Efavirenz / Lamivudine / Tenofovir Disoproxil FumarateBrand Name: Symfi Other Names: EFV/3TC/TDF Drug Class: Combination Drugs
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What are the most important things to know about Symfi?
Symfi can cause serious, life-threatening side effects. These include a buildup ofin the blood ( ), severe 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
Some people taking Symfi have had liver problems. Your liver may become large () and you may develop fat in your liver (steatosis). Inflammation of the liver ( ) leading to liver failure requiring a liver transplant has been reported in some people taking Symfi. Liver function tests may be done before and during treatment with Symfi.
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 ( )
- Dark-colored urine
- Light-colored bowel movements
- Loss of appetite for several days or longer
- Nausea and vomiting
- Pain, aching, or tenderness on the right side of your stomach area
- Stomach (abdomen) swelling
If you have both HIV and(HBV) and take Symfi, your HBV may get worse (flare up) if you stop taking Symfi. To help avoid this, take Symfi exactly as prescribed. Do not run out of Symfi or stop taking Symfi without talking to your health care provider.
Worsening of liver disease (sometimes resulting in death) has occurred in people being treated for ribavirin. If you are taking Symfi and interferon alfa with or without ribavirin and you have any new symptoms, tell your health care provider.(HCV) taking HIV medicines and alfa with or without
Some people taking Symfi have developed new or worse kidney problems, including kidney failure. Your health care provider may do blood and urine tests to check yourbefore and during treatment with Symfi.
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
- 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, you should not take other HIV medicines.
While taking Symfi, it is important to keep all of your appointments with your health care provider.
What is Symfi?
Symfi is a prescription medicine approved by the U.S.(FDA) for the treatment of HIV infection in adults and children weighing at least 88 lb (40 kg).
Symfi is a complete regimen for the treatment of HIV infection and should not be used with other HIV medicines.Symfi contains the following three different medicines combined in one tablet:
- Efavirenz – an HIV medicine called a (NNRTI)
- Lamivudine – an HIV medicine called a (NRTI)
- Tenofovir disoproxil fumarate – another HIV medicine (also an NRTI)
NNRTIs and NRTIs attach to and block an HIVcalled . 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) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV . If you are taking HIV medicines, including Symfi, 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?
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 or have ever had liver problems, including HBV infection or HCV infection.
- If you have or have ever had kidney problems, including (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 or have ever had heart problems, including QT prolongation.
- If you have or have ever had 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 may harm your unborn baby. You should not become pregnant during treatment with Symfi. Tell your healthcare provider right away if you think you may be pregnant or become pregnant during treatment with Symfi.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking Symfi.
- If you are using HIV and Birth Control infographic. -based birth control (such as pills, implants, or vaginal rings). You should use effective birth control during treatment with Symfi 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
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products 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?
Symfi comes in tablet form. Each tablet contains:
- 600 mg efavirenz (brand name: Sustiva)
- 300 mg lamivudine (brand name: Epivir)
- 300 mg tenofovir disoproxil fumarate (brand name: Viread)
Take Symfi according to your health care provider’s instructions.
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 take 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?
If you miss aof 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?
Symfi 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 can be serious. Serious side effects of Symfi 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?)Other possible side effects of Symfi include:
- Nervous system symptoms (including dizziness, trouble concentrating, drowsiness, trouble sleeping, unusual dreams, and hallucinations). Some nervous system symptoms (e.g., confusion, slow thoughts and physical movement, and delusions [false beliefs] or hallucinations [seeing or hearing things that others do not see or hear]) may occur months to years after beginning treatment with efavirenz, a component of Symfi. Contact your health care provider if you experience any of these symptoms.
- 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 ( ). 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.
- Increases in blood fats levels, such as and . Your health care provider will check your blood fat levels before and during treatment with Symfi.
- Bone problems (bone pain, softening or thinning).
- Changes in your (called 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 ( ).
- 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.
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 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?
- 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?
More information about Symfi is available:
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: March 28, 2019