Emtricitabine Rilpivirine Tenofovir alafenamide Brand Name– ODEFSEY
What is Emtricitabine Rilpivirine Tenofovir alafenamide
Emtricitabine Rilpivirine Tenofovir alafenamide (Odefsey) is indicated for treatment of human immunodeficiency virus (HIV-1) infection in antiretroviral-naive adult and pediatric patients who weigh at least 35 kg and have a baseline HIV RNA concentration 100,000 copies/mL or lower.
The drug is also approved for use as a replacement therapy in treatment-experienced adults who have been virologically-suppressed (i.e., HIV RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months, have no history of treatment failure, and who are without known substitutions associated with resistance to any of the individual components.
Similar to Complera, Odefsey is a fixed-dose combination tablet containing 3 medications (rilpivirine, a non-nucleoside reverse transcriptase inhibitor or NNRTI; emtricitabine, a nucleoside reverse transcriptase inhibitor or NRTI; tenofovir, an acyclic nucleotide reverse transcriptase inhibitor) in a single tablet that is administered once daily.
However, Odefsey contains a different tenofovir prodrug, tenofovir alafenamide, that provides lower concentrations in the bloodstream, but higher concentrations within the cells where HIV replicates; tenofovir alafenamide was developed to help reduce adverse events.
This combination product constitutes a complete HIV treatment regimen; thus, administration with other antiretroviral medications is not recommended.
Healthcare providers are advised of the potential for treatment-emergent resistance and treatment failure in patients with baseline HIV RNA concentrations greater than 100,000 copies/mL; thus, use must be avoided in these patients.
Indications
- human immunodeficiency virus (HIV)
- human immunodeficiency virus (HIV) infection
NOTE: HIV guidelines recommend consideration be given to avoiding use of rilpivirine-containing regimens in patients with pre-existing psychiatric illnesses or prolongation of the QTc interval.
NOTE: HIV guidelines recommend consideration be given to avoiding use of tenofovir alafenamide-containing regimens in patients coinfected with tuberculosis and receiving a rifamycin
Side Effects
- abdominal pain
- bone pain
- depression
- depression
- diabetes insipidus
- diarrhea
- dizziness
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- dysphoria
- Fanconi syndrome
- fatigue
- headache
- hepatic decompensation
- hepatic failure
- hepatitis B exacerbation
- hepatomegaly
- hypercholesterolemia
- hypertriglyceridemia
- hypophosphatemia
- insomnia
- interstitial nephritis
- lactic acidosis
- myalgia
- nausea
- nephrotic syndrome
- osteopenia
- osteoporosis
- polyuria
- rash
- rash
- renal failure (unspecified)
- steatosis
- suicidal ideation
- vomiting
- weakness
- weight gain
Monitoring Parameters
- blood glucose
- CBC with differential
- CD4+ T cell count
- hepatitis B serology
- LFTs
- plasma hepatitis C RNA
- plasma HIV RNA
- pregnancy testing
- serum bilirubin (total and direct)
- serum cholesterol
- serum creatinine
- serum lipid profile
- serum phosphate
- urinalysis
Contraindications
- alcoholism
- autoimmune disease
- Black patients
- breast-feeding
- children
- depression
- females
- Graves’ disease
- Guillain-Barre syndrome
- hepatic disease
- hepatitis
- hepatitis B and HIV coinfection
- hepatitis B exacerbation
- hepatitis C and HIV coinfection
- hepatomegaly
- hepatotoxicity or lactic acidosis
- Hispanic patients
- human immunodeficiency virus (HIV) infection resistance
- hypercholesterolemia
- hyperlipidemia
- hypertriglyceridemia
- hypophosphatemia
- immune reconstitution syndrome
- infants
- neonates
- obesity
- osteomalacia
- osteoporosis
- pregnancy
- QT prolongation
- renal disease
- renal failure
- renal impairment
- serious rash
- suicidal ideation
- torsade de pointes
Interactions
- Abacavir; Dolutegravir; Lamivudine
- Abacavir; Lamivudine, 3TC
- Abacavir; Lamivudine, 3TC; Zidovudine, ZDV
- Abarelix
- Acalabrutinib
- Acetaminophen; Aspirin, ASA; Caffeine
- Acetaminophen; Butalbital
- Acetaminophen; Butalbital; Caffeine
- Acetaminophen; Butalbital; Caffeine; Codeine
- Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine
- Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide
- Aclidinium; Formoterol
- Acyclovir
- Adefovir
- Albuterol
- Albuterol; Ipratropium
- Aldesleukin, IL-2
- Alfuzosin
- Alogliptin; Metformin
- Amikacin
- Aminoglycosides
- Aminosalicylate sodium, Aminosalicylic acid
- Amiodarone
- Amitriptyline
- Amitriptyline; Chlordiazepoxide
- Amlodipine; Celecoxib
- Amobarbital
- Amoxicillin; Clarithromycin; Lansoprazole
- Amoxicillin; Clarithromycin; Omeprazole
- Amphotericin B
- Amphotericin B cholesteryl sulfate complex (ABCD)
- Amphotericin B lipid complex (ABLC)
- Amphotericin B liposomal (LAmB)
- Anagrelide
- Antacids
- Apalutamide
- Apomorphine
- Aprepitant, Fosaprepitant
- Arformoterol
- Aripiprazole
- Armodafinil
- Arsenic Trioxide
- Artemether; Lumefantrine
- Asenapine
- Aspirin, ASA
- Aspirin, ASA; Butalbital; Caffeine
- Aspirin, ASA; Butalbital; Caffeine; Codeine
- Aspirin, ASA; Caffeine; Dihydrocodeine
- Aspirin, ASA; Caffeine; Orphenadrine
- Aspirin, ASA; Carisoprodol
- Aspirin, ASA; Carisoprodol; Codeine
- Aspirin, ASA; Citric Acid; Sodium Bicarbonate
- Aspirin, ASA; Dipyridamole
- Aspirin, ASA; Omeprazole
- Aspirin, ASA; Oxycodone
- Aspirin, ASA; Pravastatin
- Atazanavir
- Atazanavir; Cobicistat
- Atomoxetine
- Atropine; Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate
- Atropine; Hyoscyamine; Phenobarbital; Scopolamine
- Azithromycin
- Bacitracin
- Barium Sulfate
- Bedaquiline
- Belladonna Alkaloids; Ergotamine; Phenobarbital
- Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate
- Bepridil
- Bexarotene
- Bismuth Subcitrate Potassium; Metronidazole; Tetracycline
- Bismuth Subsalicylate
- Bismuth Subsalicylate; Metronidazole; Tetracycline
- Boceprevir
- Bosentan
- Brigatinib
- Budesonide; Formoterol
- Buprenorphine
- Buprenorphine; Naloxone
- Butabarbital
- Cabozantinib
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- Calcium Carbonate; Risedronate
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- Canagliflozin; Metformin
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- Carbamazepine
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- Carvedilol
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- Class IA Antiarrhythmics
- Clofazimine
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- Codeine; Phenylephrine; Promethazine
- Codeine; Promethazine
- Colchicine; Probenecid
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- Cyclosporine
- Dabrafenib
- Daclatasvir
- Danazol
- Dapagliflozin; Metformin
- Darolutamide
- Darunavir
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- Dasatinib
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- Deutetrabenazine
- Dexamethasone
- Dexlansoprazole
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- Diclofenac
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- Disopyramide
- Dofetilide
- Dolasetron
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- Donepezil
- Donepezil; Memantine
- Doravirine; Lamivudine; Tenofovir disoproxil fumarate
- Doxepin
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- Echinacea
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- Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
- Elagolix
- Elagolix; Estradiol; Norethindrone acetate
- Elexacaftor; tezacaftor; ivacaftor
- Eliglustat
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
- Empagliflozin; Linagliptin; Metformin
- Empagliflozin; Metformin
- Enalapril; Felodipine
- Encorafenib
- Enflurane
- Entrectinib
- Enzalutamide
- Eribulin
- Ertugliflozin; Metformin
- Erythromycin
- Erythromycin; Sulfisoxazole
- Escitalopram
- Eslicarbazepine
- Esomeprazole
- Esomeprazole; Naproxen
- Estradiol; Norgestimate
- Ethinyl Estradiol; Norgestimate
- Etodolac
- Etravirine
- Ezogabine
- Famotidine
- Famotidine; Ibuprofen
- Fedratinib
- Felodipine
- Fenoprofen
- Fingolimod
- Flecainide
- Flibanserin
- Fluconazole
- Fluoxetine
- Fluoxetine; Olanzapine
- Fluphenazine
- Flurbiprofen
- Flutamide
- Fluticasone; Salmeterol
- Fluticasone; Umeclidinium; Vilanterol
- Fluticasone; Vilanterol
- Fluvoxamine
- food
- Formoterol
- Formoterol; Mometasone
- Fosamprenavir
- Foscarnet
- Fosphenytoin
- Fostamatinib
- Fostemsavir
- Gadobutrol
- Gadoversetamide
- Ganciclovir
- Gemifloxacin
- Gemtuzumab Ozogamicin
- Gentamicin
- Gilteritinib
- Glasdegib
- Glecaprevir; Pibrentasvir
- Glipizide; Metformin
- Glyburide; Metformin
- Glycopyrrolate; Formoterol
- Goserelin
- Granisetron
- grapefruit juice
- Halofantrine
- Halogenated Anesthetics
- Haloperidol
- Halothane
- Histrelin
- Hydrocodone; Ibuprofen
- Hydroxychloroquine
- Hydroxyzine
- Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Biphosphate
- Ibuprofen
- Ibuprofen; Oxycodone
- Ibuprofen; Pseudoephedrine
- Ibutilide
- Idelalisib
- Iloperidone
- Imatinib
- Imipramine
- Indacaterol
- Indacaterol; Glycopyrrolate
- Indinavir
- Indomethacin
- Inotuzumab Ozogamicin
- Interferon Alfa-2a
- Interferon Alfa-2b
- Interferon Alfa-2b; Ribavirin
- Interferon Alfa-n3
- Interferon Alfacon-1
- Interferon Beta-1a
- Interferon Beta-1b
- Interferon Gamma-1b
- Interferons
- Isavuconazonium
- Isoflurane
- Isoniazid, INH; Pyrazinamide, PZA; Rifampin
- Isoniazid, INH; Rifampin
- Itraconazole
- Ivacaftor
- Ivosidenib
- Kanamycin
- Ketoconazole
- Ketoprofen
- Ketorolac
- Lamivudine, 3TC
- Lamivudine, 3TC; Zidovudine, ZDV
- Lamivudine; Tenofovir Disoproxil Fumarate
- Lansoprazole
- Lansoprazole; Naproxen
- Lapatinib
- Ledipasvir; Sofosbuvir
- Lefamulin
- Lenvatinib
- Lesinurad
- Lesinurad; Allopurinol
- Letermovir
- Leuprolide
- Leuprolide; Norethindrone
- Levalbuterol
- Levofloxacin
- Levomethadyl
- Linagliptin; Metformin
- Lithium
- Lofexidine
- Long-acting beta-agonists
- Loperamide
- Loperamide; Simethicone
- Lopinavir; Ritonavir
- Lorlatinib
- Lumacaftor; Ivacaftor
- Lumacaftor; Ivacaftor
- Macimorelin
- Magnesium Salicylate
- Maprotiline
- Meclofenamate Sodium
- Mefenamic Acid
- Mefloquine
- Meloxicam
- Meperidine; Promethazine
- Mephobarbital
- Mesoridazine
- Metaproterenol
- Metformin
- Metformin; Pioglitazone
- Metformin; Repaglinide
- Metformin; Rosiglitazone
- Metformin; Saxagliptin
- Metformin; Sitagliptin
- Methadone
- Methohexital
- Metronidazole
- Midostaurin
- Mifepristone
- Mirtazapine
- Mitotane
- Modafinil
- Moxifloxacin
- Nabumetone
- Nafcillin
- Naproxen
- Naproxen; Pseudoephedrine
- Naproxen; Sumatriptan
- Nefazodone
- Nelfinavir
- Nevirapine
- Nicardipine
- Nilotinib
- Nitisinone
- Nizatidine
- Non-Ionic Contrast Media
- Nonsteroidal antiinflammatory drugs
- Norfloxacin
- Nortriptyline
- Obeticholic Acid
- Octreotide
- Ofloxacin
- Olanzapine
- Olodaterol
- Omeprazole
- Omeprazole; Amoxicillin; Rifabutin
- Omeprazole; Sodium Bicarbonate
- Ondansetron
- Oritavancin
- Orlistat
- Osilodrostat
- Osimertinib
- Oxaliplatin
- Oxaprozin
- Oxcarbazepine
- Ozanimod
- Paliperidone
- Pamidronate
- Panobinostat
- Pantoprazole
- Paromomycin
- Pasireotide
- Pazopanib
- Peginterferon Alfa-2a
- Peginterferon Alfa-2b
- Peginterferon beta-1a
- Pentamidine
- Pentobarbital
- Perphenazine
- Perphenazine; Amitriptyline
- Phenobarbital
- Phentermine; Topiramate
- Phenylephrine; Promethazine
- Phenytoin
- Pimavanserin
- Pimozide
- Pirbuterol
- Pirfenidone
- Piroxicam
- Pitolisant
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- Polymyxin B
- Polymyxins
- Posaconazole
- Primaquine
- Primidone
- Probenecid
- Procainamide
- Prochlorperazine
- Promethazine
- Propafenone
- Proton pump inhibitors
- Protriptyline
- Quetiapine
- Quinidine
- Quinine
- Rabeprazole
- Ranitidine
- Ranolazine
- Regorafenib
- Ribavirin
- Ribociclib
- Ribociclib; Letrozole
- Rifabutin
- Rifampin
- Rifapentine
- Rifaximin
- Risperidone
- Rivaroxaban
- Rofecoxib
- Rolapitant
- Romidepsin
- Salicylates
- Salmeterol
- Salsalate
- Sapropterin
- Saquinavir
- Secobarbital
- Selpercatinib
- Sertraline
- Sevoflurane
- Short-acting beta-agonists
- Simeprevir
- Siponimod
- Sodium Bicarbonate
- Sofosbuvir; Velpatasvir
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- Solifenacin
- Sorafenib
- Sotalol
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- Tezacaftor; Ivacaftor
- Thiopental
- Thioridazine
- Ticagrelor
- Tiotropium; Olodaterol
- Tipranavir
- Tobramycin
- Tolmetin
- Tolterodine
- Tolvaptan
- Topiramate
- Toremifene
- Trandolapril; Verapamil
- Trazodone
- Triclabendazole
- Tricyclic antidepressants
- Trifluoperazine
- Trimipramine
- Triptorelin
- Trospium
- Tucatinib
- Umeclidinium; Vilanterol
- Valacyclovir
- Valdecoxib
- Valganciclovir
- Valproic Acid, Divalproex Sodium
- Vancomycin
- Vandetanib
- Vardenafil
- Vemurafenib
- Venlafaxine
- Verapamil
- Voriconazole
- Vorinostat
- Zafirlukast
- Ziprasidone
- Zoledronic Acid
- Zonisamide
