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Efavirenz / Lamivudine / Tenofovir Disoproxil Fumarate

Efavirenz / Lamivudine / Tenofovir Disoproxil Fumarate

Brand Name: Symfi Lo Other Names: EFV/3TC/TDF Drug Class: Combination Drugs

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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 and vomiting
  • Feeling cold, especially in your arms and legs
  • Feeling dizzy or lightheaded
  • Fast or irregular heartbeat

Some people taking Symfi Lo have had liver problems. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Inflammation of the liver (hepatitis) leading to liver failure requiring a liver transplant has been reported in some people taking Symfi Lo. Liver function tests may be done before and during treatment with Symfi Lo.

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
  • Feeling sick to your stomach (nausea)
  • Pain, aching, or tenderness on the right side of your stomach area
  • Weakness
  • Stomach swelling

If you have both HIV and hepatitis B virus infection (HBV) and take Symfi Lo, your HBV infection may get worse (flare up) if you stop taking Symfi Lo. To help avoid this, take Symfi Lo exactly as prescribed. Do not run out of Symfi Lo or stop taking Symfi Lo without talking to your health care provider.

Worsening of liver disease (sometimes resulting in death) has occurred in people being treated for hepatitis C virus infection (HCV) taking HIV medicines and interferon alfa with or without ribavirin. If you are taking Symfi Lo and interferon alfa with or without ribavirin and you have any new symptoms, tell your health care provider.

Some people taking Symfi Lo have developed new or worse kidney problems, including kidney failure. Your health care provider may do blood and urine tests to check your kidneys before and during treatment with Symfi Lo.

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 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
  • Having thoughts of hurting yourself (suicide) or having tried to hurt yourself or others
  • Not being able to tell the difference between what is true or real and what is false or unreal

If you take Symfi Lo, you should not take other HIV medicines.

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?

Symfi Lo is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) to treat HIV infection in adults and children weighing at least 77 pounds (35 kg).

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

Symfi Lo contains the following three different medicines combined in one pill:

NNRTIs and NRTIs attach to and block an HIV enzyme called reverse transcriptase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking reverse transcriptase, these three drugs work in combination to prevent HIV from multiplying and can reduce the amount of HIV in the body.

HIV medicines can’t cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) 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, including Symfi Lo, 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?

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.
  • 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. Symfi Lo may harm your unborn baby. You should not become pregnant during treatment with Symfi Lo. Tell your healthcare 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 another type of birth control. For more information about using birth control and HIV medicines at the same time, view the AIDSinfo 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.

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 from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)

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?

Symfi Lo may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the AIDSinfo 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 the WARNING box above.)

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 the face, blisters or skin lesions, peeling skin, mouth sores, or red or inflamed eyes.
  • Seizures.
  • Increases in blood fats levels, such as cholesterol and triglycerides. Your health care provider will check your blood fat levels before and during treatment with Symfi Lo.
  • Bone problems (bone pain, softening or thinning).
  • Inflammation of the pancreas (pancreatitis). 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.
  • 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 (including gain or loss of fat).
  • Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that 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 at https://www.accessdata.fda.gov/scripts/medwatch/.

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?

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 4, 2018

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