Boxed WARNING and
Important Safety Information

SYMFI LO is a prescription medicine approved for the treatment of HIV-1 infected adults and children weighing at least 35 kg (77 lbs). Each tablet contains three drugs – Efavirenz (400 mg), Lamivudine (300 mg), and Tenofovir disoproxil fumarate (300 mg).

SYMFI LO is not a cure for HIV-1 infection or AIDS. You may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using SYMFI LO.

Ask your doctor if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids. Never reuse or share needles or other items that have body fluids on them.

IMPORTANT SAFETY INFORMATION

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WARNING: POST TREATMENT WORSENING OF HEPATITIS B

If you have Human Immunodeficiency Virus type 1 (HIV-1) and hepatitis B Virus (HBV) infection, your HBV may get worse (flare-up) if you stop taking SYMFI LO. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. Your healthcare provider will test you for HBV infection before you start treatment with SYMFI LO.

INDICATION

SYMFI LO is a prescription medicine that is used without other antiviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in people weighing at least 35 kg. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). SYMFI LO contains the prescription medicines efavirenz, lamivudine and tenofovir disoproxil fumarate. SYMFI LO is not for use in children weighing less than 35kg.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SYMFI LO?

SYMFI LO can cause serious side effects:

Too much lactic acid in your blood (lactic acidosis). Lactic acidosis is a serious medical emergency that can lead to death. Tell your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis: feel very weak or tired, feel cold especially in your arm and legs, unusual (not normal) muscle pain, feel dizzy or lightheaded, trouble breathing, have a fast or irregular heartbeat, stomach pain with nausea or vomiting

Severe liver problems. In some cases, severe liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Inflammation of your liver (hepatitis) that can lead to liver failure requiring a liver transplant has been reported in some people treated with SYMFI LO. Your healthcare provider may do blood tests to check your liver before and during treatment.

Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems: your skin or the white part of your eyes turns yellow (jaundice), dark or “tea-colored” urine, light-colored stools (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.

Worsening of hepatitis B (HBV) infection. If you have Human Immunodeficiency Virus type 1 (HIV-1) and HBV infection, your HBV may get worse (flare-up) if you stop taking SYMFI LO. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. Your healthcare provider will test you for HBV infection before you start treatment with SYMFI LO.

  • It is not known if SYMFI LO is safe and effective in people who have both HIV-1 and HBV infection.
  • Do not run out of SYMFI LO. Refill your prescription or talk to your healthcare provider before your SYMFI LO is all gone.
  • Do not stop SYMFI LO without first talking to your healthcare provider. If you stop taking SYMFI LO, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver.

New or worse kidney problems, including kidney failure. Your healthcare provider may do blood and urine tests to check your kidneys before and during treatment with SYMFI LO. Tell your healthcare provider if you get signs and symptoms of kidney problems, including 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.

Serious mental health problems. Get medical help right away if you get any of the following symptoms: feel sad or hopeless, feel anxious or restless, do not trust other people, hear or see things that are not real, are not able to move or speak normally, have thoughts of hurting yourself (suicide) or have tried to hurt yourself or others, are not able to tell the difference between what is real and what is false or unreal.

Do not take SYMFI LO if you: are allergic to efavirenz, lamivudine, tenofovir disoproxil fumarate, or any of the ingredients in SYMFI LO or are currently taking elbasvir and grazoprevir commonly known as Zepatier®.

Before you take SYMFI LO, tell your healthcare provider about all of your medical conditions, including if you: have liver problems, including hepatitis B or C infection, have kidney problems, including end-stage renal disease (ESRD) that requires dialysis, have a history of mental health problems, have a history of drug or alcohol abuse, have a heart problem, including QT prolongation, have bone problems, including a history of bone fractures, have a history of seizures, are breastfeeding or plan to breastfeed, 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. Females who can become pregnant 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. If you can become pregnant, your healthcare provider should do a pregnancy test before you start SYMFI LO.

Pregnancy Registry. There is a pregnancy registry for women who take SYMFI LO during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take SYMFI LO with other medicines.

What are the possible side effects of SYMFI LO?

SYMFI LO may cause serious side effects, including:

See “What is the most important information I should know about SYMFI LO?”

Nervous system symptoms are common in people who take SYMFI LO, but can be severe. These symptoms usually begin during the first or second day of treatment with SYMFI LO and usually go away after 2 to 4 weeks of treatment. These symptoms may become worse if you drink alcohol or take a medicine for mental health problems. Symptoms may include: dizziness, trouble concentrating, trouble sleeping, unusual dreams, drowsiness, hallucinations. If you get nervous system symptoms during treatment with SYMFI LO, you should avoid driving, operating machinery, or doing anything that needs you to be alert.

Skin reactions and allergic reactions. Skin reactions or rash can happen and can sometimes be severe. Skin rash usually goes away without any change in treatment. If you develop a rash or a rash with any of the following symptoms, call your healthcare provider right away: itching, fever, swelling of your face, blisters or skin lesions, peeling skin, mouth sores, red or inflamed eyes.

Use with interferon and ribavirin-based regimens. Worsening of liver disease that has caused death has happened in people infected with HIV-1 and hepatitis C virus who were taking antiretroviral medicines for HIV-1 and were also being treated for hepatitis C with interferon alfa with or without ribavirin.

Seizures. Seizures are more likely to happen if you have had seizures in the past.

Increases in blood fat levels (cholesterol and triglycerides). Your healthcare provider will check your blood fat levels before and during treatment with SYMFI LO.

Bone problems can happen in some people who take SYMFI LO. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do tests to check your bones. Tell your healthcare provider if you have any bone pain, pain in your hands or feet, or muscle pain or weakness during treatment with SYMFI LO.

Risk of inflammation of the pancreas (pancreatitis). Children may be at risk for developing pancreatitis during treatment with SYMFI LO if they: have taken nucleoside analogue medicines in the past, have a history of pancreatitis, have other risk factors for pancreatitis. Call your healthcare provider right away if your child develops signs and symptoms of pancreatitis including severe upper stomach-area pain, with or without nausea and vomiting. Your healthcare provider may tell you to stop giving SYMFI LO to your child if their symptoms and blood test results show that your child may have pancreatitis.

Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting your HIV-1 medicine.

Changes in body fat can happen in some people who take HIV-1 medicines. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known.

Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Tell your healthcare provider if you feel faint, lightheaded, dizzy, or feel your heart beating irregularly or fast during treatment with SYMFI LO.

The most common side effects of SYMFI LO are rash and dizziness. These are not all the possible side effects of SYMFI LO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch

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