Drug information

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Brand Name
Symfi
Other Names
EFV/3TC/TDF
Drug Class
Combination Drugs
Non-Nucleoside Reverse Transcriptase Inhibitor (efavirenz)
Nucleoside Reverse Transcriptase Inhibitor (lamivudine, tenofovir DF)
Drug Image(s): (Click to enlarge)
 
What are the most important things to know about Symfi?What are the most important things to know about Symfi?

What are the most important things to know about Symfi?

Symfi can cause serious, life-threatening side effects. These include a buildup of lactic acid in the blood (lactic acidosis), liver problems, new or worsening kidney problems, including kidney failure, mental health problems, and severe skin rash and allergic reactions.

Contact your health care provider right away if you have any of the following symptoms that could be signs of lactic acidosis:

  • Weakness or tiredness
  • Unusual muscle pain
  • Shortness of breath or fast breathing
  • Stomach pain with nausea and vomiting
  • Cold or blue hands and feet
  • Dizziness or lightheadedness
  • Fast or abnormal heartbeat

Some people taking efavirenz, a component of Symfi, may develop liver problems. People with a history of hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV) or who have elevated results on liver function tests may have an increased risk of developing new or worsening liver problems while taking Symfi. Liver problems have also occurred in people without a history of liver problems or other risk factors.

Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:

  • Yellowing of your skin or the whites of your eyes (jaundice)
  • Dark-colored urine
  • Light-colored bowel movements
  • Loss of appetite for several days or longer
  • Nausea or vomiting
  • Pain, aching, or tenderness on the right side of your stomach/abdominal area
  • Itching

If you have both HIV and HBV and take Symfi, your HBV infection may get much worse (flare up) if you stop taking Symfi. Do not stop taking Symfi without first talking to your health care provider.

Contact your health care provider right away if you have any of the following symptoms that could be signs of a worsening kidney problem (called Fanconi Syndrome), which may be related to tenofovir-containing drugs:

  • Bone pain that does not go away or gets worse
  • Pain in your arms, hands, legs or feet
  • Broken bones
  • Muscle pain or weakness

Contact your health care provider right away if you have any of the following symptoms that could be signs of mental health problems:

  • Feeling sad or hopeless
  • Feeling anxious or restless
  • Not trusting other people
  • Hearing or seeing things that are not real
  • Not being able to move or speak normally
  • Harming yourself or others, or having thoughts about harming yourself (including suicidal thoughts)
  • Not being able to tell the difference between what is true or real and what is false or unreal

Contact your health care provider right away if you develop a rash while taking Symfi. Stop taking Symfi and get medical help right away if you develop a rash with any of the following symptoms:

  • General ill feeling
  • Extreme tiredness
  • Muscle or joint aches
  • Fever
  • Blistering or peeling skin
  • Blisters or sores in your mouth
  • Redness or swelling of the eyes (conjunctivitis)
  • Swelling of your face, lips, mouth, tongue or throat
  • Trouble breathing or swallowing

While taking Symfi, it is important to keep all of your appointments with your health care provider.

What is Symfi?What is Symfi?

What is Symfi?

Symfi is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children weighing at least 88 lb (40 kg).

Symfi is a complete HIV treatment regimen and should not be used with other HIV medicines.

Symfi contains three different medicines: efavirenz, lamivudine, and tenofovir disoproxil fumarate.

For more information on the use of Symfi in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.

HIV medicines cannot cure HIV/AIDS, but taking HIV medicines every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, do not cut down on, skip, or stop taking them unless your health care provider tells you to.

What should I tell my health care provider before taking Symfi?What should I tell my health care provider before taking Symfi?

What should I tell my health care provider before taking Symfi?

Before taking Symfi, tell your health care provider:

  • If you are allergic to any of the HIV medicines in Symfi (efavirenz, lamivudine, and tenofovir disoproxil fumarate) or any other medicines.
  • If you have liver problems, including HBV infection or HCV infection.
  • If you have kidney problems, including end-stage renal disease (ESRD) that requires dialysis.
  • If you have a history of mental health problems.
  • If you have a history of drug or alcohol abuse.
  • If you have a heart problem, including QT prolongation.
  • If you have bone problems, including a history of bone fractures.
  • If you have a history of seizures.
  • If you have any other medical conditions.
  • If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of taking Symfi during pregnancy. For more information on the use of Symfi during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
  • If you are breastfeeding or plan to breastfeed. For women with HIV in the United States, the Guideline does not recommend breastfeeding. Before your baby is born, or if you are already breastfeeding, talk to your health care provider to discuss alternative options for feeding your baby.
  • If you are using hormone-based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the HIVinfo HIV and Birth Control infographic.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (particularly St. John's wort) you are taking or plan to take. Symfi may affect the way other medicines or products work, and other medicines or products may affect how Symfi works. Taking Symfi together with certain medicines or products may cause serious side effects.
How should I take Symfi?How should I take Symfi?

How should I take Symfi?

Symfi comes in tablet form. Each tablet contains:

Take Symfi according to your health care provider’s instructions. Do not miss a dose of Symfi, and do not change your dose or stop taking Symfi without first talking with your health care provider.

Take Symfi on an empty stomach and preferably at bedtime. Taking Symfi at bedtime might help to make some of the side effects less bothersome.

If you have taken too much Symfi, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.

For more information on how to take Symfi, see the FDA drug label.

What should I do if I forget a dose?What should I do if I forget a dose?

What should I do if I forget a dose?

If you miss a dose of Symfi, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.

What side effects can Symfi cause?What side effects can Symfi cause?

What side effects can Symfi cause?

Symfi may cause side effects. Some side effects of Symfi can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.

Other possible side effects of Symfi include:
  • Nervous system symptoms (including dizziness, trouble concentrating, drowsiness, trouble sleeping, unusual dreams, lack of coordination or balance, delusions, and hallucinations).
  • Inflammation of the pancreas (pancreatitis) in some children. Contact your health care provider right away if your child develops signs and symptoms of pancreatitis, including severe pain in the upper stomach/abdominal area, with or without nausea and vomiting.
  • Seizures, which are more likely to happen if you have had seizures in the past.
  • Increases in blood fat levels, such as cholesterol and triglycerides.
  • Bone problems, including bone pain, or softening or thinning of the bones (osteopenia), which may lead to fractures.
  • Changes in your immune system (called immune reconstitution inflammatory syndrome or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
  • Changes in body fat (lipodystrophy syndrome).
  • QT prolongation, which is a heart disorder that causes irregular heartbeats. QT prolongation can be life-threatening. Contact your health care provider if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast during treatment with Symfi.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Symfi. To learn more about possible side effects of Symfi, read the drug label or package insert or talk to your health care provider or pharmacist.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.

How should Symfi be stored?How should Symfi be stored?

How should Symfi be stored?

  • Store Symfi below 86°F (30°C).
  • Keep Symfi in the container that it came in and keep the container tightly closed. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture.
  • Do not use Symfi if the original seal over the container opening is broken or missing.
  • Throw away Symfi that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep Symfi and all medicines out of reach of children.
Where can I find more information about Symfi?Where can I find more information about Symfi?

Where can I find more information about Symfi?

Manufacturer Information

Mylan

Main number: 724-514-1800
Patient assistance: 800-796-9526 

 

 

Last Reviewed: April 13, 2022