Emtricitabine, Rilpivirine, and Tenofovir Alafenamide Combination (Oral)

The emtricitabine, rilpivirine, and tenofovir alafenamide combination is prescribed to patients with HIV to stabilize the immune system and lower the HIV level within the bloodstream.

Overview

The emtricitabine, rilpivirine, and tenofovir alafenamide combination is prescribed to treat HIV (human immunodeficiency virus). HIV causes AIDS (acquired immune deficiency syndrome). This prescription is a medication that is typically given to patients who have never received treatment for HIV previously.

This prescription will not completely treat or cure AIDS or the HIV infection. It will, however, reduce the level of HIV that is present within the bloodstream; and it will aid in stabilizing the immune system for patients. These benefits can assist in the delay of certain medical issues that could arise from the HIV or AIDS diseases. This medication will not inhibit the spreading of HIV to others.

The emtricitabine, rilpivirine, and tenofovir alafenamide combination can only be obtained with a valid prescription from your doctor. It is currently manufactured in tablet form under the US brand name Odefsey.

Condition treated

  • Human immunodeficiency virus (HIV)

Side Effects

Medications can occasionally trigger undesirable side effects in addition to the needed effects of the drug. While not every side effect may take place, they could warrant the need for medical care if they do occur. Consult with your physician right away if you experience any of the subsequent side effects.

More Common Side Effects (Medical Care Required)

  • Weariness or tiredness
  • Suicidal thoughts
  • Sleeping difficulty
  • Pleasure or interest lost
  • Irritability
  • Feelings of discontent or emptiness
  • Discouragement
  • Difficulty concentrating
  • Depression (mental)
  • Appetite loss

Less Common Side Effects (Medical Care Required)

  • Weakness or tiredness (unusual)
  • Weakness of the feet, legs, hands, or arms
  • Voice loss
  • Stuffy or runny nose
  • Sore throat
  • Sneezing
  • Itching, burning, numbness, crawling, prickling, or tingling sensations
  • Headache
  • Cough
  • Congestion of the ears
  • Chills or fevers
  • Chest tightness
  • Chest pain
  • Breathing difficulties
  • Body pains or aches
  • Awkwardness or unsteadiness

Side Effects Occurrence Rate Unknown (Medical Care Required)

  • Weight gain (sudden or quick)
  • Vomiting
  • Urine darkened in color
  • Urination decrease
  • Urination (increasingly frequent)
  • Thirst increase
  • Swelling of lower legs, feet, ankles, or face
  • Swallowing difficulty
  • Stools light in color
  • Stomach or abdominal discomfort
  • Sleepiness
  • Skin or eye yellowing
  • Shallow, fast breathing
  • Seizures
  • Nausea
  • Muscle weakness, wasting, or tenderness
  • Muscle cramps or pains
  • Mouth dryness
  • Lethargy
  • Itching, hives, or skin rash
  • Irritability
  • Indigestion
  • Hostility
  • Hive-like swollen parts of the sex organs, feet, legs, hands, throat, lips, eyelids, or face
  • Heartbeat quickened
  • Dizziness
  • Diarrhea
  • Constipation
  • Confusion
  • Cloudy or bloody urine
  • Bone pain
  • Bloating
  • Appetite decrease
  • Agitation
  • Abdominal, side, or stomach pain (could be moving to the area near the back)

Sometimes, side effects can take place that may be less invasive and will likely not require medical care. In addition, your doctor can inform you of additional ways to reduce or even prevent certain unwanted side effects. Consult with your medical care professional if you experience any of the subsequent side effects and if they become prolonged, cause issues, or simply if you have questions regarding any of them.

More Common Side Effects (Medical Care Not Required)

  • Abnormal dreams

Less Common Side Effects (Medical Care Not Required)

  • Stomach upset or discomfort
  • Sour or acid stomach
  • Moving difficulty
  • Joint pain
  • Heartburn
  • Cheekbone or eye tenderness or pain
  • Belching
  • Back pain

Side Effects Occurrence Rate Unknown (Medical Care Not Required)

  • Strength loss (or lack of)

Certain patients may experience other side effects that have not been listed here. If patients experience other effects they should consult with their medical care professional. Always check with your physician regarding medical advice that is related to side effects. The FDA also accepts side effect reports, and they can be reached at 1-800-FDA-1088.

Dosage

When considering whether or not one should take a medicine, they should carefully compare the dangers of taking the drug with the benefits it may provide. Patients should make this decision with their doctor.

Always take this medication precisely as recommended by your physician. Never take an amount that is greater than what was prescribed. Never use this medication for a longer duration than ordered by your physician.

Take this medication for the entire course of treatment, even if the symptoms begin to subside. Consult with your physician prior to ending the treatment with this medication. Fulfill your prescriptions ahead of time, and be sure to monitor your medication supply to watch for when it is running low. Patients should not run out of this medication.

An informational booklet is included with this medication. Always follow all directions on the booklet. Consult with your physician if you have questions regarding the emtricitabine, rilpivirine, and tenofovir alafenamide combination.

This medication should always be taken with food.

Patients who take antacids containing calcium, magnesium, or aluminum should take the antacid before this medication (2 hours prior). Alternatively, patients can wait four hours after taking this drug.

Patients who have to take a stomach medication for ulcers or heartburn such as nizatidine, cimetidine, famotidine, or ranitidine should take the heartburn medication a full 12 hours prior to or 4 hours after this medication is taken.

Different patients will receive different doses of the emtricitabine, rilpivirine, and tenofovir alafenamide combination. Patients must always follow the instructions on the medication container or their physician's instructions.

The information included here will cover only average doses of the emtricitabine, rilpivirine, and tenofovir alafenamide combination. Patients who were prescribed different doses should not adjust their dose unless otherwise instructed by their doctor.

Patients will be prescribed an amount of medication that depends on the medication's strength. Other influences that impact the prescription amount are the total number of doses taken per day, the time allotted in between doses, and the total duration of time for which the medication is taken.

Oral Dose (Tablet) Instructions

  • Adults and children over 12 who weigh 77 lbs (35 kg) or more should take one tablet once per day.
  • Children under 12 should not take this medication without first consulting a physician.

Missed Dose

If a dose of this medication is missed, the patient should take it as soon as they remember it. Alternatively, if it is closer to the scheduled next dose, the patient should allow the skipped dose to remain missed and they should resume the regular dosing agenda. Never double doses of the emtricitabine, rilpivirine, and tenofovir alafenamide combination.

Interactions

Drug Interactions

Sometimes, it is best not to combine certain medications; under other circumstances, it is perfectly acceptable to combine medications, even if there is the likelihood that an interaction could take place. Under these circumstances, your physician may decide to change your dose, or they may take other types of precautions.

Ensure that your medical professional is aware if you are already prescribed any of the following medications.

The subsequent list of medications could have a significant interaction, however, this list is not completely all-inclusive.

It is not typically suggested to combine the emtricitabine, rilpivirine, and tenofovir alafenamide combination with any of the subsequent medications. Your physician may choose to treat you with an alternate medication, or may adjust the dosage for other drugs that you may also need to take.

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

It is typically not recommended to combine the emtricitabine, rilpivirine, and tenofovir alafenamide combination with any of the subsequent medications, however, certain circumstances may require it. If it is necessary to have both medications prescribed, consult with your physician to see if they need to adjust the dose of frequency of dosing for either or both medications.

  • Vandetanib
  • Triptorelin
  • Tipranavir
  • Tacrolimus
  • St John's Wort
  • Sevoflurane
  • Rifapentine
  • Rifampin
  • Rifabutin
  • Ranitidine
  • Phenytoin
  • Phenobarbital
  • Pazopanib
  • Pasireotide
  • Paritaprevir
  • Panobinostat
  • Oxcarbazepine
  • Orlistat
  • Ondansetron
  • Ombitasvir
  • Nizatidine
  • Nevirapine
  • Nafarelin
  • Moxifloxacin
  • Metronidazole
  • Magnesium Trisilicate
  • Magnesium Oxide
  • Magnesium Hydroxide
  • Magnesium Carbonate
  • Magaldrate
  • Levofloxacin
  • Leuprolide
  • Idelalisib
  • Hydroxychloroquine
  • Histrelin
  • Goserelin
  • Gonadorelin
  • Fluoxetine
  • Famotidine
  • Etravirine
  • Escitalopram
  • Efavirenz
  • Donepezil
  • Domperidone
  • Dihydroxyaluminum Sodium Carbonate
  • Dihydroxyaluminum Aminoacetate
  • Deslorelin
  • Delavirdine
  • Delamanid
  • Degarelix
  • Dasabuvir
  • Dabrafenib
  • Crizotinib
  • Cimetidine
  • Ceritinib
  • Carbamazepine
  • Calcium Carbonate
  • Buserelin
  • Arsenic Trioxide
  • Aripiprazole
  • Anagrelide
  • Aluminum Phosphate
  • Aluminum Hydroxide
  • Aluminum Carbonate (Basic)

The emtricitabine, rilpivirine, and tenofovir alafenamide combination in addition to the subsequent medication could trigger some side effects to be increased. However, the combination of the two medications could turn out to be the most optimal form of treatment in your unique circumstances. If both medications are prescribed, your physician may adjust the frequency or dosage amount for both or just one of the medications.

  • Boceprevir

Other Interactions

Some drugs should not be taken around times of eating or drinking as interactions can even take place with various kinds of food. The use of tobacco or alcohol in combination with some drugs could also trigger interactions. It is important to always converse with your doctor regarding how this medication may interact with tobacco, alcohol, or food.

Interactions with Additional Medical Issues

Patients with additional medical issues could encounter issues that may impact the effectiveness of this drug. Be sure to inform your physician if you currently have, or ever have had any of the subsequent medical issues:

  • Bone fracture (history of)
  • Depression (history of)
  • Kidney disease (Fanconi syndrome, history of)
  • Heart rhythmic issues (QT prolongation)
  • Hepatitis (B or C) infection (history of)
  • Kidney failure (history of)
  • Bone softness (osteomalacia, history of)
  • Bone weakness or brittle tendencies (osteoporosis, history of) take caution; conditions could be made worse

Warnings

It is imperative that your progress is monitored regularly by your physician to ensure that the medication is working as it should. Urine or blood tests may be required in order to monitor for undesirable effects.

Patients must understand that this medication does not reduce the likelihood of spreading HIV to others through blood contamination or sexual exchanges. HIV can be transferred to others or can be contracted by coming into contact with infected fluids of the body, including semen, vaginal fluid, or blood. Individuals who have gotten the infection should stay away from types of sexual activity that includes exchanging bodily fluids with another individual. Patients with the HIV virus who decide to have sex should ensure to wear a condom every time they have sex, or they should be sure that their partner wears a condom. Polyurethane or latex condoms are the best types of materials when looking for one that is reliable. A condom should be used each time a patient of HIV comes into contact with semen, blood, or vaginal secretion. Consult your physician with any questions you may have regarding these instructions.

Patients with HIV should never use needles that are dirty, and should never share equipment or needles with others. Consult with your doctor if you have any further questions regarding needles and potential infections that could be contracted.

The emtricitabine, rilpivirine, and tenofovir alafenamide combination should never be combined with some seizure medications (such as phenobarbital, carbamazepine, phenytoin, oxcarbazepine), dexamethasone, medications for tuberculosis (such as rifapentine, rifampin, rimactane, rifadin), St. John's wort, some stomach medicines (such as lansoprazole, esomeprazole, dexlansoprazole, rabeprazole, omeprazole, pantoprazole, Prevacid®, Nexium®, Aciphex®, Prilosec®, or Dexilant®). The medications in this tablet can also be obtained in the form of Viread®, Truvada®, Stribild®, Emtriva®, Edurant®, and Atripla®. Because of this, the emtricitabine, rilpivirine, and tenofovir alafenamide combination should not be taken with any of the previous medication.

Lactic acidosis (an excess of acid within the blood) is a serious, undesirable, and rare condition that can be caused by this medication. Consult with your physician immediately if you experience stomach discomfort, abdominal discomfort, decreased appetite, general sensations of discomfort, nausea, diarrhea, muscle cramping or pain, unusual sleepiness or weakness, sleepiness, breath shortness, or shallow or fast breathing.

This medication can occasionally trigger severe (but rare) liver issues. Patients who currently have liver disease or those who have a medical past that includes hepatitis B or C have a higher chance of this taking place. Consult with your physician immediately if you experience urine that is darker than normal, an appetite decrease, stools that are similar in color to clay, fever, itching, headache, vomiting or nausea, stomach tenderness or pain, skin rash, atypical weakness or tiredness, swelling of the lower legs or feet, or yellowing of the skin or eyes.

Allergic reactions can occur due to the use of this medication. These can include drug reactions (DRESS syndrome) with eosinophilia and systemic symptoms and skin reactions. Consult with your physician immediately if you experience peeling, blistering, loose skin, swelling, chills, fever, skin sores, acne, or skin rash on the sex organs, feet, legs, hands, throat, tongue, lips, eyelids, or face.

Patients who experience shifts in their heart rhythm should inform their physician right away. Dizziness or faintness could occur, or patients could experience an uneven, pounding, or fast heartbeat. Ensure your physician is aware if you or any individuals within your family have ever experienced a heart rhythm issue, including QT prolongation.

Inform your physician immediately if you begin to experience feelings of depression or if you begin to have ideas that include hurting yourself. Always let your doctor know if any unusual behaviors or troubling thoughts arise, specifically if they become worse or are new.

The production of additional body fat can take place when taking this medication. If you see your body changing shape, such as noticing more fat accumulating in the neck, chest, stomach, or upper back area. Fat can also be lost while on this medication, specifically from the face, arms, or legs.

Patients may notice that their immune system can become stronger after taking HIV medications. If you notice shifts in your health, be sure to inform your doctor as soon as possible. The immune system may begin to combat infections previously hidden within the body, such as herpes, tuberculosis, or pneumonia. Other disorders that attach the autoimmune system can occur, including polymyositis, Graves disease, and Guillain-Barré syndrome.

The emtricitabine, rilpivirine, and tenofovir alafenamide combination can cause bones to become brittle and weak. These possibilities may increase the likelihood that fractures or broken bones could occur. Consult with your physician if you have questions or concerns.

Additional prescription medications should not be taken unless previously approved by your doctor. This refers to nonprescription and prescription drugs, as well as vitamin supplements or herbal remedies.

Allergies

Your doctor must be aware of any allergic reactions or unusual allergies you may have to this medication or other medications. In addition, be sure to inform your medical care professional of other kinds of allergies you may have, including to dyes, animals, preservatives, or foods. Patients should always read the container label summarizing the ingredients within the package prior to ingesting any kind of medication.

Specific Demographic Use

Pediatric

Relevant research has not examined how age affects the emtricitabine, rilpivirine, and tenofovir alafenamide combination. Children under age 12 should not take this medication and should instead seek the advice of a medical professional.

Geriatric

Current research has not effectively examined the effects that the emtricitabine, rilpivirine, and tenofovir alafenamide combination could have on the geriatric population. A doctor can answer any questions or concerns patients may have in regards to this medication and the elderly.

Pregnancy

Breastfeeding

Research in regards the emtricitabine, rilpivirine, and tenofovir alafenamide combination and breastfeeding women has not yet been conducted. It is not currently known whether or not there is a valid risk to the infant when women take this medication while breastfeeding. In addition to consulting a physician, women should compare the pros of the medication against the cons and should use their best judgment.

Storage

This medication must be kept far from children's reach. Never keep prescription drugs past the expiration date. Medication that is not needed any longer should not be kept. The medication should be kept in a sealed temperature far from freezing or hot temperatures. Keep away from direct light and moisture.

Summary

The emtricitabine, rilpivirine, and tenofovir alafenamide combination treats HIV by soothing the immune system and reducing the HIV level in the bloodstream. This medication treats, but will not cure the HIV infection. Patient progress must be regularly monitored by a medical care professional while taking this medication in order to ensure safety and efficacy.