Pronunciation:

em-trye-SYE-ta-been, ril-pi-VIR-een, ten-OF-oh-vir al-a-FEN-a-mide

Brand Names:

• Odefsey

Dosage Forms:

• Tablet

Warnings:

Emtricitabine/rilpivirine/tenofovir alafenamide is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of emtricitabine/rilpivirine/tenofovir alafenamide have not been established in patients coinfected with human immunodeficiency virus-1 (HIV-1) and HBV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with emtricitabine/rilpivirine/tenofovir alafenamide. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several moths in patients who are coinfected with HIV-1 and HBV and discontinue emtricitabine/rilpivirine/tenofovir alafenamide. If appropriate, initiation of antihepatitis B therapy may be warranted .

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Nucleoside Reverse Transcriptase Inhibitor

Uses of This Medicine:

Emtricitabine, rilpivirine, and tenofovir alafenamide combination is used to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is usually given to patients who have not received any HIV treatment in the past or to replace their current antiviral medicines provided that they meet certain requirements.

This medicine 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.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of emtricitabine, rilpivirine, and tenofovir alafenamide combination in children younger than 12 years of age weighing less than 35 kilograms (kg). Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of emtricitabine, rilpivirine, and tenofovir alafenamide combination in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Carbamazepine
• Cisapride
• Dexamethasone
• Dexlansoprazole
• Esomeprazole
• Fosphenytoin
• Lansoprazole
• Omeprazole
• Oxcarbazepine
• Pantoprazole
• Phenobarbital
• Phenytoin
• Primidone
• Rabeprazole
• Rifampin
• Rifapentine
• Saquinavir
• St John's Wort
• Vonoprazan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Aceclofenac
• Acemetacin
• Acyclovir
• Adagrasib
• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Amikacin
• Amikacin Liposome
• Amiodarone
• Amtolmetin Guacil
• Anagrelide
• Apalutamide
• Aripiprazole
• Arsenic Trioxide
• Aspirin
• Bromfenac
• Bufexamac
• Buserelin
• Cabotegravir
• Calcium Carbonate
• Capmatinib
• Capreomycin
• Carvedilol
• Celecoxib
• Ceritinib
• Choline Salicylate
• Cidofovir
• Cimetidine
• Clarithromycin
• Clonazepam
• Clonixin
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclosporine
• Dabrafenib
• Darolutamide
• Dasabuvir
• Degarelix
• Delamanid
• Delavirdine
• Deslorelin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Dipyrone
• Domperidone
• Donepezil
• Dronedarone
• Drospirenone
• Droxicam
• Efavirenz
• Enasidenib
• Encorafenib
• Erythromycin
• Eslicarbazepine Acetate
• Ethinyl Estradiol
• Etodolac
• Etofenamate
• Etoricoxib
• Etravirine
• Famotidine
• Fedratinib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Fexinidazole
• Flibanserin
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ganciclovir
• Gentamicin
• Gonadorelin
• Goserelin
• Histrelin
• Horsetail
• Hydroxychloroquine
• Ibuprofen
• Indomethacin
• Itraconazole
• Kanamycin
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lapatinib
• Leflunomide
• Leniolisib
• Levofloxacin
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Mavacamten
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Midostaurin
• Momelotinib
• Morniflumate
• Moxifloxacin
• Nabumetone
• Nafarelin
• Naproxen
• Neomycin
• Nepafenac
• Netilmicin
• Nevirapine
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nizatidine
• Norethindrone
• Norgestimate
• Omaveloxolone
• Ombitasvir
• Ondansetron
• Orlistat
• Oxaprozin
• Oxcarbazepine
• Oxyphenbutazone
• Panobinostat
• Parecoxib
• Paritaprevir
• Paromomycin
• Pasireotide
• Pazopanib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Plazomicin
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Quinidine
• Ranitidine
• Ranolazine
• Rifabutin
• Rifapentine
• Ritonavir
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sevoflurane
• Sodium Bicarbonate
• Sodium Salicylate
• Spectinomycin
• Streptomycin
• Sulindac
• Tacrolimus
• Tafamidis
• Telaprevir
• Tenoxicam
• Teriflunomide
• Tiaprofenic Acid
• Tipranavir
• Tobramycin
• Tolfenamic Acid
• Tolmetin
• Triptorelin
• Valacyclovir
• Valdecoxib
• Valganciclovir
• Vandetanib
• Vemurafenib
• Verapamil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Boceprevir
• Eltrombopag

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression, history of or
• Fanconi syndrome (kidney disease), history of or
• Heart rhythm problems (eg, QT prolongation) or
• Hepatitis B or C infection, history of or
• Kidney failure, history of—Use with caution. May make these conditions worse.

• Kidney disease, end stage (who are not receiving hemodialysis) or
• Kidney disease, severe—Use is not recommended in patients with these conditions.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Keep using this medicine for the full time of treatment, even if you begin to feel better. Do not stop using it without checking first with your doctor. When your supply of the medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of the medicine.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take the tablet with food.

If you take antacids that contain aluminum, magnesium, or calcium, take the antacid at least 2 hours before or 4 hours after you take this medicine.

If you take a stomach medicine for heartburn or ulcers such as cimetidine, famotidine, or nizatidine, take the heartburn medicine at least 12 hours before or 4 hours after you take this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of HIV infection:
    • Adults and children 12 years of age and older, weighing 35 kilograms (kg) or more, and with a creatinine clearance greater than or equal to 30 mL per minute—One tablet once a day. Each tablet contains 200 milligrams (mg) emtricitabine, 25 mg rilpivirine, and 25 mg tenofovir alafenamide.
    • Children younger than 12 years of age and weighing less than 35 kg—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the medicine in the original bottle that you were given at the pharmacy and keep it tightly closed.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine does not decrease the risk of transmitting HIV infection to others through sexual contact or by contamination through blood. HIV may be acquired from or spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex or polyurethane and use them every time you have contact with semen, vaginal secretions, or blood. Also, do not share needles or equipment with anyone or use dirty needles. If you have any questions about this, check with your doctor.

This medicine should not be used together with dexamethasone (Decadron®), certain seizure medicines (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®, Trileptal®), medicines for tuberculosis (eg, rifampin, rifapentine, Priftin®, Rifadin®, Rimactane®), certain stomach medicines (eg, dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, Aciphex®, Dexilant®, Nexium®, Prevacid®, Prilosec®), or St. John's wort.

The medicines in this combination tablet are also available as Atripla®, Edurant®, Emtriva®, Stribild®, Truvada®, and Viread®. Do not take the emtricitabine, rilpivirine, and tenofovir alafenamide combination with any of these medicines.

This medicine may cause a rare, but serious, unwanted effect called lactic acidosis (too much acid in the blood). Call your doctor right away if you have abdominal or stomach discomfort, decreased appetite, diarrhea, fast, shallow breathing, general feeling of discomfort, muscle pain or cramping, nausea, sleepiness, or unusual tiredness or weakness.

This medicine may cause rare, but serious, liver problems. This is more common in patients with a history of hepatitis B or C infection or those who already have liver disease. Check with your doctor right away if you have clay-colored stools, dark urine, decreased appetite, fever, headache, itching, nausea and vomiting, skin rash, stomach pain or tenderness, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.

This medicine may cause serious types of allergic reactions, including skin reactions and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Check with your doctor right away if you have blistering, peeling, or loosening of the skin, large, hive-like swelling of the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, severe acne or skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

Contact your doctor right away if you have any changes to your 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.

Tell your doctor right away if you start to feel depressed or have thoughts about hurting yourself. Report any unusual thoughts or behavior that troubles you, especially if they are new or get worse quickly.

Your immune system may get stronger when you start using 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 such as Graves disease, polymyositis, and Guillain-Barré syndrome may also occur.

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 or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

More common

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

Less common

Body aches or pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain

chills

cough

difficulty with breathing

ear congestion

fever

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

Incidence not known

Agitation

bloating

bloody or cloudy urine

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 genitals

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

stomach discomfort

swelling of the face, ankles, hands, feet, or lower legs

unusual drowsiness, dullness, or feeling of sluggishness

vomiting

yellow eyes or skin

Some side effects 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:

More common

Abnormal dreams

Less common

Back pain

belching

difficulty with moving

heartburn

pain in the joints

pain or tenderness around the eyes and cheekbones

stomach discomfort or upset

Incidence not known

Lack or loss of strength

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.