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Symfi Lo

Generic Name: efavirenz, lamivudine and tenofovir disoproxil fumarate
Dosage Form: Tablets
Date of Approval: February 5, 2018
Company: Mylan N.V.

Treatment for: HIV Infection

FDA Approves Symfi Lo

The U.S. Food and Drug Administration (FDA) has approved Symfi Lo (efavirenz, lamivudine and tenofovir disoproxil fumarate), a three-drug combination of a non-nucleoside reverse transcriptase inhibitor (efavirenz), and two nucleo(t)side reverse transcriptase inhibitors (lamivudine and tenofovir disoproxil fumarate) indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

Patient Information

Read this Patient Information carefully before you start treatment. This information does not take the place of talking with your doctor about your medical condition or your treatment.

Important information

Symfi Lo can cause serious side effects, including:

  • 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
    • unusual (not normal) muscle pain
    • trouble breathing
    • stomach pain with nausea or vomiting
    • feel cold, especially in your arms and legs
    • feel dizzy or lightheaded
    • have a fast or irregular heartbeat
  • 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 infection. 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.
    • 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 this medicine. Refill your prescription or talk to your healthcare provider before your Symfi Lo is all gone.
    • Do not stop treatment 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. 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 true or real and what is false or unreal

For more information about side effects, see Symfi Lo side effects.

What is Symfi Lo?

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 35 kg.

Who should not take Symfi Lo?

You should not take Symfi Lo if you:

  • are allergic to efavirenz, lamivudine, tenofovir disoproxil fumarate, or any of the other ingredients. See the end of this Patient Information leaflet for a complete list of ingredients.
  • are currently taking elbasvir and grazoprevir.

Before taking Symfi Lo

Before you start treatment, 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 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.
    • Females who are able to become pregnant should use effective birth control during treatment, 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 are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment.
    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.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take Symfi Lo.
    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
    • Talk to your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Some medicines interact with Symfi Lo. Symfi Lo may affect the way other medicines work, and vice versa. Keep a list of your medicines and show it to your healthcare provider and pharmacist whenyou get a new medicine.

  • You can ask your healthcare provider or pharmacist for a list of medicines that interact with Symfi Lo.
  • 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.

How should I take Symfi Lo?

  • Take this medicine exactly as your healthcare provider tells you to take it.
  • Take Symfi Lo one time each day, preferably at bedtime. Taking your dose at bedtime might help to make some of the side effects less bothersome.
  • Take the tablet on an empty stomach.
  • Do not miss a dose. If you miss a dose, take the missed dose as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time.
  • Stay under the care of your healthcare provider during treatment.
  • Do not run out of this medicine. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy.
  • If you take too much or overdose, go to the nearest hospital emergency room right away.

What should I avoid while taking Symfi Lo?

You should avoid taking medicines that contain sorbitol during treatment.

Symfi Lo side effects

Symfi Lo may cause serious side effects, including:

  • See Important information.
  • 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, 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
    • drowsiness
    • trouble sleeping
    • unusual dreams
    • hallucinations
    If you get nervous system symptoms during treatment, 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. If you are taking Symfi Lo and interferon alfa with or without ribavirin, tell your healthcare provider if you have any new symptoms.
  • 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.
  • 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.
  • Risk of inflammation of the pancreas (pancreatitis). Children may be at risk for developing pancreatitis during treatment 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.

The most common side effects of Symfi Lo are rash and dizziness.

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

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Symfi Lo?

  • Store the tablets below 86°F (30°C).
  • Keep the tablets in the original container.

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Symfi Lo

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for health professionals.

What are the ingredients in Symfi Lo?

Active ingredients: efavirenz, lamivudine, and tenofovir disoproxil fumarate

Inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, talc, titanium dioxide and yellow iron oxide.

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