Drug information

What are the most important things to know about Symfi Lo?What are the most important things to know about Symfi Lo?

What are the most important things to know about Symfi Lo?

Symfi Lo can cause serious, life-threatening side effects. These include a buildup of lactic acid in the blood (lactic acidosis), severe liver problems, new or worse kidney problems, and mental health problems.

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

  • Feeling very weak or tired
  • Unusual (not normal) muscle pain
  • Trouble breathing
  • Stomach pain with nausea or vomiting
  • Feeling cold, especially in your arms and legs
  • Feeling dizzy or lightheaded
  • Fast or irregular heartbeat

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
  • Confusion
  • Tiredness
  • Loss of appetite for several days or longer
  • Nausea and vomiting
  • Pain, aching, or tenderness on the right side of your stomach area
  • Weakness
  • Stomach (abdomen) swelling

If you have both HIV and hepatitis B virus infection (HBV) and take Symfi Lo, your HBV infection may get much worse (flare up) if you stop taking Symfi Lo. Do not stop taking Symfi Lo 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 kidney problems:

  • Bone pain that does not go away or worsening bone pain
  • Pain in your arms, hands, legs, or feet
  • Broken (fractured) 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

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

What is Symfi Lo?What is Symfi Lo?

What is Symfi Lo?

Symfi Lo 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 77 lb (35 kg).

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

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

HIV medicines can't 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, don't 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 Lo?What should I tell my health care provider before taking Symfi Lo?

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

Before taking Symfi Lo, tell your health care provider:

  • If you are allergic to any of the HIV medicines in Symfi Lo (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 heart problems, 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. You should not become pregnant during treatment with Symfi Lo because Symfi Lo may harm your unborn baby. Tell your health care provider right away if you think you may be pregnant or become pregnant during treatment with Symfi Lo.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking Symfi Lo.
  • If you are using hormone-based birth control (such as pills, implants, or vaginal rings). You should use effective birth control during treatment with Symfi Lo and for 12 weeks after stopping treatment. A barrier form of birth control should always be used along with hormone-based birth control. For more information about using birth control and HIV medicines at the same time, view the ClinicalInfo HIV and Birth Control infographic.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Symfi Lo may affect the way other medicines or products work, and other medicines or products may affect how Symfi Lo works. Taking Symfi Lo together with certain medicines or products may cause serious side effects. Symfi Lo should not be taken with elbasvir / grazoprevir.

How should I take Symfi Lo?How should I take Symfi Lo?

How should I take Symfi Lo?

Symfi Lo comes in tablet form. Each tablet contains:

Take Symfi Lo according to your health care provider’s instructions.

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

If you take too much Symfi Lo, 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 Lo, 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 Lo, 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 Lo cause?What side effects can Symfi Lo cause?

What side effects can Symfi Lo cause?

Symfi Lo may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the ClinicalInfo fact sheet on HIV Medicines and Side Effects for more information.

Some side effects of Symfi Lo can be serious. Serious side effects of Symfi Lo include a buildup of lactic acid in the blood (lactic acidosis), severe liver problems, new or worse kidney problems, and mental health problems. (See section above: What are the most important things to know about Symfi Lo?)

Other possible side effects of Symfi Lo include:
  • Nervous system symptoms (including dizziness, trouble concentrating, drowsiness, trouble sleeping, unusual dreams, and hallucinations).
  • Skin reactions and allergic reactions. Contact your health care provider right away if you develop a rash or a rash with itching, fever, swelling of your face, blisters or skin lesions, peeling skin, mouth sores, or red or inflamed eyes.
  • Inflammation of the pancreas (pancreatitis). Some children may be at risk of developing pancreatitis while taking Symfi Lo. Contact your health care provider right away if your child develops signs and symptoms of pancreatitis, including severe upper stomach-area pain, with or without nausea and vomiting.
  • Seizures.
  • Increases in blood fat levels, such as cholesterol and triglycerides.
  • Bone problems (bone pain, softening or thinning).
  • 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 Lo.

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 Lo. To learn more about possible side effects of Symfi Lo, 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 Lo be stored?How should Symfi Lo be stored?

How should Symfi Lo be stored?

  • Store Symfi Lo below 86°F (30°C).
  • Keep Symfi Lo 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 Lo if the original seal over the container opening is broken or missing.
  • Throw away Symfi Lo that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep Symfi Lo and all medicines out of reach of children.

Where can I find more information about Symfi Lo?Where can I find more information about Symfi Lo?

Where can I find more information about Symfi Lo?

More information about Symfi Lo is available:

Manufacturer Information

Mylan

Main number: 724-514-1800
Patient assistance: 877-446-3679

Robert J. Coury Global Center
1000 Mylan Blvd.
Canonsburg, PA 15317

The above Patient Version drug summary is based on the following FDA label(s): Tablet.

Last Reviewed: April 17, 2020