Emtricitabine, rilpivirine, and tenofovir

Emtricitabine, rilpivirine, and tenofovir are antiviral medicines that prevent human immunodeficiency virus (HIV) from multiplying in your body.

Emtricitabine, rilpivirine, and tenofovir is a combination medicine used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS.

This medicine is for use in adults and children who are at least 12 years old and who have never taken HIV medicines before.

Emtricitabine, rilpivirine, and tenofovir should not be taken together with other antiviral medications to treat HIV or AIDS.

Emtricitabine, rilpivirine, and tenofovir may also be used for purposes not listed in this medication guide.

There are many other drugs that can make rilpivirine less effective and should not be used at the same time. Tell your doctor about all your the medicines you use.

This medicine may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

If you have hepatitis B you may develop liver symptoms after you stop taking this medicine. Your doctor may want to check your liver function for several months after you stop using this medicine.

You should not take this medicine if you are allergic to emtricitabine, rilpivirine, or tenofovir.

Do not take this medicine with other medicines that also contain emtricitabine, rilpivirine, tenofovir, adefovir, or lamivudine.

There are many other drugs that can make rilpivirine less effective and should not be used at the same time:

• dexamethasone;

• St. John's wort;

• tuberculosis medication--rifabutin, rifampin, rifapentine;

• seizure medicine--carbamazepine, oxcarbazepine, phenobarbital, phenytoin; or

• stomach acid reducers--dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• kidney disease;

• liver disease (including hepatitis B or C);

• a history of depression or mental illness;

• a personal or family history of Long QT syndrome; or

• osteoporosis, or osteopenia (low bone mineral density).

Some people taking tenofovir develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.

HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection. Tell your doctor if you become pregnant during treatment. If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of the medicine on the baby.

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.

This medicine is not approved for use by anyone younger than 12 years old.

Taking this medicine will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

If you also take an antacid, take it at least 2 hours before or 4 hours after taking Complera or Odefsey. If you also take a heartburn or GERD medicine (such as Tagamet, Pepcid, Zantac), take it at least 12 hours before or 4 hours after taking Complera or Odefsey.

In the U.S.

• Complera

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

Emtricitabine, rilpivirine, and tenofovir combination is used to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). emtricitabine, rilpivirine, and tenofovir is usually given to patients who have not received any HIV treatment in the past.

emtricitabine, rilpivirine, and tenofovir will not cure HIV infection or AIDS. It works by lowering the amount of HIV in the blood and it will also help your immune system. This may help delay some of the medical conditions that usually result from AIDS or HIV disease. It will not keep you from spreading HIV to other people.

emtricitabine, rilpivirine, and tenofovir is available only with your doctor's prescription.

Applies to emtricitabine / rilpivirine / tenofovir: oral tablet

Along with its needed effects, emtricitabine / rilpivirine / tenofovir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking emtricitabine / rilpivirine / tenofovir:

• Discouragement
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• mental depression
• thoughts of killing oneself
• tiredness
• trouble concentrating
• trouble sleeping

• Body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• cough
• difficulty with breathing
• ear congestion
• fever or chills
• headache
• loss of voice
• runny or stuffy nose
• sneezing
• sore throat
• tightness in the chest
• unsteadiness or awkwardness
• unusual tiredness or weakness
• weakness in the arms, hands, legs, or feet

• Abdominal or stomach discomfort
• agitation
• bloating
• bloody or cloudy urine
• bone pain
• confusion
• constipation
• dark urine
• decreased appetite
• decreased urination
• diarrhea
• difficulty swallowing
• dizziness
• dry mouth
• fast heartbeat
• fast, shallow breathing
• frequent urination
• hostility
• increased thirst
• indigestion
• irritability
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lethargy
• light-colored stools
• muscle pain or cramps
• muscle tenderness, wasting, or weakness
• nausea
• pain in the stomach, side, or abdomen, possibly radiating to the back
• rapid weight gain
• seizures
• skin rash, hives, itching
• sleepiness
• swelling of the face, ankles, hands, feet, or lower legs
• vomiting
• yellow eyes or skin

Some side effects of emtricitabine / rilpivirine / tenofovir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abnormal dreams

• Acid or sour stomach
• back pain
• belching
• difficulty with moving
• heartburn
• pain in the joints
• pain or tenderness around the eyes and cheekbones
• stomach discomfort or upset

• Lack or loss of strength

US BOXED WARNINGS:
-LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS: Lactic acidosis and severe hepatomegaly with steatosis (including fatalities) reported with nucleoside analogs in combination with other antiretrovirals.
-POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B: This drug is not approved for treatment of chronic HBV infection; safety and efficacy not established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B reported in patients coinfected with HBV and HIV-1 after stopping products containing emtricitabine and/or tenofovir DF, and may occur when tenofovir alafenamide-containing products are stopped. Hepatic function of coinfected patients should be closely monitored with clinical and laboratory follow-up for at least several months after stopping this drug. If appropriate, initiation/resumption of antihepatitis B therapy may be necessary.

Safety and efficacy have not been established in patients younger than 12 years or weighing less than 35 kg; this drug is not recommended for use in these patients.

Consult WARNINGS section for additional precautions.

Emtricitabine/rilpivirine/tenofovir alafenamide: Data not available
Emtricitabine/rilpivirine/tenofovir DF: Not recommended.