Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate Tablets

What is this medication?

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE (e fa VEER ens; la ME vyoo deen; te NOE fo veer) helps manage the symptoms of HIV infection. It works by limiting the spread of HIV in the body. It is a combination of three antiretroviral medications. This medication is not a cure for HIV or AIDS and it may still be possible to spread HIV to others while taking it. It does not prevent other sexually transmitted infections (STIs).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): SYMFI, SYMFI LO

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bone problems
• Heart disease
• History of substance abuse
• History of depression or other mental health conditions
• Pancreatitis
• Seizures
• An unusual or allergic reaction to efavirenz, lamivudine, tenofovir, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take this medication on an empty stomach, at least 30 minutes before or 2 hours after food. Take your dose at bedtime.

For your therapy to work as well as possible, take each dose exactly as prescribed on the prescription label. Do not skip doses. Skipping doses can make the HIV virus resistant to this and other medications. Keep taking this therapy unless your care team tells you to stop.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Any medication that contains efavirenz, emtricitabine, lamivudine, tenofovir
• Disopyramide
• Elbasvir; grazoprevir
• Rifapentine
• Voriconazole

This medication may also interact with the following:

• Amiodarone
• Artemether; lumefantrine
• Atovaquone; proguanil
• Cyclosporine
• Certain antibiotics, such as clarithromycin, gentamicin, rifabutin, rifampin
• Estrogen or progestin hormones
• Medications for cholesterol, such as atorvastatin, pravastatin, simvastatin
• Medications for depression, anxiety, or mental health conditions, such as bupropion, sertraline
• Medications for fungal infections, such as ketoconazole, itraconazole, posaconazole
• Medications for heart rate and blood pressure, such as diltiazem, felodipine, nicardipine, nifedipine, verapamil
• Medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Medications for viral infections, such as adefovir, boceprevir, simeprevir, ledipasvir; sofosbuvir, pibrentasvir; glecaprevir, velpatasvir; sofosbuvir, velpatasvir; sofosbuvir; voxilaprevir, interferon, ribavirin, cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir
• Methadone
• NSAIDS, medications for pain and inflammation, such as ibuprofen or naproxen
• Other medications for HIV
• Red yeast rice
• Sirolimus
• Tacrolimus
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Discuss any new symptoms with your care team. You will need to have important blood work done while taking this medication.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

HIV is spread to others through sexual or blood contact. Talk to your care team about how to stop the spread of HIV.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

If you have hepatitis B and HIV, talk to your care team if you plan to stop this medication. The symptoms of hepatitis B may get worse if you stop this medication.

Estrogen and progestin hormones may not work as well while you are taking this medication. If you are using these hormones for contraception, talk to your care team about using a second type of contraception. A barrier contraceptive, such as a condom or diaphragm, is recommended.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• High lactic acid level—muscle pain or cramps, stomach pain, trouble breathing, general discomfort and fatigue
• Infection—fever, chills, cough, or sore throat
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Lipodystrophy—increased fat in the upper back or midsection, decreased fat in the face, arms, or legs
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Back pain
• Diarrhea
• Headache
• Nausea
• Stomach pain
• Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature below 30 degrees C (86 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.