Emtricitabine, rilpivirine, and tenofovir alafenamide (Oral)

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 if 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 will also help your immune system. This may help delay some of the medical conditions that usually occur from AIDS or HIV disease. It will not prevent you from spreading HIV to other people.

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

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

This medicine does not reduce the risk of passing HIV infection to others through sexual contact or through blood. HIV can be acquired from or passed to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity that involves exchanging body fluids with other people. If you do have sex, always use a condom (“rubber”), or have your partner use one. 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, consult your doctor.

This medicine should not be taken with dexamethasone (Decadron®), certain seizure medications (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®, Trileptal®), medications for tuberculosis (such as rifampin, rifapentine, Priftin®, Rifadin®, Rimactane®), certain stomach medications (such as 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 lead to a rare but serious unwanted effect called lactic acidosis (excess acid in the blood). Contact your doctor immediately if you experience abdominal or stomach discomfort, decreased appetite, diarrhea, rapid, shallow breathing, a 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 likely to happen in patients with a history of hepatitis B or C infection or those who already have liver disease. Contact your doctor immediately if you notice 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 yellowing of the eyes or skin.

This medicine may cause serious allergic reactions, including skin reactions and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Contact your doctor immediately if you experience 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 while using this medicine.

Contact your doctor right away if you notice any changes in 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 like 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 concerns you, especially if they are new or get worse quickly.

Your immune system may become 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 begin to fight infections that were previously hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders like Graves disease, polymyositis, and Guillain-Barré syndrome may also occur.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it may provide. For this medicine, here are some important points to think about:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been enough studies to determine how emtricitabine, rilpivirine, and tenofovir alafenamide combination affects children younger than 12 years old and weighing less than 35 kilograms (kg). Safety and effectiveness have not been established for this group.

Geriatric

Studies so far have not found any specific problems in elderly patients that would limit the usefulness of emtricitabine, rilpivirine, and tenofovir alafenamide combination in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together despite potential interactions. In these situations, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant and are not necessarily a complete list.

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 necessary 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 increase the risk of certain side effects, but using both may be the best option for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Boceprevir
• Eltrombopag

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food due to possible interactions. Alcohol or tobacco may also cause interactions with certain medicines. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to inform your doctor about any other medical problems, especially:

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

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

Along with its intended effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical help.

Contact your doctor right away if any of the following side effects occur:

More common

• Feeling discouraged
• Feeling sad or empty
• Feeling irritable
• Not wanting to eat
• Losing interest or pleasure
• Mental depression
• Having thoughts of self-harm
• Feeling tired
• Having trouble concentrating
• Having trouble sleeping

Less common

• Body aches or pain
• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling sensations
• Chest pain
• Chills
• Cough
• Difficulty breathing
• Ear congestion
• Fever
• Headache
• Losing your voice
• Runny or stuffy nose
• Sneezing
• Sore throat
• Tightness in the chest
• Feeling unsteady or awkward
• Unusual tiredness or weakness
• Weakness in 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 sluggishness
• Vomiting
• Yellowing of the eyes or skin

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adapts to the medicine. Your health care professional may also have suggestions to prevent or reduce some of these side effects. Contact your health care professional if any of the following side effects persist, become bothersome, or if you have any questions about them:

More common

• Having abnormal dreams

Less common

• Back pain
• Belching
• Difficulty moving
• Heartburn
• Joint pain
• 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, consult your health care professional.

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

In the U.S.

• Odefsey

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

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.

• What is the difference between HIV treatments Odefsey and Complera?