, trouble concentrating, trouble sleeping, slow thoughts and movements
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast or troubled breathing, lightheadedness, severe weakness, tiredness, confusion
• Fast, pounding, or uneven heartbeat
• Seizures
• Severe sleepiness, decreased awareness or responsiveness
• Sudden and severe stomach pain, fever

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Headache
• Weight gain around your neck, upper back, breast, or waist

If you notice other side effects that you think are caused by this medicine, tell your doctor

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