Symfi

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

Call your doctor at once if you have swelling or pain in your upper stomach pain, unusual tiredness, loss of appetite, dark urine, clay-colored stools, or yellowing of the skin or eyes.

Symfi Lo may cause serious mental health problems. Get medical help if you have unusual sadness, paranoia, hallucinations, or thoughts about hurting yourself or others.

If you've ever had hepatitis B, it may become active or get worse after you stop using Symfi Lo. You may need frequent liver function tests for several months.

Avoid eating or drinking anything that contains sorbitol (an artificial sweetener).

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Call your doctor at once if you have:

• severe dizziness or drowsiness, trouble concentrating;

• fast or pounding heartbeats, shortness of breath, feeling like you might pass out;

• strange dreams, hallucinations;

• new or worsening bone pain;

• pain in your arms, legs, hands, or feet;

• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting;

• unusual thoughts--fear, paranoia, feeling sad or hopeless, thoughts of hurting yourself or others; or

• liver problems--swelling around your midsection, upper stomach pain, unusual tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Symfi Lo affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

• dizziness;

• rash; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 1.01.

Medical Disclaimer

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of too much lactic acid in the blood (lactic acidosis) like fast breathing, fast heartbeat, a heartbeat that does not feel normal, very bad upset stomach or throwing up, feeling very sleepy, shortness of breath, feeling very tired or weak, very bad dizziness, feeling cold, or muscle pain or cramps.
• Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Hallucinations (seeing or hearing things that are not there).
• Bone pain.
• Muscle pain or weakness.
• Pain in arms or legs.
• Seizures.
• Change in body fat.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• A type of abnormal heartbeat (prolonged QT interval) can happen with this drug. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Drug Interactions: Symfi may interact with many drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription, nonprescription medication, or herbal products, particularly St. John’s wort [see Contraindications (4) and Drug Interactions (7)].

Lactic Acidosis and Severe Hepatomegaly: Inform patients that lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Treatment with Symfi should be suspended in any patient who develops clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity (including nausea, vomiting, unusual or unexpected stomach discomfort, and weakness) [see Warnings and Precautions (5.1)].

Post Treatment Acute Exacerbation of Hepatitis B in Patients with HBV Co-Infection: Severe acute exacerbations of hepatitis have been reported in patients who are infected with HBV or coinfected with HBV and HIV-1 and have discontinued 3TC and TDF, components of Symfi. Test patients with HIV-1 for hepatitis B virus (HBV) before initiating antiretroviral therapy. In patients with chronic hepatitis B, it is important to obtain HIV antibody testing prior to initiating 3TC and TDF, components of Symfi [see Warnings and Precautions (5.2)].

New Onset or Worsening Renal Impairment: Inform patients that renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported. Advise patients with impaired renal function (i.e., creatinine clearance less than 50 mL/min) or patients with end-stage renal disease (ESRD) requiring hemodialysis to avoid Symfi with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple NSAIDs) for patients [see Dosage and Administration (2.3), Warnings and Precautions (5.4)].

Psychiatric Symptoms: Inform patients that serious psychiatric symptoms including severe depression, suicide attempts, aggressive behavior, delusions, paranoia, psychosis-like symptoms and catatonia have been reported in patients receiving EFV [see Warnings and Precautions (5.5)]. Advise patients to seek immediate medical evaluation if they experience severe psychiatric adverse experiences. Advise patients to inform their physician of any history of mental illness or substance abuse.

Nervous System Symptoms: Inform patients that central nervous system symptoms (NSS) including dizziness, insomnia, impaired concentration, drowsiness, and abnormal dreams are commonly reported during the first weeks of therapy with EFV, a component of Symfi [see Warnings and Precautions (5.6)]. Dosing at bedtime may improve the tolerability of these symptoms, which are likely to improve with continued therapy. Alert patients to the potential for additive effects when used concomitantly with alcohol or psychoactive drugs. Instruct patients that if they experience NSS they should avoid potentially hazardous tasks such as driving or operating machinery.

Embryo-Fetal Toxicity: Advise female patients that EFV, a component of Symfi may cause fetal harm when administered during the first trimester to a pregnant woman. Advise females of reproductive potential to use effective contraception as well as a barrier method during treatment with Symfi and for 12 weeks after discontinuation of use. Advise patients to contact their healthcare provider if they plan to become pregnant, become pregnant, or if pregnancy is suspected during treatment with Symfi [see Warnings and Precautions (5.7), Use in Specific Populations (8.1, 8.3)].

Rash: Inform patients that rash is a common side effect of EFV [see Warnings and Precautions (5.8)]. Rashes usually go away without any change in treatment. However, since rash may be serious, patients should be advised to contact their physician promptly if rash occurs.

Hepatotoxicity: Inform patients to watch for early warning signs of liver inflammation or failure, such as fatigue, weakness, lack of appetite, nausea and vomiting, as well as later signs such as jaundice, confusion, abdominal swelling, and discolored feces and to consult their healthcare provider promptly if such symptoms occur [see Warnings and Precautions (5.9)].

Risk of Hepatic Decompensation in Patients with HIV-1/HCV Co-Infection: Inform patients with HIV-1/HCV co-infection that hepatic decompensation (some fatal) has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin [see Warnings and Precautions (5.10)].

Pancreatitis: Advise patients or guardians to monitor pediatric patients for signs and symptoms of pancreatitis [see Warnings and Precautions (5.11)].

Convulsions: Advise patients that convulsions have been observed in patients receiving EFV, a component of Symfi, generally in patients with known medical history of seizures [see Warnings and Precautions (5.12)].

Lipid Elevations: Advise patients treatment with EFV, a component of Symfi has resulted in increases in the concentration of total cholesterol and triglycerides [see Warnings and Precautions (5.13)].

Decreases in Bone Mineral Density: Advise patients that decreases in bone mineral density have been observed with the use of 3TC and TDF, components of Symfi, in patients with HIV [see Warnings and Precautions (5.14)].

Immune Reconstitution Syndrome: Advise patients to inform their healthcare provider immediately of any symptoms of infection, as in some patients with advanced HIV infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started [see Warnings and Precautions (5.15)].

Fat Redistribution: Inform patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy, including Symfi, and that the cause and long‑term health effects of these conditions are not known at this time [see Warnings and Precautions (5.16)].

Administration Instructions: Inform patients that it is important to take Symfi once daily on a regular dosing schedule on an empty stomach, preferably at bedtime, and to avoid missing doses as it can result in development of resistance. Advise patients if a dose is missed, take it as soon as possible unless it is almost time for the next dose. Also advise patients that dosing at bedtime may improve the tolerability of nervous system symptoms [see Dosage and Administration (2.2)].

Pregnancy Registry: Advise patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes in women exposed to Symfi [see Use in Specific Populations (8.1)].

Lactation: Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in breast milk [see Use in Specific Populations (8.2)].

Other brands listed are the registered trademarks of their respective owners and are not trademarks of Mylan Laboratories Limited or Mylan Pharmaceuticals Inc.

Rx only

Manufactured for:
Mylan Specialty L.P.
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Laboratories Limited
Hyderabad 500 096, India

You should not use this Symfi if:

• you also take elbasvir and grazoprevir (for hepatitis C); or

• you are allergic to antiviral medicines that contain efavirenz, lamivudine, or tenofovir (such as Atripla, Combivir, Epivir, Sustiva, Trizivir, or Triumeq).

Tell your doctor if you have ever had:

• liver disease (especially hepatitis B or C); or

• kidney disease (or if you are on dialysis);

• mental illness or psychosis;

• heart problems;

• long QT syndrome (in you or a family member);

• drug or alcohol addiction;

• a seizure; or

• fractures or other problems with your bones.

Use effective birth control to prevent pregnancy while you are using Symfi and for at least 12 weeks after your last dose. Efavirenz, lamivudine, and tenofovir could harm an unborn baby or cause birth defects. You may need to have a negative pregnancy test before starting this treatment.

Use two forms of birth control to prevent pregnancy, including a barrier form such as a condom or a diaphragm with spermicide.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Symfi only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 1.02.

Medical Disclaimer

In the U.S.

• Symfi
• Symfi Lo

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Non-Nucleoside Reverse Transcriptase Inhibitor

Efavirenz, lamivudine, and tenofovir combination is used alone to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

This medicine does not cure or prevent HIV or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems that usually result from AIDS or HIV disease. It will not keep you from spreading HIV to other people. People who receive this medicine may continue to have some of the problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check you and your child's progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for any unwanted effects.

Do not use this medicine together with elbasvir/grazoprevir (Zepatier®).

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are using this medicine and for 12 weeks after the last dose. Some birth control pills may not work as well while you are using this medicine. Use birth control pills together with another form of birth control (eg, condoms, diaphragm, or contraceptive foam or jelly). If you think you have become pregnant while using the medicine, tell your doctor right away.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity. Call your doctor right away if you or child have abdominal or stomach discomfort, cramping, nausea, vomiting, diarrhea, or a decreased appetite, muscle cramping or pain, unusual tiredness or weakness, trouble breathing, or yellow skin or eyes.

This medicine may cause a hepatitis B infection to worsen if you stop using it. Your doctor may check for the presence of hepatitis B before and during treatment with this medicine and for at least several months after your last dose.

This medicine may increase the risk of kidney problems. To lower this risk, avoid other medicines that can be harmful to the kidneys such as aminoglycoside antibiotics, certain other antiviral medicines, and NSAID pain medicines.

You or your child might have mood or behavior changes with this medicine, such as feeling sad or hopeless, or getting upset easily. You could feel nervous or hostile, or have decreased awareness or responsiveness. Some people become violent and want to hurt themselves or others. Call your doctor right away if you or your child have any strange feelings, thoughts, or behaviors.

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert upon waking up. Do not drive or do anything else that could be dangerous unless you know how this medicine affects you.

Some people who have used this medicine developed serious skin problems. Call your doctor right away if you or your child notice a severe skin rash, blistering, peeling, or loosening of the skin, red skin lesions, sores or ulcers on the skin, or fever or chills while you or your child are using this medicine.

Check with your doctor right away if you or your child have loss of appetite, nausea, or pains in the stomach, side, or abdomen, possibly radiating to the back. These could be symptoms of pancreatitis (swelling of the pancreas).

This medicine may also increase your or your child's risk of developing fractures (broken bones). Ask your doctor about this if you have any concerns.

Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, and Guillain-Barré syndrome) may also occur.

This medicine may cause you to have excess body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

Contact your doctor right away if you or your child have any changes in heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Limit the amount of alcohol you drink.

Make sure any doctor or dentist who treats you knows that you or your child are using this medicine. This medicine may affect the results of certain medical tests.

This medicine does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contaminated blood. Make sure you understand and practice safe sex, even if your partner also has HIV. Avoid sharing needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (St. John's wort) or vitamin supplements.